WO2018135534A1 - Guide wire - Google Patents

Guide wire Download PDF

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Publication number
WO2018135534A1
WO2018135534A1 PCT/JP2018/001235 JP2018001235W WO2018135534A1 WO 2018135534 A1 WO2018135534 A1 WO 2018135534A1 JP 2018001235 W JP2018001235 W JP 2018001235W WO 2018135534 A1 WO2018135534 A1 WO 2018135534A1
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WO
WIPO (PCT)
Prior art keywords
region
coil member
linear body
guide wire
distal end
Prior art date
Application number
PCT/JP2018/001235
Other languages
French (fr)
Japanese (ja)
Inventor
明彦 垂永
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
Publication of WO2018135534A1 publication Critical patent/WO2018135534A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09058Basic structures of guide wires
    • A61M2025/09083Basic structures of guide wires having a coil around a core
    • A61M2025/09091Basic structures of guide wires having a coil around a core where a sheath surrounds the coil at the distal part
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09133Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/0915Guide wires having features for changing the stiffness
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09175Guide wires having specific characteristics at the distal tip

Definitions

  • the present invention relates to a guide wire.
  • a guide wire is widely known as a medical instrument for guiding a medical device (balloon catheter or the like) used for treatment of a stenosis or the like formed in a body lumen such as a blood vessel in a living body.
  • a guide wire is provided with a core wire as a core material and a coil member disposed on the tip side of the core wire.
  • a guide wire is required to have various performances for its use.
  • One of the performances required for the guide wire is penetrability (passability) with respect to the narrowed portion.
  • Patent Document 1 proposes a guide wire including a coil member formed in a tapered shape whose outer shape becomes smaller from the proximal end side toward the distal end side.
  • the guide wire is formed with a tapered shape whose outer shape is reduced toward the distal end side, so that the pushing force that acts on the constricted portion from the distal end side of the guide wire is increased.
  • the guide wire described in Patent Document 1 is configured so that the outer diameter of a linear body (coil wire) forming the coil member is changed from the distal end side to the proximal end side of the coil member in order to give the coil member the tapered shape. It is gradually getting bigger toward.
  • the inner diameter of the coil member (the diameter of the lumen formed inside the coil member) changes so as to gradually increase from the distal end side to the proximal end side in accordance with the change in the outer diameter of the linear body. .
  • the inner diameter of the coil member is relatively small on the distal end side of the tapered shape, and the inner diameter of the coil member is relatively large on the proximal end side of the tapered shape.
  • the penetrability of the guide wire with respect to the narrowed portion can be improved satisfactorily.
  • the guide wire extends from the distal end side to the proximal end side of the coil member when passing through the stenosis portion. Through resistance.
  • the pushing force applied to the stenosis from the distal end side of the guide wire is improved and the penetration resistance when penetrating the stenosis is reduced. Is also required.
  • An object of the present invention is to provide a guide wire that can reduce penetration resistance when penetrating a lesioned part such as a stenosis part and is flexible.
  • a guide wire includes a core wire and a coil member fixed to at least a distal end portion of the core wire, and the coil member is arranged in a first direction from the distal end toward the proximal end along the axial direction of the core wire.
  • the first region includes a first region, a second region, and a third region, and the first region increases from the distal end toward the proximal end by increasing the outer diameter of the linear body that forms the coil member.
  • a first inclined portion whose outer shape increases toward the base, and the second region decreases from the distal end to the proximal end by reducing the outer diameter of the linear body forming the coil member from the distal end toward the proximal end.
  • a second inclined portion whose outer shape becomes smaller toward the outer surface, and a boundary portion between the first region and the second region forms a maximum outer shape portion where the outer shape of the coil member is largest, and in the first region, Formed by the coil member Diameter is substantially the same inner diameter as said coil member is formed in the second region.
  • the guide wire of the present invention can increase the pushing force against the constriction by the first region of the coil member.
  • the second region of the coil member reduces the penetration resistance that the guide wire receives from the constriction when it is pushed into the constriction after the first region of the coil member. Therefore, the guide wire of the present invention has further improved penetrability with respect to the narrowed portion.
  • the guide wire of the present invention controls (shapes) the outer shape of the coil member while maintaining the inner diameter formed by the coil member by adjusting the outer diameter of the linear body forming the coil member. , Ensure flexibility.
  • the inner diameter formed by the coil member is maintained substantially the same in the first region, the second region, and the maximum outer shape formed at the boundary between the first region and the second region.
  • the maximum outer shape portion is formed, the outer shape of the maximum outer shape portion of the coil member does not become excessively large.
  • the guide wire can suppress stress concentration on the maximum outer shape portion when the coil member penetrates the narrowed portion.
  • the guide wire of the present invention has a further improved pushability to the constricted portion, and can further prevent the linear member of the coil member forming the maximum outer shape portion from running on the proximal end side.
  • FIG. 1 is a partial vertical cross-sectional view (a cross-sectional view taken along the axial direction of the guide wire 10) showing the guide wire 10 according to the embodiment
  • FIG. 2 is an enlarged view of the distal end portion of the guide wire 10 in FIG.
  • FIG. 3 is an enlarged view for explaining the inner diameter of the coil member 200 of the guide wire 10
  • FIG. 4 is a view for explaining the outer diameter of the linear body 205 forming the coil member 200.
  • FIG. 5 and FIG. 6 are diagrams for explaining the operation of the guide wire.
  • the guide wire 10 has a long core wire 100 having flexibility, and a coil member 200 fixed to at least a tip 101 of the core wire 100.
  • the longitudinal direction of the core wire 100 (the left-right direction in FIG. 1) is defined as the axial direction and is indicated by a one-dot chain line A1.
  • the side of the guide wire 10 that is introduced into the living body (into the blood vessel) is defined as the distal end side (left side in FIG. 1), and the end side opposite to the distal end side is defined as the proximal end side (right side in FIG. 1).
  • the distal end portion means a portion including a certain range in the axial direction from the distal end (the most distal end), and the proximal end portion means a certain range in the axial direction from the proximal end (most proximal end).
  • the structural description of the guide wire 10 (explanation regarding the shape, dimensions, etc.) will be described by taking an example in which an external force is not applied to the guide wire 10. That is, it is assumed that the structural features of the guide wire 10 described in the present embodiment are provided in the guide wire 10 in a state where at least an external force is not applied to the guide wire 10.
  • the coil member 200 is formed by a linear body 205 wound spirally along the circumferential direction of the core wire 100 around the axis of the core wire 100.
  • the coil member 200 is disposed so as to cover the distal end side of the core wire 100 (the distal end side of the first core portion 110 described later) within a certain range along the axial direction.
  • the coil member 200 is formed of a closely wound coil in which the linear body 205 is wound without a gap.
  • the coil member 200 may be formed by a loosely wound coil in which a gap is formed between adjacent portions in the linear body 205, for example.
  • the coil member 200 may be formed of, for example, a coil that includes both a densely wound portion and a loosely wound portion at arbitrary locations.
  • size (length along an axial direction) of a clearance gap can be set to arbitrary magnitude
  • the coil member 200 includes a first linear body 206 disposed on the distal end side in the axial direction, and a second line disposed on the proximal end side in the axial direction from the first linear body 206. And a body 207.
  • first covering layer 310 and a second covering layer 320 described later is omitted.
  • the coil member 200 has a first region 210, a second region 220, and a third region 230 from the distal end toward the proximal end along the axial direction of the core wire 100.
  • the first region 210 of the coil member 200 and the second region 220 of the coil member 200 are formed by the first linear body 206.
  • the first linear body 206 is formed of one continuous member.
  • one continuous member means that the linear body is formed as one member at the stage where it is prepared as a member for forming the coil member 200.
  • a linear body formed by joining a plurality of members made of different materials in advance before forming the coil member 200 is included in “one continuous member”, but the first linear body 206 What is fixed (connected) at the stage of forming the coil member 200, such as the second linear body 207, is not included in “one continuous member”.
  • the third region 230 of the coil member 200 includes a second linear body 207 that is different from the first linear body 206.
  • the first linear body 206 and the second linear body 207 are fixed via an intermediate fixing portion 170 described later.
  • the first region 210 of the coil member 200 increases from the distal end by increasing the outer diameter of the first linear body 206 forming the coil member 200 from the distal end toward the proximal end.
  • a first inclined portion whose outer shape increases toward the proximal end is formed.
  • the first region 210 of the coil member 200 forms a tapered portion in which the outer shape of the coil member 200 gradually decreases toward the distal end side.
  • the outer diameter of the first linear body 206 forming the coil member 200 decreases from the distal end toward the proximal end, thereby reducing the outer shape from the distal end toward the proximal end.
  • Two inclined portions are formed.
  • the second region 220 of the coil member 200 forms a tapered portion in which the outer shape of the coil member 200 gradually decreases toward the proximal end side.
  • the boundary portion between the first region 210 of the coil member 200 and the second region 220 of the coil member 200 forms a maximum outer shape portion 240 where the outer shape of the coil member 200 is the largest. That is, the outer shape of the coil member 200 is largest at the boundary between the proximal end of the first region 210 and the distal end of the second region 220.
  • region 230 of the coil member 200 forms the linear part extended in the substantially constant external shape from the front-end
  • the outer shape of the coil member 200 is represented by a tangent line (outer shape line) 200A connecting the outer surfaces of the linear bodies 205 forming the coil member 200 (see FIGS. 2 and 3). .
  • the outer shape of the coil member 200 is the outer shape of the coil member 200 in a state where the first coating layer 310 and the second coating layer 320 described later are not disposed, that is, the outer shape of the coil member 200 in the state shown in FIG. means.
  • the inner surface of the coil member 200 is represented by a tangent line 200B connecting the inner surfaces of the linear bodies 205 forming the coil member 200.
  • the first linear body 206 that forms the first region 210 of the coil member 200 and the second region 220 of the coil member 200 has higher contrast than the second linear body 207 that forms the third region 230 of the coil member 200. have. For this reason, the first region 210 and the second region 220 have higher contrast than the third region 230.
  • the first linear body 206 can be formed of, for example, a material having radiopacity.
  • a material having radiopacity for example, platinum, gold, silver, titanium, tungsten, cobalt, or an alloy containing these can be used.
  • the second linear body 207 can be formed of a material that is less radiopaque than the first linear body 206.
  • a material for example, stainless steel, a superelastic alloy, or the like can be used.
  • the material forming the linear bodies 206 and 207 may be subjected to processing such as quenching.
  • the core wire 100 includes a first core part 110 disposed on the distal end side in the axial direction and a first core part 110 disposed on the proximal end side of the first core part 110 and connected to the first core part 110. 2 core portions 120.
  • the first core portion 110 of the core wire 100 includes a first tapered portion 111 formed in a tapered shape whose outer shape decreases toward the distal end, and a proximal end side of the first tapered portion 111.
  • a second tapered portion 112 formed in a tapered shape whose outer shape decreases toward the base end, and a constant outer shape portion 113 formed on the base end side of the second tapered portion 112 and extending in a substantially constant outer shape. ,have.
  • the maximum outer shape where the outer shape is the largest in the first core portion 110 At the boundary between the first taper portion 111 of the first core portion 110 of the core wire 100 and the second taper portion 112 of the first core portion 110 of the core wire 100, the maximum outer shape where the outer shape is the largest in the first core portion 110. A portion 140 is formed.
  • At least a part of the first tapered portion 111 of the first core portion 110 is disposed so as to overlap with the first region 210 of the coil member 200 in the circumferential direction of the core wire 100. Further, at least a part of the second tapered portion 112 of the first core portion 110 is disposed so as to overlap the second region 220 of the coil member 200 in the circumferential direction of the core wire 100. Further, the maximum outer shape portion 140 of the first core portion 110 is disposed so as to overlap the maximum outer shape portion 240 of the coil member 200 in the circumferential direction of the core wire 100.
  • a constituent material of the first core portion 110 of the core wire 100 for example, a Ni—Ti alloy, stainless steel, or a superelastic alloy can be used.
  • the second core portion 120 of the core wire 100 has a distal end portion 121 formed in a tapered shape whose outer shape becomes smaller toward the distal end side, and a large diameter formed on the proximal end side of the distal end portion 121. Part 122.
  • the second core portion 120 of the core wire 100 for example, stainless steel or a cobalt-based alloy can be used.
  • the first core part 110 and the second core part 120 may be formed of the same or the same kind of metal material (for example, the same main metal material in the alloy).
  • the first core part 110 and the second core part 120 can be connected by a method such as welding.
  • the core wire 100 can be configured by a single continuous member, or can be configured by connecting three or more members.
  • the linear body 205 forming the coil member 200 and the first core portion 110 of the core wire 100 are fixed to the distal end side fixing portion 160 and the proximal end side relative to the distal end side fixing portion 160. It is fixed via three fixing portions of a base end side fixing portion 180 disposed on the base end side with respect to the portion 170 and the intermediate fixing portion 170.
  • the distal-end-side fixing portion 160 includes the distal end portion of the core wire 100 (the distal end portion of the first core portion 110) 101 and the portion disposed at the most distal end of the first linear body 206 forming the coil member 200 (of the coil member 200).
  • the portion 206a that forms the tip of the first region 210 is fixed.
  • the front end side fixing portion 160 is formed in a taper shape that is curved in a convex shape toward the front end and has a smaller outer shape.
  • the length in the axial direction of the distal end side fixing portion 160, the curvature curved toward the distal end side, and the like are not particularly limited, and can be changed as appropriate.
  • the intermediate fixing part 170 fixes three members of the first linear body 206, the second linear body 207, and the first core part 110.
  • the intermediate fixing portion 170 is the portion that is disposed at the most proximal end in the first linear body 206 that forms the coil member 200 (the portion that forms the proximal end portion of the second region 220 of the coil member 200).
  • 206b and the base end part of the 2nd taper part 112 of the 1st core part 110 of the core wire 100 are being fixed.
  • the intermediate fixing portion 170 includes a portion (a portion that forms the proximal end portion of the second region 220 of the coil member 200) 206b disposed most proximally in the first linear body 206, and a second linear body.
  • a portion 207a disposed at the most distal end (portion forming the distal end portion of the third region 230 of the coil member 200) 207a is fixed.
  • the proximal end side fixing portion 180 is a portion (the portion that forms the proximal end portion of the third region 230 of the coil member 200) 207b disposed at the most proximal end in the second linear body 207 that forms the coil member 200;
  • the fixed outer shape portion 113 of the first core portion 110 of the core wire 100 is fixed.
  • Each fixing part 160, 170, 180 can be formed with, for example, solder or adhesive shaped into a predetermined shape.
  • a first coating layer 310 is provided on the outer surface of the coil member 200.
  • the first coating layer 310 is made of, for example, a cellulose polymer material, a polyethylene oxide polymer material, a maleic anhydride polymer material (for example, a maleic anhydride copolymer such as a methyl vinyl ether-maleic anhydride copolymer). ), Acrylamide polymer materials (eg, polyacrylamide, polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA) block copolymer), water-soluble nylon, polyvinyl alcohol, polyvinyl pyrrolidone, etc. can do.
  • PGMA-DMAA polyglycidyl methacrylate-dimethylacrylamide
  • a second coating layer 320 is provided on the outer surface of the second core portion 120 of the core wire 100.
  • the second coating layer 320 can be formed of, for example, a fluorine resin such as PTFE or ETFE.
  • each of the coating layers 310 and 320 is not particularly limited, but can be formed to about 0.1 to 100 ⁇ m, for example.
  • the inner diameter d1 (the inner diameter formed by the coil member 200) d1 of the first region 210 of the coil member 200 is equal to the inner diameter d2 of the second region 220 of the coil member 200 and the third region 230 of the coil member 200. It is substantially the same as the inner diameter d3.
  • inner diameters are substantially the same.
  • the flexibility of each region 210, 220, 230 of the coil member 200 is the same to the extent that it does not become significantly different due to the influence of the different inner diameters.
  • the difference in dimensions based on manufacturing tolerances is included in the substantially same range.
  • substantially the same regarding dimensions other than the inner diameter described in the present specification means that they are the same as long as the effects of the invention are not impaired, and at least the differences in dimensions based on manufacturing tolerances are substantially the same. Shall be included.
  • the first region 210 of the coil member 200 is formed by five portions 206a, 206d, 206e, 206f, and 206c arranged from the tip side to the middle portion of the first linear body 206.
  • the portion 206c arranged at the most proximal end includes a portion on the distal end side in the first region 210 and a portion on the proximal end side in the second region 220. .
  • each part of the first linear body 206 forming the second region 220 of the coil member 200 decreases from the distal end toward the proximal end.
  • the second region 220 of the coil member 200 is formed by four portions 206c, 206g, 206h, and 206b arranged from the intermediate portion to the proximal end side in the first linear body 206.
  • the portion 206c disposed at the most distal end of the second region 220 includes a portion on the distal end side in the first region 210, and a portion on the proximal end side. It is included in the second region 220.
  • an intermediate fixing portion 170 is sandwiched between the proximal end side of the portion 206b that forms the proximal end portion of the second region 220 of the coil member 200 (see FIG. 2), and the second wire A portion 207 a that forms the tip of the third region 230 of the coil member 200 is disposed in the cylindrical body 207.
  • the second linear body 207 forming the third region 230 of the coil member 200 has substantially the same outer diameter in each part. Therefore, the outer shape of the third region 230 of the coil member 200 is linear along the axial direction.
  • the outer diameter Df1 of the portion 206a that forms the distal end portion of the first region 210 of the coil member 200 in the first linear body 206 forms the proximal end portion of the second region 220 of the coil member 200 in the first linear body 206. It is substantially the same as the outer diameter Df2 of the portion 206b to be operated.
  • the outer diameter Df2 of the portion 206b that forms the proximal end portion of the second region 220 of the coil member 200 in the first linear body 206 is equal to the distal end portion of the third region 230 of the coil member 200 in the second linear body 207. Is substantially the same as the outer diameter Df3 of the portion 207a forming the. Since the second linear body 207 has substantially the same outer diameter at each part in the axial direction, the outside of the portion 207b that forms the proximal end portion of the third region 230 of the coil member 200 in the second linear body 207.
  • the diameter Df4 is substantially the same as the outer diameter Df3 of the portion 207a that forms the tip of the third region 230 of the coil member 200 in the second linear body 207. That is, in the present embodiment, the outer diameters Df1, Df2, Df3, and Df4 of each part of the linear body 205 are formed substantially the same.
  • the guide wire 10 has the following effects when the outer diameters Df1, Df2, Df3, and Df4 of each part of the linear body 205 are defined as described above.
  • the outer diameter Df2 of the portion 206b that forms the proximal end portion of the second region 220 of the coil member 200 in the first linear body 206 forms the distal end portion of the third region 230 of the coil member 200 in the second linear body 207.
  • This is substantially the same as the outer diameter Df3 of the portion 207a.
  • the guide wire 10 can suppress an increase in physical property step (rigid change width) at the boundary between the first linear body 206 and the second linear body 207. Accordingly, the guide wire 10 can prevent the core wire 100 from being broken or broken at the boundary portion between the first linear body 206 and the second linear body 207.
  • the portion 206 a that forms the tip of the first region 210 of the coil member 200 in the first linear body 206 has the smallest outer diameter as compared with the other portions of the first linear body 206. For this reason, when the guide wire 10 is pushed into the constriction S from the distal end side of the coil member 200, the portion 206a positioned at the forefront of the coil member 200 is prevented from riding on the other portion 206d adjacent to the proximal end side. it can.
  • the outer diameter Df1 of the portion 206a that forms the distal end portion of the first region 210 of the coil member 200, and in the first linear body 206, the proximal end portion of the second region 220 of the coil member 200 is formed.
  • the outer diameter Df2 of the portion 206b can be formed to be 0.02 mm to 0.1 mm, for example.
  • the outer diameter Ds of the portion 206c forming the maximum outer shape portion 240 of the coil member 200 in the first linear body 206 can be formed to 0.04 mm to 0.2 mm, for example.
  • the outer diameters of the first linear body 206 other than the above-described parts are the lengths in the axial direction of the first region 210 and the second region 220, and the first linear body of the portion forming the first region 210 and the second region 220. It can be formed in an arbitrary size according to the number of windings 206.
  • the outer diameters Df3 and Df4 of the portions 207a and 207b forming the third region 230 of the coil member 200 in the second linear body 207 are formed to 0.02 mm to 0.1 mm, similar to the outer diameters Df1 and Df2. can do.
  • the maximum outer shape portion 240 of the coil member 200 has a substantially central position in the axial direction of the portion 206 c formed with the largest outer diameter in the first linear body 206 (maximum in the first linear body 206. It is formed at a position on the extension line of the perpendicular H that passes through the center portion c1 of the portion 206c forming the outer shape portion 240 and is orthogonal to the axis of the core wire 100.
  • the maximum outer shape 240 of the coil member 200 extends along the spiral shape of the coil member 200. That is, on the cross-sectional views shown in FIGS. 2 and 3, the maximum outer shape portion 240 extends in a spiral manner obliquely from the upper side of the drawing toward the lower side of the drawing.
  • the external dimension Dm along the direction orthogonal to the axial direction of the maximum external part 240 is a perpendicular H passing through the center part c1 of the part 206c forming the maximum external part 240 in the first linear body 206. Is defined as the length of a range delimited by a virtual line 200A indicating the outer shape of the coil member 200 (see FIG. 3).
  • the outer dimension Dm along the direction orthogonal to the axial direction of the maximum outer shape portion 240 is, for example, the outer diameter of the maximum outer shape portion 240 when the axis orthogonal cross section of the maximum outer shape portion 240 is formed in a circle.
  • the external dimension Dm along the direction orthogonal to the axial direction of the maximum external part 240 can be formed to 0.28 mm to 0.80 mm, for example.
  • the outer dimension D1 of the first region 210 of the coil member 200 can be formed such that the minimum portion on the distal end side is 0.25 mm to 0.61 mm, and the maximum portion on the proximal end side is 0.27 mm. It can be formed to ⁇ 0.79 mm.
  • the outer dimension D2 of the second region 220 of the coil member 200 can be formed such that, for example, the maximum portion on the distal end side is 0.27 mm to 0.79 mm, and the minimum portion on the proximal end side is 0.25 mm. It can be formed to 0.61 mm.
  • the outer dimension D3 of the third region 230 of the coil member 200 can be formed with a constant size along the axial direction, for example, 0.24 mm to 0.60 mm.
  • the inner diameter d1 of the first region 210 of the coil member 200, the inner diameter d2 of the second region 220 of the coil member 200, and the inner diameter d3 of the third region 230 of the coil member 200 are, for example, 0.2 mm to 0.4 mm. Can be formed.
  • region 210 of the coil member 200 may be formed longer than length L2 along the axial direction of the 2nd area
  • the guide wire 10 can be formed in a more acute angle (a shape that is sharp at the tip) with the tip shape of the coil member 200 facing the tip side.
  • the length L3 along the axial direction of the third region 230 of the coil member 200 is, for example, the sum of the length L1 along the axial direction of the first region 210 and the length L2 along the axial direction of the second region 220. It can be formed longer than the length.
  • the ratio of the length L3 along the axial direction of the third region 230 to the total length along the axial direction of the coil member 200 increases. Thereby, the part in which the first region 210 and the second region 220 are formed in the coil member 200 is formed closer to the distal end side of the coil member 200.
  • the third region 230 has a length of 50% or more of the total length along the axial direction of the coil member 200. Preferably formed.
  • the length along the axial direction of the coil member 200 can be formed to 191 mm to 310 mm, for example.
  • the length L1 along the axial direction of the first region 210 can be formed to 0.5 mm to 30 mm, for example.
  • the length L2 along the axial direction of the second region 220 can be formed to 0.5 mm to 30 mm, for example.
  • the length L3 along the axial direction of the third region 230 can be formed to 190 mm to 250 mm, for example.
  • the length L1 along the axial direction of the first region 210 of the coil member 200 is preferably formed longer than the length L2 along the axial direction of the second region 220 of the coil member 200.
  • FIGS. 5 and 6 are schematic sectional views showing the state before and after the guide wire 10 is pushed through the stenosis S formed in the blood vessel and penetrated.
  • the guide wire 10 when the surgeon or the like pushes the guide wire 10 toward the narrowed portion S toward the distal end side, the guide wire 10 is pushed into the narrowed portion S from the distal end side of the first region 210 of the coil member 200. It is. In the coil member 200 of the guide wire 10, since the outer shape of the first region 210 located at the foremost end becomes smaller from the proximal end side toward the distal end side, the pushing force against the narrowed portion S is increased. Thereby, the surgeon or the like can smoothly push the guide wire 10 into the narrowed portion S.
  • the surgeon or the like pushes the guide wire 10 further into the constriction S, thereby bringing the second region 220 of the coil member 200 into the constriction S following the first region 210 of the coil member 200. To enter.
  • the second region 220 of the coil member 200 of the guide wire 10 decreases toward the proximal end side, the second region 220 and the constricted portion S are moved when the second region 220 moves in the constricted portion S.
  • the penetration resistance that the second region 220 of the coil member 200 receives from the constriction S is reduced.
  • the surgeon or the like can easily push the second region 220 following the first region 210 of the coil member 200 and the third region 230 following the second region 220 into the stenosis S,
  • the guide wire 10 can be smoothly moved in the narrowed portion S.
  • the guide wire 10 controls (shapes) the outer shape of the coil member 200 by adjusting the outer diameter of the first linear body 206 forming the coil member 200, the regions 210 and 220 of the coil member 200 are controlled. , 230 can maintain the inner diameters d1, d2, and d3 at a predetermined size, thereby ensuring flexibility. Further, in the guide wire 10, the inner diameter d1 of the first region 210 of the coil member 200 and the inner diameter d2 of the second region 220 of the coil member 200 are substantially the same.
  • the guide wire 10 is not formed with an excessively large inner diameter at the maximum outer shape portion 240 of the coil member 200, an increase in the outer shape of the maximum outer shape portion 240 accompanying an increase in the inner diameter of the coil member 200 is suppressed. For this reason, when the coil member 200 penetrates the constriction part S, the stress concentration which the largest external part 240 of the coil member 200 receives is reduced. As a result, the guide wire 10 is further improved in the pushability of the guide wire 10 with respect to the narrowed portion S, and the first linear body 206 (206c) forming the maximum outer shape portion 240 rides on the proximal end side. Can be prevented.
  • the guide wire 10 includes the core wire 100 and the coil member 200 fixed to at least the distal end portion 101 of the core wire 100, and the coil member 200 is in the axial direction of the core wire 100.
  • the first region 210, the second region 220, and the third region 230 are provided from the distal end to the proximal end along the line.
  • the outer diameter of the first linear body 206 forming the coil member 200 increases from the distal end toward the proximal end, thereby increasing the outer shape from the distal end toward the proximal end.
  • region 220 of the coil member 200 reduces the outer diameter of the 1st linear body 206 which forms the coil member 200 toward a base end from a front-end
  • a second inclined portion whose outer shape becomes smaller toward the outside is formed, and a boundary portion between the first region 210 of the coil member 200 and the second region 220 of the coil member 200 has a maximum outer shape portion 240 where the outer shape of the coil member 200 is largest.
  • the inner diameter d1 formed by the coil member 200 in the first region 210 of the coil member 200 is substantially the same as the inner diameter d2 formed by the coil member 200 in the second region 220 of the coil member 200.
  • the guide wire 10 configured as described above can increase the pushing force against the constriction S by the first region 210 of the coil member 200.
  • the second region 220 of the coil member 200 reduces the penetration resistance that the guide wire 10 receives from the constriction S when being pushed into the constriction S following the first region 210 of the coil member 200. Therefore, the guide wire 10 has further improved penetrability with respect to the narrowed portion S.
  • the guide wire 10 adjusts the outer diameter of the first linear body 206 forming the coil member 200 to control (shape) the outer shape of the coil member 200 while maintaining the inner diameter formed by the coil member 200. Therefore, flexibility can be secured.
  • the inner diameter formed by the coil member is On the distal end side of the first inclined portion and the proximal end side of the second inclined portion, it must be made smaller than other portions of the coil member. A portion of the coil member that has a smaller inner diameter than the other portions reduces the flexibility of the coil member.
  • the guide wire 10 according to the present embodiment can prevent the reduction in flexibility of the coil member 200 as described above.
  • the inner diameter formed by the coil member 200 is maintained substantially the same in the first region 210, the second region 220, and the maximum outer shape portion 240 formed at the boundary between the first region 210 and the second region 220. Therefore, when forming the maximum outer shape portion 240 of the coil member 200, the outer shape of the maximum outer shape portion 240 of the coil member 200 does not become excessively large. Thereby, when the coil member 200 penetrates the constriction part S, the guide wire 10 can suppress stress concentration on the maximum outer shape part 240. For this reason, the guide wire 10 has a further improved pushability to the narrowed portion S, and can further prevent the portion 207c forming the maximum outer shape portion 240 of the first linear body 206 from running on the proximal end side. .
  • the core wire 100 is formed in a tapered shape whose outer shape becomes smaller toward the tip, and at least a part of the first taper is arranged so as to overlap the first region 210 of the coil member 200 in the circumferential direction of the core wire 100.
  • the second taper portion is formed in a tapered shape such that the outer shape becomes smaller toward the base 111 and at least a portion thereof overlaps with the second region 220 of the coil member 200 in the circumferential direction of the core wire 100. 112.
  • the first taper portion 111 of the core wire 100 disposed so as to overlap the first region 210 of the coil member 200 in the circumferential direction of the core wire 100 is pushed into the constricted portion S together with the first region 210 of the coil member 200. Improve sexiness.
  • the second taper portion 112 of the core wire 100 that is arranged so as to overlap the second region 220 of the coil member 200 in the circumferential direction of the core wire 100 is the first taper on the core wire 100 when the guide wire 10 is pushed into the constriction S. It is possible to mitigate the occurrence of stress concentration in the one taper portion 111.
  • the core wire 100 forms a maximum outer shape 140 at the boundary between the first tapered portion 111 of the core wire 100 and the second tapered portion 112 of the core wire 100.
  • the guide wire 10 has an intermediate fixing portion 170 that fixes the coil member 200 and the proximal end portion of the second tapered portion 112 of the core wire 100.
  • the intermediate fixing portion 170 has a proximal end portion of the second taper portion 112 formed at the first taper portion 111 and the second taper portion 112 that is relatively less rigid than the other portions of the core wire 100 with respect to the coil member 200. By fixing (connecting), the core wire 100 is prevented from being broken or broken at the proximal end portion of the second tapered portion 112.
  • the guide wire 10 is formed such that the length L1 along the axial direction of the first region 210 of the coil member 200 is longer than the length L2 along the axial direction of the second region 220 of the coil member 200. For this reason, the length L1 along the axial direction of the 1st area
  • the guide wire 10 has a length L3 along the axial direction of the third region 230 of the coil member 200 and a length L1 along the axial direction of the first region 210 of the coil member 200 and the length L3 of the second region 220 of the coil member 200. It is formed longer than the length obtained by adding the length L2 along the axial direction. For this reason, the portion of the coil member 200 where the first region 210 and the second region 220 are formed is formed closer to the tip side of the coil member 200. As a result, the guide wire 10 is effectively improved in penetrability with respect to the narrowed portion S due to the first region 210 and the second region 220 arranged on the distal end side of the coil member 200.
  • the guide wire 10 includes an outer diameter of a portion 206b that forms a proximal end portion of the second region 220 of the coil member 200 in the first linear body 206, and a third region of the coil member 200 in the second linear body 207.
  • the outer diameter of the portion 207a that forms the tip of 230 is formed to be substantially the same.
  • the coil member 200 is caused by the difference in outer diameter between the portions 206b and 207a from the proximal end portion of the second region 220 to the distal end portion of the third region 230 whose outer shape decreases from the distal end side toward the proximal end side. It is possible to suppress an increase in the physical property step (change width of rigidity). Thereby, the guide wire 10 can prevent breakage such as breakage at the boundary portion between the proximal end portion of the second region 220 of the coil member 200 and the distal end portion of the third region 230 of the coil member 200.
  • the guide wire 10 also has a distal end side fixing portion 160 that fixes the distal end portion 101 of the core wire 100 and the coil member 200.
  • the distal-end-side fixing portion 160 is formed in a tapered shape that is curved in a convex shape toward the distal end and whose outer shape becomes smaller toward the distal end. As described above, in the guide wire 10, the distal end fixing portion 160 is tapered toward the distal end side, so that the pushing force against the narrowed portion S is further improved.
  • the distal end side fixing portion 160 has a shape that is convexly curved toward the distal end, when the guide wire 10 is moved in the living body, a living organ such as a blood vessel is moved from the distal end of the guide wire 10. Can be protected.
  • the first linear body 206 that forms the first region 210 of the coil member 200 and the second region 220 of the coil member 200 is higher than the second linear body 207 that forms the third region 230 of the coil member 200.
  • first linear body 206 forming the first region 210 of the coil member 200 and the second region 220 of the coil member 200 is formed of one continuous member. By forming the first region 210 and the second region 220 with one continuous member, the coil member 200 can be manufactured easily.
  • the guide wire according to the present invention has been described through the embodiments.
  • the present invention is not limited to the contents described in the specification, and can be appropriately changed based on the description of the scope of claims. is there.
  • the number of windings of the linear body forming the coil member and the outer diameter of each part of the linear body are not particularly limited as long as the first region, the second region, and the third region can be formed in the coil member.
  • the shape of the third region of the coil member is exemplified as a shape having a constant outer shape, but the shape of the third region is not limited to such a shape.
  • the third region may be formed by an inclined portion in which the outer diameter of the linear body decreases toward the base end and the outer shape decreases toward the base end.
  • the maximum outer shape of the third region is preferably formed to be equal to or smaller than the base end portion of the second region.
  • the inner diameter of the third region may not be the same as the inner diameters of the first region and the second region, and may not be a constant size along the axial direction.
  • each part of the coil member for example, the length along the axial direction of each region
  • the dimensions of each part of the core wire for example, the length along the axial direction of each part
  • etc. are limited to those described in the specification. It can be changed as appropriate.
  • the material forming the coil member and the material forming the core wire are not limited to those exemplified in the specification, and can be appropriately changed.
  • the guide wire may have a structure in which the core wire is wound in a plurality of layers such as double or triple around the core wire.
  • region of a coil member are formed of the coil member arrange
  • the internal diameter which a coil member forms is an internal diameter which the coil member arrange
  • the coil member may not be formed of one continuous member in which the linear body forming the first region and the linear body forming the second region are formed.
  • the first region and the maximum outer shape portion are formed by one linear body
  • the second region is formed by another linear body
  • the first region is formed by one linear body
  • the second region and You may form a largest external shape part with another linear body.
  • the shape of the core wire is not limited by the shape described with reference to the drawings.
  • the core wire may have a shape extending substantially linearly along the axial direction in which the first tapered portion and the second tapered portion are not formed.

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Abstract

[Problem] To provide a guide wire which ensures flexibility and is capable of reducing pass-through resistance when passing through a lesion such as a constricted section. [Solution] A coil member 200 provided in a guide wire 10 has a first region 210, second region 220, and third region 230 located along the axial direction of a core wire 100 from the tip end to the base end thereof. The first region forms a first angled section exhibiting an increase in the outer contour thereof from the tip end toward the base end, by increasing the outer diameter of a first linear body 206 which forms the coil member in a direction from the tip end toward the base end. The second region forms a second angled section exhibiting a decrease in the outer contour thereof from the tip end toward the base end, by decreasing the outer diameter of the first linear body which forms the coil member in a direction from the tip end toward the base end. The boundary between the first and second regions forms the maximum outer contour section 240, at which the outer contour of the coil member is largest. The inner diameter d1 of the coil member in the first region is substantially identical to the inner diameter d2 of the coil member in the second region.

Description

ガイドワイヤGuide wire
 本発明は、ガイドワイヤに関する。 The present invention relates to a guide wire.
 血管等の生体管腔に形成された狭窄部等の治療に用いられる医療装置(バルーンカテー等)を生体内で誘導するための医療器具として、ガイドワイヤが広く知られている。一般的に、ガイドワイヤには、芯材となるコアワイヤと、コアワイヤの先端側に配置されるコイル部材が備えられる。 A guide wire is widely known as a medical instrument for guiding a medical device (balloon catheter or the like) used for treatment of a stenosis or the like formed in a body lumen such as a blood vessel in a living body. Generally, a guide wire is provided with a core wire as a core material and a coil member disposed on the tip side of the core wire.
 ガイドワイヤには、その用途上、種々の性能が求められる。ガイドワイヤに求められる性能の一つとして、狭窄部に対する貫通性(通過性)が挙げられる。 A guide wire is required to have various performances for its use. One of the performances required for the guide wire is penetrability (passability) with respect to the narrowed portion.
 上記のような課題に関連して、下記特許文献1では、基端側から先端側に向けて外形が小さくなるテーパー形状に形成されたコイル部材を備えるガイドワイヤが提案されている。ガイドワイヤは、先端側に向けて外形が小さくなるテーパー形状がコイル部材に形成されることにより、ガイドワイヤの先端側から狭窄部に対して作用させる押し込み力(プッシャビリティ)が高められる。 In relation to the above problems, Patent Document 1 below proposes a guide wire including a coil member formed in a tapered shape whose outer shape becomes smaller from the proximal end side toward the distal end side. The guide wire is formed with a tapered shape whose outer shape is reduced toward the distal end side, so that the pushing force that acts on the constricted portion from the distal end side of the guide wire is increased.
 また、特許文献1に記載されたガイドワイヤは、コイル部材に上記テーパー形状を付与するために、コイル部材を形成する線状体(コイル線材)の外径をコイル部材の先端側から基端側へ向けて徐々に大きくしている。コイル部材の内径(コイル部材の内側に形成される内腔の径)は、線状体の外径の変化に応じて先端側から基端側へ向けて徐々に大きくなるように変化している。このため、テーパー形状の先端側では、コイル部材の内径は比較的小さくなっており、テーパー形状の基端側では、コイル部材の内径は比較的大きくなっている。 In addition, the guide wire described in Patent Document 1 is configured so that the outer diameter of a linear body (coil wire) forming the coil member is changed from the distal end side to the proximal end side of the coil member in order to give the coil member the tapered shape. It is gradually getting bigger toward. The inner diameter of the coil member (the diameter of the lumen formed inside the coil member) changes so as to gradually increase from the distal end side to the proximal end side in accordance with the change in the outer diameter of the linear body. . For this reason, the inner diameter of the coil member is relatively small on the distal end side of the tapered shape, and the inner diameter of the coil member is relatively large on the proximal end side of the tapered shape.
特開2007-135645号JP 2007-135645 A
 上記特許文献1に記載されたガイドワイヤによれば、狭窄部に対するガイドワイヤの貫通性は良好に高められる。しかしながら、例えば、血管の延伸方向に沿って狭窄部が比較的長く形成されているような場合、ガイドワイヤは狭窄部を貫通する際、コイル部材の先端側から基端側に至る比較的長い範囲に亘って貫通抵抗を受ける。このため、ガイドワイヤには、狭窄部に対する貫通性の向上を図るために、ガイドワイヤの先端側から狭窄部に対して作用させる押し込み力の向上とともに、狭窄部を貫通する際の貫通抵抗の低減も求められる。 According to the guide wire described in Patent Document 1, the penetrability of the guide wire with respect to the narrowed portion can be improved satisfactorily. However, for example, when the stenosis portion is formed relatively long along the blood vessel extending direction, the guide wire extends from the distal end side to the proximal end side of the coil member when passing through the stenosis portion. Through resistance. For this reason, in order to improve the penetration of the guide wire into the stenosis, the pushing force applied to the stenosis from the distal end side of the guide wire is improved and the penetration resistance when penetrating the stenosis is reduced. Is also required.
 また、特許文献1に記載されたガイドワイヤは、テーパー部の先端側におけるコイル部材の内径がコイル部材の他の部分の内径よりも小さいため、コイル部材の先端側での柔軟性を確保し難い。 Moreover, since the guide wire described in Patent Document 1 has an inner diameter of the coil member on the distal end side of the tapered portion that is smaller than an inner diameter of other portions of the coil member, it is difficult to ensure flexibility on the distal end side of the coil member. .
 本発明は、狭窄部等の病変部を貫通する際の貫通抵抗を低減することができ、かつ、柔軟性が確保されたガイドワイヤの提供を目的とする。 An object of the present invention is to provide a guide wire that can reduce penetration resistance when penetrating a lesioned part such as a stenosis part and is flexible.
 本発明に係るガイドワイヤは、コアワイヤと、前記コアワイヤの少なくとも先端部に固定されたコイル部材と、を備え、前記コイル部材は、前記コアワイヤの軸方向に沿って先端から基端に向かって、第1領域、第2領域、および第3領域を有し、前記第1領域は、先端から基端に向かって前記コイル部材を形成する線状体の外径を大きくすることで、先端から基端に向かって外形が大きくなる第1傾斜部を形成し、前記第2領域は、先端から基端に向かって前記コイル部材を形成する線状体の外径を小さくすることで、先端から基端に向かって外形が小さくなる第2傾斜部を形成し、前記第1領域と前記第2領域の境界部は、前記コイル部材の外形が最も大きくなる最大外形部を形成し、前記第1領域において前記コイル部材が形成する内径は、前記第2領域において前記コイル部材が形成する内径と略同一である。 A guide wire according to the present invention includes a core wire and a coil member fixed to at least a distal end portion of the core wire, and the coil member is arranged in a first direction from the distal end toward the proximal end along the axial direction of the core wire. The first region includes a first region, a second region, and a third region, and the first region increases from the distal end toward the proximal end by increasing the outer diameter of the linear body that forms the coil member. A first inclined portion whose outer shape increases toward the base, and the second region decreases from the distal end to the proximal end by reducing the outer diameter of the linear body forming the coil member from the distal end toward the proximal end. A second inclined portion whose outer shape becomes smaller toward the outer surface, and a boundary portion between the first region and the second region forms a maximum outer shape portion where the outer shape of the coil member is largest, and in the first region, Formed by the coil member Diameter is substantially the same inner diameter as said coil member is formed in the second region.
 本発明のガイドワイヤは、コイル部材の第1領域により、狭窄部に対する押し込み力を高めることができる。コイル部材の第2領域は、コイル部材の第1領域に続いて狭窄部内に押し込まれる際、ガイドワイヤが狭窄部から受ける貫通抵抗を低減させる。したがって、本発明のガイドワイヤは、狭窄部に対する貫通性がより一層向上したものとなる。 The guide wire of the present invention can increase the pushing force against the constriction by the first region of the coil member. The second region of the coil member reduces the penetration resistance that the guide wire receives from the constriction when it is pushed into the constriction after the first region of the coil member. Therefore, the guide wire of the present invention has further improved penetrability with respect to the narrowed portion.
 また、本発明のガイドワイヤは、コイル部材を形成する線状体の外径を調整することにより、コイル部材が形成する内径を維持しつつ、コイル部材の外形を制御(整形)しているため、柔軟性を確保できる。 Further, the guide wire of the present invention controls (shapes) the outer shape of the coil member while maintaining the inner diameter formed by the coil member by adjusting the outer diameter of the linear body forming the coil member. , Ensure flexibility.
 また、本発明のガイドワイヤは、コイル部材が形成する内径が第1領域、第2領域、および第1領域と第2領域の境界部に形成される最大外形部で略同一に維持されるため、最大外形部を形成する際、コイル部材の最大外形部の外形が過度に大きくならない。これにより、ガイドワイヤは、コイル部材が狭窄部を貫通する際、最大外形部への応力集中を抑制できる。このため、本発明のガイドワイヤは、狭窄部に対する押し込み性がより一層向上したものとなり、さらに、最大外形部を形成するコイル部材の線状体が基端側に乗り上げるのを防止できる。 In the guide wire of the present invention, the inner diameter formed by the coil member is maintained substantially the same in the first region, the second region, and the maximum outer shape formed at the boundary between the first region and the second region. When the maximum outer shape portion is formed, the outer shape of the maximum outer shape portion of the coil member does not become excessively large. Thereby, the guide wire can suppress stress concentration on the maximum outer shape portion when the coil member penetrates the narrowed portion. For this reason, the guide wire of the present invention has a further improved pushability to the constricted portion, and can further prevent the linear member of the coil member forming the maximum outer shape portion from running on the proximal end side.
本発明の実施形態に係るガイドワイヤを示す部分縦断面図である。It is a fragmentary longitudinal cross-section which shows the guide wire which concerns on embodiment of this invention. ガイドワイヤの先端部を拡大して示す図である。It is a figure which expands and shows the front-end | tip part of a guide wire. コアワイヤおよびコイル部材を拡大して示す断面図である。It is sectional drawing which expands and shows a core wire and a coil member. コイル部材を形成する線状体の一部を拡大して示す断面図である。It is sectional drawing which expands and shows a part of linear body which forms a coil member. ガイドワイヤの作用を説明するための図であって、ガイドワイヤを狭窄部に貫通させる前の状態を模式的に示す断面図である。It is a figure for demonstrating the effect | action of a guide wire, Comprising: It is sectional drawing which shows typically the state before penetrating a guide wire to a constriction part. ガイドワイヤの作用を説明するための図であって、ガイドワイヤを狭窄部に貫通させた後の状態を模式的に示す断面図である。It is a figure for demonstrating the effect | action of a guide wire, Comprising: It is sectional drawing which shows typically the state after having penetrated the guide wire to the constriction part.
 以下、添付した図面を参照しながら、本発明の実施形態を説明する。なお、以下の記載は特許請求の範囲に記載される技術的範囲や用語の意義を限定するものではない。また、図面の寸法比率は説明の都合上誇張されており、実際の比率とは異なる場合がある。 Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In addition, the following description does not limit the technical scope and terms used in the claims. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may differ from actual ratios.
 図1は、実施形態に係るガイドワイヤ10を示す部分縦断面図(ガイドワイヤ10の軸方向に沿う断面図)、図2は、図1のガイドワイヤ10の先端部を拡大して示す図、図3は、ガイドワイヤ10のコイル部材200の内径を説明するための拡大図、図4は、コイル部材200を形成する線状体205の外径を説明するための図である。また、図5および図6は、ガイドワイヤの作用の説明に供する図である。 FIG. 1 is a partial vertical cross-sectional view (a cross-sectional view taken along the axial direction of the guide wire 10) showing the guide wire 10 according to the embodiment, and FIG. 2 is an enlarged view of the distal end portion of the guide wire 10 in FIG. FIG. 3 is an enlarged view for explaining the inner diameter of the coil member 200 of the guide wire 10, and FIG. 4 is a view for explaining the outer diameter of the linear body 205 forming the coil member 200. FIG. 5 and FIG. 6 are diagrams for explaining the operation of the guide wire.
 図1に示すように、ガイドワイヤ10は、可撓性を備える長尺状のコアワイヤ100と、コアワイヤ100の少なくとも先端部101に固定されたコイル部材200と、を有している。 As shown in FIG. 1, the guide wire 10 has a long core wire 100 having flexibility, and a coil member 200 fixed to at least a tip 101 of the core wire 100.
 本明細書の説明では、コアワイヤ100の長手方向(図1中の左右方向)を軸方向と定義し、一点鎖線A1で示す。また、ガイドワイヤ10において生体内(血管内)に導入される側を先端側(図1の左側)と定義し、先端側と反対の端部側を基端側(図1の右側)と定義する。また、本明細書において先端部とは、先端(最先端)から軸方向における一定の範囲を含む部分を意味し、基端部とは、基端(最基端)から軸方向における一定の範囲を含む部分を意味するものとする。 In the description of the present specification, the longitudinal direction of the core wire 100 (the left-right direction in FIG. 1) is defined as the axial direction and is indicated by a one-dot chain line A1. Further, the side of the guide wire 10 that is introduced into the living body (into the blood vessel) is defined as the distal end side (left side in FIG. 1), and the end side opposite to the distal end side is defined as the proximal end side (right side in FIG. 1). To do. Further, in this specification, the distal end portion means a portion including a certain range in the axial direction from the distal end (the most distal end), and the proximal end portion means a certain range in the axial direction from the proximal end (most proximal end). Means a part containing
 なお、以下の説明では、ガイドワイヤ10の構造的な説明(形状や寸法等に関する説明)は、ガイドワイヤ10に対して外力が付加されていない状態を例にして説明をする。つまり、本実施形態で説明するガイドワイヤ10の構造的な特徴は、少なくともガイドワイヤ10に対して外力が付加されていない状態において当該ガイドワイヤ10に備えられているものとする。 In the following description, the structural description of the guide wire 10 (explanation regarding the shape, dimensions, etc.) will be described by taking an example in which an external force is not applied to the guide wire 10. That is, it is assumed that the structural features of the guide wire 10 described in the present embodiment are provided in the guide wire 10 in a state where at least an external force is not applied to the guide wire 10.
 図1および図2に示すように、コイル部材200は、コアワイヤ100の軸心を中心として、コアワイヤ100の周方向に沿って螺旋状に巻回された線状体205により形成している。コイル部材200は、コアワイヤ100の先端側(後述する第1コア部110の先端側)を軸方向に沿って一定の範囲で覆うように配置している。 As shown in FIGS. 1 and 2, the coil member 200 is formed by a linear body 205 wound spirally along the circumferential direction of the core wire 100 around the axis of the core wire 100. The coil member 200 is disposed so as to cover the distal end side of the core wire 100 (the distal end side of the first core portion 110 described later) within a certain range along the axial direction.
 コイル部材200は、線状体205が隙間なく巻かれた密巻きコイルで形成している。ただし、コイル部材200は、例えば、線状体205において隣接する部分の間に隙間が形成された疎巻きコイルで形成してもよい。また、コイル部材200は、例えば、密巻き部分と疎巻き部分の両方を任意の箇所に備えるコイルで形成してもよい。なお、コイル部材200に隙間を形成する場合、隙間の大きさ(軸方向に沿う長さ)は任意の大きさに設定できる。 The coil member 200 is formed of a closely wound coil in which the linear body 205 is wound without a gap. However, the coil member 200 may be formed by a loosely wound coil in which a gap is formed between adjacent portions in the linear body 205, for example. In addition, the coil member 200 may be formed of, for example, a coil that includes both a densely wound portion and a loosely wound portion at arbitrary locations. In addition, when forming a clearance gap in the coil member 200, the magnitude | size (length along an axial direction) of a clearance gap can be set to arbitrary magnitude | sizes.
 図2に示すように、コイル部材200は、軸方向の先端側に配置された第1線状体206と、第1線状体206よりも軸方向の基端側に配置された第2線状体207と、を有している。図2においては、説明を簡略化するために、後述する第1被覆層310と第2被覆層320の図示を省略している。 As shown in FIG. 2, the coil member 200 includes a first linear body 206 disposed on the distal end side in the axial direction, and a second line disposed on the proximal end side in the axial direction from the first linear body 206. And a body 207. In FIG. 2, for the sake of simplicity, illustration of a first covering layer 310 and a second covering layer 320 described later is omitted.
 コイル部材200は、コアワイヤ100の軸方向に沿って先端から基端に向かって、第1領域210、第2領域220、および第3領域230を有している。 The coil member 200 has a first region 210, a second region 220, and a third region 230 from the distal end toward the proximal end along the axial direction of the core wire 100.
 コイル部材200の第1領域210およびコイル部材200の第2領域220は、第1線状体206で形成している。また、第1線状体206は、一つの連続した部材で形成している。 The first region 210 of the coil member 200 and the second region 220 of the coil member 200 are formed by the first linear body 206. The first linear body 206 is formed of one continuous member.
 上記の「一つの連続した部材」とは、コイル部材200を形成するための部材として準備された段階で線状体が一つの部材として形成されていることを意味する。例えば、異種の材料からなる複数の部材を、コイル部材200を形成する前の段階で予め接合して形成した線状体は「一つの連続した部材」に含まれるが、第1線状体206と第2線状体207のように、コイル部材200を形成する段階で固定(接続)されるものは「一つの連続した部材」には含まれない。 The above "one continuous member" means that the linear body is formed as one member at the stage where it is prepared as a member for forming the coil member 200. For example, a linear body formed by joining a plurality of members made of different materials in advance before forming the coil member 200 is included in “one continuous member”, but the first linear body 206 What is fixed (connected) at the stage of forming the coil member 200, such as the second linear body 207, is not included in “one continuous member”.
 コイル部材200の第3領域230は、第1線状体206とは異なる第2線状体207で構成している。第1線状体206と第2線状体207は、後述する中間固定部170を介して固定している。 The third region 230 of the coil member 200 includes a second linear body 207 that is different from the first linear body 206. The first linear body 206 and the second linear body 207 are fixed via an intermediate fixing portion 170 described later.
 図3および図4に示すように、コイル部材200の第1領域210は、先端から基端に向かってコイル部材200を形成する第1線状体206の外径を大きくすることで、先端から基端に向かって外形が大きくなる第1傾斜部を形成している。換言すると、コイル部材200の第1領域210は、先端側へ向けてコイル部材200の外形が徐々に小さくなるテーパー部を形成している。 As shown in FIGS. 3 and 4, the first region 210 of the coil member 200 increases from the distal end by increasing the outer diameter of the first linear body 206 forming the coil member 200 from the distal end toward the proximal end. A first inclined portion whose outer shape increases toward the proximal end is formed. In other words, the first region 210 of the coil member 200 forms a tapered portion in which the outer shape of the coil member 200 gradually decreases toward the distal end side.
 コイル部材200の第2領域220は、先端から基端に向かってコイル部材200を形成する第1線状体206の外径を小さくすることで、先端から基端に向かって外形が小さくなる第2傾斜部を形成している。換言すると、コイル部材200の第2領域220は、基端側へ向けてコイル部材200の外形が徐々に小さくなるテーパー部を形成している。 In the second region 220 of the coil member 200, the outer diameter of the first linear body 206 forming the coil member 200 decreases from the distal end toward the proximal end, thereby reducing the outer shape from the distal end toward the proximal end. Two inclined portions are formed. In other words, the second region 220 of the coil member 200 forms a tapered portion in which the outer shape of the coil member 200 gradually decreases toward the proximal end side.
 コイル部材200の第1領域210とコイル部材200の第2領域220の境界部は、コイル部材200の外形が最も大きくなる最大外形部240を形成している。つまり、コイル部材200の外形は、第1領域210の基端と第2領域220の先端との境界で最も大きくなっている。 The boundary portion between the first region 210 of the coil member 200 and the second region 220 of the coil member 200 forms a maximum outer shape portion 240 where the outer shape of the coil member 200 is the largest. That is, the outer shape of the coil member 200 is largest at the boundary between the proximal end of the first region 210 and the distal end of the second region 220.
 コイル部材200の第3領域230は、先端から基端に向かって略一定の外形で延在する直線部を形成している。 3rd area | region 230 of the coil member 200 forms the linear part extended in the substantially constant external shape from the front-end | tip to the base end.
 本明細書の説明において、コイル部材200の外形は、コイル部材200を形成する線状体205の各々の外表面を結ぶ接線(外形線)200Aで表している(図2および図3を参照)。なお、コイル部材200の外形とは、後述する第1被覆層310および第2被覆層320が配置されていない状態におけるコイル部材200の外形、つまり、図2に示す状態のコイル部材200の外形を意味する。 In the description of the present specification, the outer shape of the coil member 200 is represented by a tangent line (outer shape line) 200A connecting the outer surfaces of the linear bodies 205 forming the coil member 200 (see FIGS. 2 and 3). . Note that the outer shape of the coil member 200 is the outer shape of the coil member 200 in a state where the first coating layer 310 and the second coating layer 320 described later are not disposed, that is, the outer shape of the coil member 200 in the state shown in FIG. means.
 また、各図において、コイル部材200の内表面は、コイル部材200を形成する線状体205の各々の内表面を結ぶ接線200Bで表している。 In each figure, the inner surface of the coil member 200 is represented by a tangent line 200B connecting the inner surfaces of the linear bodies 205 forming the coil member 200.
 コイル部材200の第1領域210およびコイル部材200の第2領域220を形成する第1線状体206は、コイル部材200の第3領域230を形成する第2線状体207よりも高い造影性を有している。このため、第1領域210および第2領域220は、第3領域230よりも高い造影性を有している。 The first linear body 206 that forms the first region 210 of the coil member 200 and the second region 220 of the coil member 200 has higher contrast than the second linear body 207 that forms the third region 230 of the coil member 200. have. For this reason, the first region 210 and the second region 220 have higher contrast than the third region 230.
 コイル部材200の各領域210、220、230における造影性の大小関係を上記のように調整する場合、第1線状体206は、例えば、X線不透過性を有する材料で形成することができる。X線不透過性を有する材料としては、例えば、白金、金、銀、チタン、タングステン、コバルト、またはこれらを含む合金等を用いることができる。一方、第2線状体207は、第1線状体206よりもX線不透過性が小さい材料で形成することができる。このような材料としては、例えば、ステンレス鋼、超弾性合金等を用いることができる。なお、各線状体206、207を形成する材料には焼き入れ等の加工が施してあってもよい。 When adjusting the magnitude relationship of contrast in each region 210, 220, 230 of the coil member 200 as described above, the first linear body 206 can be formed of, for example, a material having radiopacity. . As the material having radiopacity, for example, platinum, gold, silver, titanium, tungsten, cobalt, or an alloy containing these can be used. On the other hand, the second linear body 207 can be formed of a material that is less radiopaque than the first linear body 206. As such a material, for example, stainless steel, a superelastic alloy, or the like can be used. The material forming the linear bodies 206 and 207 may be subjected to processing such as quenching.
 図1に示すように、コアワイヤ100は、軸方向の先端側に配置された第1コア部110と、第1コア部110の基端側に配置され、第1コア部110に接続された第2コア部120と、を有している。 As shown in FIG. 1, the core wire 100 includes a first core part 110 disposed on the distal end side in the axial direction and a first core part 110 disposed on the proximal end side of the first core part 110 and connected to the first core part 110. 2 core portions 120.
 図2および図3に示すように、コアワイヤ100の第1コア部110は、先端に向けて外形が小さくなるテーパー状に形成された第1テーパー部111と、第1テーパー部111の基端側に形成され、基端に向けて外形が小さくなるテーパー状に形成された第2テーパー部112と、第2テーパー部112の基端側に形成され、略一定の外形で延びる外形一定部113と、を有している。 As shown in FIGS. 2 and 3, the first core portion 110 of the core wire 100 includes a first tapered portion 111 formed in a tapered shape whose outer shape decreases toward the distal end, and a proximal end side of the first tapered portion 111. A second tapered portion 112 formed in a tapered shape whose outer shape decreases toward the base end, and a constant outer shape portion 113 formed on the base end side of the second tapered portion 112 and extending in a substantially constant outer shape. ,have.
 コアワイヤ100の第1コア部110の第1テーパー部111と、コアワイヤ100の第1コア部110の第2テーパー部112との境界部には、第1コア部110において外形が最も大きくなる最大外形部140が形成されている。 At the boundary between the first taper portion 111 of the first core portion 110 of the core wire 100 and the second taper portion 112 of the first core portion 110 of the core wire 100, the maximum outer shape where the outer shape is the largest in the first core portion 110. A portion 140 is formed.
 第1コア部110の第1テーパー部111の少なくとも一部は、コイル部材200の第1領域210とコアワイヤ100の周方向において重なるように配置されている。また、第1コア部110の第2テーパー部112の少なくとも一部は、コイル部材200の第2領域220とコアワイヤ100の周方向において重なるように配置されている。また、第1コア部110の最大外形部140は、コイル部材200の最大外形部240とコアワイヤ100の周方向において重なるように配置されている。 At least a part of the first tapered portion 111 of the first core portion 110 is disposed so as to overlap with the first region 210 of the coil member 200 in the circumferential direction of the core wire 100. Further, at least a part of the second tapered portion 112 of the first core portion 110 is disposed so as to overlap the second region 220 of the coil member 200 in the circumferential direction of the core wire 100. Further, the maximum outer shape portion 140 of the first core portion 110 is disposed so as to overlap the maximum outer shape portion 240 of the coil member 200 in the circumferential direction of the core wire 100.
 コアワイヤ100の第1コア部110の構成材料としては、例えば、Ni-Ti系合金、ステンレス鋼、超弾性合金を用いることができる。 As a constituent material of the first core portion 110 of the core wire 100, for example, a Ni—Ti alloy, stainless steel, or a superelastic alloy can be used.
 図1に示すように、コアワイヤ100の第2コア部120は、先端側に向けて外形が小さくなるテーパー状に形成された先端部121と、先端部121の基端側に形成された大径部122と、を有している。 As shown in FIG. 1, the second core portion 120 of the core wire 100 has a distal end portion 121 formed in a tapered shape whose outer shape becomes smaller toward the distal end side, and a large diameter formed on the proximal end side of the distal end portion 121. Part 122.
 コアワイヤ100の第2コア部120の構成材料としては、例えば、ステンレス鋼やコバルト系合金を用いることができる。なお、第1コア部110と第2コア部120は、同一または同種(例えば、合金において主とする金属材料が同一)の金属材料で形成してもよい。 As a constituent material of the second core portion 120 of the core wire 100, for example, stainless steel or a cobalt-based alloy can be used. The first core part 110 and the second core part 120 may be formed of the same or the same kind of metal material (for example, the same main metal material in the alloy).
 第1コア部110と第2コア部120は、例えば、溶接などの方法で接続することができる。なお、コアワイヤ100は、例えば、一本の連続した部材で構成することも可能であるし、三つ以上の部材を接続して構成することも可能である。 The first core part 110 and the second core part 120 can be connected by a method such as welding. For example, the core wire 100 can be configured by a single continuous member, or can be configured by connecting three or more members.
 図2に示すように、コイル部材200を形成する線状体205とコアワイヤ100の第1コア部110は、先端側固定部160、先端側固定部160よりも基端側に配置された中間固定部170、および中間固定部170よりも基端側に配置された基端側固定部180の三つの固定部を介して固定している。 As shown in FIG. 2, the linear body 205 forming the coil member 200 and the first core portion 110 of the core wire 100 are fixed to the distal end side fixing portion 160 and the proximal end side relative to the distal end side fixing portion 160. It is fixed via three fixing portions of a base end side fixing portion 180 disposed on the base end side with respect to the portion 170 and the intermediate fixing portion 170.
 先端側固定部160は、コアワイヤ100の先端部(第1コア部110の先端部)101と、コイル部材200を形成する第1線状体206において最も先端に配置された部分(コイル部材200の第1領域210の先端部を形成する部分)206aを固定している。 The distal-end-side fixing portion 160 includes the distal end portion of the core wire 100 (the distal end portion of the first core portion 110) 101 and the portion disposed at the most distal end of the first linear body 206 forming the coil member 200 (of the coil member 200). The portion 206a that forms the tip of the first region 210 is fixed.
 先端側固定部160は、先端に向けて凸状に湾曲しつつ外形が小さくなるテーパー状に形成している。なお、先端側固定部160の軸方向における長さや、先端側に湾曲する曲率等は特に限定されず、適宜変更することが可能である。 The front end side fixing portion 160 is formed in a taper shape that is curved in a convex shape toward the front end and has a smaller outer shape. In addition, the length in the axial direction of the distal end side fixing portion 160, the curvature curved toward the distal end side, and the like are not particularly limited, and can be changed as appropriate.
 中間固定部170は、第1線状体206、第2線状体207、および第1コア部110の三つの部材を固定している。具体的には、中間固定部170は、コイル部材200を形成する第1線状体206において最も基端に配置された部分(コイル部材200の第2領域220の基端部を形成する部分)206bと、コアワイヤ100の第1コア部110の第2テーパー部112の基端部を固定している。また、中間固定部170は、第1線状体206においても最も基端に配置された部分(コイル部材200の第2領域220の基端部を形成する部分)206bと、第2線状体207において最も先端に配置された部分(コイル部材200の第3領域230の先端部を形成する部分)207aを固定している。 The intermediate fixing part 170 fixes three members of the first linear body 206, the second linear body 207, and the first core part 110. Specifically, the intermediate fixing portion 170 is the portion that is disposed at the most proximal end in the first linear body 206 that forms the coil member 200 (the portion that forms the proximal end portion of the second region 220 of the coil member 200). 206b and the base end part of the 2nd taper part 112 of the 1st core part 110 of the core wire 100 are being fixed. In addition, the intermediate fixing portion 170 includes a portion (a portion that forms the proximal end portion of the second region 220 of the coil member 200) 206b disposed most proximally in the first linear body 206, and a second linear body. A portion 207a disposed at the most distal end (portion forming the distal end portion of the third region 230 of the coil member 200) 207a is fixed.
 基端側固定部180は、コイル部材200を形成する第2線状体207において最も基端に配置された部分(コイル部材200の第3領域230の基端部を形成する部分)207bと、コアワイヤ100の第1コア部110の外形一定部113を固定している。 The proximal end side fixing portion 180 is a portion (the portion that forms the proximal end portion of the third region 230 of the coil member 200) 207b disposed at the most proximal end in the second linear body 207 that forms the coil member 200; The fixed outer shape portion 113 of the first core portion 110 of the core wire 100 is fixed.
 各固定部160、170、180は、例えば、所定の形状に整形した半田や接着剤等で形成することができる。 Each fixing part 160, 170, 180 can be formed with, for example, solder or adhesive shaped into a predetermined shape.
 図1に示すように、コイル部材200の外表面には第1被覆層310を設けている。第1被覆層310は、例えば、セルロース系高分子物質、ポリエチレンオキサイド系高分子物質、無水マレイン酸系高分子物質(例えば、メチルビニルエーテル-無水マレイン酸共重合体のような無水マレイン酸共重合体)、アクリルアミド系高分子物質(例えば、ポリアクリルアミド、ポリグリシジルメタクリレート-ジメチルアクリルアミド(PGMA-DMAA)のブロック共重合体)、水溶性ナイロン、ポリビニルアルコール、ポリビニルピロリドン等からなる公知の親水性物質で形成することができる。 As shown in FIG. 1, a first coating layer 310 is provided on the outer surface of the coil member 200. The first coating layer 310 is made of, for example, a cellulose polymer material, a polyethylene oxide polymer material, a maleic anhydride polymer material (for example, a maleic anhydride copolymer such as a methyl vinyl ether-maleic anhydride copolymer). ), Acrylamide polymer materials (eg, polyacrylamide, polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA) block copolymer), water-soluble nylon, polyvinyl alcohol, polyvinyl pyrrolidone, etc. can do.
 図1に示すように、コアワイヤ100の第2コア部120の外表面には第2被覆層320を設けている。第2被覆層320は、例えば、PTFEやETFE等のフッ素系樹脂で形成することができる。 As shown in FIG. 1, a second coating layer 320 is provided on the outer surface of the second core portion 120 of the core wire 100. The second coating layer 320 can be formed of, for example, a fluorine resin such as PTFE or ETFE.
 各被覆層310、320の厚さは特に限定されないが、例えば、0.1~100μm程度に形成することができる。 The thickness of each of the coating layers 310 and 320 is not particularly limited, but can be formed to about 0.1 to 100 μm, for example.
 次に、コイル部材200の各部の寸法等について説明する。 Next, the dimensions of each part of the coil member 200 will be described.
 図3に示すように、コイル部材200の第1領域210の内径(コイル部材200が形成する内径)d1は、コイル部材200の第2領域220の内径d2およびコイル部材200の第3領域230の内径d3と略同一である。 As shown in FIG. 3, the inner diameter d1 (the inner diameter formed by the coil member 200) d1 of the first region 210 of the coil member 200 is equal to the inner diameter d2 of the second region 220 of the coil member 200 and the third region 230 of the coil member 200. It is substantially the same as the inner diameter d3.
 上記の「内径が略同一である」とは、コイル部材200の各領域210、220、230の柔軟性が各内径の相違の影響を受けて著しく異なるものとならない程度に同一であることを意味する。例えば、製造公差に基づく寸法の相違は上記略同一の範囲に含まれる。また、本明細書において説明する上記内径以外における寸法に関する「略同一」は、発明の効果が損なわれることがない範囲で同一であることを意味し、少なくとも製造公差に基づく寸法の相違は略同一に含まれるものとする。 The above-mentioned "inner diameters are substantially the same" means that the flexibility of each region 210, 220, 230 of the coil member 200 is the same to the extent that it does not become significantly different due to the influence of the different inner diameters. To do. For example, the difference in dimensions based on manufacturing tolerances is included in the substantially same range. Further, “substantially the same” regarding dimensions other than the inner diameter described in the present specification means that they are the same as long as the effects of the invention are not impaired, and at least the differences in dimensions based on manufacturing tolerances are substantially the same. Shall be included.
 図4に示すように、コイル部材200の第1領域210を形成する第1線状体206の各部(軸方向に沿う断面図上において円形で示される線状体205の素線部分)の外径は、先端から基端に向けて大きくなっている。 As shown in FIG. 4, outside of each part of the first linear body 206 forming the first region 210 of the coil member 200 (wire portion of the linear body 205 shown in a circle on the cross-sectional view along the axial direction). The diameter increases from the distal end toward the proximal end.
 コイル部材200の第1領域210は、第1線状体206において先端側から中間部にかけて配置された5つの部分206a、206d、206e、206f、206cで形成している。なお、第1領域210において最も基端に配置された部分206cは、先端側の一部が第1領域210に含まれており、基端側の一部が第2領域220に含まれている。 The first region 210 of the coil member 200 is formed by five portions 206a, 206d, 206e, 206f, and 206c arranged from the tip side to the middle portion of the first linear body 206. In the first region 210, the portion 206c arranged at the most proximal end includes a portion on the distal end side in the first region 210 and a portion on the proximal end side in the second region 220. .
 コイル部材200の第2領域220を形成する第1線状体206の各部の外径は、先端から基端に向けて小さくなっている。 The outer diameter of each part of the first linear body 206 forming the second region 220 of the coil member 200 decreases from the distal end toward the proximal end.
 コイル部材200の第2領域220は、第1線状体206において中間部から基端側にかけて配置された4つの部分206c、206g、206h、206bで形成している。前述したように、第1線状体206において第2領域220の最も先端に配置された部分206cは、先端側の一部が第1領域210に含まれており、基端側の一部が第2領域220に含まれている。 The second region 220 of the coil member 200 is formed by four portions 206c, 206g, 206h, and 206b arranged from the intermediate portion to the proximal end side in the first linear body 206. As described above, in the first linear body 206, the portion 206c disposed at the most distal end of the second region 220 includes a portion on the distal end side in the first region 210, and a portion on the proximal end side. It is included in the second region 220.
 第1線状体206においてコイル部材200の第2領域220の基端部を形成する部分206bの基端側には、中間固定部170を間に挟んで(図2を参照)、第2線状体207においてコイル部材200の第3領域230の先端部を形成する部分207aを配置している。 In the first linear body 206, an intermediate fixing portion 170 is sandwiched between the proximal end side of the portion 206b that forms the proximal end portion of the second region 220 of the coil member 200 (see FIG. 2), and the second wire A portion 207 a that forms the tip of the third region 230 of the coil member 200 is disposed in the cylindrical body 207.
 コイル部材200の第3領域230を形成する第2線状体207は、各部における外径が略同一である。したがって、コイル部材200の第3領域230の外形は、軸方向に沿って直線状をなしている。 The second linear body 207 forming the third region 230 of the coil member 200 has substantially the same outer diameter in each part. Therefore, the outer shape of the third region 230 of the coil member 200 is linear along the axial direction.
 第1線状体206においてコイル部材200の第1領域210の先端部を形成する部分206aの外径Df1は、第1線状体206においてコイル部材200の第2領域220の基端部を形成する部分206bの外径Df2と略同一である。 The outer diameter Df1 of the portion 206a that forms the distal end portion of the first region 210 of the coil member 200 in the first linear body 206 forms the proximal end portion of the second region 220 of the coil member 200 in the first linear body 206. It is substantially the same as the outer diameter Df2 of the portion 206b to be operated.
 また、第1線状体206においてコイル部材200の第2領域220の基端部を形成する部分206bの外径Df2は、第2線状体207においてコイル部材200の第3領域230の先端部を形成する部分207aの外径Df3と略同一である。なお、第2線状体207は、軸方向の各部における外径が略同一であるため、第2線状体207においてコイル部材200の第3領域230の基端部を形成する部分207bの外径Df4は、第2線状体207においてコイル部材200の第3領域230の先端部を形成する部分207aの外径Df3と略同一である。つまり、本実施形態では、線状体205の各部の外径Df1、Df2、Df3、Df4は、略同一に形成している。 In addition, the outer diameter Df2 of the portion 206b that forms the proximal end portion of the second region 220 of the coil member 200 in the first linear body 206 is equal to the distal end portion of the third region 230 of the coil member 200 in the second linear body 207. Is substantially the same as the outer diameter Df3 of the portion 207a forming the. Since the second linear body 207 has substantially the same outer diameter at each part in the axial direction, the outside of the portion 207b that forms the proximal end portion of the third region 230 of the coil member 200 in the second linear body 207. The diameter Df4 is substantially the same as the outer diameter Df3 of the portion 207a that forms the tip of the third region 230 of the coil member 200 in the second linear body 207. That is, in the present embodiment, the outer diameters Df1, Df2, Df3, and Df4 of each part of the linear body 205 are formed substantially the same.
 ガイドワイヤ10は、線状体205の各部の外径Df1、Df2、Df3、Df4が上記のように規定されることにより、以下のような効果を奏するものとなる。 The guide wire 10 has the following effects when the outer diameters Df1, Df2, Df3, and Df4 of each part of the linear body 205 are defined as described above.
 第1線状体206においてコイル部材200の第2領域220の基端部を形成する部分206bの外径Df2は、第2線状体207においてコイル部材200の第3領域230の先端部を形成する部分207aの外径Df3と略同一である。このため、ガイドワイヤ10は、第1線状体206と第2線状体207の境界部において物性段差(剛性の変化幅)が大きくなるのを抑制できる。これにより、ガイドワイヤ10は、第1線状体206と第2線状体207の境界部でコアワイヤ100に折れ等の破損が生じるのを防止できる。 The outer diameter Df2 of the portion 206b that forms the proximal end portion of the second region 220 of the coil member 200 in the first linear body 206 forms the distal end portion of the third region 230 of the coil member 200 in the second linear body 207. This is substantially the same as the outer diameter Df3 of the portion 207a. For this reason, the guide wire 10 can suppress an increase in physical property step (rigid change width) at the boundary between the first linear body 206 and the second linear body 207. Accordingly, the guide wire 10 can prevent the core wire 100 from being broken or broken at the boundary portion between the first linear body 206 and the second linear body 207.
 また、第1線状体206においてコイル部材200の第1領域210の先端部を形成する部分206aは、第1線状体206の他の部分に比べて外径が最も小さい。このため、ガイドワイヤ10は、コイル部材200の先端側から狭窄部Sに押し込まれる際、コイル部材200の最先端に位置する部分206aが基端側に隣接する他の部分206dに乗り上げるのを防止できる。 Further, the portion 206 a that forms the tip of the first region 210 of the coil member 200 in the first linear body 206 has the smallest outer diameter as compared with the other portions of the first linear body 206. For this reason, when the guide wire 10 is pushed into the constriction S from the distal end side of the coil member 200, the portion 206a positioned at the forefront of the coil member 200 is prevented from riding on the other portion 206d adjacent to the proximal end side. it can.
 第1線状体206においてコイル部材200の第1領域210の先端部を形成する部分206aの外径Df1、第1線状体206においてコイル部材200の第2領域220の基端部を形成する部分206bの外径Df2は、例えば、0.02mm~0.1mmに形成することができる。また、第1線状体206においてコイル部材200の最大外形部240を形成する部分206cの外径Dsは、例えば、0.04mm~0.2mmに形成することができる。第1線状体206の上記各部以外の外径は、第1領域210および第2領域220の軸方向における長さや、第1領域210および第2領域220を形成する部分の第1線状体206の巻き数等に応じて任意の大きさに形成することができる。 In the first linear body 206, the outer diameter Df1 of the portion 206a that forms the distal end portion of the first region 210 of the coil member 200, and in the first linear body 206, the proximal end portion of the second region 220 of the coil member 200 is formed. The outer diameter Df2 of the portion 206b can be formed to be 0.02 mm to 0.1 mm, for example. Further, the outer diameter Ds of the portion 206c forming the maximum outer shape portion 240 of the coil member 200 in the first linear body 206 can be formed to 0.04 mm to 0.2 mm, for example. The outer diameters of the first linear body 206 other than the above-described parts are the lengths in the axial direction of the first region 210 and the second region 220, and the first linear body of the portion forming the first region 210 and the second region 220. It can be formed in an arbitrary size according to the number of windings 206.
 第2線状体207においてコイル部材200の第3領域230を形成する各部分207a、207bの外径Df3、Df4は、上記外径Df1およびDf2と同様に、0.02mm~0.1mmに形成することができる。 The outer diameters Df3 and Df4 of the portions 207a and 207b forming the third region 230 of the coil member 200 in the second linear body 207 are formed to 0.02 mm to 0.1 mm, similar to the outer diameters Df1 and Df2. can do.
 図3に示すように、コイル部材200の最大外形部240は、第1線状体206において外径が最も大きく形成された部分206cの軸方向の略中心位置(第1線状体206において最大外形部240を形成する部分206cの中心部c1を通るとともにコアワイヤ100の軸心と直交する垂線Hの延長線上の位置)に形成している。 As shown in FIG. 3, the maximum outer shape portion 240 of the coil member 200 has a substantially central position in the axial direction of the portion 206 c formed with the largest outer diameter in the first linear body 206 (maximum in the first linear body 206. It is formed at a position on the extension line of the perpendicular H that passes through the center portion c1 of the portion 206c forming the outer shape portion 240 and is orthogonal to the axis of the core wire 100.
 コイル部材200は、コアワイヤ100の軸心を中心として螺旋状に巻回されているため、コイル部材200の最大外形部240は、コイル部材200の螺旋形状に沿って延在している。つまり、図2や図3に示す断面図上では、最大外形部240は、図面上側から図面下側に向けて斜めに螺旋状に延在している。 Since the coil member 200 is spirally wound around the axis of the core wire 100, the maximum outer shape 240 of the coil member 200 extends along the spiral shape of the coil member 200. That is, on the cross-sectional views shown in FIGS. 2 and 3, the maximum outer shape portion 240 extends in a spiral manner obliquely from the upper side of the drawing toward the lower side of the drawing.
 このため、本実施形態では、最大外形部240の軸方向と直交する方向に沿う外形寸法Dmは、第1線状体206において最大外形部240を形成する部分206cの中心部c1を通る垂線Hにおいて、コイル部材200の外形を示す仮想線200Aにより区切られた範囲の長さと定義する(図3を参照)。なお、最大外形部240の軸方向と直交する方向に沿う外形寸法Dmは、例えば、最大外形部240の軸直交断面が円形に形成される場合、最大外形部240の外径となる。 For this reason, in this embodiment, the external dimension Dm along the direction orthogonal to the axial direction of the maximum external part 240 is a perpendicular H passing through the center part c1 of the part 206c forming the maximum external part 240 in the first linear body 206. Is defined as the length of a range delimited by a virtual line 200A indicating the outer shape of the coil member 200 (see FIG. 3). The outer dimension Dm along the direction orthogonal to the axial direction of the maximum outer shape portion 240 is, for example, the outer diameter of the maximum outer shape portion 240 when the axis orthogonal cross section of the maximum outer shape portion 240 is formed in a circle.
 図3を参照して、最大外形部240の軸方向と直交する方向に沿う外形寸法Dmは、例えば、0.28mm~0.80mmに形成することができる。 Referring to FIG. 3, the external dimension Dm along the direction orthogonal to the axial direction of the maximum external part 240 can be formed to 0.28 mm to 0.80 mm, for example.
 また、コイル部材200の第1領域210の外形寸法D1は、例えば、先端側の最小の部分を0.25mm~0.61mmに形成することができ、基端側の最大の部分を0.27mm~0.79mmに形成することができる。また、コイル部材200の第2領域220の外形寸法D2は、例えば、先端側の最大の部分を0.27mm~0.79mmに形成することができ、基端側の最小の部分を0.25mm~0.61mmに形成することができる。 In addition, the outer dimension D1 of the first region 210 of the coil member 200 can be formed such that the minimum portion on the distal end side is 0.25 mm to 0.61 mm, and the maximum portion on the proximal end side is 0.27 mm. It can be formed to ˜0.79 mm. Further, the outer dimension D2 of the second region 220 of the coil member 200 can be formed such that, for example, the maximum portion on the distal end side is 0.27 mm to 0.79 mm, and the minimum portion on the proximal end side is 0.25 mm. It can be formed to 0.61 mm.
 また、コイル部材200の第3領域230の外形寸法D3は、例えば、0.24mm~0.60mmで軸方向に沿って一定の大きさで形成することができる。 Further, the outer dimension D3 of the third region 230 of the coil member 200 can be formed with a constant size along the axial direction, for example, 0.24 mm to 0.60 mm.
 また、コイル部材200の第1領域210の内径d1、コイル部材200の第2領域220の内径d2、およびコイル部材200の第3領域230の内径d3は、例えば、0.2mm~0.4mmに形成することができる。 The inner diameter d1 of the first region 210 of the coil member 200, the inner diameter d2 of the second region 220 of the coil member 200, and the inner diameter d3 of the third region 230 of the coil member 200 are, for example, 0.2 mm to 0.4 mm. Can be formed.
 図2を参照して、コイル部材200の第1領域210の軸方向に沿う長さL1は、例えば、コイル部材200の第2領域220の軸方向に沿う長さL2よりも長く形成することができる。 With reference to FIG. 2, length L1 along the axial direction of the 1st area | region 210 of the coil member 200 may be formed longer than length L2 along the axial direction of the 2nd area | region 220 of the coil member 200, for example. it can.
 上記のように長さL1と長さL2の関係を調整すると、コイル部材200の軸方向に沿う全長(コイル部材200がコアワイヤ100の周囲に巻き付けられた部分の軸方向に沿う長さ)に対して、先端側に向けて外形が小さくなる第1領域210の軸方向に沿う長さL1がより長く確保される。これにより、ガイドワイヤ10は、コイル部材200の先端形状を先端側に向けてより鋭角(先端に尖るような形状)に形成することができる。 When the relationship between the length L1 and the length L2 is adjusted as described above, the total length along the axial direction of the coil member 200 (the length along the axial direction of the portion where the coil member 200 is wound around the core wire 100). Thus, the length L1 along the axial direction of the first region 210 whose outer shape becomes smaller toward the distal end side is secured longer. Thereby, the guide wire 10 can be formed in a more acute angle (a shape that is sharp at the tip) with the tip shape of the coil member 200 facing the tip side.
 また、コイル部材200の第3領域230の軸方向に沿う長さL3は、例えば、第1領域210の軸方向に沿う長さL1と第2領域220の軸方向に沿う長さL2を足し合わせた長さよりも長く形成することができる。 The length L3 along the axial direction of the third region 230 of the coil member 200 is, for example, the sum of the length L1 along the axial direction of the first region 210 and the length L2 along the axial direction of the second region 220. It can be formed longer than the length.
 上記のように長さL1、L2、L3の関係を調整すると、第3領域230の軸方向に沿う長さL3は、コイル部材200の軸方向に沿う全長に占める割合が大きくなる。これにより、コイル部材200において第1領域210および第2領域220が形成された部分は、コイル部材200の先端側寄りに形成される。 When the relationship between the lengths L1, L2, and L3 is adjusted as described above, the ratio of the length L3 along the axial direction of the third region 230 to the total length along the axial direction of the coil member 200 increases. Thereby, the part in which the first region 210 and the second region 220 are formed in the coil member 200 is formed closer to the distal end side of the coil member 200.
 なお、第1領域210および第2領域220をコイル部材200のより先端側に形成するために、例えば、第3領域230は、コイル部材200の軸方向に沿う全長の50%以上の長さで形成することが好ましい。 In order to form the first region 210 and the second region 220 on the more distal end side of the coil member 200, for example, the third region 230 has a length of 50% or more of the total length along the axial direction of the coil member 200. Preferably formed.
 コイル部材200の長さに関する上記寸法関係を満たす例として、ガイドワイヤ10の軸方向に沿う長さ(全長)を、例えば、1750mm~3050mmに形成する場合、コイル部材200の軸方向に沿う長さ(全長)は、例えば、191mm~310mmに形成することができる。また、この場合、第1領域210の軸方向に沿う長さL1は、例えば、0.5mm~30mmに形成することができる。また、第2領域220の軸方向に沿う長さL2は、例えば、0.5mm~30mmに形成することができる。また、第3領域230の軸方向に沿う長さL3は、例えば、190mm~250mmに形成することができる。なお、コイル部材200の第1領域210の軸方向に沿う長さL1は、コイル部材200の第2領域220の軸方向に沿う長さL2よりも長く形成することが好ましい。 As an example of satisfying the above dimensional relationship regarding the length of the coil member 200, when the length (full length) along the axial direction of the guide wire 10 is, for example, 1750 mm to 3050 mm, the length along the axial direction of the coil member 200 The (full length) can be formed to 191 mm to 310 mm, for example. In this case, the length L1 along the axial direction of the first region 210 can be formed to 0.5 mm to 30 mm, for example. Further, the length L2 along the axial direction of the second region 220 can be formed to 0.5 mm to 30 mm, for example. Further, the length L3 along the axial direction of the third region 230 can be formed to 190 mm to 250 mm, for example. The length L1 along the axial direction of the first region 210 of the coil member 200 is preferably formed longer than the length L2 along the axial direction of the second region 220 of the coil member 200.
 次に、図5および図6を参照して、ガイドワイヤ10の作用について説明する。図5および図6には、血管に形成された狭窄部Sにガイドワイヤ10を押し込んで貫通させる前後の様子を模式的な断面図で示している。 Next, the action of the guide wire 10 will be described with reference to FIGS. 5 and 6 are schematic sectional views showing the state before and after the guide wire 10 is pushed through the stenosis S formed in the blood vessel and penetrated.
 図5に示すように、術者等は、狭窄部Sに向けてガイドワイヤ10を先端側へ押し込むと、コイル部材200の第1領域210の先端側からガイドワイヤ10が狭窄部S内に押し込まれる。ガイドワイヤ10のコイル部材200は、最先端に位置する第1領域210の外形が基端側から先端側に向けて小さくなっているため、狭窄部Sに対する押し込み力が高められている。これにより、術者等は、狭窄部S内にガイドワイヤ10を円滑に押し込むことができる。 As shown in FIG. 5, when the surgeon or the like pushes the guide wire 10 toward the narrowed portion S toward the distal end side, the guide wire 10 is pushed into the narrowed portion S from the distal end side of the first region 210 of the coil member 200. It is. In the coil member 200 of the guide wire 10, since the outer shape of the first region 210 located at the foremost end becomes smaller from the proximal end side toward the distal end side, the pushing force against the narrowed portion S is increased. Thereby, the surgeon or the like can smoothly push the guide wire 10 into the narrowed portion S.
 図6に示すように、術者等は、ガイドワイヤ10を狭窄部S内へさらに押し込むことにより、コイル部材200の第1領域210に続いてコイル部材200の第2領域220を狭窄部S内に進入させる。 As shown in FIG. 6, the surgeon or the like pushes the guide wire 10 further into the constriction S, thereby bringing the second region 220 of the coil member 200 into the constriction S following the first region 210 of the coil member 200. To enter.
 ガイドワイヤ10のコイル部材200の第2領域220は、基端側に向けて外形が小さくなっているため、第2領域220が狭窄部S内を移動する際、第2領域220と狭窄部Sとの間の接触面積が小さくなる。その結果、コイル部材200の第2領域220が狭窄部Sから受ける貫通抵抗が小さくなる。これにより、術者等は、コイル部材200の第1領域210に続いて第2領域220を、さらに第2領域220に続いて第3領域230を狭窄部S内へ容易に押し込むことができ、狭窄部S内でガイドワイヤ10を円滑に移動させることができる。 Since the outer shape of the second region 220 of the coil member 200 of the guide wire 10 decreases toward the proximal end side, the second region 220 and the constricted portion S are moved when the second region 220 moves in the constricted portion S. The contact area between and becomes smaller. As a result, the penetration resistance that the second region 220 of the coil member 200 receives from the constriction S is reduced. Thereby, the surgeon or the like can easily push the second region 220 following the first region 210 of the coil member 200 and the third region 230 following the second region 220 into the stenosis S, The guide wire 10 can be smoothly moved in the narrowed portion S.
 また、ガイドワイヤ10は、コイル部材200を形成する第1線状体206の外径を調整してコイル部材200の外形を制御(整形)しているため、コイル部材200の各領域210、220、230における内径d1、d2、d3を所定の大きさに維持することができ、柔軟性を確保できる。さらに、ガイドワイヤ10は、コイル部材200の第1領域210の内径d1およびコイル部材200の第2領域220の内径d2が略同一である。つまり、ガイドワイヤ10は、コイル部材200の最大外形部240における内径が過度に大きく形成されていないため、コイル部材200の内径の増加に伴う最大外形部240の外形の増加が抑えられている。このため、ガイドワイヤ10は、コイル部材200が狭窄部Sを貫通する際に、コイル部材200の最大外形部240が受ける応力集中が低減する。これにより、ガイドワイヤ10は、狭窄部Sに対するガイドワイヤ10の押し込み性がより一層向上したものとなり、さらに、最大外形部240を形成する第1線状体206(206c)が基端側に乗り上げるのを防止できる。 Further, since the guide wire 10 controls (shapes) the outer shape of the coil member 200 by adjusting the outer diameter of the first linear body 206 forming the coil member 200, the regions 210 and 220 of the coil member 200 are controlled. , 230 can maintain the inner diameters d1, d2, and d3 at a predetermined size, thereby ensuring flexibility. Further, in the guide wire 10, the inner diameter d1 of the first region 210 of the coil member 200 and the inner diameter d2 of the second region 220 of the coil member 200 are substantially the same. That is, since the guide wire 10 is not formed with an excessively large inner diameter at the maximum outer shape portion 240 of the coil member 200, an increase in the outer shape of the maximum outer shape portion 240 accompanying an increase in the inner diameter of the coil member 200 is suppressed. For this reason, when the coil member 200 penetrates the constriction part S, the stress concentration which the largest external part 240 of the coil member 200 receives is reduced. As a result, the guide wire 10 is further improved in the pushability of the guide wire 10 with respect to the narrowed portion S, and the first linear body 206 (206c) forming the maximum outer shape portion 240 rides on the proximal end side. Can be prevented.
 以上のように、本実施形態に係るガイドワイヤ10は、コアワイヤ100と、コアワイヤ100の少なくとも先端部101に固定されたコイル部材200と、を備えており、コイル部材200は、コアワイヤ100の軸方向に沿って先端から基端に向かって、第1領域210、第2領域220、および第3領域230を有している。コイル部材200の第1領域210は、先端から基端に向かってコイル部材200を形成する第1線状体206の外径を大きくすることで、先端から基端に向かって外形が大きくなる第1傾斜部を形成し、コイル部材200の第2領域220は、先端から基端に向かってコイル部材200を形成する第1線状体206の外径を小さくすることで、先端から基端に向かって外形が小さくなる第2傾斜部を形成し、コイル部材200の第1領域210とコイル部材200の第2領域220の境界部は、コイル部材200の外形が最も大きくなる最大外形部240を形成している。そして、コイル部材200の第1領域210においてコイル部材200が形成する内径d1は、コイル部材200の第2領域220においてコイル部材200が形成する内径d2と略同一である。 As described above, the guide wire 10 according to the present embodiment includes the core wire 100 and the coil member 200 fixed to at least the distal end portion 101 of the core wire 100, and the coil member 200 is in the axial direction of the core wire 100. The first region 210, the second region 220, and the third region 230 are provided from the distal end to the proximal end along the line. In the first region 210 of the coil member 200, the outer diameter of the first linear body 206 forming the coil member 200 increases from the distal end toward the proximal end, thereby increasing the outer shape from the distal end toward the proximal end. 1 slope part is formed, and the 2nd area | region 220 of the coil member 200 reduces the outer diameter of the 1st linear body 206 which forms the coil member 200 toward a base end from a front-end | tip, and it is from a front-end | tip to a base end. A second inclined portion whose outer shape becomes smaller toward the outside is formed, and a boundary portion between the first region 210 of the coil member 200 and the second region 220 of the coil member 200 has a maximum outer shape portion 240 where the outer shape of the coil member 200 is largest. Forming. The inner diameter d1 formed by the coil member 200 in the first region 210 of the coil member 200 is substantially the same as the inner diameter d2 formed by the coil member 200 in the second region 220 of the coil member 200.
 上記のように構成したガイドワイヤ10は、コイル部材200の第1領域210により、狭窄部Sに対する押し込み力を高めることができる。コイル部材200の第2領域220は、コイル部材200の第1領域210に続いて狭窄部S内に押し込まれる際、ガイドワイヤ10が狭窄部Sから受ける貫通抵抗を低減させる。したがって、ガイドワイヤ10は、狭窄部Sに対する貫通性がより一層向上したものとなる。 The guide wire 10 configured as described above can increase the pushing force against the constriction S by the first region 210 of the coil member 200. The second region 220 of the coil member 200 reduces the penetration resistance that the guide wire 10 receives from the constriction S when being pushed into the constriction S following the first region 210 of the coil member 200. Therefore, the guide wire 10 has further improved penetrability with respect to the narrowed portion S.
 ガイドワイヤ10は、コイル部材200を形成する第1線状体206の外径を調整することで、コイル部材200が形成する内径を維持しつつ、コイル部材200の外形を制御(整形)しているため、柔軟性を確保できる。例えば、コイル部材の外形を制御するために、コイル部材を形成する線状体の外径を一定にし、線状体の巻き回し径(巻き付け径)を大きくすると、コイル部材が形成する内径は、第1傾斜部の先端側や第2傾斜部の基端側では、コイル部材の他の部分に比べて小さくせざるを得ない。コイル部材において他の部分よりも内径が小さく形成された部分は、コイル部材の柔軟性を低下させる。本実施形態に係るガイドワイヤ10は、上記のようなコイル部材200の柔軟性の低下が発生するのを防止できる。 The guide wire 10 adjusts the outer diameter of the first linear body 206 forming the coil member 200 to control (shape) the outer shape of the coil member 200 while maintaining the inner diameter formed by the coil member 200. Therefore, flexibility can be secured. For example, in order to control the outer shape of the coil member, when the outer diameter of the linear body forming the coil member is made constant and the winding diameter (winding diameter) of the linear body is increased, the inner diameter formed by the coil member is On the distal end side of the first inclined portion and the proximal end side of the second inclined portion, it must be made smaller than other portions of the coil member. A portion of the coil member that has a smaller inner diameter than the other portions reduces the flexibility of the coil member. The guide wire 10 according to the present embodiment can prevent the reduction in flexibility of the coil member 200 as described above.
 ガイドワイヤ10は、コイル部材200が形成する内径が第1領域210、第2領域220、および第1領域210と第2領域220の境界部に形成される最大外形部240で略同一に維持されるため、コイル部材200の最大外形部240を形成する際、コイル部材200の最大外形部240の外形が過度に大きくならない。これにより、ガイドワイヤ10は、コイル部材200が狭窄部Sを貫通する際、最大外形部240への応力集中を抑制できる。このため、ガイドワイヤ10は、狭窄部Sに対する押し込み性がより一層向上したものとなり、さらに、第1線状体206において最大外形部240を形成する部分207cが基端側に乗り上げるのを防止できる。 In the guide wire 10, the inner diameter formed by the coil member 200 is maintained substantially the same in the first region 210, the second region 220, and the maximum outer shape portion 240 formed at the boundary between the first region 210 and the second region 220. Therefore, when forming the maximum outer shape portion 240 of the coil member 200, the outer shape of the maximum outer shape portion 240 of the coil member 200 does not become excessively large. Thereby, when the coil member 200 penetrates the constriction part S, the guide wire 10 can suppress stress concentration on the maximum outer shape part 240. For this reason, the guide wire 10 has a further improved pushability to the narrowed portion S, and can further prevent the portion 207c forming the maximum outer shape portion 240 of the first linear body 206 from running on the proximal end side. .
 また、コアワイヤ100は、先端に向けて外形が小さくなるテーパー状に形成されており、少なくとも一部がコイル部材200の第1領域210とコアワイヤ100の周方向において重なるように配置される第1テーパー部111と、基端に向けて外形が小さくなるテーパー状に形成されており、少なくとも一部がコイル部材200の第2領域220とコアワイヤ100の周方向において重なるように配置される第2テーパー部112と、を有している。 Further, the core wire 100 is formed in a tapered shape whose outer shape becomes smaller toward the tip, and at least a part of the first taper is arranged so as to overlap the first region 210 of the coil member 200 in the circumferential direction of the core wire 100. The second taper portion is formed in a tapered shape such that the outer shape becomes smaller toward the base 111 and at least a portion thereof overlaps with the second region 220 of the coil member 200 in the circumferential direction of the core wire 100. 112.
 コイル部材200の第1領域210とコアワイヤ100の周方向において重なるように配置されたコアワイヤ100の第1テーパー部111は、コイル部材200の第1領域210とともに、狭窄部Sに対するガイドワイヤ10の押し込み性を向上させる。また、コイル部材200の第2領域220とコアワイヤ100の周方向において重なるように配置されたコアワイヤ100の第2テーパー部112は、ガイドワイヤ10が狭窄部Sに押し込まれる際、コアワイヤ100上で第1テーパー部111に応力集中が発生するのを緩和することができる。なお、コアワイヤ100は、コアワイヤ100の第1テーパー部111とコアワイヤ100の第2テーパー部112との間の境界部に最大外形部140を形成する。 The first taper portion 111 of the core wire 100 disposed so as to overlap the first region 210 of the coil member 200 in the circumferential direction of the core wire 100 is pushed into the constricted portion S together with the first region 210 of the coil member 200. Improve sexiness. In addition, the second taper portion 112 of the core wire 100 that is arranged so as to overlap the second region 220 of the coil member 200 in the circumferential direction of the core wire 100 is the first taper on the core wire 100 when the guide wire 10 is pushed into the constriction S. It is possible to mitigate the occurrence of stress concentration in the one taper portion 111. The core wire 100 forms a maximum outer shape 140 at the boundary between the first tapered portion 111 of the core wire 100 and the second tapered portion 112 of the core wire 100.
 また、ガイドワイヤ10は、コイル部材200とコアワイヤ100の第2テーパー部112の基端部とを固定する中間固定部170を有している。中間固定部170は、第1テーパー部111及び第2テーパー部112において、コアワイヤ100の他の部分よりも剛性が比較的小さく形成される第2テーパー部112の基端部をコイル部材200に対して固定(接続)することにより、第2テーパー部112の基端部でコアワイヤ100に折れ等の破損が生じるのを防止する。 Further, the guide wire 10 has an intermediate fixing portion 170 that fixes the coil member 200 and the proximal end portion of the second tapered portion 112 of the core wire 100. The intermediate fixing portion 170 has a proximal end portion of the second taper portion 112 formed at the first taper portion 111 and the second taper portion 112 that is relatively less rigid than the other portions of the core wire 100 with respect to the coil member 200. By fixing (connecting), the core wire 100 is prevented from being broken or broken at the proximal end portion of the second tapered portion 112.
 また、ガイドワイヤ10は、コイル部材200の第1領域210の軸方向に沿う長さL1がコイル部材200の第2領域220の軸方向に沿う長さL2よりも長く形成されている。このため、コイル部材200の軸方向に沿う全長に対して、先端側に向けて外形が小さくなる第1領域210の軸方向に沿う長さL1がより長く確保される。これにより、コイル部材200の先端形状は、先端側に向けてより鋭角(先端に尖るような形状)に形成できる。このため、ガイドワイヤ10は、狭窄部Sに対する押し込み性がより一層向上したものとなる。 Further, the guide wire 10 is formed such that the length L1 along the axial direction of the first region 210 of the coil member 200 is longer than the length L2 along the axial direction of the second region 220 of the coil member 200. For this reason, the length L1 along the axial direction of the 1st area | region 210 where an external shape becomes small toward the front end side with respect to the full length along the axial direction of the coil member 200 is ensured longer. Thereby, the front-end | tip shape of the coil member 200 can be formed in an acute angle (shape which sharpens to a front-end | tip) toward the front end side. For this reason, the guide wire 10 has a further improved pushability to the constriction S.
 また、ガイドワイヤ10は、コイル部材200の第3領域230の軸方向に沿う長さL3がコイル部材200の第1領域210の軸方向に沿う長さL1とコイル部材200の第2領域220の軸方向に沿う長さL2を足し合わせた長さよりも長く形成されている。このため、コイル部材200において第1領域210および第2領域220が形成された部分は、コイル部材200の先端側寄りに形成される。これにより、ガイドワイヤ10は、コイル部材200の先端側に配置された第1領域210および第2領域220により、狭窄部Sに対する貫通性が効果的に向上したものとなる。 The guide wire 10 has a length L3 along the axial direction of the third region 230 of the coil member 200 and a length L1 along the axial direction of the first region 210 of the coil member 200 and the length L3 of the second region 220 of the coil member 200. It is formed longer than the length obtained by adding the length L2 along the axial direction. For this reason, the portion of the coil member 200 where the first region 210 and the second region 220 are formed is formed closer to the tip side of the coil member 200. As a result, the guide wire 10 is effectively improved in penetrability with respect to the narrowed portion S due to the first region 210 and the second region 220 arranged on the distal end side of the coil member 200.
 また、ガイドワイヤ10は、第1線状体206においてコイル部材200の第2領域220の基端部を形成する部分206bの外径と、第2線状体207においてコイル部材200の第3領域230の先端部を形成する部分207aの外径が略同一に形成されている。このため、先端側から基端側に向かって外形が小さくなる第2領域220の基端部から第3領域230の先端部にかけて、コイル部材200は、各部分206b、207aの外径差に起因した物性段差(剛性の変化幅)が大きくなるのを抑制できる。これにより、ガイドワイヤ10は、コイル部材200の第2領域220の基端部とコイル部材200の第3領域230の先端部の境界部で折れ等の破損が生じるのを防止できる。 The guide wire 10 includes an outer diameter of a portion 206b that forms a proximal end portion of the second region 220 of the coil member 200 in the first linear body 206, and a third region of the coil member 200 in the second linear body 207. The outer diameter of the portion 207a that forms the tip of 230 is formed to be substantially the same. For this reason, the coil member 200 is caused by the difference in outer diameter between the portions 206b and 207a from the proximal end portion of the second region 220 to the distal end portion of the third region 230 whose outer shape decreases from the distal end side toward the proximal end side. It is possible to suppress an increase in the physical property step (change width of rigidity). Thereby, the guide wire 10 can prevent breakage such as breakage at the boundary portion between the proximal end portion of the second region 220 of the coil member 200 and the distal end portion of the third region 230 of the coil member 200.
 また、ガイドワイヤ10は、コアワイヤ100の先端部101とコイル部材200とを固定する先端側固定部160を有している。先端側固定部160は、先端に向けて凸状に湾曲しつつ先端に向けて外形が小さくなるテーパー状に形成されている。このように、ガイドワイヤ10は、先端側固定部160が先端側に向けてテーパー状に形成されているため、狭窄部Sに対する押し込み力がより一層向上したものとなる。また、先端側固定部160は、先端に向けて凸状に湾曲した形状を有しているため、ガイドワイヤ10を生体内で移動させる際に、ガイドワイヤ10の先端から血管等の生体器官を保護することができる。 The guide wire 10 also has a distal end side fixing portion 160 that fixes the distal end portion 101 of the core wire 100 and the coil member 200. The distal-end-side fixing portion 160 is formed in a tapered shape that is curved in a convex shape toward the distal end and whose outer shape becomes smaller toward the distal end. As described above, in the guide wire 10, the distal end fixing portion 160 is tapered toward the distal end side, so that the pushing force against the narrowed portion S is further improved. Moreover, since the distal end side fixing portion 160 has a shape that is convexly curved toward the distal end, when the guide wire 10 is moved in the living body, a living organ such as a blood vessel is moved from the distal end of the guide wire 10. Can be protected.
 また、コイル部材200の第1領域210およびコイル部材200の第2領域220を形成する第1線状体206は、コイル部材200の第3領域230を形成する第2線状体207よりも高い造影性を有している。このため、術者等は、狭窄部Sに対してガイドワイヤ10を貫通させる際、ガイドワイヤ10において貫通性が高められた部分をX線画像上において容易に確認できるため、ガイドワイヤ10を使用した処置を円滑に実施できる。 The first linear body 206 that forms the first region 210 of the coil member 200 and the second region 220 of the coil member 200 is higher than the second linear body 207 that forms the third region 230 of the coil member 200. Has contrast properties. For this reason, when the surgeon or the like allows the guide wire 10 to penetrate the stenosis S, the portion of the guide wire 10 with improved penetrability can be easily confirmed on the X-ray image, so the guide wire 10 is used. Can be implemented smoothly.
 また、コイル部材200の第1領域210およびコイル部材200の第2領域220を形成する第1線状体206は、一つの連続した部材で形成されている。一つの連続した部材で第1領域210および第2領域220を形成することにより、コイル部材200の製造作業が容易なものとなる。 Further, the first linear body 206 forming the first region 210 of the coil member 200 and the second region 220 of the coil member 200 is formed of one continuous member. By forming the first region 210 and the second region 220 with one continuous member, the coil member 200 can be manufactured easily.
 以上、実施形態を通じて本発明に係るガイドワイヤを説明したが、本発明は明細書において説明した内容のみに限定されるものでなく、特許請求の範囲の記載に基づいて適宜変更することが可能である。 As described above, the guide wire according to the present invention has been described through the embodiments. However, the present invention is not limited to the contents described in the specification, and can be appropriately changed based on the description of the scope of claims. is there.
 例えば、コイル部材を形成する線状体の巻き数や線状体の各部の外径等は、コイル部材に第1領域、第2領域、第3領域を形成し得る限り特に限定されない。 For example, the number of windings of the linear body forming the coil member and the outer diameter of each part of the linear body are not particularly limited as long as the first region, the second region, and the third region can be formed in the coil member.
 また、コイル部材の第3領域の形状として外形が一定の形状を例示したが、第3領域の形状はこのような形状のみに限定されない。例えば、第3領域は、線状体の外径が基端へ向けて小さくなることで基端へ向けて外形が小さくなる傾斜部により形成してもよい。ただし、第3領域の最大外形は、ガイドワイヤ10の貫通性の向上を図る観点より、第2領域の基端部と同等又は第2領域の基端部よりも小さく形成されることが好ましい。また、第3領域の内径は、第1領域および第2領域の内径と同一でなくてもよいし、軸方向に沿って一定の大きさでなくてもよい。 Further, the shape of the third region of the coil member is exemplified as a shape having a constant outer shape, but the shape of the third region is not limited to such a shape. For example, the third region may be formed by an inclined portion in which the outer diameter of the linear body decreases toward the base end and the outer shape decreases toward the base end. However, from the viewpoint of improving the penetrability of the guide wire 10, the maximum outer shape of the third region is preferably formed to be equal to or smaller than the base end portion of the second region. Further, the inner diameter of the third region may not be the same as the inner diameters of the first region and the second region, and may not be a constant size along the axial direction.
 また、コイル部材の各部の寸法(例えば、各領域の軸方向に沿う長さ)およびコアワイヤの各部の寸法(例えば、各部の軸方向に沿う長さ)等は、明細書において説明したものに限定されることはなく、適宜変更することが可能である。また、コイル部材を形成する材料およびコアワイヤを形成する材料についても、明細書において例示したものに限定されず、適宜変更することが可能である。 Further, the dimensions of each part of the coil member (for example, the length along the axial direction of each region), the dimensions of each part of the core wire (for example, the length along the axial direction of each part), etc. are limited to those described in the specification. It can be changed as appropriate. Further, the material forming the coil member and the material forming the core wire are not limited to those exemplified in the specification, and can be appropriately changed.
 また、ガイドワイヤは、コアワイヤの周囲に二重や三重といったように複数の層状に巻かれた構造を有していてもよい。このように構成する場合、コイル部材の第1領域の外形およびコイル部材の第2領域の外形は、最も外側に配置されるコイル部材により形成される。また、このように構成する場合、コイル部材が形成する内径は、最も内側に配置されるコイル部材が形成する内径である。 Further, the guide wire may have a structure in which the core wire is wound in a plurality of layers such as double or triple around the core wire. When comprised in this way, the external shape of the 1st area | region of a coil member and the external shape of the 2nd area | region of a coil member are formed of the coil member arrange | positioned on the outermost side. Moreover, when comprised in this way, the internal diameter which a coil member forms is an internal diameter which the coil member arrange | positioned innermost forms.
 また、コイル部材は、第1領域を形成する線状体と第2領域を形成する線状体が一つの連続した部材で形成されていなくてもよい。例えば、第1領域および最大外形部を一つの線状体で形成し、第2領域を別の線状体で形成したり、第1領域を一つの線状体で形成し、第2領域および最大外形部を別の線状体で形成したりしてもよい。 Further, the coil member may not be formed of one continuous member in which the linear body forming the first region and the linear body forming the second region are formed. For example, the first region and the maximum outer shape portion are formed by one linear body, the second region is formed by another linear body, the first region is formed by one linear body, the second region and You may form a largest external shape part with another linear body.
 また、コアワイヤの形状は図示により説明した形状により限定されない。コアワイヤは、例えば、第1テーパー部や第2テーパー部が形成されていない軸方向に沿って略直線状に延在した形状でもよい。 Further, the shape of the core wire is not limited by the shape described with reference to the drawings. For example, the core wire may have a shape extending substantially linearly along the axial direction in which the first tapered portion and the second tapered portion are not formed.
 本出願は、2017年1月23日に出願された日本国特許出願第2017-009761号に基づいており、その開示内容は、参照により全体として引用されている。 This application is based on Japanese Patent Application No. 2017-009761 filed on January 23, 2017, the disclosure of which is incorporated by reference in its entirety.
10 ガイドワイヤ、
100 コアワイヤ、
101 コアワイヤの先端部、
110 第1コア部、
111 第1テーパー部、
112 第2テーパー部、
113 外径一定部、
120 第2コア部、
140 コアワイヤの最大外形部、
160 先端側固定部、
170 中間固定部、
180 基端側固定部、
200 コイル部材、
205 線状体、
206、206a、206b、206c、206d、206e、206f、206g、206h、 第1線状体、
207、207a、207b 第2線状体、
210 第1領域(第1傾斜部)、
220 第2領域(第2傾斜部)、
230 第3領域、
240 コイル部材の最大外形部、
310 第1被覆層、
320 第2被覆層、
d1 第1領域の内径、
d2 第2領域の内径、
d3 第3領域の内径、
L1 第1領域の軸方向に沿う長さ、
L2 第2領域の軸方向に沿う長さ、
L3 第3領域の軸方向に沿う長さ、
S 狭窄部。
10 guide wire,
100 core wire,
101 The tip of the core wire,
110 first core part,
111 1st taper part,
112 second taper portion,
113 outer diameter constant part,
120 second core part,
140 The maximum outer shape of the core wire,
160 distal end side fixing portion,
170 intermediate fixing part,
180 base end side fixing part,
200 coil member,
205 linear body,
206, 206a, 206b, 206c, 206d, 206e, 206f, 206g, 206h, first linear body,
207, 207a, 207b second linear body,
210 1st area | region (1st inclination part),
220 2nd area | region (2nd inclination part),
230 third region,
240 The maximum outer shape of the coil member,
310 first covering layer,
320 second coating layer,
d1 inner diameter of the first region,
d2 inner diameter of the second region,
d3 inner diameter of the third region,
L1 is the length along the axial direction of the first region,
L2 is a length along the axial direction of the second region,
L3 is the length along the axial direction of the third region,
S Stenosis.

Claims (9)

  1.  コアワイヤと、
     前記コアワイヤの少なくとも先端部に固定されたコイル部材と、を備え、
     前記コイル部材は、前記コアワイヤの軸方向に沿って先端から基端に向かって、第1領域、第2領域、および第3領域を有し、
     前記第1領域は、先端から基端に向かって前記コイル部材を形成する線状体の外径を大きくすることで、先端から基端に向かって外形が大きくなる第1傾斜部を形成し、
     前記第2領域は、先端から基端に向かって前記コイル部材を形成する線状体の外径を小さくすることで、先端から基端に向かって外形が小さくなる第2傾斜部を形成し、
     前記第1領域と前記第2領域の境界部は、前記コイル部材の外形が最も大きくなる最大外形部を形成し、
     前記第1領域において前記コイル部材が形成する内径は、前記第2領域において前記コイル部材が形成する内径と略同一である、ことを特徴とするガイドワイヤ。
    Core wire,
    A coil member fixed to at least the tip of the core wire,
    The coil member has a first region, a second region, and a third region from the distal end toward the proximal end along the axial direction of the core wire,
    The first region forms a first inclined portion whose outer shape increases from the distal end toward the proximal end by increasing the outer diameter of the linear body forming the coil member from the distal end toward the proximal end,
    The second region forms a second inclined portion whose outer shape decreases from the distal end to the proximal end by decreasing the outer diameter of the linear body forming the coil member from the distal end toward the proximal end,
    The boundary between the first region and the second region forms a maximum outer shape where the outer shape of the coil member is the largest,
    An inner diameter formed by the coil member in the first region is substantially the same as an inner diameter formed by the coil member in the second region.
  2.  前記コアワイヤは、
     先端に向けて外形が小さくなるテーパー状に形成されており、少なくとも一部が前記第1領域と前記コアワイヤの周方向において重なるように配置される第1テーパー部と、
     基端に向けて外形が小さくなるテーパー状に形成されており、少なくとも一部が前記第2領域と前記コアワイヤの周方向において重なるように配置される第2テーパー部と、を有することを特徴とする請求項1に記載のガイドワイヤ。
    The core wire is
    A first tapered portion which is formed in a tapered shape whose outer shape becomes smaller toward the tip, and is arranged so that at least a part thereof overlaps the first region in the circumferential direction of the core wire;
    It is formed in a tapered shape whose outer shape becomes smaller toward the proximal end, and has a second tapered portion that is arranged so that at least a part thereof overlaps with the second region in the circumferential direction of the core wire. The guide wire according to claim 1.
  3.  前記コイル部材と前記コアワイヤの第2テーパー部の基端部とを固定する中間固定部を有する、ことを特徴とする請求項2に記載のガイドワイヤ。 The guide wire according to claim 2, further comprising an intermediate fixing portion that fixes the coil member and a proximal end portion of the second taper portion of the core wire.
  4.  前記第1領域の軸方向に沿う長さは、前記第2領域の軸方向に沿う長さよりも長い、ことを特徴とする請求項1~3のいずれか1項に記載のガイドワイヤ。 The guide wire according to any one of claims 1 to 3, wherein a length of the first region along the axial direction is longer than a length of the second region along the axial direction.
  5.  前記第3領域の軸方向に沿う長さは、前記第1領域の軸方向に沿う長さと前記第2領域の軸方向に沿う長さを足し合わせた長さよりも長い、ことを特徴とする請求項1~4のいずれか1項に記載のガイドワイヤ。 The length along the axial direction of the third region is longer than the sum of the length along the axial direction of the first region and the length along the axial direction of the second region. Item 5. The guidewire according to any one of Items 1 to 4.
  6.  前記第2領域の基端部を形成する前記線状体の外径と、前記第3領域の先端部を形成する前記線状体の外径は、略同一である、ことを特徴とする請求項1~5のいずれか1項に記載のガイドワイヤ。 The outer diameter of the linear body forming the proximal end portion of the second region and the outer diameter of the linear body forming the distal end portion of the third region are substantially the same. Item 6. The guide wire according to any one of Items 1 to 5.
  7.  前記コアワイヤの先端部と前記コイル部材とを固定する先端側固定部を有し、
     前記先端側固定部は、先端に向けて凸状に湾曲しつつ先端に向けて外形が小さくなるテーパー状に形成されている、ことを特徴とする請求項1~6のいずれか1項に記載のガイドワイヤ。
    A distal end side fixing portion that fixes the distal end portion of the core wire and the coil member;
    7. The tip side fixing portion is formed in a taper shape that is curved in a convex shape toward the tip end and has an outer shape that decreases toward the tip end. Guide wire.
  8.  前記第1領域を形成する前記線状体および前記第2領域を形成する前記線状体は、前記第3領域を形成する前記線状体よりも高い造影性を有することを特徴とする請求項1~7のいずれか1項に記載のガイドワイヤ。 The linear body forming the first region and the linear body forming the second region have higher contrast than the linear body forming the third region. The guide wire according to any one of 1 to 7.
  9.  前記第1領域を形成する前記線状体および前記第2領域を形成する前記線状体は、一つの連続した部材で形成されている、ことを特徴とする請求項1~8のいずれか1項に記載のガイドワイヤ。 9. The linear body forming the first region and the linear body forming the second region are formed of one continuous member. The guide wire according to the item.
PCT/JP2018/001235 2017-01-23 2018-01-17 Guide wire WO2018135534A1 (en)

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JP2017009761A JP2020039377A (en) 2017-01-23 2017-01-23 Guide wire
JP2017-009761 2017-01-23

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WO2018135534A1 true WO2018135534A1 (en) 2018-07-26

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116600848A (en) * 2020-12-22 2023-08-15 朝日英达科株式会社 Guide wire

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001212243A (en) * 2000-02-02 2001-08-07 Ci Medeikku:Kk Medical guide wire
JP2007135645A (en) * 2005-11-14 2007-06-07 Terumo Corp Guide wire
JP2014100300A (en) * 2012-11-20 2014-06-05 Asahi Intecc Co Ltd Guide wire
JP2017196368A (en) * 2016-04-28 2017-11-02 株式会社エフエムディ Medical guide wire

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001212243A (en) * 2000-02-02 2001-08-07 Ci Medeikku:Kk Medical guide wire
JP2007135645A (en) * 2005-11-14 2007-06-07 Terumo Corp Guide wire
JP2014100300A (en) * 2012-11-20 2014-06-05 Asahi Intecc Co Ltd Guide wire
JP2017196368A (en) * 2016-04-28 2017-11-02 株式会社エフエムディ Medical guide wire

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116600848A (en) * 2020-12-22 2023-08-15 朝日英达科株式会社 Guide wire

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