JP2016221199A - Medical guide wire - Google Patents

Medical guide wire Download PDF

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JP2016221199A
JP2016221199A JP2015121515A JP2015121515A JP2016221199A JP 2016221199 A JP2016221199 A JP 2016221199A JP 2015121515 A JP2015121515 A JP 2015121515A JP 2015121515 A JP2015121515 A JP 2015121515A JP 2016221199 A JP2016221199 A JP 2016221199A
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coil
diameter
tip
rear end
truncated cone
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JP5953461B1 (en
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剛 寺師
Takeshi Terashi
剛 寺師
志村 誠司
Seiji Shimura
誠司 志村
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FMD Co Ltd
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    • 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
    • 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

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Abstract

PROBLEM TO BE SOLVED: To provide a medical guide wire which is formed by inserting a core wire having a reduced diameter into an outside coil formed of wires of different kinds of metals, and constituted of outside first coil and outside second coil, capable of solving such technical problems that the outside coil formed by integrally joining wires of different kinds of metals, cannot draw a uniform arc when it is bent and deformed at a front part and a rear part of an integrally joined boundary part, and rotation transmission performance to a distal end side accompanying the reduced diameter of the core wire and piercing performance of a lesion part have to be improved.SOLUTION: Initial tension is made to act on dense winding parts of an outside first coil and an outside second coil, and torsional stress by the initial tension is set to be in a fixed range, so that, when the coil is bent and deformed at the front part and the rear part of a boundary part, a uniform arc can be drawn. In addition, a distal end part of the core wire has a concatenated truncated-cone structure satisfying a certain relational expression, in which truncated cones are concatenated, and thus, torsional moment to the distal end side is increased and piercing performance at an obstructed lesion part can be improved.SELECTED DRAWING: Figure 6

Description

この発明は、血管病変部治療用等に用いられる医療用ガイドワイヤに関する。  The present invention relates to a medical guide wire used for treating a vascular lesion.

従来血管の狭窄部、及び、完全閉塞部等の血管病変部治療に際して、先端部に単一のコイルスプリング等を設けた医療用ガイドワイヤ(以下ガイドワイヤという)を用い、又は、芯線を貫挿した内側コイルの外側に、内側コイルと同心状の外側コイルの二層構造から成るコイルスプリングを設けたガイドワイヤを用いて、先端部を血管病変部まで到達させて血管の狭窄部、及び、完全閉塞部等の血管病変部の拡径治療を行っている。  Conventional treatment of vascular lesions such as stenosis and complete occlusion of blood vessels uses a medical guide wire (hereinafter referred to as a guide wire) provided with a single coil spring or the like at the tip, or penetrates the core. Using a guide wire with a coil spring consisting of a two-layer structure of an outer coil concentric with the inner coil on the outside of the inner coil, the distal end reaches the vascular lesion, and the stenosis of the blood vessel and completely We are expanding the diameter of vascular lesions such as obstructions.

かかる場合において、ガイドワイヤを血管病変部内へ貫通させる為、手元側(後端側)から先端側への高度の、回転伝達性能と穿孔性能と繰り返し耐疲労特性を必要とする。  In such a case, in order to penetrate the guide wire into the vascular lesion, high rotation transmission performance, perforation performance, and repeated fatigue resistance from the proximal side (rear end side) to the distal end side are required.

特許文献1には、コイルの中央部に密巻き部が設けられ、この密巻き部の両端に疎巻き部が設けられたガイドワイヤが記載されている。  Patent Document 1 describes a guide wire in which a densely wound portion is provided at the center of a coil and a loosely wound portion is provided at both ends of the densely wound portion.

特許文献2には、先端部のコイルスプリングよりも後端側の芯線について、芯線の曲げ剛性等の特性に関するガイドワイヤが記載されている。  Patent Document 2 describes a guide wire related to characteristics such as the bending rigidity of the core wire with respect to the core wire on the rear end side of the coil spring at the front end portion.

特許文献3には、先端部のコイルスプリングが同心状の内側コイルと外側コイルの二層構造から成るガイドワイヤが記載されている。  Patent Document 3 describes a guide wire having a two-layer structure of an inner coil and an outer coil in which a coil spring at a tip portion is concentric.

特開2010−0222号公報JP 2010-0222 A 特許第4623906号公報Japanese Patent No. 4623906 特開平8−317989号公報JP-A-8-317989

特許文献1に記載のガイドワイヤは、コイルの両端部に疎巻き部を設け、中央部の密巻き部に初張力を作用させることにより、コイルの外周に樹脂被覆する際の偏りを防止させる技術内容である。  The guide wire described in Patent Document 1 is a technique for preventing unevenness when resin is coated on the outer periphery of a coil by providing a loosely wound portion at both ends of the coil and applying an initial tension to the densely wound portion at the center. Content.

特許文献2に記載のガイドワイヤは、芯線がステンレス鋼、又は、ニッケルチタンの超弾性金属から成り、先端部のコイルよりも後端側の芯線が長手方向に曲げ剛性が線形に変化して急激な抵抗感をなくし、術者の操作性を向上させる技術内容である。  In the guide wire described in Patent Document 2, the core wire is made of stainless steel or a nickel-titanium superelastic metal, and the core wire on the rear end side of the coil at the front end portion changes linearly in the longitudinal direction and the rigidity changes linearly. It is a technical content that eliminates a sense of resistance and improves the operability of the surgeon.

特許文献3に記載のガイドワイヤは、放射線不透過の線材から成る内側コイルと、ステンレス、形状記憶合金等から成る外側コイルとの二層構造から成り、主にばね用弾性材料から成る芯線を用いて先端側への回転伝達性能を向上させる技術内容である。  The guide wire described in Patent Document 3 has a two-layer structure of an inner coil made of a radiopaque wire and an outer coil made of stainless steel, a shape memory alloy, etc., and uses a core wire made mainly of an elastic material for a spring. The technical contents to improve the rotation transmission performance to the tip side.

そして、特許文献1〜3のいずれについても、本発明のような異種金属の線材を用いて2つのコイルを一体化させた外側コイルについて、コイルの初張力に着目して初張力によるねじり応力を一定範囲とすることにより、屈曲変形させた場合に均一な円弧を描くと共に、コイルに作用する初張力を利用して屈曲蛇行血管内での挿入性を向上させる技術内容についての記載はない。又、コイル内の芯線について、芯線が連接截頭円錐体の構造を備えることにより、後端側の回転角度を減少させて、先端側へのねじり力を増大させ、さらに初張力が作用するコイルとを兼備することにより、先端側への高度の回転伝達性能と完全閉塞病変部での穿孔性能を向上させた技術内容については、何ら記載されていない。これらの性能は、血管病変部でガイドワイヤを通過させる為の重要な技術課題である。  And in any of patent documents 1-3, about the outer coil which united two coils using the wire of different metals like this invention, paying attention to the initial tension of a coil, the torsional stress by initial tension is applied. There is no description of the technical contents that draw a uniform arc when bent and deformed by using a certain range, and improve the insertion property in the bent meandering blood vessel using the initial tension acting on the coil. In addition, with respect to the core wire in the coil, the core wire has a structure of an articulated truncated cone, so that the rotation angle on the rear end side is decreased, the torsional force toward the front end side is increased, and the initial tension acts. Thus, there is no description of the technical contents that improve the high rotation transmission performance to the distal end side and the perforation performance in the completely occluded lesion. These performances are important technical issues for passing a guide wire through a vascular lesion.

本発明は、上記課題を鑑みてなされたものであり、屈曲蛇行血管内、及び血管病変部での通過性を飛躍的に向上させるガイドワイヤを提供することを目的とする。  The present invention has been made in view of the above problems, and an object of the present invention is to provide a guide wire that dramatically improves the passability in a bent meandering blood vessel and in a vascular lesion.

上記目的を達成する為、本発明のガイドワイヤは、後端側から先端側へ徐変縮径する部分を有する芯線の芯線先端部を外側コイル内へ貫挿する。
外側コイルは、先端側が放射線不透過性の線材を螺旋状に巻回した外側第1コイルと、後端側が放射線透過性の線材を螺旋状に巻回した外側第2コイルから成る。
外側第1コイルの先端と芯線先端部の先端と接合して先端接合部とし、外側第2コイルの後端と芯線先端部の後端と接合して外側第2コイル後端接合部とする。
In order to achieve the above-mentioned object, the guide wire of the present invention inserts the core wire tip end portion of the core wire having a portion gradually changing from the rear end side toward the tip end side into the outer coil.
The outer coil is composed of an outer first coil in which a radiopaque wire is wound spirally on the front end side, and an outer second coil in which a radiation transparent wire is spirally wound on the rear end side.
The tip of the outer first coil and the tip of the core wire tip are joined to form a tip joint, and the rear end of the outer second coil and the tail of the core wire tip are joined to form the outer second coil rear end joint.

外側第1コイルは、白金とニッケルの合金から成る放射線不透過性の線材を、後端側が密巻きで先端側が疎巻きに巻回する。外側第2コイルは、ステンレス鋼から成る放射線透過性の線材を密巻きに巻回する。  The outer first coil is formed by winding a radiopaque wire made of an alloy of platinum and nickel so that the rear end side is closely wound and the front end side is loosely wound. The outer second coil winds a radiolucent wire made of stainless steel in a tight winding.

外側第1コイルと外側第2コイルは、ばね指数が2.8以上6.8以下で、外側第1コイルと外側第2コイルとのコイル平均径の差が10%以内のとき、外側第1コイルの密巻きの初張力によるねじり応力をτ1とし、外側第2コイルの密巻きの初張力によるねじり応力をτ2とした場合に、外側第1コイルのねじり応力τ1は、
0.62τ2≦τ1≦1.02τ2
の関係式を満たす。
When the outer first coil and the outer second coil have a spring index of 2.8 to 6.8 and the difference in coil average diameter between the outer first coil and the outer second coil is within 10%, the outer first coil When the torsional stress due to the initial tension of the tight winding of the coil is τ1, and the torsional stress due to the initial tension of the tight winding of the outer second coil is τ2, the torsional stress τ1 of the outer first coil is
0.62τ2 ≦ τ1 ≦ 1.02τ2
Is satisfied.

芯線先端部は、少なくとも2個以上の截頭円錐体を長手方向に連接した連接截頭円錐体で、1個の截頭円錐体は、長手方向の長さが後端側の截頭円錐体から先端側の截頭円錐体へ向かって徐変減少し、かつ、後端の径大外径と先端の径小外径との外径比(後端の径大外径/先端の径小外径)が、後端側の截頭円錐体から先端側の截頭円錐体へ向かって徐変増大する。  The leading end of the core wire is an articulated truncated cone in which at least two truncated cones are connected in the longitudinal direction, and one truncated cone is a truncated cone whose longitudinal length is the rear end side. Gradually decreases from the tip end to the truncated cone, and the outer diameter ratio between the outer diameter of the rear end and the outer diameter of the tip is smaller (the outer diameter of the rear end is larger / the outer diameter of the tip is smaller). (Outer diameter) gradually increases from the truncated cone on the rear end side toward the truncated cone on the distal end side.

そして、連接截頭円錐体の最大外径がD0で、最小外径をD1、全長がL、最大外径D0の横断面の中心位置から先端へ、任意の位置Xにおける連接截頭円錐体の外径をDmとし、任意の位置Xが0<X<Lの関係にある場合に、連接截頭円錐体の外径Dmは、
Dm>{D0−(D0−D1)X/L}の関係式を満たし、連接截頭円錐体の外側に、初張力が作用する外側第1コイルの密巻きと外側第2コイルの密巻きとを備えたことを特徴とする。
The maximum width of the connecting truncated cone is D0, the minimum outer diameter is D1, the total length is L, and the maximum outer diameter D0 from the center position of the cross-section to the tip of the connecting truncated cone is at an arbitrary position X. When the outer diameter is Dm and the arbitrary position X is in a relationship of 0 <X <L, the outer diameter Dm of the connecting truncated cone is
Dm> {D0− (D0−D1) X / L} satisfying the relational expression, and the outer winding of the outer first coil and the outer winding of the outer second coil on the outside of the connecting truncated cone It is provided with.

外側コイルは、後端側から先端側へ向かって後端径大等径部と中間テーパ部と先端径小部を備え、後端径大等径部と中間テーパ部は密巻きで、先端径小等径部は先端側に疎巻きを有する。
外側コイルは、後端径大等径部の外側第2コイルと、中間テーパ部と先端径小等径部との外側第1コイルから成る。又は、後端径大等径部と中間テーパ部の後端側との外側第2コイルと、中間テーパ部の先端側と先端径小等径部との外側第1コイルから成る。
The outer coil has a rear end diameter large equal diameter portion, an intermediate taper portion, and a small tip diameter portion from the rear end side toward the front end side. The small-diameter portion has a loose winding on the tip side.
The outer coil is composed of an outer second coil having a large rear end diameter equal diameter portion and an outer first coil having an intermediate taper portion and a small tip diameter equal diameter portion. Or it consists of an outer second coil on the rear end side of the rear end diameter large diameter portion and the intermediate taper portion, and an outer first coil on the front end side of the intermediate taper portion and the smaller end diameter equal diameter portion.

連接截頭円錐体は、先端の截頭円錐体を第1截頭円錐体とし、第1截頭円錐体の外側に、外側コイルの中間テーパ部を配置する。第1截頭円錐体の外径が、後端から先端へ徐変減少するのに伴って、外側コイルの中間テーパ部の密巻きの初張力が、後端から先端へ徐変増大する。  The articulated truncated cone has a truncated cone at the tip as a first truncated cone, and an intermediate taper portion of the outer coil is disposed outside the first truncated cone. As the outer diameter of the first truncated cone gradually decreases from the rear end to the tip, the initial tension of the tight winding of the intermediate taper portion of the outer coil gradually increases from the rear end to the tip.

外側コイルの後端径大等径部の外径をB1、先端径小等径部の外径をB2、連接截頭円錐体の第1截頭円錐体の後端の径大外径をD2とした場合に、第1截頭円錐体の先端の径小外径がD1であることから、第1截頭円錐体の径大外径D2と径小外径D1との外径比(D2/D1)は、外側コイルの外径比(B1/B2)よりも大きい{(D2/D1)>(B1/B2)}。  The outer diameter of the outer coil having the same diameter at the rear end of the outer coil is B1, the outer diameter of the smaller diameter portion at the tip is B2, and the outer diameter of the rear end of the first truncated cone of the connecting truncated cone is D2. In this case, since the small outer diameter at the tip of the first truncated cone is D1, the outer diameter ratio (D2) between the large outer diameter D2 and the small outer diameter D1 of the first truncated cone. / D1) is larger than the outer coil outer diameter ratio (B1 / B2) {(D2 / D1)> (B1 / B2)}.

外側コイルと内側コイルは、後端側から先端側へ向かって後端径大等径部と中間テーパ部と先端径小等径部とを備える。内側コイルは、芯線先端部の外側で、外側コイルの内側に、外側コイルよりも長手方向の長さが短く同心状に配置する。
又、外側コイルの先端と内側コイルの先端径小等径部の先端と芯線先端部の先端と接合して先端接合部とし、内側コイルの後端径大等径部の後端と芯線先端部と接合して内側コイル後端接合部とする。
内側コイルは、ステンレス鋼から成る放射線透過性の線材を用いて、後端径大等径部と中間テーパ部は密巻きで、先端径小等径部の先端側が疎巻きに巻回する。
The outer coil and the inner coil include a rear end diameter large equal diameter portion, an intermediate taper portion, and a front end diameter small equal diameter portion from the rear end side toward the front end side. The inner coil is disposed concentrically with a shorter length in the longitudinal direction than the outer coil, inside the outer coil, outside the tip of the core wire.
Also, the front end of the outer coil, the front end of the inner coil with a smaller diameter part and the front end of the core wire are joined to form a front end joint, and the rear end diameter of the inner coil with the larger diameter part and the front end of the core wire are joined. To be the inner coil rear end joint.
The inner coil is made of a radiolucent wire made of stainless steel. The rear end diameter large-diameter portion and the intermediate taper portion are closely wound, and the front end side of the small end diameter equal-diameter portion is wound loosely.

連接截頭円錐体の先端の第1截頭円錐体の外側に、内側コイルの中間テーパ部と外側コイルの中間テーパ部とを配置し、第1截頭円錐体の外径が、後端側から先端側へ徐変減少するのに伴って、外側第1コイルの中間テーパ部の密巻きの初張力と内側コイルの中間テーパ部の初張力とが共に、後端側から先端側へ徐変増大する。  An intermediate taper portion of the inner coil and an intermediate taper portion of the outer coil are disposed outside the first truncated cone at the tip of the articulated truncated cone, and the outer diameter of the first truncated cone is on the rear end side. As the gradual decrease from the leading end to the leading end side, both the initial winding tension of the intermediate taper portion of the outer first coil and the initial tension of the intermediate taper portion of the inner coil gradually change from the rear end side to the leading end side. Increase.

本発明のガイドワイヤは、外側コイルは、先端側が白金とニッケルの合金から成る放射線不透過性の線材を先端側が疎巻きに巻回した外側第1コイルと、後端側がステンレス鋼から成る放射線透過性の線材を密巻きに巻回した外側第2コイルから成る。
外側第1コイルと外側第2コイルは、ばね指数が2.8以上6.8以下で、外側第1コイルと外側第2コイルとのコイル平均径の差が10%以内のとき、外側第1コイルの密巻きの初張力によるねじり応力をτ1とし、外側第2コイルの密巻きの初張力によるねじり応力をτ2とした場合に、外側第1コイルのねじり応力τ1は、
0.62τ2≦τ1≦1.02τ2
の関係式を満たす。
この理由は、外側コイルに、放射線不透過性の線材と放射線透過性の線材との異種金属線を巻回して一体化したコイルは、異種金属のそれぞれの線材のもつ機械的強度特性の差から屈曲変形させた場合に、一体化した接合部を境にして曲率半径が異なり、均一な円弧を描くことができない。又、手元側を回転させた場合に、異種金属の線材のもつねじり応力の差から、一体化した接合部を境にしてねじり溜まりが発生し、先端側への回転伝達性能が劣ることとなる。
密巻きコイルの巻回成形によって発生する初張力の強弱から初張力によるねじり応力を制御し、外側第1コイルのねじり応力τ1と外側第2コイルのねじり応力τ2とを前記一定範囲とすることにより、屈曲変形させた場合に接合部での異なる曲率半径の発生を低減させて均一な円弧形状を描く為と、接合部でのねじり溜まりを防いで、先端側への回転伝達性能の向上を図る為である。
In the guide wire of the present invention, the outer coil is composed of an outer first coil in which a distal end side is wound with a radiopaque wire made of an alloy of platinum and nickel, and a distal end side made of stainless steel. It consists of an outer second coil wound with a dense wire.
When the outer first coil and the outer second coil have a spring index of 2.8 to 6.8 and the difference in coil average diameter between the outer first coil and the outer second coil is within 10%, the outer first coil When the torsional stress due to the initial tension of the tight winding of the coil is τ1, and the torsional stress due to the initial tension of the tight winding of the outer second coil is τ2, the torsional stress τ1 of the outer first coil is
0.62τ2 ≦ τ1 ≦ 1.02τ2
Is satisfied.
The reason for this is that the coil in which the dissimilar metal wire of the radiopaque wire and the radiolucent wire is wound around the outer coil is integrated into the outer coil because of the difference in mechanical strength characteristics of the respective dissimilar metal wires. When bent and deformed, the curvature radii are different from each other at the integrated joint, and a uniform arc cannot be drawn. In addition, when the hand side is rotated, the difference in torsional stress of different metal wires causes torsional accumulation at the boundary of the integrated joint, resulting in inferior rotation transmission performance to the tip side. .
By controlling the torsional stress due to the initial tension based on the strength of the initial tension generated by the winding forming of the densely wound coil, the torsional stress τ1 of the outer first coil and the torsional stress τ2 of the outer second coil are set within the predetermined range. In order to draw a uniform arc shape by reducing the occurrence of different radii of curvature at the joint when bent and deformed, and to prevent torsion accumulation at the joint and improve the rotation transmission performance to the tip side Because of that.

又、外側コイル内を貫挿する芯線先端部は、少なくとも2個以上の截頭円錐体を長手方向に連接した連接截頭円錐体で、1個の截頭円錐体は、長手方向の長さが後端側の截頭円錐体から先端側の截頭円錐体へ向かって徐変減少し、かつ、後端の径大外径と先端の径小外径との外径比(後端の径大外径/先端の径小外径)が、後端側の截頭円錐体から先端側の截頭円錐体へ向かって徐変増大する。この理由は、後端側から先端側へ向かって回転操作による手元側の回転角度を低減させて先端側へのねじりモーメントを増大させる芯線先端部の構造を得る為である。  Further, the tip of the core wire penetrating through the outer coil is an articulated truncated cone having at least two truncated cones connected in the longitudinal direction, and one truncated cone has a length in the longitudinal direction. Gradually decreases from the truncated cone on the rear end toward the truncated cone on the distal end, and the outer diameter ratio between the larger outer diameter of the rear end and the smaller outer diameter of the distal end (the rear end The larger outer diameter / the smaller outer diameter of the tip) gradually increases from the truncated cone on the rear end side toward the truncated cone on the distal end side. The reason for this is to obtain a structure of the tip end portion of the core wire that increases the torsional moment toward the tip end side by reducing the rotation angle on the hand side by the rotation operation from the rear end side toward the tip end side.

そして、連接截頭円錐体の外径は、前記一定の関係式を満たし、連接截頭円錐体の外側に、初張力が作用する外側第1コイルの密巻きと外側第2コイルの密巻きとを備えたことを特徴とする。この理由は、芯線先端部が細径の先細り形状でありながら先端の截頭円錐体(第1截頭円錐体)の外径比を後端側の截頭円錐体の外径比よりも最も高い値とする為である。又、異種金属の線材から成る外側第1コイルと外側第2コイルとの初張力によるねじり応力を前記一定範囲とし、かつ外側コイル内の芯線先端部が連接截頭円錐体の構造とし、これらを併用することにより、手元側の回転操作によるねじり溜まりを防いで先端側への回転伝達性能の向上を図ると共に、手元側の回転角度を減少させて先端側へのねじりモーメントを増大させ、閉塞病変部の穿孔性能を飛躍的に向上させる為である。  The outer diameter of the articulated truncated cone satisfies the above-mentioned fixed relational expression, and the outer coil of the outer first coil and the outer coil of the outer second coil on which the initial tension acts on the outer side of the articulated truncated cone It is provided with. The reason for this is that the outer diameter ratio of the truncated cone (first truncated cone) at the distal end is more than the outer diameter ratio of the truncated cone at the rear end, although the tip of the core wire has a tapered shape. This is to make the value high. Further, the torsional stress due to the initial tension between the outer first coil and the outer second coil made of different metal wires is within the above-mentioned range, and the core wire tip portion in the outer coil has a structure of a connecting truncated cone. By using it together, it prevents twist accumulation due to the rotation operation on the hand side and improves the rotation transmission performance to the tip side, while reducing the rotation angle on the hand side and increasing the torsion moment to the tip side, thereby obstructing the lesion. This is to dramatically improve the perforation performance of the part.

外側コイルは、後端側から先端側へ向かって、密巻きの後端径大等径部の外側第2コイルと密巻きの中間テーパ部と先端側に疎巻きを有する先端径小等径部との外側第1コイルから成る。又は、密巻きの後端径大等径部と密巻きの中間テーパ部の後端側との外側第2コイルと、密巻きの中間テーパ部の先端側と先端側に疎巻きを有する先端径小等径部と
の外側第1コイルから成る。
芯線先端部の連接截頭円錐体は、先端の截頭円錐体を第1截頭円錐体とし、第1截頭円錐体の外側に、外側コイルの中間テーパ部を配置する。
第1截頭円錐体の外径が、後端から先端へ徐変減少するのに伴って、外側コイルの中間テーパ部の密巻きの初張力が、後端から先端へ徐変増大する。
これにより、外径比(後端の径大外径/先端の径小外径)を最も高めた第1截頭円錐体を有する連接截頭円錐体の構造により、先端側への回転伝達性能を高めることができる。又、後端から先端へ徐変増大する外側コイルの中間テーパ部は、後端から先端へコイル線間の密着力(圧縮力)が増大する。
そして、後端から先端へコイル線間の密着力(圧縮力)が徐変増大する中間テーパ部を後端から先端へ外径が徐変減少する第1截頭円錐体の外側へ配置することにより、第1截頭円錐体の外径が先端側へ細径化するのに伴って、中間テーパ部のコイル線間の密着力(圧縮力)が先端側へ高められることとなり、細径の第1截頭円錐体でありながら先端側への回転伝達性能の向上を、コイルに作用する初張力により、より補完することができる。
The outer coil is formed from the rear end side toward the front end side, the outer second coil of the tightly wound rear end diameter large equal diameter portion, the tightly wound intermediate taper portion, and the distal end small diameter equal diameter portion having a loose winding on the front end side. And the outer first coil. Alternatively, the outer second coil on the back end side of the densely wound intermediate taper portion and the back end side of the closely wound intermediate taper portion, and the distal end diameter having loose winding on the distal end side and the distal end side of the closely wound intermediate tapered portion It consists of an outer first coil with a small isometric part.
The connecting truncated cone at the front end of the core wire has the first truncated cone as the first truncated cone, and the intermediate taper portion of the outer coil is disposed outside the first truncated cone.
As the outer diameter of the first truncated cone gradually decreases from the rear end to the tip, the initial tension of the tight winding of the intermediate taper portion of the outer coil gradually increases from the rear end to the tip.
As a result, the structure of the articulated truncated cone having the first truncated cone having the highest outer diameter ratio (large outer diameter at the rear end / small outer diameter at the distal end) has the ability to transmit rotation to the distal end side. Can be increased. Further, the intermediate taper portion of the outer coil that gradually increases from the rear end to the front end increases the adhesion (compression force) between the coil wires from the rear end to the front end.
Then, an intermediate taper portion in which the adhesion force (compression force) between the coil wires gradually increases from the rear end to the front end is disposed outside the first truncated cone whose outer diameter gradually decreases from the rear end to the front end. Thus, as the outer diameter of the first truncated cone is reduced toward the tip side, the adhesion force (compression force) between the coil wires of the intermediate taper portion is increased toward the tip side. Although it is the first truncated cone, the improvement of the rotation transmission performance toward the tip side can be more complemented by the initial tension acting on the coil.

外側コイルは、後端側から先端側へ向かって後端径大等径部と中間テーパ部を先端径小部を備え、外側コイルの後端径大等径部の外径をB1、先端径小等径部の外径をB2、連接截頭円錐体の第1截頭円錐体の後端の径大外径をD2とした場合に、第1截頭円錐体の先端の径小外径がD1であることから、第1截頭円錐体の外径比(D2/D1)は、外側コイルの外径比(B1/B2)よりも大きい{(D2/D1)>(B1/B2)}。
これにより、外側コイルを先細り形状とすることによって外側コイル内の芯線先端部の細径に伴うねじり力の低下分を補完し、細径の芯線先端部でありながら先端の第1截頭円錐体の外径比を高めることにより、先端側へのねじりモーメントの増大を図り、先細り形状の外側コイルとの併用により、先端側への回転伝達性をより高めることができる。
The outer coil includes a rear end diameter large equal diameter portion and an intermediate taper portion from the rear end side toward the front end side, and a small front end diameter portion. The outer coil rear end diameter large equal diameter portion has an outer diameter B1 and a front end diameter. When the outer diameter of the small isometric part is B2 and the large outer diameter of the rear end of the first truncated cone of the articulated truncated cone is D2, the outer diameter of the tip of the first truncated cone is smaller. Therefore, the outer diameter ratio (D2 / D1) of the first truncated cone is larger than the outer diameter ratio (B1 / B2) of the outer coil {(D2 / D1)> (B1 / B2). }.
As a result, the outer coil has a tapered shape to compensate for the decrease in torsional force associated with the small diameter of the core wire tip in the outer coil, and the first truncated cone at the tip while being a thin core wire tip. By increasing the outer diameter ratio, it is possible to increase the torsional moment toward the distal end side, and it is possible to further enhance the rotational transmission to the distal end side by using it together with the tapered outer coil.

外側コイルと内側コイルは、後端側から先端側へ向かって、後端径大等径部と中間テーパ部と先端径小等径部を備える。この内側コイルを芯線先端部の外側で、外側コイルの内側に、外側コイルよりも長手方向の長さが短く、外側コイルと同心状に配置する。又、外側コイルの先端と内側コイルの先端径小等径部の先端と芯線先端部の先端と接合して先端接合部とし、内側コイルの後端径大等径部の後端と芯線先端部と接合して内側コイル後端接合部とする。
内側コイルは、ステンレス鋼から成る放射線透過性の線材を用いて後端径大等径部と中間テーパ部は密巻きで、先端径小等径部は先端側が疎巻きを有して巻回して成る。
連接截頭円錐体の第1截頭円錐体の外側に、内側コイルの密巻きの中間テーパ部と外側第1コイルの密巻きの中間テーパ部とを共に配置する。
そして、第1截頭円錐体の外径が、後端側から先端側へ徐変減少するのに伴って、外側第1コイルの中間テーパ部の密巻きの初張力と内側コイルの密巻きの中間テーパ部の初張力とが共に、後端側から先端側へ徐変増大する。
これにより、後端から先端へ初張力が徐変増大する外側コイルの中間テーパ部と内側コイルの中間テーパ部は、後端から先端へコイル線間の密着力(圧縮力)が増大する。
そして、後端から先端へコイル線間の密着力(圧縮力)が徐変増大する2つの中間テーパ部を、後端から先端へ外径が徐変減少する第1截頭円錐体の外側へ配置することにより、第1截頭円錐体の外径が先端側へ細径化するのに伴って、2つの中間テーパ部のコイル線間の密着力(圧縮力)が先端側へ高められることとなり、細径の第1截頭円錐体でありながら先端側への回転伝達性能の向上を、2つの中間テーパに作用する初張力によってさらに補完することができる。
The outer coil and the inner coil include a rear end diameter large-diameter portion, an intermediate taper portion, and a front end diameter small equal-diameter portion from the rear end side toward the front end side. This inner coil is arranged outside the core wire tip, inside the outer coil, in a longitudinal direction shorter than the outer coil, and concentrically with the outer coil. Also, the front end of the outer coil, the front end of the inner coil with a smaller diameter part and the front end of the core wire are joined to form a front end joint, and the rear end diameter of the inner coil with the larger diameter part and the front end of the core wire are joined. To be the inner coil rear end joint.
The inner coil is made of stainless steel with a radiolucent wire, and the rear end diameter large-diameter part and the intermediate taper part are closely wound, and the front end small-diameter part is wound with a sparse winding on the front side. Become.
The tightly wound intermediate taper portion of the inner coil and the tightly wound intermediate taper portion of the outer first coil are both arranged outside the first truncated cone of the articulated truncated cone.
Then, as the outer diameter of the first truncated cone gradually decreases from the rear end side to the front end side, the initial tension of the tight winding of the intermediate taper portion of the outer first coil and the tight winding of the inner coil are increased. Both the initial tension of the intermediate taper portion gradually increases from the rear end side to the front end side.
As a result, the intermediate taper portion of the outer coil and the intermediate taper portion of the inner coil, whose initial tension gradually increases from the rear end to the front end, increase the adhesion force (compression force) between the coil wires from the rear end to the front end.
Then, the two intermediate taper portions where the cohesive force (compression force) between the coil wires gradually increases from the rear end to the front end are extended to the outside of the first truncated cone whose outer diameter gradually decreases from the rear end to the front end. By arranging, the adhesion force (compression force) between the coil wires of the two intermediate taper portions is increased to the tip side as the outer diameter of the first truncated cone is reduced to the tip side. Thus, the improvement in the rotation transmission performance toward the tip side can be further supplemented by the initial tension acting on the two intermediate tapers while being the first truncated cone having a small diameter.

本発明の第1実施形態のガイドワイヤの全体を示す一部切欠き側面図である。It is a partial notch side view which shows the whole guide wire of 1st Embodiment of this invention. 内側コイルと外側コイルのばね指数とねじり応力との相関関係を示す。The correlation between the spring index and torsional stress of the inner and outer coils is shown. 先端細径体と2個の截頭円錐体が連接する連接截頭円錐体を備えたガイドワイヤの先端部を示す一部切欠き側面図である。FIG. 6 is a partially cutaway side view showing a distal end portion of a guide wire provided with an articulated frustoconical body in which a distal end small-diameter body and two frustoconical bodies are connected. 3個の截頭円錐体が連接する第2実施形態の連接截頭円錐体を示す側面図である。It is a side view which shows the connection truncated cone of 2nd Embodiment to which three truncated cones are connected. 2個の截頭円錐体が連接する連接截頭円錐体の外径比と、仮想の単一截頭円錐体の外径との関係式を示す説明図である。It is explanatory drawing which shows the relational expression of the outer-diameter ratio of the connection truncated cone which the two truncated cones connect, and the outer diameter of a virtual single truncated cone. 本発明の第3実施形態のガイドワイヤの先端部を示す一部切欠き側面図である。It is a partially notched side view which shows the front-end | tip part of the guide wire of 3rd Embodiment of this invention. 本発明の第3実施形態の変形例のガイドワイヤの先端部を示す一部切欠き側面図である。It is a partially notched side view which shows the front-end | tip part of the guide wire of the modification of 3rd Embodiment of this invention. 本発明の第4実施形態のガイドワイヤの先端部を示す一部切欠き側面図である。It is a partially notched side view which shows the front-end | tip part of the guide wire of 4th Embodiment of this invention.

本発明を実施するための形態Mode for carrying out the present invention

以下本発明のガイドワイヤの実施形態について説明する。  Hereinafter, embodiments of the guide wire of the present invention will be described.

図1は、本発明の第1実施形態のガイドワイヤ1の全体図を示す。ガイドワイヤ1は、芯線2と、外側コイル3と、ふっ素樹脂被膜6と、親水性樹脂被膜7を有する。芯線2は、芯線後端部2Aと芯線先端部2Bとを有し、後端側から先端側へ徐変縮径する部分を有している。
外側コイル3は、先端側が放射線不透過性の線材を螺旋状に巻回した外側第1コイル31と、後端側が放射線透過性の線材を螺旋状に巻回した外側第2コイル32から成り、外側第1コイル31の後端部のコイル線と外側第2コイルの先端部のコイル線とをねじ込んだ後に、ろう材を用いて中間接合部5Dにて接合する。又、特開2002−336360、特開平9−38210の公開特許公報に示すような溶接接合手段を用いて接合してもよい。又、中間接合部5Dは、外側コイルと共に芯線先端部と接合されていてもよい。
外側コイル3は、芯線先端部2Bが貫挿し、接合部材を用いて外側第コイル31の先端と芯線先端部2Bの先端と接合して先丸形状の先端接合部5Aを形成し、外側第2コイル32の後端と芯線先端部2Bと接合して外側コイル後端接合部5Bを形成している。
ふっ素樹脂被膜6は、後端側の太径の芯線後端部2Aの外周に形成されている。親水性樹脂被膜7は、外側コイル3の外周に形成されている。尚、本発明のガイドワイヤ1は、長さに比べて直径が極めて小さな値となっている。この為、本発明のガイドワイヤ1は、縦横の縮尺率を同じにすると所定のエリアに図示することが困難となる為、一部を誇張したり、省略したりして図示している。
FIG. 1 shows an overall view of a guide wire 1 according to a first embodiment of the present invention. The guide wire 1 has a core wire 2, an outer coil 3, a fluorine resin film 6, and a hydrophilic resin film 7. The core wire 2 has a core wire rear end portion 2A and a core wire front end portion 2B, and has a portion that gradually changes in diameter from the rear end side to the front end side.
The outer coil 3 is composed of an outer first coil 31 in which a distal end side is spirally wound with a radiopaque wire, and an outer second coil 32 in which a rear end side is spirally wound with a radiation transmissive wire, After the coil wire at the rear end portion of the outer first coil 31 and the coil wire at the front end portion of the outer second coil are screwed together, the intermediate wire 5D is joined using a brazing material. Moreover, you may join using the welding joining means as shown in Unexamined-Japanese-Patent No. 2002-336360 and Unexamined-Japanese-Patent No. 9-38210. Moreover, intermediate | middle junction part 5D may be joined to the core wire front-end | tip part with the outer side coil.
The outer coil 3 is inserted through the core wire tip 2B and joined to the tip of the outer coil 31 and the tip of the core wire tip 2B using a joining member to form a tip-shaped tip joint 5A. An outer coil rear end joint portion 5B is formed by joining the rear end of the coil 32 and the core wire front end portion 2B.
The fluororesin coating 6 is formed on the outer periphery of the rear end portion 2A having a large diameter core wire on the rear end side. The hydrophilic resin film 7 is formed on the outer periphery of the outer coil 3. Note that the guide wire 1 of the present invention has a very small diameter compared to the length. For this reason, the guide wire 1 of the present invention is difficult to show in a predetermined area when the vertical and horizontal scale ratios are the same.

芯線2は、後端側から先端側へ向かって、第1等径部21、第1テーパ部22、第2等径部23、第2テーパ部24、第3等径部25、第1截頭円錐体26Aと第2截頭円錐体26Bとを連接させた連接截頭円錐体26、先端細径体27の順に、外径が0.3556mm(0.014インチで心臓血管治療用)から0.060mmへ徐変縮径する。
連接截頭円錐体26は、径大側の後端の外径0.180mmから径小側の先端の外径0.060mmへ徐変縮径する。外側コイル3の外側コイル後端接合部5Bは、第2截頭円錐体26Bの径大側の後端の外径0.180mmと、ろう材等の手段を用いて接合されている。又、外側コイル後端接合部5Bは、外径が0.180mmの第3等径部25と接合部材を用いて接合されていてもよい。
The core wire 2 has a first constant diameter portion 21, a first tapered portion 22, a second constant diameter portion 23, a second tapered portion 24, a third constant diameter portion 25, a first flange, from the rear end side toward the front end side. The outer diameter is 0.3556 mm (0.014 inch for cardiovascular treatment) in the order of the connecting truncated cone 26 in which the head cone 26 </ b> A and the second truncated cone 26 </ b> B are connected in order. The diameter is gradually changed to 0.060 mm.
The articulated truncated cone 26 gradually decreases in diameter from the outer diameter of 0.180 mm at the rear end of the larger diameter side to the outer diameter of 0.060 mm at the distal end of the smaller diameter side. The outer coil rear end joining portion 5B of the outer coil 3 is joined to the outer diameter 0.180 mm of the rear end on the larger diameter side of the second truncated cone 26B using means such as a brazing material. The outer coil rear end joint portion 5B may be joined to the third constant diameter portion 25 having an outer diameter of 0.180 mm using a joining member.

芯線2は、ステンレス鋼線、Ni−Ti合金線等が用いられる。例えば、特開2002−241836に示すように伸線加工と焼きなまし処理を繰り返した高強度のステンレス鋼線が用いられる。又は、特開2002−69555に示すように所定条件下で熱処理を施して製造されるNi−Ti合金線等が用いられる。好ましくは、引張強さが2200MPa以上3500MPa以下のオーステナイト系ステンレス鋼線が用いられる。
この理由は、縮径伸線加工により引張強さを容易に向上できるとともに、後述する連接截頭円錐体26の形状のセンターレス研削加工が容易になるからである。尚、ここでいう連接截頭円錐体26とは、1本の線材を用いて研削加工等を行い、截頭円錐体の形状を複数個長手方向へ設けた構造体のことをいう。又、芯線先端部2Bと芯線後端部2Aとは、異なる線材を溶接接合した芯線2としてもよく、例えば前記芯線の材質等の組合せ(具体的には、芯線後端部2Aがステンレス鋼線で、芯線先端部2BがNi−Ti合金線)等である。
As the core wire 2, a stainless steel wire, a Ni-Ti alloy wire, or the like is used. For example, as shown in Japanese Patent Application Laid-Open No. 2002-241836, a high-strength stainless steel wire obtained by repeating wire drawing and annealing is used. Alternatively, as shown in JP-A-2002-69555, a Ni—Ti alloy wire manufactured by heat treatment under a predetermined condition is used. Preferably, an austenitic stainless steel wire having a tensile strength of 2200 MPa to 3500 MPa is used.
This is because the tensile strength can be easily improved by the reduced diameter drawing process, and the centerless grinding process of the shape of the connecting truncated cone 26 described later is facilitated. Here, the connected truncated cone 26 refers to a structure in which a plurality of truncated cones are provided in the longitudinal direction by performing grinding or the like using one wire. Further, the core wire front end portion 2B and the core wire rear end portion 2A may be a core wire 2 in which different wire materials are welded together. For example, a combination of the core wire materials and the like (specifically, the core wire rear end portion 2A is a stainless steel wire). The core wire tip 2B is a Ni—Ti alloy wire) or the like.

外側コイル3は、外径B1が0.330mmの等径で、長手方向の長さが160mm、コイル線は1本、又は複数本の線材を巻回成形したコイルである。
先端側の外側第1コイル31は、引張強さが1200MPa以上2000MPa以下で白金が90重量%以上99重量%以下で残部がニッケルの白金とニッケルの合金線で、線直径t1が0.060mmの放射線不透過性の合金線を巻回したコイルから成り、長手方向の長さが40mmで後端側の25mmは初張力が作用する密巻きで先端側の15mmは線間間隙が線直径t1の0.07倍以上1.90倍以下の疎巻きである。
後端側の外側第2コイル32は、引張強さが1400MPa以上3500MPa以下のオーステナイト系ステンレス鋼線で、線直径t2が0.060mmの放射線透過性の金属線を巻回したコイルから成り、長手方向の長さが120mmの初張力が作用する密巻きである。
The outer coil 3 has a constant outer diameter B1 of 0.330 mm, a length in the longitudinal direction of 160 mm, and the coil wire is a coil formed by winding one or a plurality of wires.
The outer first coil 31 on the distal end side is a platinum-nickel alloy wire having a tensile strength of 1200 MPa to 2000 MPa, platinum of 90 wt% to 99 wt% and the balance of nickel, and a wire diameter t1 of 0.060 mm. It consists of a coil wound with a radiopaque alloy wire, the length in the longitudinal direction is 40 mm, the rear end 25 mm is tightly wound with the initial tension, and the front end 15 mm has a line-to-line gap t1 Sparse winding of 0.07 times or more and 1.90 times or less.
The outer second coil 32 on the rear end side is an austenitic stainless steel wire having a tensile strength of 1400 MPa or more and 3500 MPa or less, and is composed of a coil wound with a radiolucent metal wire having a wire diameter t2 of 0.060 mm. It is a close winding in which an initial tension of 120 mm in the direction acts.

そして、外側第1コイル31と外側第2コイル32の引張強さと材質を前記内容とした理由は、縮径伸線加工により引張強さが向上する異種金属線から成る外側第1コイル31と外側第2コイルとのコイル同士を長手方向に一体接合した場合、一体接合によって生ずる境界部の機械的強度の差を少なくする為と、コイル同士の初張力によるねじり応力差を少なくする為である。好ましくは、外側第1コイル31と外側第2コイル32の前記引張強さの範囲が重複する範囲の線材を用いることである。  The reason why the tensile strength and material of the outer first coil 31 and the outer second coil 32 are as described above is that the outer first coil 31 made of a dissimilar metal wire whose tensile strength is improved by the reduced diameter wire drawing and the outer This is because, when the coils of the second coil are integrally joined in the longitudinal direction, the difference in mechanical strength at the boundary caused by the integral joining is reduced, and the difference in torsional stress due to the initial tension between the coils is reduced. Preferably, a wire rod in a range where the ranges of the tensile strengths of the outer first coil 31 and the outer second coil 32 overlap is used.

次に、外側第1コイル31と外側第2コイル32とを一体接合した場合に、コイル同士の初張力によるねじり応力について説明する。  Next, the torsional stress due to the initial tension between the coils when the outer first coil 31 and the outer second coil 32 are integrally joined will be described.

図2は、外側第1コイル31と外側第2コイル32のねじり応力τとばね指数Cとの相関関係を示し、外側第1コイル31のねじり応力をτ1、ばね指数をC1とし、外側第2コル32のねじり応力をτ2、ばね指数をC2とする。
外側第1コイル31は、ばね指数C1が2.8以上6.8以下のとき、密巻きのねじり応力τ1(N/mm)は、
−17.2C1+165.7≦τ1≦−35.3C1+341.2 ・・(1)
の関係式(1)を満たすことが好ましい(図示符号ロとニ)。
より好ましくは、
−22.1C1+224.3≦τ1≦−35.3C1+341.2 ・・(2)
の関係式(2)を満たすことである(図示符号ロとハ)。
FIG. 2 shows the correlation between the torsional stress τ of the outer first coil 31 and the outer second coil 32 and the spring index C, wherein the torsional stress of the outer first coil 31 is τ1 and the spring index is C1. The torsional stress of the collar 32 is τ2, and the spring index is C2.
The outer first coil 31 has a tight winding torsional stress τ1 (N / mm 2 ) when the spring index C1 is not less than 2.8 and not more than 6.8.
−17.2C1 + 165.7 ≦ τ1 ≦ −35.3C1 + 341.2 (1)
It is preferable to satisfy the relational expression (1).
More preferably,
-22.1C1 + 224.3 ≦ τ1 ≦ −35.3C1 + 341.2 (2)
(2 in the figure).

又、既に出願した特許出願(特願2013−183140)によれば、オーステナイト系ステンレス鋼線を用いた外側第2コイル32は、ばね指数C2が2.8以上6.8以下のとき、密巻きのねじり応力τ2(N/mm)は、
−11.2C1+111.7≦τ2≦−38.7C2+370.6 ・・・(3)
の関係式(3)を満たすこととしている(図示符号イとホ)。
Further, according to the already filed patent application (Japanese Patent Application No. 2013-183140), the outer second coil 32 using the austenitic stainless steel wire is closely wound when the spring index C2 is 2.8 or more and 6.8 or less. The torsional stress τ2 (N / mm 2 ) of
−11.2C1 + 111.7 ≦ τ2 ≦ −38.7C2 + 370.6 (3)
The relational expression (3) is satisfied (indicated symbols a and e).

そして、本発明では、白金とニッケルの合金線(本発明の第1実施形態では、白金が95重量%、残部がニッケル)を用いた外側第1コイル31の密巻きのねじり応力τ1(N/mm)とオーステナイト系ステンレス鋼線を用いた外側第2コイル32の密巻きのねじり応力τ2(N/mm)との双方満たす好ましい範囲は、上限値がオーステナイト系ステンレス鋼線を用いた外側第2コイル32の図示符号イで、下限値が前記白金とニッケルの合金線を用いた外側第1コイル31の図示符号ハで、図示符号イとハの範囲となる。
従って、外側第1コイル31のねじり応力τ1(N/mm)と外側第2コイル32のねじり応力τ2(N/mm)は、
−22.1C1+224.3≦τ1≦−38.7C1+370.6 ・・(4)
−22.1C2+224.3≦τ2≦−38.7C2+370.6 ・・(5)
の関係式(4)(5)を満たすことが好ましい(図示符号イとハ)。
この理由は、前記範囲であれば、放射線不透過性の線材と放射線透過性の線材との異種金属を巻回して一体化した外側コイルを屈曲させた場合に、接合部での異なる曲率半径の発生を低減させて均一な円弧形状を描くことができ、さらに、接合部でのねじり溜まりを防いで、先端側への回転伝達性能の向上を図ることができるからである。
In the present invention, the torsional stress τ1 (N / N) of the tightly wound outer first coil 31 using an alloy wire of platinum and nickel (in the first embodiment of the present invention, platinum is 95% by weight and the balance is nickel). mm 2 ) and a preferable range satisfying both the tight winding torsional stress τ 2 (N / mm 2 ) of the outer second coil 32 using the austenitic stainless steel wire, the upper limit is the outer value using the austenitic stainless steel wire. The lower limit of the second coil 32 is indicated by the reference sign A of the outer first coil 31 using the alloy wire of platinum and nickel.
Therefore, the torsional stress τ1 (N / mm 2 ) of the outer first coil 31 and the torsional stress τ2 (N / mm 2 ) of the outer second coil 32 are:
-22.1C1 + 224.3 ≦ τ1 ≦ −38.7C1 + 370.6 (4)
-22.1C2 + 224.3≤τ2≤-38.7C2 + 370.6 (5)
It is preferable to satisfy the following relational expressions (4) and (5) (indicated symbols a and c).
The reason for this is that, within the above range, when the outer coil integrated by winding different metals of the radiopaque wire and the radiolucent wire is bent, the radius of curvature at the joint is different. This is because it is possible to reduce the occurrence and draw a uniform arc shape, and further prevent the accumulation of torsion at the joint and improve the rotation transmission performance to the tip side.

そして、外側第1コイル31のねじり応力τ1(N/mm)と外側第2コイル32のねじり応力τ2(N/mm)との双方を満たす、より好ましい範囲は、上限値が図示符号ロで、下限値が図示符号ハで、図示符号ロとハの範囲となる。
従って、外側第1コイル31のねじり応力τ1(N/mm)と外側第2コイル32のねじり応力τ2(N/mm)は、
−22.1C1+224.3≦τ1≦−35.3C1+341.2 ・・(6)
−22.1C2+224.3≦τ2≦−35.3C2+341.2 ・・(7)
の関係式(6)(7)を満たすことが、より好ましい(図示符号ロとハ)。
尚、密巻きコイルの初張力Fは、コイル平均径をD,コイル線の線直径をt、密巻きのねじり応力をτとすると、
F=πtτ/(8D) ・・・(8)
の関係式(8)で表すことができる。図2は、試験品の初張力を測定し、前記関係式(8)から密巻きのねじり応力τを算出し、コイル平均径と密巻きコイルのねじり応力τとの相関関係を整理し、多くの試験結果から導き出した相関関係を図に表したものである。
Then, to satisfy both the torsional stress τ1 of the first outer coil 31 and (N / mm 2) and the torsional stress τ2 of the second outer coil 32 (N / mm 2), more preferably in the range of the upper limit value is shown code b Thus, the lower limit value is indicated by the symbol C and is in the range indicated by symbols B and C.
Therefore, the torsional stress τ1 (N / mm 2 ) of the outer first coil 31 and the torsional stress τ2 (N / mm 2 ) of the outer second coil 32 are:
-22.1C1 + 224.3 ≦ τ1 ≦ −35.3C1 + 341.2 (6)
-22.1C2 + 224.3≤τ2≤-35.3C2 + 341.2 (7)
It is more preferable that the relational expressions (6) and (7) are satisfied (indicated symbols B and C).
The initial tension F of the densely wound coil is as follows: the average coil diameter is D, the wire diameter of the coil wire is t, and the tightly twisted torsional stress is τ.
F = πt 3 τ / (8D) (8)
It can be expressed by the relational expression (8). FIG. 2 shows the initial tension of the test product, calculates the tight winding torsional stress τ from the relational expression (8), sorts out the correlation between the average coil diameter and the torsional stress τ of the closely wound coil, The correlation derived from the test results is shown in the figure.

そして、外側第1コイル31と外側第2コイル32とを一体接合した場合に、異種金属線から成るコイル同士の密巻きの初張力によるねじり応力差を、図2を用いて整理すると以下となる。
一体接合する外側第1コイル31と外側第2コイル32のばね指数C1とC2は、共に、2.8以上6.8以下の範囲内のコイルを用いて、接合するコイルの外側第1コイル31のコイル平均径と、外側第2コイル32のコイル平均径との差が10%以内のとき、外側第1コイル31のねじり応力τ1(N/mm)と外側第2コイル32のねじり応力τ2(N/mm)との関係は、
0.62τ2≦τ1≦1.02τ2 ・・・(9)
の関係式(9)を満たすことが好ましい。
より好ましくは、
0.65τ2≦τ1≦1.02τ2 ・・・(10)
の関係式(10)を満たすことである。
Then, when the outer first coil 31 and the outer second coil 32 are integrally joined, the torsional stress difference due to the initial tension of the tight winding between the coils made of different metal wires is organized as follows using FIG. .
The spring indices C1 and C2 of the outer first coil 31 and the outer second coil 32 that are integrally joined are both in the range of 2.8 to 6.8, and the outer first coil 31 of the coil to be joined. When the difference between the coil average diameter of the outer second coil 32 and the coil average diameter of the outer second coil 32 is within 10%, the torsional stress τ1 (N / mm 2 ) of the outer first coil 31 and the torsional stress τ2 of the outer second coil 32 The relationship with (N / mm 2 ) is
0.62τ2 ≦ τ1 ≦ 1.02τ2 (9)
It is preferable to satisfy the relational expression (9).
More preferably,
0.65τ2 ≦ τ1 ≦ 1.02τ2 (10)
The relational expression (10) is satisfied.

図2において図示符号イの関係式{関係式(4)(5)の上限を示す直線}は、図示符号ロの関係式{関係式(6)(7)の上限を示す直線}よりも上部に位置する。このことは、オーステナイト系ステンレス鋼の線材を巻回して成る外側第2コイル32のねじり応力τ2は、白金とニッケルの合金線を巻回して成る外側第1コイル31のねじり応力τ1よりも大きいことを示している。このことは、オーステナイト系ステンレス鋼から成る線材を用いた方が白金とニッケルの合金線よりも横弾性係数高く、ねじり応力を高く設定できる材質特性による。
従って、ねじり応力τ1の外側第1コイル31と、ねじり応力τ1よりも大きなねじり応力τ2の外側第2コイル32とを一体接合した場合には、一般的には、外側第1コイル31のねじり応力τ1が下限の値を示し、外側第2コイル32のねじり応力τ2が上限の値を示すこととなる。
具体例として、第1実施形態の外側コイル3の外側第1コイル31のばね指数C1と外側第2コイル32のばね指数C2とは、共に4.5であることから、双方の好ましい範囲の前記関係式(4)(5)を用いると、下限値は、外側第1コイル31のねじり応力τ1である為、ばね指数C1を関係式(4)へ代入すると、外側第1コイル31のねじり応力τ1は、約124.9N/mmとなる。上限値は、外側第2コイル32のねじり応力τ2である為、ばね指数C2を関係式(5)へ代入すると、外側第2コイル32のねじり応力τ2は、約196.5N/mmとなる。
そして、外側第1コイルのねじり応力τ1(N/mm)と外側第2コイル32のねじり応力τ2(N/mm)とのねじり応力比(τ1/τ2)は、約0.64となり、前記関係式(9)(10)を満たしている。
前記同様に、より好ましい範囲の前記関係式(6)(7)を用いると、外側第1コイル31のねじり応力τ1(N/mm)と外側第2コイル32のねじり応力τ2(N/mm)とのねじり応力比(τ1/τ2)は、約0.68となり、前記関係式(9)(10)を満たしている。
2, the relational expression {the straight line indicating the upper limit of the relational expressions (4) and (5)} is higher than the relational expression {the straight line indicating the upper limit of the relational expressions (6) and (7)}. Located in. This means that the torsional stress τ2 of the outer second coil 32 formed by winding an austenitic stainless steel wire is greater than the torsional stress τ1 of the outer first coil 31 formed by winding an alloy wire of platinum and nickel. Is shown. This is because the wire material made of austenitic stainless steel has higher transverse elastic modulus and higher torsional stress than the alloy wire of platinum and nickel.
Therefore, when the outer first coil 31 having the torsional stress τ1 and the outer second coil 32 having the torsional stress τ2 larger than the torsional stress τ1 are integrally joined, generally, the torsional stress of the outer first coil 31 is generally determined. τ1 indicates a lower limit value, and torsional stress τ2 of the outer second coil 32 indicates an upper limit value.
As a specific example, the spring index C1 of the outer first coil 31 and the spring index C2 of the outer second coil 32 of the outer coil 3 of the first embodiment are both 4.5. If the relational expressions (4) and (5) are used, the lower limit value is the torsional stress τ1 of the outer first coil 31. Therefore, when the spring index C1 is substituted into the relational expression (4), the torsional stress of the outer first coil 31 is calculated. τ1 is approximately 124.9 N / mm 2 . Since the upper limit is the torsional stress τ2 of the outer second coil 32, when the spring index C2 is substituted into the relational expression (5), the torsional stress τ2 of the outer second coil 32 is about 196.5 N / mm 2. .
The torsional stress ratio (τ1 / τ2) between the torsional stress τ1 (N / mm 2 ) of the outer first coil and the torsional stress τ2 (N / mm 2 ) of the outer second coil 32 is about 0.64. The relational expressions (9) and (10) are satisfied.
Similarly, when the relational expressions (6) and (7) in a more preferable range are used, the torsional stress τ1 (N / mm 2 ) of the outer first coil 31 and the torsional stress τ2 (N / mm) of the outer second coil 32 are used. 2 ) torsional stress ratio (τ1 / τ2) is about 0.68, which satisfies the relational expressions (9) and (10).

尚、補足すれば、例えば、引張強さが1400MPa以上3500MPa以下の範囲で、低い引張強さのオーステナイト系ステンレス鋼の線材から成る外側第2コイル32と、引張強さが1200MPa以上200MPa以下の範囲で、高い引張強さの白金とニッケルの合金線から成る外側第1コイル31とを用いることにより、さらに、コイルを巻回する場合の負のコイルピッチの負の量を制御することにより、外側第1コイル31のねじり応力τ1と外側第2コイル32のねじり応力τ2との差を僅差とすることができる。
例えば、後述する第3実施形態の外側第1コイル31の径大側のねじり応力τ1が約138.6N/mmの場合、外側第2コイル32のコイル線の引張強さを低くして、コイル線の密巻き加工時の初張力を低く制御することにより、外側第1コイル31のコイル平均径と線直径が同一の、外側第2コイル32のねじり応力τ2を135.9N/mmにすると、ねじり応力τ1とτ2のねじり応力比(τ1/τ2)は、約1.019となり、前記関係式(9)(10)を満たしている。尚、外側第2コイル32のねじり応力τ2の135.9N/mmも前記関係式(5)(7)を満たしている。
In addition, for example, in the range where the tensile strength is 1400 MPa or more and 3500 MPa or less, the outer second coil 32 made of a low tensile strength austenitic stainless steel wire, and the tensile strength is 1200 MPa or more and 200 MPa or less. By using the outer first coil 31 made of a high tensile strength platinum and nickel alloy wire, and further by controlling the negative amount of the negative coil pitch when the coil is wound, The difference between the torsional stress τ1 of the first coil 31 and the torsional stress τ2 of the outer second coil 32 can be made small.
For example, when the torsional stress τ1 on the large diameter side of the outer first coil 31 of the third embodiment described later is about 138.6 N / mm 2 , the tensile strength of the coil wire of the outer second coil 32 is reduced, By controlling the initial tension at the time of dense winding of the coil wire to be low, the torsional stress τ2 of the outer second coil 32 having the same coil average diameter and the same wire diameter as the outer first coil 31 is set to 135.9 N / mm 2 . Then, the torsional stress ratio (τ1 / τ2) between the torsional stresses τ1 and τ2 is about 1.019, which satisfies the relational expressions (9) and (10). The torsional stress τ2 of 135.9 N / mm 2 of the outer second coil 32 also satisfies the relational expressions (5) and (7).

前記したように、外側第1コイル31のねじり応力τ1と外側第2コイル32ねじり応力τ2とのねじり応力比(τ1/τ2)は、約0.68となり、前記関係式(9)(10)を満たしている。この理由は、外側コイル3に白金とニッケルの合金線(白金が90重量%以上99重量%以下で残部がニッケル)から成る放射線不透過性の線材とオーステナイト系ステンレス鋼の放射線透過性の線材との異種金属線を用いて巻回し、一体化したコイルは、異種金属のそれぞれの線材のもつ機械的強度特性の差から、屈曲変形させた場合に、一体化した接合部を境にして放射線不透過性の金属線側と放射線透過性の金属線側とでは曲率半径が異なり、均一な円弧を描くことができない。又、手元側を回転させた場合に、異種金属の線材のもつねじり応力の差から一体化した接合部の近傍でねじり溜まりが発生し、先端側への回転伝達性能が劣ることとなる。
そして、外側第1コイル31のねじり応力τ1と外側第2コイル32のねじり応力τ2とを前記関係式(9)(10)で示す一定範囲とすることにより、屈曲変形させた場合に、一体化した接合部を境にして異なる曲率半径の発生を低減させて均一な円弧形状を描く為と、接合部の近傍でのねじり溜まりを防いで、先端側への回転伝達性能を向上させる為である。
As described above, the torsional stress ratio (τ1 / τ2) between the torsional stress τ1 of the outer first coil 31 and the torsional stress τ2 of the outer second coil 32 is about 0.68, and the relational expressions (9) and (10) Meet. The reason for this is that the outer coil 3 has a radiopaque wire made of an alloy wire of platinum and nickel (platinum is 90% by weight or more and 99% by weight or less and the balance is nickel) and a radiolucent wire of austenitic stainless steel. Because of the difference in mechanical strength characteristics of the different metal wires, the integrated coil wound with different dissimilar metal wires, when bent and deformed, does not emit radiation at the integrated joint. The radius of curvature differs between the transparent metal wire side and the radiation transparent metal wire side, and a uniform arc cannot be drawn. Further, when the proximal side is rotated, a torsion pool is generated in the vicinity of the integrated joint due to a difference in torsional stress of different metal wires, resulting in poor rotation transmission performance to the tip side.
Then, when the torsional stress τ1 of the outer first coil 31 and the torsional stress τ2 of the outer second coil 32 are set within a certain range shown by the relational expressions (9) and (10), they are integrated when bent and deformed. This is to reduce the occurrence of different radii of curvature at the boundary of the joint and draw a uniform arc shape, to prevent torsion accumulation near the joint and to improve the rotation transmission performance to the tip side .

そして、初張力は、コイルの密巻き加工時に負のコイルピッチを設けて巻回成形することにより得ることができる。負の量を大きくすることにより初張力を大きく(隣接線間の圧縮力を大きく)することができ、又、負の量を小さくすることにより初張力を小さく(隣接線間の圧縮力を小さく)することができる。
従って、密巻きコイルの巻回成形によって発生する初張力の大小(強弱)から初張力によるねじり応力を制御することにより、異種金属の線材から成るコイルであっても初張力によるねじり応力の範囲を、前記関係式(9)(10)で示す一定範囲とすることができる。又、異種金属の線材から成るコイルを一体化して屈曲変形させた場合に、一体化した接合部を境にした異なる曲率半径の発生を低減させることができ、さらに一体化した接合部の近傍でのねじり溜まりの発生を防いで、先端側への回転伝達性能を向上させることができる。
And initial tension can be obtained by providing a negative coil pitch at the time of dense winding processing of a coil, and carrying out winding forming. By increasing the negative amount, the initial tension can be increased (the compressive force between adjacent lines can be increased), and by decreasing the negative amount, the initial tension can be decreased (the compressive force between adjacent lines can be decreased). )can do.
Therefore, by controlling the torsional stress due to the initial tension based on the magnitude (intensity) of the initial tension generated by the winding of the densely wound coil, the range of the torsional stress due to the initial tension can be reduced even for coils made of different metal wires. , And can be within a certain range shown by the relational expressions (9) and (10). In addition, when the coils made of different metal wires are integrated and bent, the generation of different radii of curvature with the integrated joint as a boundary can be reduced, and in the vicinity of the integrated joint. Generation of torsion pools can be prevented, and the rotation transmission performance to the tip side can be improved.

次に、芯線2の芯線先端部2Bの構造について説明する。  Next, the structure of the core wire tip 2B of the core wire 2 will be described.

図3及び図4は、形状の異なる芯線先端部2B、2Cを示し、図3は截頭円錐体が2個の連接截頭円錐体26を有する第1実施形態の芯線先端部2Bを示し、図4は截頭円錐体が3個の場合の第2実施形態の芯線先端部2Cを示している。尚、芯線先端部2Cを除き、他の仕様は第1実施形態と同様であり、同一構成部材には同一符号が付してある。
図3について、芯線先端部2Bは、後端側から先端側へ連接截頭円錐体26と先端細径部27から成る。連接截頭円錐体26は、長手方向の長さL2が100mm、径大外径
D0が0.180mm、径小外径D2が0.125mmの第2截頭円錐体26Bと、長手方向の長さL1が50mm、第1截頭円錐体26Aからみて径大外径D2が0.125mm、径小外径D1が0.060mmの第1截頭円錐体26Aの2個の截頭円錐体から成る。
先端細径体27は、長手方向の長さL4が15mm、外径が第1截頭円錐体26Aの径小外径D1と同じで0.060mmの横断面の形状が円形である。又、外径が0.060mmの横断面が円形の形状を、押圧加工又は切削加工によりアスペクト比(長辺/短辺)が、1.676以上3.958以下の横断面が矩形としてもよい。
そして、初張力が作用する密巻きと初張力が作用しない疎巻きとを有する外側第1コイル31を、先端細径体27の外側に配置することにより、後述する別段の作用効果を発揮する。
3 and 4 show the core tip portions 2B and 2C having different shapes, and FIG. 3 shows the core tip portion 2B of the first embodiment in which the truncated cone has two connected truncated cones 26. FIG. 4 shows the core wire tip 2C of the second embodiment when there are three truncated cones. Except for the core wire tip 2C, other specifications are the same as those of the first embodiment, and the same constituent members are denoted by the same reference numerals.
3, the core wire front end portion 2 </ b> B includes an articulated truncated cone 26 and a front end narrow diameter portion 27 from the rear end side to the front end side. The articulated truncated cone 26 has a longitudinal length L2 of 100 mm, a large diameter outer diameter D0 of 0.180 mm, and a small diameter outer diameter D2 of 0.125 mm. From the two truncated cones of the first truncated cone 26A having a length L1 of 50 mm and a large outer diameter D2 of 0.125 mm and a small outer diameter D1 of 0.060 mm as viewed from the first truncated cone 26A. Become.
The tip small-diameter body 27 has a longitudinal length L4 of 15 mm, an outer diameter that is the same as the small outer diameter D1 of the first truncated cone 26A, and a circular cross-sectional shape of 0.060 mm. Further, the cross section having a circular outer cross-section with an outer diameter of 0.060 mm may be rectangular, and the cross-section with an aspect ratio (long side / short side) of 1.676 or more and 3.958 or less may be rectangular by pressing or cutting. .
Then, by arranging the outer first coil 31 having a dense winding in which the initial tension acts and a loose winding in which the initial tension does not act on the outside of the distal end small-diameter body 27, another advantageous effect described later is exhibited.

第2截頭円錐体26Bの長手方向の長さL2は100mm、第1截頭円錐体26Aの長手方向の長さL1は50mm、後端側から先端側へ減少し(L2>L1)、かつ、第2截頭円錐体26Bの外径比D0/D2は1.44で、第1截頭円錐体26Aの外径比D2/D1は約2.08で、後端側から先端側へ増大する{(D0/D2)<(D2/D1)}。  The length L2 in the longitudinal direction of the second truncated cone 26B is 100 mm, the length L1 in the longitudinal direction of the first truncated cone 26A is 50 mm, decreases from the rear end side to the front end side (L2> L1), and The outer diameter ratio D0 / D2 of the second truncated cone 26B is 1.44, and the outer diameter ratio D2 / D1 of the first truncated cone 26A is about 2.08, increasing from the rear end side to the front end side. {(D0 / D2) <(D2 / D1)}.

図4において、芯線先端部2Cは、第1〜3截頭円錐体26A、26B、26Cを連接した連接截頭円錐体260から成る。第3截頭円錐体26Cは、後端側から先端側へ長手方向の長さがL3(mm)で、径大外径がD0(mm)で、径小外径がD3(mm)である。第2截頭円錐体26Bは、長手方向の長さがL2(mm)、径大外径がD3(mm)、径小外径がD2(mm)である。第1截頭円錐体26Aは、長手方向の長さがL1(mm)、径大外径がD2(mm)、径小外径がD1(mm)である。尚、図3に示す先端細径体27は省略している。  In FIG. 4, the core wire tip 2C is composed of an articulated truncated cone 260 connecting the first to third truncated cones 26A, 26B, and 26C. The third truncated cone 26C has a longitudinal length of L3 (mm) from the rear end side to the front end side, a large outer diameter of D0 (mm), and a small outer diameter of D3 (mm). . The second truncated cone 26B has a length in the longitudinal direction of L2 (mm), a large outer diameter of D3 (mm), and a small outer diameter of D2 (mm). The first truncated cone 26A has a length in the longitudinal direction of L1 (mm), a large outer diameter of D2 (mm), and a small outer diameter of D1 (mm). Note that the tip small-diameter body 27 shown in FIG. 3 is omitted.

連接截頭円錐体260の各截頭円錐体26A、26B、26Cの長手方向の長さL3、L2、L1は、後端側から先端側へ徐変減少し(L3>L2>L1)、かつ、各截頭円錐体26C、26B、26Aの外径比(D0/D3)、(D3/D2)、(D2/D1)は、後端側から先端側へ徐変増大する{(D0/D3)<(D3/D2)<(D2/D1)}。  The longitudinal lengths L3, L2, L1 of the respective truncated cones 26A, 26B, 26C of the articulated truncated cone 260 are gradually decreased from the rear end side to the front end side (L3> L2> L1), and The outer diameter ratios (D0 / D3), (D3 / D2), and (D2 / D1) of the truncated cones 26C, 26B, and 26A gradually increase from the rear end side to the front end side {(D0 / D3 ) <(D3 / D2) <(D2 / D1)}.

このように、本発明の芯線先端部2B、2Cは、少なくとも2個以上の截頭円錐体を長手方向に連接した連接截頭円錐体26、260であり、1個の截頭円錐体の長手方向の長さは、第3截頭円錐体26Cから第2截頭円錐体26Bへ、さらに第1截頭円錐体26Aへ、後端側から先端側の截頭円錐体へ徐変減少し、かつ、1個の截頭円錐体の後端の径大外径と先端の径小外径との外径比(後端の径大外径/先端の径小外径)は、後端側の截頭円錐体から先端側の截頭円錐体へ向かって徐変増大することを特徴とする。
この理由は、後端側を回転させたとき、後端側の回転角度を減少させて先端側へのねじりモーメントの増大を図り、さらに初張力が作用する外側第1コイル31と外側第2コイル32との併用により、先端側への高度の回転伝達性能の向上を図ると共に、狭窄部、及び、完全閉塞病変部での穿孔性能を向上させる為である。
As described above, the core wire tip portions 2B and 2C of the present invention are the connecting truncated cones 26 and 260 obtained by connecting at least two truncated cones in the longitudinal direction, and the longitudinal length of one truncated cone. The length of the direction gradually decreases from the third truncated cone 26C to the second truncated cone 26B, further to the first truncated cone 26A, from the rear end side to the distal truncated cone, And the outer diameter ratio between the large outer diameter at the rear end of one truncated cone and the small outer diameter at the front end (the large outer diameter at the rear end / the small outer diameter at the front end) is the rear end side. It is characterized by gradually increasing from the truncated cone to the truncated cone on the tip side.
The reason for this is that when the rear end side is rotated, the rotation angle on the rear end side is decreased to increase the torsional moment toward the front end side, and further, the outer first coil 31 and the outer second coil on which initial tension acts. This is because the combined use with 32 improves the rotation transmission performance to the distal end side and improves the perforation performance in the stenosis part and the completely occluded lesion part.

より詳しくは、先端の回転角度が同一のとき、後端側の回転角度を低減させることができる。この理由は、後端側の回転角度、つまり、ねじり角はねじり剛性が高い程減少し、ねじり剛性は横弾性係数と断面二次極モーメントの積で表すことができ、連接截頭円錐体26、260の構造のほうが図4及び図5において二点鎖線で示した仮想の単一截頭円錐体100の構造よりも断面二次極モーメントが高いからである。  More specifically, when the rotation angle of the front end is the same, the rotation angle on the rear end side can be reduced. The reason for this is that the rotation angle on the rear end side, that is, the torsion angle decreases as the torsional rigidity increases, and the torsional rigidity can be expressed by the product of the transverse elastic modulus and the cross-sectional secondary pole moment. , 260 has a higher cross-sectional secondary pole moment than the structure of the virtual single truncated cone 100 indicated by a two-dot chain line in FIGS. 4 and 5.

又、後端側を押し引き操作させる際に、先端の曲げ剛性と耐座屈強度を向上させることができる。この理由は、曲げ剛性は、縦弾性係数と断面二次モーメントの積で表すことができ、連接截頭円錐体26、260の構造のほうが単一截頭円錐体100の構造よりも断面二次モーメントが高いからである。又、圧縮応力は横断面の面積に反比例し、横断面の面積が増大すれば圧縮応力は低下する。連接截頭円錐体26、260の、特に節部28(芯線の外径が他に比較して大きく変化する位置)の横断面積は、節部28と同一位置における単一截頭円錐体100の横断面積よりも大きく、圧縮応力は低い値となる。
従って、長手方向に押し引き操作した場合に、特に横断面積が増大した節部28の存在により、連接截頭円錐体26、260の構造のほうが単一截頭円錐体100の構造よりも耐座屈強度を向上させることができるからである。
In addition, when the rear end side is pushed and pulled, the bending rigidity and buckling resistance of the tip can be improved. The reason for this is that the bending stiffness can be expressed by the product of the longitudinal elastic modulus and the moment of inertia of the cross section, and the structure of the articulated truncated cones 26 and 260 is more secondary than the structure of the single truncated cone 100. This is because the moment is high. The compressive stress is inversely proportional to the area of the cross section, and the compressive stress decreases as the cross section area increases. The cross-sectional area of the articulated truncated cones 26, 260, especially the node 28 (a position where the outer diameter of the core wire greatly changes compared to the other), is the same as that of the single truncated cone 100 at the same position as the node 28. The compressive stress is lower than the cross-sectional area.
Therefore, when the push-pull operation is performed in the longitudinal direction, the structure of the articulated truncated cones 26 and 260 is more resistant to seating than the structure of the single truncated cone 100 due to the presence of the node 28 having an increased cross-sectional area. This is because the bending strength can be improved.

図5は、本発明の芯線先端部2Bの連接截頭円錐体26の外径と、仮想の単一截頭円錐体100との外径の関係式を示す説明図である。
実線は、本発明の第1実施形態の截頭円錐体が2個の場合の連接截頭円錐体26を示し、二点鎖線は、関係式を説明する為の仮想の単一截頭円錐体100を示す。尚、先端細径体27は省略している。
連接截頭円錐体26の最大外径がD0(mm)、最小外径がD1(mm)、全長がL(mm)である。又、連接截頭円錐体26の最大外径D0(mm)の横断面の中心位置から先端へ、任意の位置をX(mm)として、任意の位置X(mm)が0mmを超えてLmmを下回る関係(0<X<L)にある場合で、任意の位置X(mm)における連接截頭円錐体26の外径をDm(mm)とし、仮想の単一截頭円錐体100の外径をDx(mm)とした場合に、外径Dx(mm)は、
Dx=D0−(D0−D1)X/L ・・・(11)
の関係式(11)で表すことができる。
そして、任意の位置X(mm)における連接截頭円錐体26の外径Dm(mm)は、外径Dx(mm)よりも大きいことから(Dm>Dx)、
Dm>{D0−(D0−D1)X/L} ・・・(12)
の関係式(12)で表すことができる。
FIG. 5 is an explanatory diagram showing a relational expression between the outer diameter of the connecting truncated cone 26 of the core wire tip 2B and the outer diameter of the virtual single truncated cone 100 of the present invention.
The solid line shows the articulated truncated cone 26 in the case where there are two truncated cones according to the first embodiment of the present invention, and the alternate long and two short dashes line indicates a virtual single truncated cone for explaining the relational expression. 100 is shown. Note that the tip small-diameter body 27 is omitted.
The maximum outer diameter of the articulated truncated cone 26 is D0 (mm), the minimum outer diameter is D1 (mm), and the total length is L (mm). Also, from the center position of the cross section of the maximum outer diameter D0 (mm) of the articulated truncated cone 26 to the tip, an arbitrary position is X (mm), and the arbitrary position X (mm) exceeds 0 mm and Lmm. When the relationship is lower (0 <X <L), the outer diameter of the articulated truncated cone 26 at an arbitrary position X (mm) is Dm (mm), and the outer diameter of the virtual single truncated cone 100 is Is Dx (mm), the outer diameter Dx (mm) is
Dx = D0− (D0−D1) X / L (11)
The relational expression (11) can be expressed.
Since the outer diameter Dm (mm) of the articulated truncated cone 26 at an arbitrary position X (mm) is larger than the outer diameter Dx (mm) (Dm> Dx),
Dm> {D0- (D0-D1) X / L} (12)
The relational expression (12) can be expressed.

本発明は、芯線先端部2B、2Cの連接截頭円錐体26、260が前記関係式(12)を満たすことを特徴とする。
この理由は、後端側の回転角度を低減させ、先端の曲げ剛性と耐座屈強度を向上させ、先端のねじりモーメントを増大させて病変部での穿孔性能と耐疲労特性を向上させる芯線先端部2B、2Cの構造を得ることができるからである。
さらに、初張力が作用する外側第1コイル31と外側第2コイル32との併用により、先端側への高度の回転伝達性能の向上を図ると共に、狭窄部、及び完全閉塞病変部での穿孔性能を、より向上させることができるからである。
The present invention is characterized in that the connecting truncated cones 26 and 260 of the core wire tip portions 2B and 2C satisfy the relational expression (12).
The reason for this is that the tip of the core wire reduces the rotation angle on the rear end side, improves the bending rigidity and buckling strength of the tip, and increases the torsional moment of the tip to improve the drilling performance and fatigue resistance at the lesion. This is because the structure of the parts 2B and 2C can be obtained.
Further, by using both the first outer coil 31 and the second outer coil 32 on which initial tension acts, a high degree of rotation transmission performance to the distal end side is improved, and perforation performance in a stenosis part and a completely occlusion lesion part is achieved. It is because it can improve more.

次に、図6は第3実施形態のガイドワイヤ11を示し、第1実施形態のガイドワイヤ1と異なるところは、外側コイル30が後端側から先端側へ向かって先細り形状である。尚、ふっ素樹脂被膜6と親水性樹脂被膜7は省略している。
外側コイル30は、後端径大等径部311の外径B1が0.330mm、長手方向の長さが125mm、中間テーパ部312の外径が0.330mmから0.260mmへ徐変減少し、長手方向の長さが20mm、先端径小等径部313の外径B2が0.260mmで長手方向の長さが15mmである。
コイル線の線直径t1と材質は、前記第1実施形態と同様で、外側第2コイル320は放射線透過の線材で、外側第1コイル310は放射線不透過の線材であり、外側コイル30の後端径大等径部311と中間テーパ部312は密巻きで、先端径小等径部313は、前記第1実施形態の外側コイル3の外側第1コイル31と同様に、疎巻きに巻回したコイルである。尚、先端径小等径部313は、後端側が密巻きで先端側が疎巻きに巻回したコイルとしてもよい。
Next, FIG. 6 shows the guide wire 11 of the third embodiment. The difference from the guide wire 1 of the first embodiment is that the outer coil 30 is tapered from the rear end side toward the front end side. Note that the fluorine resin film 6 and the hydrophilic resin film 7 are omitted.
In the outer coil 30, the outer diameter B1 of the rear end diameter equal-diameter portion 311 is 0.330 mm, the length in the longitudinal direction is 125 mm, and the outer diameter of the intermediate taper portion 312 is gradually decreased from 0.330 mm to 0.260 mm. The length in the longitudinal direction is 20 mm, the outer diameter B2 of the small-diameter portion 313 having a small tip diameter is 0.260 mm, and the length in the longitudinal direction is 15 mm.
The wire diameter t1 and material of the coil wire are the same as those in the first embodiment, the outer second coil 320 is a radiation transmissive wire, the outer first coil 310 is a radiation opaque wire, The large end diameter equal diameter portion 311 and the intermediate taper portion 312 are closely wound, and the small tip diameter equal diameter portion 313 is wound loosely in the same manner as the outer first coil 31 of the outer coil 3 of the first embodiment. Coil. In addition, the tip diameter small equal diameter part 313 is good also as a coil by which the rear end side was densely wound and the front end side was wound loosely.

外側コイル30の後端径大等径部311の外径B1と、先端径小等径部313の外径B2との外径比B1/B2は、心臓血管治療用に用いられているガイドワイヤの最大外径0.3556mm(0.0014インチ)と下肢血管治療用に用いられているガイドワイヤの最大外径0.4572mm(0.018インチ)との双方を併せ考慮すると、外径比B1/B2は1.10以上1.80以下で、好ましくは1.15以上1.80以下である。第3実施形態の外側コイル30の外径比B1/B2は、約1.27である。  The outer diameter ratio B1 / B2 between the outer diameter B1 of the rear end diameter larger equal diameter portion 311 of the outer coil 30 and the outer diameter B2 of the smaller tip diameter equal diameter portion 313 is a guide wire used for cardiovascular treatment. Considering both the maximum outer diameter of 0.3556 mm (0.0014 inch) and the maximum outer diameter of the guide wire used for lower limb vascular treatment 0.4572 mm (0.018 inch), the outer diameter ratio B1 / B2 is 1.10 or more and 1.80 or less, preferably 1.15 or more and 1.80 or less. The outer diameter ratio B1 / B2 of the outer coil 30 of the third embodiment is about 1.27.

そして、連接截頭円錐体26の第1截頭円錐体26Aの後端の径大外径D2と先端の径小外径D1の外径比D2/D1は、外側コイル30の外径比B1/B2よりも大きい{(D2/D1)>(B1/B2)}。
第3実施形態では、外側コイル30の外径比B1/B2が約1.27であり、第1截頭円錐体26Aの外径比D2/D1が約2.08であることから、第1截頭円錐体26Aの外径比D2/D1は、外側コイルの外径比B1/B2よりも大きい{(D2/D1)>(B1/B2)}。この理由は、以下である。
先端側へ先細り形状の外側コイル30とすることにより、外側コイル30内の芯線先端部2Bの細径に伴うねじり力の低下分を補完することができ、又、後端と先端の外径比D2/D1を外側コイル30の外径比B1/B2よりも大きくした第1截頭円錐体26Aを有する連接截頭円錐体26の構造とすることにより、先端側への回転伝達性能を向上させることができるからである。
さらに、後端から先端へ初張力が徐変増大する外側コイル30の中間テーパ部312は、後端から先端へコイル線間の圧縮力(密着力)が徐変増大する。
後端から先端へコイル線間の圧縮力が徐変増大する中間テーパ部312を、後端から先端へ外径が徐変減少する第1截頭円錐体26Aの外側へ配置することにより、第1截頭円錐体26Aの外径が先端側へ細径化するのに伴って、中間テーパ部312のコイル線間の圧縮力(密着力)が先端側へ高められることにより、細径の第1截頭円錐体26Aでありながら、先端側への回転伝達性能を、より補完することができるからである。
The outer diameter ratio D2 / D1 between the large outer diameter D2 at the rear end of the first truncated cone 26A and the small outer diameter D1 at the tip of the articulated truncated cone 26 is equal to the outer diameter ratio B1 of the outer coil 30. Larger than / B2 {(D2 / D1)> (B1 / B2)}.
In the third embodiment, the outer diameter ratio B1 / B2 of the outer coil 30 is about 1.27, and the outer diameter ratio D2 / D1 of the first truncated cone 26A is about 2.08. The outer diameter ratio D2 / D1 of the truncated cone 26A is larger than the outer diameter ratio B1 / B2 of the outer coil {(D2 / D1)> (B1 / B2)}. The reason for this is as follows.
By using the outer coil 30 that is tapered toward the front end side, the decrease in torsional force due to the small diameter of the core wire front end portion 2B in the outer coil 30 can be complemented, and the outer diameter ratio between the rear end and the front end The structure of the articulated truncated cone 26 having the first truncated cone 26A in which D2 / D1 is larger than the outer diameter ratio B1 / B2 of the outer coil 30 improves the rotation transmission performance to the tip side. Because it can.
Furthermore, in the intermediate taper portion 312 of the outer coil 30 in which the initial tension gradually increases from the rear end to the front end, the compressive force (adhesion force) between the coil wires gradually increases from the rear end to the front end.
The intermediate taper portion 312 in which the compression force between the coil wires gradually increases from the rear end to the front end is disposed outside the first truncated cone 26A in which the outer diameter gradually decreases from the rear end to the front end. As the outer diameter of the first truncated cone 26A is reduced to the tip side, the compression force (adhesion force) between the coil wires of the intermediate taper portion 312 is increased to the tip side, so This is because the rotation transmission performance to the distal end side can be more complemented with the single truncated cone 26A.

そして、第3実施形態の外側第1コイル31の中間テーパ部312は、外径が0.330mmから0.260mmへ徐変減少し、コイル線の線直径t1が0.060mmであることから、ばね指数C1は、径大側の4.5から径小側の約3.3へ徐変減少する。
かかる場合のねじり応力τ1は、径大側から径小側へ約138.6N/mmから約189.0N/mmへ徐変増大する。
径大側のねじり応力τ1が約138.6N/mmで、ばね指数C1が4.5であることから、前記関係式(4)へ代入すると、ねじり応力τ1の範囲は、約124.9N/mm以上196.5N/mm以下となり、前記関係式(6)へ代入すると、ねじり応力τ1の範囲は、約124.9N/mm以上182.4N/mm以下となり、いずれの場合も前記関係式(4)(6)を満たしている。
そして、径大側のねじり応力が約138.6N/mmのときの初張力は、前記関係式(8)を用いると約4.35×10−2Nとなり、又径小側のねじり応力が約189.0N/mmのときの初張力は前記関係式(8)を用いると約8.0×10−2Nとなる。
従って、第3実施形態の外側第1コイル31の中間テーパ部312は、第1截頭円錐体26Aの外径が先端側へ細径化するのに伴って、中間テーパ部312の初張力は、後端側から先端側へ約4.35×10−2Nから約8.0×10−2Nとなって、コイル線間の圧縮力(密着力)を後端側から先端側へ高めている。
And since the intermediate taper part 312 of the outer side 1st coil 31 of 3rd Embodiment decreases gradually from 0.330 mm to 0.260 mm, and the wire diameter t1 of a coil wire is 0.060 mm, The spring index C1 gradually decreases from 4.5 on the large diameter side to about 3.3 on the small diameter side.
Torsional stress τ1 of such a case, gradual change increases from the large-diameter side to about 138.6N / mm 2 to the small diameter side about 189.0N / mm 2.
Since the torsional stress τ1 on the large diameter side is about 138.6 N / mm 2 and the spring index C1 is 4.5, the range of the torsional stress τ1 is about 124.9 N when substituted into the relational expression (4). / Mm 2 or more and 196.5 N / mm 2 or less, and when substituted into the relational expression (6), the range of the torsional stress τ1 is about 124.9 N / mm 2 or more and 182.4 N / mm 2 or less. Satisfies the relational expressions (4) and (6).
When the torsional stress on the large diameter side is about 138.6 N / mm 2 , the initial tension is about 4.35 × 10 −2 N using the relational expression (8), and the torsional stress on the small diameter side. When the relational expression (8) is used, the initial tension at about 189.0 N / mm 2 is about 8.0 × 10 −2 N.
Therefore, the intermediate taper portion 312 of the outer first coil 31 of the third embodiment has an initial tension of the intermediate taper portion 312 as the outer diameter of the first truncated cone 26A is reduced to the tip side. From about 4.35 × 10 −2 N to about 8.0 × 10 −2 N from the rear end side to the front end side, the compression force (adhesion force) between the coil wires is increased from the rear end side to the front end side. ing.

そして、図7は前記第3実施形態の変形例を示し、前記第3実施形態と異なるところは、後端径大等径部311と中間テーパ部312の後端側が外側第2コイル320で、中間テーパ部312の先端側と先端径小等径部313とが外側第1コイル310から成る。
中間接合部5Dは、中間テーパ部312の傾斜部に位置しており、外側第1コイル310と外側第2コイル320とが接合部材により一体接合されている。他は、前記第3実施形態と同様である。
FIG. 7 shows a modification of the third embodiment. The difference from the third embodiment is that the rear end side large-diameter portion 311 and the rear end side of the intermediate taper portion 312 are outer second coils 320. The tip end side of the intermediate taper portion 312 and the tip end small diameter portion 313 are formed of the outer first coil 310.
The intermediate joint portion 5D is located at an inclined portion of the intermediate taper portion 312 and the outer first coil 310 and the outer second coil 320 are integrally joined by a joining member. Others are the same as the said 3rd Embodiment.

次に、図8は、第4実施形態のガイドワイヤ111を示し、前記第3実施形態のガイドワイヤ11と異なるところは、外側コイル30の内側に、長手方向の長さが短く、かつ、同心状で、後端側から先端側へ向かって先細り形状の内側コイル4を配置していることである。尚、ふっ素樹脂被膜6と親水性樹脂被膜7は省略している。
内側コイル4は、芯線先端部2Bが貫挿し、接合部材等を用いて外側コイル30の先端と内側コイル4の先端と芯線先端部2Bの先端と接合して先丸形状の先端接合部5Aを形成し、内側コイル4の後端と芯線先端部2Bと接合して内側コイル後端接合部5Cを形成する。中間接合部5Eは、内側コイル4と外側コイル30と芯線先端部2Bと一体接合している。尚、中間接合部5Eは、内側コイル4と芯線先端部2Bとの接合、又は、内側コイル4と外側コイル30との接合としてもよい。
Next, FIG. 8 shows a guide wire 111 according to the fourth embodiment. The difference from the guide wire 11 according to the third embodiment is that the length in the longitudinal direction is short and concentric inside the outer coil 30. In other words, the tapered inner coil 4 is disposed from the rear end side toward the front end side. Note that the fluorine resin film 6 and the hydrophilic resin film 7 are omitted.
The inner coil 4 has a core wire tip 2B inserted therethrough, and a joining member or the like is used to join the tip of the outer coil 30, the tip of the inner coil 4, and the tip of the core wire tip 2B to form a tip-shaped tip joint 5A. The inner coil 4 is joined to the rear end of the inner coil 4 and the core wire tip 2B to form the inner coil rear end joint 5C. The intermediate joint 5E is integrally joined to the inner coil 4, the outer coil 30, and the core wire tip 2B. The intermediate joint 5E may be a joint between the inner coil 4 and the core wire tip 2B or a joint between the inner coil 4 and the outer coil 30.

内側コイル4は、後端径大等径部411の外径A1は0.185mmで長手方向の長さが20mm、中間テーパ部412の外径は0.185mmから0.130mm先端側へ徐変縮径して長手方向の長さが20mm、先端径小等径部413の外径A2は0.130mmで長手方向の長さは15mm、又、コイル線の線直径t3が0.030mmで、1本又は複数本の線材を用いて後端径大等径部411と中間テーパ部412は密巻きで、先端径小等径部413は前記第3実施形態の外側第1コイル310と同様に疎巻き、又は後端側が密巻きで先端側が疎巻きに巻回したコイルである。
内側コイル4のコイル線は、前記外側第1コイル31のコイル線と同様に放射線不透過の線材を用いてもよいが、前記外側第2コイル32のコイル線のオーステナイト系ステンレス鋼から成る放射線透過性の線材が好ましい。この理由は、オーステナイト系ステンレス鋼の線材のほうが白金とニッケルの合金線よりも横弾性係数が高く、ねじり応力を高く設定することができるからである。
In the inner coil 4, the outer diameter A1 of the rear end diameter large-diameter portion 411 is 0.185 mm, the length in the longitudinal direction is 20 mm, and the outer diameter of the intermediate taper portion 412 gradually changes from 0.185 mm to 0.130 mm on the front end side. The length in the longitudinal direction is reduced to 20 mm, the outer diameter A2 of the small-diameter tip 413 is 0.130 mm, the length in the longitudinal direction is 15 mm, and the wire diameter t3 of the coil wire is 0.030 mm. Using one or a plurality of wires, the rear end diameter large equal diameter portion 411 and the intermediate taper portion 412 are tightly wound, and the front end small diameter equal diameter portion 413 is the same as the outer first coil 310 of the third embodiment. It is a coil that is loosely wound, or a coil that is closely wound on the rear end side and wound loosely on the front end side.
The coil wire of the inner coil 4 may use a radiopaque wire material like the coil wire of the outer first coil 31, but the radiation wire made of austenitic stainless steel of the coil wire of the outer second coil 32. Wire is preferable. The reason for this is that the austenitic stainless steel wire has a higher transverse elastic coefficient than the alloy wire of platinum and nickel, and the torsional stress can be set higher.

このように、内側コイル4は、ステンレス鋼から成る放射線透過性の線材を用いて後端径大等径部411と中間テーパ部412が密巻きで、先端径小等径部413は、先端側が疎巻きを有して巻回して成る。内側コイル4は、ステンレス鋼から成る放射線透過性の線材を用いて後端径大等径部411と中間テーパ部412は密巻きで、先端径小等径部413は先端側が疎巻きを有して巻回して成る。
連接截頭円錐体26の第1截頭円錐体26Aの外側に、内側コイル4の密巻きの中間テーパ部412と外側第1コイル31の密巻きの中間テーパ部312とを共に配置する。
そして、第1截頭円錐体26Aの外径が、後端側から先端側へ徐変減少するのに伴って、外側第1コイル31の中間テーパ部312の密巻きの初張力と内側コイル4の密巻きの中間テーパ部412の初張力とが共に後端側から先端側へ徐変増大する。
これにより、後端から先端へ徐変増大する外側コイル30の中間テーパ部312と内側コイル4の中間テーパ部412は、後端から先端へコイル線間の密着力(圧縮力)が徐変増大する。
そして、後端から先端へコイル線間の密着力(圧縮力)が徐変増大する2つの中間テーパ部312、412を、後端から先端へ外径が徐変減少する第1截頭円錐体26Aの外側へ配置することにより、第1截頭円錐体26Aの外径が先端側へ細径化するのに伴って、2つの中間テーパ部312、412のコイル線間の密着力(圧縮力)が先端側へ高められることとなり、細径の第1截頭円錐体26Aでありながら先端側への回転伝達性能の向上を、高めた初張力を用いてさらに補完することができる。
As described above, the inner coil 4 is formed by using a radiolucent wire made of stainless steel, the rear end diameter large equal diameter portion 411 and the intermediate taper portion 412 are tightly wound, and the tip diameter small equal diameter portion 413 is formed on the front end side. It has a loose winding and is wound. The inner coil 4 uses a radiolucent wire made of stainless steel, the rear end diameter large equal diameter portion 411 and the intermediate taper portion 412 are closely wound, and the front end small diameter equal diameter portion 413 is loosely wound on the front end side. Wrapped up.
On the outside of the first truncated cone 26 </ b> A of the articulated truncated cone 26, the tightly wound intermediate tapered portion 412 of the inner coil 4 and the densely wound intermediate tapered portion 312 of the outer first coil 31 are disposed together.
Then, as the outer diameter of the first truncated cone 26A gradually decreases from the rear end side to the front end side, the tightly wound initial tension of the intermediate tapered portion 312 of the outer first coil 31 and the inner coil 4 are increased. The initial tension of the closely wound intermediate taper portion 412 gradually increases from the rear end side to the front end side.
As a result, the intermediate taper portion 312 of the outer coil 30 and the intermediate taper portion 412 of the inner coil 4 that gradually increase from the rear end to the front end gradually increase the adhesion force (compression force) between the coil wires from the rear end to the front end. To do.
Then, the two intermediate taper portions 312 and 412 in which the adhesion force (compression force) between the coil wires gradually increases from the rear end to the front end, and the first truncated cone in which the outer diameter gradually decreases from the rear end to the front end. As a result of the outer diameter of the first truncated cone 26A being reduced to the distal end side by arranging it outside the 26A, the adhesion force between the coil wires of the two intermediate taper portions 312 and 412 (compressive force) ) Is increased to the tip side, and the improvement of the rotation transmission performance to the tip side can be further supplemented by using the increased initial tension while being the first truncated cone 26A having a small diameter.

内側コイル4の後端径大等径部411の外径A1と、先端径小等径部413の外径A2との外径比A1/A2は、心臓血管治療用に用いられている最大外径0.3556mm(0.014インチ)と下肢血管治療用に用いられているガイドワイヤの最大外径0.4572mm(0.018インチ)との双方を併せ考慮すると、外径比A1/A2は1.15以上2.80以下で、好ましくは1.15以上2.75以下で、より好ましくは1.25以上2.75以下である。第4実施形態の内側コイル4の外径比A1/A2は約1.42である。  The outer diameter ratio A1 / A2 between the outer diameter A1 of the rear end diameter larger equal diameter portion 411 of the inner coil 4 and the outer diameter A2 of the smaller tip diameter equal diameter portion 413 is the maximum outer diameter used for cardiovascular treatment. Considering both the diameter of 0.3556 mm (0.014 inch) and the maximum outer diameter of the guide wire used for lower limb vascular treatment 0.4572 mm (0.018 inch), the outer diameter ratio A1 / A2 is It is 1.15 or more and 2.80 or less, preferably 1.15 or more and 2.75 or less, more preferably 1.25 or more and 2.75 or less. The outer diameter ratio A1 / A2 of the inner coil 4 of the fourth embodiment is about 1.42.

そして、連接截頭円錐体26の第1截頭円錐体26Aの後端の径大外径D2と先端の径小外径D1との外径比D2/D1は、第2截頭円錐体26Bの外径比D0/D2よりも大きく{(D2/D1)>(D0/D2)}、かつ、第1截頭円錐体26Aの外径比D2/D1と、内側コイル4の外径比A1/A2と、外側コイル30の外径比B1/B2とは、
(D2/D1)>(A1/A2)>(B1/B2)・・・(13)
の関係式(13)を満たす。
The outer diameter ratio D2 / D1 between the large outer diameter D2 of the rear end of the first truncated cone 26A and the small outer diameter D1 of the tip of the articulated truncated cone 26 is the second truncated cone 26B. Is larger than the outer diameter ratio D0 / D2 of {{D2 / D1)> (D0 / D2)}, and the outer diameter ratio D2 / D1 of the first truncated cone 26A and the outer diameter ratio A1 of the inner coil 4 are / A2 and the outer diameter ratio B1 / B2 of the outer coil 30 are
(D2 / D1)> (A1 / A2)> (B1 / B2) (13)
The relational expression (13) is satisfied.

第4実施形態では、第1截頭円錐体26Aの外径比D2/D1が約2.08であり、第2截頭円錐体26Bの外径比D0/D2が1.44であることから第1截頭円錐体26Aの外径比D2/D1は、第2截頭円錐体26Bの外径比D0/D2よりも大きく(約2.08>1.44)、かつ、内側コイル4の外径比A1/A2が約1.42であり、外側コイル30の外径比B1/B2が約1.27であることから第1截頭円錐体26Aの外径比D2/D1と、内側コイル4の外径比A1/A2と、外側コイル30の外径比B1/B2とは、約2.08>約1.42>約1.27となって(D2/D1)>(A1/A2)>(B1/B2)の関係式(13)を満たしている。
このように関係式(13)を満たすこととする理由は、先細り形状の、内側コイル4と外側コイル30との併用により、内側コイル4内の芯線先端部2Bの第1截頭円錐体26Aの、細径に伴うねじり力の低下分を、より補完することができるからである。
そして、第1截頭円錐体26Aの外径比D2/D1を最も大きくすることにより、細径の第1截頭円錐体26Aでありながら先端側へのねじりモーメント増大を図ることができる。
さらに、外側コイル30と内側コイル4の密巻き中間テーパ部312、412は、後端から先端への初張力を増大させ、後端から先端へコイル線間の圧縮力(密着力)を徐変増大させる。後端から先端へコイル線間の圧縮力(密着力)を徐変増大させた中間テーパ部312、412を第1截頭円錐体26Aの外側に配置することにより、先端側へのねじりモーメントを増大させて、閉塞部、及び完全閉塞病変部での穿孔性能を飛躍的に向上させることができる。
In the fourth embodiment, the outer diameter ratio D2 / D1 of the first truncated cone 26A is about 2.08, and the outer diameter ratio D0 / D2 of the second truncated cone 26B is 1.44. The outer diameter ratio D2 / D1 of the first truncated cone 26A is larger than the outer diameter ratio D0 / D2 of the second truncated cone 26B (about 2.08> 1.44), and the inner coil 4 Since the outer diameter ratio A1 / A2 is about 1.42 and the outer diameter ratio B1 / B2 of the outer coil 30 is about 1.27, the outer diameter ratio D2 / D1 of the first truncated cone 26A is The outer diameter ratio A1 / A2 of the coil 4 and the outer diameter ratio B1 / B2 of the outer coil 30 are about 2.08> about 1.42> about 1.27 (D2 / D1)> (A1 / The relational expression (13) of A2)> (B1 / B2) is satisfied.
The reason for satisfying the relational expression (13) in this way is that the tapered first inner truncated cone 26 </ b> A of the core wire tip 2 </ b> B in the inner coil 4 is obtained by the combined use of the inner coil 4 and the outer coil 30. This is because the decrease in torsional force associated with the small diameter can be more complemented.
By increasing the outer diameter ratio D2 / D1 of the first truncated cone 26A to the maximum, it is possible to increase the torsional moment toward the distal end side even though the first truncated cone 26A has a small diameter.
Further, the closely wound intermediate taper portions 312 and 412 of the outer coil 30 and the inner coil 4 increase the initial tension from the rear end to the front end, and gradually change the compression force (adhesion force) between the coil wires from the rear end to the front end. Increase. By disposing intermediate taper portions 312 and 412 that gradually increase the compression force (adhesion force) between the coil wires from the rear end to the front end on the outside of the first truncated cone 26A, the torsional moment toward the front end is reduced. By increasing, the perforation performance in the occluded portion and the completely occluded lesion portion can be dramatically improved.

本発明の外側コイル3、30内の芯線先端部2Bの連接截頭円錐体26、260は、連接する截頭円錐体の個数は、外側コイル3、30の全長に影響されるが外側コイル3、30の全長が20mm以上350mm以下の場合には、少なくとも2個以上で20個以下のであることが好ましい。  The number of the connecting truncated cones 26 and 260 of the core wire tip 2B in the outer coils 3 and 30 of the present invention is affected by the total length of the outer coils 3 and 30, although the number of the connected truncated cones is affected by the total length of the outer coils 3 and 30. When the total length of 30 is 20 mm or more and 350 mm or less, it is preferably at least 2 and 20 or less.

又、前記第1〜4実施形態において、初張力が作用するコイル(外側コイル3、30、内側コイル4)について述べた。前記実施形態において、先端細径体27の外側のコイル(外側第1コイル31の先端側、外側第1コイル310の先端径小等径部313、内側コイル4の先端径小等径部413)が疎巻きで、第1截頭円錐体26Aの外側のコイル(外側第1コイル31の後端側、外側第1コイル310の中間テーパ部312、内側コイル4の中間テーパ部412)が密巻きの場合に、先端細径体27と第1截頭円錐体26Aとの境界部で別段の作用効果がある。
つまり、近年の手技において、特開2012−5724号公報に記載されているように、病変部の入口部へ迅速にガイドワイヤを到達させる為、先端部を意図的にU字形状に屈曲させる手技がある。
かかる場合において、本発明は、第1截頭円錐体26Aが先端側へ徐変縮径する構造であり、第1截頭円錐体26Aの外側のコイルは先端側へ徐変増大する初張力を備えている構造である。又、先端細径体27の外側のコイルは初張力が作用しない疎巻き構造である。
先端側へ細径化する第1截頭円錐体26Aの構造と、先端側へ初張力が徐変増大する外側コイル構造と、初張力が作用しない先端細径体27の外側コイル構造との併用により、細径化と初張力が増大する第1截頭円錐体26Aの先端と、外側のコイルの初張力が働かない先端細径体27の後端の境界部近傍では、応力が集中する為にU字形状に屈曲させ易く、この結果、病変部の入口部へ迅速に到達できる別段の作用効果を発揮する。
In the first to fourth embodiments, the coils (outer coils 3, 30 and inner coil 4) on which initial tension acts have been described. In the above-described embodiment, the outer coil of the distal end small-diameter body 27 (the distal end side of the outer first coil 31, the outer diameter of the distal first coil 310 is the same diameter portion 313, the inner diameter of the inner coil 4 is the smaller diameter of the distal end portion 413). Are loosely wound, and the outer coil of the first truncated cone 26A (the rear end side of the outer first coil 31, the intermediate tapered portion 312 of the outer first coil 310, the intermediate tapered portion 412 of the inner coil 4) is closely wound. In this case, there is an extraordinary effect at the boundary between the tip small-diameter body 27 and the first truncated cone 26A.
That is, in recent techniques, as described in JP 2012-5724 A, a technique for intentionally bending the distal end portion into a U-shape in order to quickly reach the entrance of the lesioned portion. There is.
In such a case, the present invention has a structure in which the first truncated cone 26A gradually changes in diameter toward the distal end, and the coil outside the first truncated cone 26A has an initial tension that gradually increases toward the distal end. It is a structure provided. Further, the coil on the outer side of the tip small-diameter body 27 has a loosely wound structure in which initial tension does not act.
Combined use of the structure of the first truncated cone 26A that is reduced in diameter toward the distal end, the outer coil structure that gradually increases and increases the initial tension toward the distal end, and the outer coil structure of the distal narrow body 27 that does not act on the initial tension As a result, stress concentrates in the vicinity of the boundary between the tip of the first truncated cone 26A where the diameter and the initial tension increase and the rear end of the tip thin body 27 where the initial tension of the outer coil does not work. It is easy to bend into a U-shape, and as a result, a separate effect that can quickly reach the entrance of the lesion is exhibited.

そして、前記第1〜4実施形態において、芯線先端部2Bは、後端側から先端側へ徐変縮径する少なくとも2個以上の截頭円錐体を連接した連接截頭円錐体26、260として説明したが、本発明の内容は、芯線先端部2Bの截頭円錐体が1個(第1截頭円錐体26Aに相当する場合)で、コイルのねじり応力が一定範囲の場合についても、前記同様の考え方が適用できる。
つまり、
後端側から先端側へ徐変縮径する部分を有する芯線の芯線先端部を外側コイルへ貫挿し、芯線先端部は、後端側から先端側へ徐変縮径する少なくとも1個の截頭円錐体を有し、
前記外側コイルは、先端側が放射線不透過性の線材を螺旋状に巻回した外側第1コイルと、後端側が放射線透過性の線材を螺旋状に巻回した外側第2コイルから成り、
前記外側第1コイルの先端と前記芯線先端部の先端と接合して先端接合部とし、
前記外側第2コイルの後端と前記芯線先端部の後端と接合して外側第2コイル後端接合部とした医療用ガイドワイヤであって、
前記外側第1コイルは、白金とニッケルの合金から成る放射線不透過性の線材を、後端側が密巻きで先端側が疎巻きに巻回し、
前記外側第2コイルは、ステンレス鋼から成る放射線透過性の線材を密巻きに巻回し、
前記外側第1コイルと前記外側第2コイルは、ばね指数が2.8以上6.8以下で、前記外側第1コイルと前記外側第2コイルとのコイル平均径の差が10%以内のとき、前記外側第1コイルの密巻きの初張力によるねじり応力をτ1とし、前記外側第2コイルの密巻きの初張力によるねじり応力をτ2とした場合に、前記外側第1コイルのねじり応力τ1は、
0.62τ2≦τ1≦1.02τ2
の関係式を満たすことを特徴とする。
又、前記截頭円錐体の径大外径D2と径小外径D1との外径比D2/D1は、外側コイルの外径比B1/B2よりも大きい{(D2/D1)>(B1/B2)}。
そして又、前記截頭円錐体の外径比D2/D1と外側コイルの外径比B1/B2と内側コイルの外径比A1/A2とは、(D2/D1)>(A1/A2)>(B1>B2)の関係式を満たすことを特徴とする。
And in the said 1st-4th embodiment, the core wire front-end | tip part 2B is as the connection truncated cones 26 and 260 which connected the at least 2 or more truncated cones which carry out a diameter change gradually from the rear end side to the front end side. As described above, the content of the present invention is also the case where the number of truncated cones of the core wire tip 2B is one (when corresponding to the first truncated cone 26A) and the torsional stress of the coil is in a certain range. A similar idea can be applied.
That means
The core wire tip having a portion that gradually changes in diameter from the rear end side to the tip side is inserted into the outer coil, and the core wire tip portion has at least one wharf that gradually changes in diameter from the rear end side to the tip side. Having a cone,
The outer coil is composed of an outer first coil in which a distal end side is spirally wound with a radiopaque wire, and an outer second coil in which a rear end side is spirally wound with a radiolucent wire,
Joining the tip of the outer first coil and the tip of the core wire tip to form a tip joint,
A medical guide wire that joins the rear end of the outer second coil and the rear end of the core wire tip part to form the outer second coil rear end joint part,
The outer first coil is a radiopaque wire made of an alloy of platinum and nickel, with the rear end side wound closely and the front end side loosely wound,
The outer second coil is formed by winding a radiolucent wire made of stainless steel in close winding,
The outer first coil and the outer second coil have a spring index of 2.8 or more and 6.8 or less, and a difference in coil average diameter between the outer first coil and the outer second coil is within 10%. When the torsional stress due to the initial tension of the outer first coil is τ1, and the torsional stress due to the initial tension of the outer second coil is τ2, the torsional stress τ1 of the outer first coil is ,
0.62τ2 ≦ τ1 ≦ 1.02τ2
The above relational expression is satisfied.
The outer diameter ratio D2 / D1 between the large outer diameter D2 and the small outer diameter D1 of the truncated cone is larger than the outer diameter ratio B1 / B2 of the outer coil {(D2 / D1)> (B1 / B2)}.
Further, the outer diameter ratio D2 / D1 of the truncated cone, the outer diameter ratio B1 / B2 of the outer coil, and the outer diameter ratio A1 / A2 of the inner coil are (D2 / D1)> (A1 / A2)> The relational expression (B1> B2) is satisfied.

そして、本発明の内容は、外側コイル3、30が放射線不透過性の線材から成る外側第1コイル31のみから成る場合であっても前記同様に適用でき、外側コイル3、30が放射線不透過性の線材から成る外側第1コイルと芯線先端部が連接截頭円錐体26、260を有する構造の場合と、さらに、外側コイル3、30が放射線不透過性の線材のみから成る外側第1コイルと芯線先端部が1個の截頭円錐体を有する場合である。
後者の適用例として、
後端側から先端側へ徐変縮径する部分を有する芯線の芯線先端部を外側第1コイルへ貫挿し、前記芯線先端部は、後端側から先端側へ徐変縮径する少なくとも1個の截頭円錐体を有し、前記外側第1コイルは、前記外側第1コイルの先端と前記芯線先端部の先端と接合して先端接合部とし、前記外側第1コイルの後端と前記芯線先端部の後端と接合して外側第1コイル後端接合部とした医療用ガイドワイヤであって、
前記外側第1コイルは、白金が90重量%以上99重量%以下で残部がニッケルの放射線不透過性の線材を螺旋状に巻回し、後端側が密巻きで先端側は疎巻きから成り、
ばね指数をC1、密巻きの初張力によるねじり応力をτ1(N/mm)とすると、ばね指数C1が2.8以上6.8以下で、密巻きの初張力によるねじり応力τ1(N/mm)は、
−17.2C1+165.7≦τ1≦−35.3C1+341.2
の関係式を満たすことを特徴とする。
又、前記截頭円錐体の径大外径D2と径小外径D1との外径比D2/D1は、外側コイルの外径比B1/B2よりも大きい{(D2/D1)>(B1/B2)}。
そして又、前記截頭円錐体の外径比D2/D1と外側コイルの外径比B1/B2と内側コイルの外径比A1/A2とは、(D2/D1)>(A1/A2)>(B1>B2)の関係式を満たすことを特徴とする。又、外側第1コイルは、全長に亘って初張力が作用する密巻きとしてもよい。
The contents of the present invention can also be applied to the case where the outer coils 3 and 30 are composed of only the first outer coil 31 made of a radiopaque wire, and the outer coils 3 and 30 are radiopaque. The outer first coil made of a conductive wire and the structure in which the core tip has the connecting truncated cones 26 and 260, and the outer first coil made of only the radiopaque wire. And the core wire tip has one truncated cone.
As an application example of the latter,
The core wire tip having a portion gradually changing from the rear end side to the tip end side is inserted into the outer first coil, and the tip end portion of the core wire has at least one diameter gradually changing from the rear end side to the tip end side. The outer first coil is joined to the tip of the outer first coil and the tip of the core wire tip to form a tip joint, and the rear end of the outer first coil and the core wire A medical guide wire joined to the rear end of the front end portion to form an outer first coil rear end joint portion,
The outer first coil is formed by spirally winding a radiopaque wire rod of platinum of 90 wt% or more and 99 wt% or less of the nickel, and the rear end side is closely wound and the front end side is loosely wound,
Assuming that the spring index is C1 and the torsional stress due to the initial tension of dense winding is τ1 (N / mm 2 ), the spring index C1 is 2.8 to 6.8 and the torsional stress τ1 (N / N mm 2 )
−17.2C1 + 165.7 ≦ τ1 ≦ −35.3C1 + 341.2
The above relational expression is satisfied.
The outer diameter ratio D2 / D1 between the large outer diameter D2 and the small outer diameter D1 of the truncated cone is larger than the outer diameter ratio B1 / B2 of the outer coil {(D2 / D1)> (B1 / B2)}.
Further, the outer diameter ratio D2 / D1 of the truncated cone, the outer diameter ratio B1 / B2 of the outer coil, and the outer diameter ratio A1 / A2 of the inner coil are (D2 / D1)> (A1 / A2)> The relational expression (B1> B2) is satisfied. Further, the outer first coil may be a tight winding in which the initial tension acts over the entire length.

1 医療用ガイドワイヤ
2 芯線
2A 芯線後端部
2B、2C 芯線先端部
3、30 外側コイル
31、310 外側第1コイル
32、320 外側第2コイル
5A 先端接合部
5B 外側コイル後端接合部
5C 内側コイル後端接合部
26、260 連接截頭円錐体
26A 第1截頭円錐体
26B 第2截頭円錐体
26C 第3截頭円錐体
DESCRIPTION OF SYMBOLS 1 Medical guide wire 2 Core wire 2A Core wire rear end part 2B, 2C Core wire front-end | tip part 3, 30 Outer coil 31, 310 Outer first coil 32, 320 Outer second coil 5A End joint part 5B Outer coil rear end joint part 5C Inner side Coil rear end joint portion 26, 260 articulated truncated cone 26A first truncated cone 26B second truncated cone 26C third truncated cone

上記目的を達成する為、本発明のガイドワイヤは、後端側から先端側へ徐変縮径する部分を有する芯線の芯線先端部を外側コイル内へ貫挿する。
外側コイルは、先端側が放射線不透過性の線材を螺旋状に巻回した外側第1コイルと、後端側が放射線透過性の線材を螺旋状に巻回した外側第2コイルから成る。
外側第1コイルの先端と芯線先端部の先端と接合して先端接合部とし、外側第2コイルの後端と芯線先端部の後端と接合して外側第2コイル後端接合部とする。
In order to achieve the above-mentioned object, the guide wire of the present invention inserts the core wire tip end portion of the core wire having a portion gradually changing from the rear end side toward the tip end side into the outer coil.
The outer coil is composed of an outer first coil in which a radiopaque wire is wound spirally on the front end side, and an outer second coil in which a radiation transparent wire is spirally wound on the rear end side.
A tip joint by joining a leading end of the tip and the core wire distal end portion of the outer first coil, a second outer coil rear end joint by joining a rear end of the rear end the core wire distal end portion of the outer second coil To do.

外側第1コイルと外側第2コイルは、ばね指数が2.8以上6.8以下で、外側第1コイルの密巻きの初張力によるねじり応力をτ1とし、外側第2コイルの密巻きの初張力によるねじり応力をτ2とした場合に、外側第1コイルのねじり応力τ1は、
0.62τ2≦τ1≦1.02τ2
の関係式を満たす。
The outer first coil and the second outer coil, the spring index is 2.8 or more 6.8 or less, the torsional stress due to the initial tension of the closed winding of the outer side first coil and .tau.1, the outer second coil tightly wound When the torsional stress due to the initial tension is τ2, the torsional stress τ1 of the outer first coil is
0.62τ2 ≦ τ1 ≦ 1.02τ2
Is satisfied.

外側コイルと内側コイルは、後端側から先端側へ向かって後端径大等径部と中間テーパ部と先端径小等径部とを備える。内側コイルは、芯線先端部の外側で、外側コイルの内側に、外側コイルよりも長手方向の長さが短く同心状に配置する。
又、外側コイルの先端と内側コイルの先端径小等径部の先端と芯線先端部の先端と接合して先端接合部とし、内側コイルの後端径大等径部の後端と芯線先端部と接合して内側コイル後端接合部とする。
内側コイルは、ステンレス鋼から成る放射線透過性の線材を用いて、後端径大等径部と中間テーパ部は密巻きで、先端径小等径部の先端側が疎巻きに巻回する。
The outer coil and the inner coil include a rear end diameter large equal diameter portion, an intermediate taper portion, and a front end diameter small equal diameter portion from the rear end side toward the front end side. The inner coil is disposed concentrically with a shorter length in the longitudinal direction than the outer coil, inside the outer coil, outside the tip of the core wire.
Also, the tip of the outer coil, the tip of the inner coil with the smaller diameter portion and the tip of the core wire are joined to form a tip joint, and the rear end of the inner coil with the larger diameter portion and the core wire tip are joined. the inner coil rear end joint by joining a part.
The inner coil is made of a radiolucent wire made of stainless steel. The rear end diameter large-diameter portion and the intermediate taper portion are closely wound, and the front end side of the small end diameter equal-diameter portion is wound loosely.

本発明のガイドワイヤは、外側コイルは、先端側が白金とニッケルの合金から成る放射線不透過性の線材を先端側が疎巻きに巻回した外側第1コイルと、後端側がステンレス鋼から成る放射線透過性の線材を密巻きに巻回した外側第2コイルから成る。
外側第1コイルと外側第2コイルは、ばね指数が2.8以上6.8以下で、外側第1コイルの密巻きの初張力によるねじり応力をτ1とし、外側第2コイルの密巻きの初張力によるねじり応力をτ2とした場合に、外側第1コイルのねじり応力τ1は、
0.62τ2≦τ1≦1.02τ2
の関係式を満たす。
この理由は、外側コイルに、放射線不透過性の線材と放射線透過性の線材との異種金属線を巻回して一体化したコイルは、異種金属のそれぞれの線材のもつ機械的強度特性の差から屈曲変形させた場合に、一体化した接合部を境にして曲率半径が異なり、均一な円弧を描くことができない。又、手元側を回転させた場合に、異種金属の線材のもつねじり応力の差から、一体化した接合部を境にしてねじり溜まりが発生し、先端側への回転伝達性能が劣ることとなる。
密巻きコイルの巻回成形によって発生する初張力の強弱から初張力によるねじり応力を制御し、外側第1コイルのねじり応力τ1と外側第2コイルのねじり応力τ2とを前記一定範囲とすることにより、屈曲変形させた場合に接合部での異なる曲率半径の発生を低減させて均一な円弧形状を描く為と、接合部でのねじり溜まりを防いで、先端側への回転伝達性能の向上を図る為である。
In the guide wire of the present invention, the outer coil is composed of an outer first coil in which a distal end side is wound with a radiopaque wire made of an alloy of platinum and nickel, and a distal end side made of stainless steel. It consists of an outer second coil wound with a dense wire.
The outer first coil and the second outer coil, the spring index is 2.8 or more 6.8 or less, the torsional stress due to the initial tension of the closed winding of the outer side first coil and .tau.1, the outer second coil tightly wound When the torsional stress due to the initial tension is τ2, the torsional stress τ1 of the outer first coil is
0.62τ2 ≦ τ1 ≦ 1.02τ2
Is satisfied.
The reason for this is that the coil in which the dissimilar metal wire of the radiopaque wire and the radiolucent wire is wound around the outer coil is integrated into the outer coil because of the difference in mechanical strength characteristics of the respective dissimilar metal wires. When bent and deformed, the curvature radii are different from each other at the integrated joint, and a uniform arc cannot be drawn. In addition, when the hand side is rotated, the difference in torsional stress of different metal wires causes torsional accumulation at the boundary of the integrated joint, resulting in inferior rotation transmission performance to the tip side. .
By controlling the torsional stress due to the initial tension based on the strength of the initial tension generated by the winding forming of the densely wound coil, the torsional stress τ1 of the outer first coil and the torsional stress τ2 of the outer second coil are set within the predetermined range. In order to draw a uniform arc shape by reducing the occurrence of different radii of curvature at the joint when bent and deformed, and to prevent torsion accumulation at the joint and improve the rotation transmission performance to the tip side Because of that.

外側コイルは、後端側から先端側へ向かって、密巻きの後端径大等径部の外側第2コイルと密巻きの中間テーパ部と先端側に疎巻きを有する先端径小等径部との外側第1コイルから成る。又は、密巻きの後端径大等径部と密巻きの中間テーパ部の後端側との外側第2コイルと、密巻きの中間テーパ部の先端側と先端側に疎巻きを有する先端径小等径部との外側第1コイルから成る。
芯線先端部の連接截頭円錐体は、先端の截頭円錐体を第1截頭円錐体とし、第1截頭円錐体の外側に、外側コイルの中間テーパ部を配置する。
第1截頭円錐体の外径が、後端から先端へ徐変減少するのに伴って、外側コイルの中間テーパ部の密巻きの初張力が、後端から先端へ徐変増大する。
これにより、外径比(後端の径大外径/先端の径小外径)を最も高めた第1截頭円錐体を有する連接截頭円錐体の構造により、先端側への回転伝達性能を高めることができる。又、後端から先端へ徐変増大する外側コイルの中間テーパ部は、後端から先端へコイル線間の密着力(圧縮力)が増大する。
そして、後端から先端へコイル線間の密着力(圧縮力)が徐変増大する中間テーパ部を後端から先端へ外径が徐変減少する第1截頭円錐体の外側へ配置することにより、第1截頭円錐体の外径が先端側へ細径化するのに伴って、中間テーパ部のコイル線間の密着力(圧縮力)が先端側へ高められることとなり、細径の第1截頭円錐体でありながら先端側への回転伝達性能の向上を、コイルに作用する初張力により、より補完することができる。
The outer coil is formed from the rear end side toward the front end side, the outer second coil of the tightly wound rear end diameter large equal diameter portion, the tightly wound intermediate taper portion, and the distal end small diameter equal diameter portion having a loose winding on the front end side. And the outer first coil. Alternatively, the outer second coil on the back end side of the densely wound intermediate taper portion and the back end side of the closely wound intermediate taper portion, and the distal end diameter having loose winding on the distal end side and the distal end side of the closely wound intermediate tapered portion It consists of an outer first coil with a small diameter section.
The connecting truncated cone at the front end of the core wire has the first truncated cone as the first truncated cone, and the intermediate taper portion of the outer coil is disposed outside the first truncated cone.
As the outer diameter of the first truncated cone gradually decreases from the rear end to the tip, the initial tension of the tight winding of the intermediate taper portion of the outer coil gradually increases from the rear end to the tip.
As a result, the structure of the articulated truncated cone having the first truncated cone having the highest outer diameter ratio (large outer diameter at the rear end / small outer diameter at the distal end) has the ability to transmit rotation to the distal end side. Can be increased. Further, the intermediate taper portion of the outer coil that gradually increases from the rear end to the front end increases the adhesion (compression force) between the coil wires from the rear end to the front end.
Then, an intermediate taper portion in which the adhesion force (compression force) between the coil wires gradually increases from the rear end to the front end is disposed outside the first truncated cone whose outer diameter gradually decreases from the rear end to the front end. Thus, as the outer diameter of the first truncated cone is reduced toward the tip side, the adhesion force (compression force) between the coil wires of the intermediate taper portion is increased toward the tip side. Although it is the first truncated cone, the improvement of the rotation transmission performance toward the tip side can be more complemented by the initial tension acting on the coil.

外側コイルは、後端側から先端側へ向かって後端径大等径部と中間テーパ部先端径小等径部を備え、外側コイルの後端径大等径部の外径をB1、先端径小等径部の外径をB2、連接截頭円錐体の第1截頭円錐体の後端の径大外径をD2とした場合に、第1截頭円錐体の先端の径小外径がD1であることから、第1截頭円錐体の外径比(D2/D1)は、外側コイルの外径比(B1/B2)よりも大きい{(D2/D1)>(B1/B2)}。
これにより、外側コイルを先細り形状とすることによって外側コイル内の芯線先端部の細径に伴うねじり力の低下分を補完し、細径の芯線先端部でありながら先端の第1截頭円錐体の外径比を高めることにより、先端側へのねじりモーメントの増大を図り、先細り形状の外側コイルとの併用により、先端側への回転伝達性をより高めることができる。
The outer coil, comprises a rear end large diameter such as diameter portion and the intermediate tapered portion and a distal small-diameter such diameter portion toward the rear side to the tip side, the outer diameter of the rear end a large diameter such as diameter of the outer coil B1, When the outer diameter of the small-diameter portion of the tip end is B2, and the large outer diameter of the rear end of the first truncated cone of the connecting truncated cone is D2, the diameter of the tip of the first truncated cone is small. Since the outer diameter is D1, the outer diameter ratio (D2 / D1) of the first truncated cone is larger than the outer diameter ratio (B1 / B2) of the outer coil {(D2 / D1)> (B1 / B2)}.
As a result, the outer coil has a tapered shape to compensate for the decrease in torsional force associated with the small diameter of the core wire tip in the outer coil, and the first truncated cone at the tip while being a thin core wire tip. By increasing the outer diameter ratio, it is possible to increase the torsional moment toward the distal end side, and it is possible to further enhance the rotational transmission to the distal end side by using it together with the tapered outer coil.

外側コイルと内側コイルは、後端側から先端側へ向かって、後端径大等径部と中間テーパ部と先端径小等径部を備える。この内側コイルを芯線先端部の外側で、外側コイルの内側に、外側コイルよりも長手方向の長さが短く、外側コイルと同心状に配置する。又、外側コイルの先端と内側コイルの先端径小等径部の先端と芯線先端部の先端と接合して先端接合部とし、内側コイルの後端径大等径部の後端と芯線先端部と接合して内側コイル後端接合部とする。
内側コイルは、ステンレス鋼から成る放射線透過性の線材を用いて後端径大等径部と中間テーパ部は密巻きで、先端径小等径部は先端側が疎巻きを有して巻回して成る。
連接截頭円錐体の第1截頭円錐体の外側に、内側コイルの密巻きの中間テーパ部と外側第1コイルの密巻きの中間テーパ部とを共に配置する。
そして、第1截頭円錐体の外径が、後端側から先端側へ徐変減少するのに伴って、外側第1コイルの中間テーパ部の密巻きの初張力と内側コイルの密巻きの中間テーパ部の初張力とが共に、後端側から先端側へ徐変増大する。
これにより、後端から先端へ初張力が徐変増大する外側コイルの中間テーパ部と内側コイルの中間テーパ部は、後端から先端へコイル線間の密着力(圧縮力)が増大する。
そして、後端から先端へコイル線間の密着力(圧縮力)が徐変増大する2つの中間テーパ部を、後端から先端へ外径が徐変減少する第1截頭円錐体の外側へ配置することにより、第1截頭円錐体の外径が先端側へ細径化するのに伴って、2つの中間テーパ部のコイル線間の密着力(圧縮力)が先端側へ高められることとなり、細径の第1截頭円錐体でありながら先端側への回転伝達性能の向上を、2つの中間テーパに作用する初張力によってさらに補完することができる。
The outer coil and the inner coil include a rear end diameter large-diameter portion, an intermediate taper portion, and a front end diameter small equal-diameter portion from the rear end side toward the front end side. This inner coil is arranged outside the core wire tip, inside the outer coil, in a longitudinal direction shorter than the outer coil, and concentrically with the outer coil. Also, the tip of the outer coil, the tip of the inner coil with the smaller diameter portion and the tip of the core wire are joined to form a tip joint, and the rear end of the inner coil with the larger diameter portion and the core wire tip are joined. the inner coil rear end joint by joining a part.
The inner coil is made of stainless steel with a radiolucent wire, and the rear end diameter large-diameter part and the intermediate taper part are closely wound, and the front end small-diameter part is wound with a sparse winding on the front side. Become.
The tightly wound intermediate taper portion of the inner coil and the tightly wound intermediate taper portion of the outer first coil are both arranged outside the first truncated cone of the articulated truncated cone.
Then, as the outer diameter of the first truncated cone gradually decreases from the rear end side to the front end side, the initial tension of the tight winding of the intermediate taper portion of the outer first coil and the tight winding of the inner coil are increased. Both the initial tension of the intermediate taper portion gradually increases from the rear end side to the front end side.
As a result, the intermediate taper portion of the outer coil and the intermediate taper portion of the inner coil, whose initial tension gradually increases from the rear end to the front end, increase the adhesion force (compression force) between the coil wires from the rear end to the front end.
Then, the two intermediate taper portions where the cohesive force (compression force) between the coil wires gradually increases from the rear end to the front end are extended to the outside of the first truncated cone whose outer diameter gradually decreases from the rear end to the front end. By arranging, the adhesion force (compression force) between the coil wires of the two intermediate taper portions is increased to the tip side as the outer diameter of the first truncated cone is reduced to the tip side. Thus, the improvement in the rotation transmission performance toward the tip side can be further supplemented by the initial tension acting on the two intermediate tapers while being the first truncated cone having a small diameter.

図1は、本発明の第1実施形態のガイドワイヤ1の全体図を示す。ガイドワイヤ1は、芯線2と、外側コイル3と、ふっ素樹脂被膜6と、親水性樹脂被膜7を有する。芯線2は、芯線後端部2Aと芯線先端部2Bとを有し、後端側から先端側へ徐変縮径する部分を有している。
外側コイル3は、先端側が放射線不透過性の線材を螺旋状に巻回した外側第1コイル31と、後端側が放射線透過性の線材を螺旋状に巻回した外側第2コイル32から成り、外側第1コイル31の後端部のコイル線と外側第2コイルの先端部のコイル線とをねじ込んだ後に、ろう材を用いて中間接合部5Dにて接合する。又、特開2002−336360、特開平9−38210の公開特許公報に示すような溶接接合手段を用いて接合してもよい。又、中間接合部5Dは、外側コイルと共に芯線先端部と接合されていてもよい。
外側コイル3は、芯線先端部2Bが貫挿し、接合部材を用いて外側第コイル31の先端と芯線先端部2Bの先端と接合して先丸形状の先端接合部5Aを形成し、外側第2コイル32の後端と芯線先端部2Bと接合して外側コイル後端接合部5Bを形成している。
ふっ素樹脂被膜6は、後端側の太径の芯線後端部2Aの外周に形成されている。親水性樹脂被膜7は、外側コイル3の外周に形成されている。尚、本発明のガイドワイヤ1は、長さに比べて直径が極めて小さな値となっている。この為、本発明のガイドワイヤ1は、縦横の縮尺率を同じにすると所定のエリアに図示することが困難となる為、一部を誇張したり、省略したりして図示している。
FIG. 1 shows an overall view of a guide wire 1 according to a first embodiment of the present invention. The guide wire 1 has a core wire 2, an outer coil 3, a fluorine resin film 6, and a hydrophilic resin film 7. The core wire 2 has a core wire rear end portion 2A and a core wire front end portion 2B, and has a portion that gradually changes in diameter from the rear end side to the front end side.
The outer coil 3 is composed of an outer first coil 31 in which a distal end side is spirally wound with a radiopaque wire, and an outer second coil 32 in which a rear end side is spirally wound with a radiation transmissive wire, After the coil wire at the rear end portion of the outer first coil 31 and the coil wire at the front end portion of the outer second coil are screwed together, the intermediate wire 5D is joined using a brazing material. Moreover, you may join using the welding joining means as shown in Unexamined-Japanese-Patent No. 2002-336360 and Unexamined-Japanese-Patent No. 9-38210. Moreover, intermediate | middle junction part 5D may be joined to the core wire front-end | tip part with the outer side coil.
The outer coil 3, the core wire distal end portion 2B is inserted through, to form the distal joint portion 5A of the previous round shape by joining a leading end of the tip and the core wire distal end portion 2B of the outer second coil 31 with a joint member, the outer second The rear end of the two coils 32 and the core wire front end portion 2B are joined to form the outer coil rear end joint portion 5B.
The fluororesin coating 6 is formed on the outer periphery of the rear end portion 2A having a large diameter core wire on the rear end side. The hydrophilic resin film 7 is formed on the outer periphery of the outer coil 3. Note that the guide wire 1 of the present invention has a very small diameter compared to the length. For this reason, the guide wire 1 of the present invention is difficult to show in a predetermined area when the vertical and horizontal scale ratios are the same.

そして、外側第1コイル31と外側第2コイル32とを一体接合した場合に、異種金属線から成るコイル同士の密巻きの初張力によるねじり応力差を、図2を用いて整理すると以下となる。
一体接合する外側第1コイル31と外側第2コイル32のばね指数C1とC2は、共に、2.8以上6.8以下の範囲内で、接合する部位のコイルの外側第1コイル31のコイル平均径と、外側第2コイル32のコイル平均径との差が10%以内で、外側第1コイル31のねじり応力τ1(N/mm)と外側第2コイル32のねじり応力τ2(N/mm)との関係は、
0.62τ2≦τ1≦1.02τ2 ・・・(9)
の関係式(9)を満たすことが好ましい。
より好ましくは、
0.65τ2≦τ1≦1.02τ2 ・・・(10)
の関係式(10)を満たすことである。
Then, when the outer first coil 31 and the outer second coil 32 are integrally joined, the torsional stress difference due to the initial tension of the tight winding between the coils made of different metal wires is organized as follows using FIG. .
Outer spring index C1 and C2 of the first coil 31 and the outer second coil 32 are both in the range of 2.8 to 6.8 or less, the first outer coil of coil 31 of the coil portion to be joined integrally bonded the average diameter, the difference between the coil average diameter of the outer second coil 32 is within 10%, torsional stress τ2 of torsional stress τ1 (N / mm 2) and the second outer coil 32 of the outer side first coil 31 (N / Mm 2 )
0.62τ2 ≦ τ1 ≦ 1.02τ2 (9)
It is preferable to satisfy the relational expression (9).
More preferably,
0.65τ2 ≦ τ1 ≦ 1.02τ2 (10)
The relational expression (10) is satisfied.

図2において図示符号イの関係式{関係式(4)(5)の上限を示す直線}は、図示符号ロの関係式{関係式(6)(7)の上限を示す直線}よりも上部に位置する。このことは、オーステナイト系ステンレス鋼の線材を巻回して成る外側第2コイル32のねじり応力τ2は、白金とニッケルの合金線を巻回して成る外側第1コイル31のねじり応力τ1よりも大きいことを示している。このことは、オーステナイト系ステンレス鋼から成る線材を用いた方が白金とニッケルの合金線よりも横弾性係数高く、ねじり応力を高く設定できる材質特性による。
従って、ねじり応力τ1の外側第1コイル31と、ねじり応力τ1よりも大きなねじり応力τ2の外側第2コイル32とを一体接合した場合には、一般的には、外側第1コイル31のねじり応力τ1が下限の値を示し、外側第2コイル32のねじり応力τ2が上限の値を示すこととなる。
具体例として、第1実施形態の外側コイル3の外側第1コイル31のばね指数C1と
外側第2コイル32のばね指数C2とは、共に4.5であることから、双方の好ましい範囲の前記関係式(4)(5)を用いると、下限値は、外側第1コイル31のねじり応力τ1である為、ばね指数C1を関係式(4)へ代入すると、外側第1コイル31のねじり応力τ1は、約124.9N/mmとなる。上限値は、外側第2コイル32のねじり応力τ2である為、ばね指数C2を関係式(5)へ代入すると、外側第2コイル32のねじり応力τ2は、約196.5N/mmとなる。
そして、外側第1コイルのねじり応力τ1(N/mm)と外側第2コイル32のねじり応力τ2(N/mm)とのねじり応力比(τ1/τ2)は、約0.64となり、前記関係式(9)を満たしている。
前記同様に、より好ましい範囲の前記関係式(6)(7)を用いると、外側第1コイル31のねじり応力τ1(N/mm)と外側第2コイル32のねじり応力τ2(N/mm)とのねじり応力比(τ1/τ2)は、約0.68となり、前記関係式(9)(10)を満たしている。
2, the relational expression {the straight line indicating the upper limit of the relational expressions (4) and (5)} is higher than the relational expression {the straight line indicating the upper limit of the relational expressions (6) and (7)}. Located in. This means that the torsional stress τ2 of the outer second coil 32 formed by winding an austenitic stainless steel wire is greater than the torsional stress τ1 of the outer first coil 31 formed by winding an alloy wire of platinum and nickel. Is shown. This is because the use of a wire made of austenitic stainless steel has a higher transverse elastic modulus than that of an alloy wire of platinum and nickel, and the material characteristics that can set a high torsional stress.
Therefore, when the outer first coil 31 having the torsional stress τ1 and the outer second coil 32 having the torsional stress τ2 larger than the torsional stress τ1 are integrally joined, generally, the torsional stress of the outer first coil 31 is generally determined. τ1 indicates a lower limit value, and torsional stress τ2 of the outer second coil 32 indicates an upper limit value.
As a specific example, the spring index C1 of the outer first coil 31 and the spring index C2 of the outer second coil 32 of the outer coil 3 of the first embodiment are both 4.5. If the relational expressions (4) and (5) are used, the lower limit value is the torsional stress τ1 of the outer first coil 31. Therefore, when the spring index C1 is substituted into the relational expression (4), the torsional stress of the outer first coil 31 is calculated. τ1 is approximately 124.9 N / mm 2 . Since the upper limit is the torsional stress τ2 of the outer second coil 32, when the spring index C2 is substituted into the relational expression (5), the torsional stress τ2 of the outer second coil 32 is about 196.5 N / mm 2. .
The torsional stress ratio (τ1 / τ2) between the torsional stress τ1 (N / mm 2 ) of the outer first coil and the torsional stress τ2 (N / mm 2 ) of the outer second coil 32 is about 0.64. The relational expression (9 ) is satisfied.
Similarly, when the relational expressions (6) and (7) in a more preferable range are used, the torsional stress τ1 (N / mm 2 ) of the outer first coil 31 and the torsional stress τ2 (N / mm) of the outer second coil 32 are used. 2 ) torsional stress ratio (τ1 / τ2) is about 0.68, which satisfies the relational expressions (9) and (10).

尚、補足すれば、例えば、引張強さが1400MPa以上3500MPa以下の範囲で、低い引張強さのオーステナイト系ステンレス鋼の線材から成る外側第2コイル32と、引張強さが1200MPa以上200MPa以下の範囲で、高い引張強さの白金とニッケルの合金線から成る外側第1コイル31とを用いることにより、さらに、コイルを巻回する場合の負のコイルピッチの負の量を制御することにより、外側第1コイル31のねじり応力τ1と外側第2コイル32のねじり応力τ2との差を僅差とすることができる。
例えば、後述する第3実施形態の外側第1コイル31の径大側のねじり応力τ1が約138.6N/mmの場合、外側第2コイル32のコイル線の引張強さを低くして、コイル線の密巻き加工時の初張力を低く制御することにより、外側第1コイル31のコイル平均径と線直径が同一の、外側第2コイル32のねじり応力τ2を135.9N/mmにすると、ねじり応力τ1とτ2のねじり応力比(τ1/τ2)は、約1.019となり、前記関係式(9)(10)を満たしている。尚、外側第2コイル32のねじり応力τ2の135.9N/mmも前記関係式(5)(7)を満たしている。
Incidentally, if supplemented, for example, a tensile strength of 3500MPa or less the range of 1400 MPa, lower and outer second coil 32 consisting of tensile strength wires of austenitic stainless steel, the tensile strength is less 200 0 MPa or more 1200MPa By using the outer first coil 31 made of an alloy wire of platinum and nickel with high tensile strength in the range, and further by controlling the negative amount of the negative coil pitch when winding the coil The difference between the torsional stress τ1 of the outer first coil 31 and the torsional stress τ2 of the outer second coil 32 can be made a small difference.
For example, when the torsional stress τ1 on the large diameter side of the outer first coil 31 of the third embodiment described later is about 138.6 N / mm 2 , the tensile strength of the coil wire of the outer second coil 32 is reduced, By controlling the initial tension at the time of dense winding of the coil wire to be low, the torsional stress τ2 of the outer second coil 32 having the same coil average diameter and the same wire diameter as the outer first coil 31 is set to 135.9 N / mm 2 . Then, the torsional stress ratio (τ1 / τ2) between the torsional stresses τ1 and τ2 is about 1.019, which satisfies the relational expressions (9) and (10). The torsional stress τ2 of 135.9 N / mm 2 of the outer second coil 32 also satisfies the relational expressions (5) and (7).

図3及び図4は、形状の異なる芯線先端部2B、2Cを示し、図3は截頭円錐体が2個の連接截頭円錐体26を有する第1実施形態の芯線先端部2Bを示し、図4は截頭円錐体が3個の場合の第2実施形態の芯線先端部2Cを示している。尚、芯線先端部2Cを除き、他の仕様は第1実施形態と同様であり、同一構成部材には同一符号が付してある。
図3について、芯線先端部2Bは、後端側から先端側へ連接截頭円錐体26と先端細径27から成る。連接截頭円錐体26は、長手方向の長さL2が100mm、径大外径D0が0.180mm、径小外径D2が0.125mmの第2截頭円錐体26Bと、長手方向の長さL1が50mm、第1截頭円錐体26Aからみて径大外径D2が0.125mm、径小外径D1が0.060mmの第1截頭円錐体26Aの2個の截頭円錐体から成る。
先端細径体27は、長手方向の長さL4が15mm、外径が第1截頭円錐体26Aの径小外径D1と同じで0.060mmの横断面の形状が円形である。又、外径が0.060mmの横断面が円形の形状を、押圧加工又は切削加工によりアスペクト比(長辺/短辺)が、1.676以上3.958以下の横断面が矩形としてもよい。
そして、初張力が作用する密巻きと初張力が作用しない疎巻きとを有する外側第1コイル31を、先端細径体27の外側に配置することにより、後述する別段の作用効果を発揮する。
3 and 4 show the core tip portions 2B and 2C having different shapes, and FIG. 3 shows the core tip portion 2B of the first embodiment in which the truncated cone has two connected truncated cones 26. FIG. 4 shows the core wire tip 2C of the second embodiment when there are three truncated cones. Except for the core wire tip 2C, other specifications are the same as those of the first embodiment, and the same constituent members are denoted by the same reference numerals.
With respect to FIG. 3, the core wire tip portion 2 </ b> B is composed of a conical truncated cone 26 and a tip small-diameter member 27 from the rear end side to the tip side. The articulated truncated cone 26 has a longitudinal length L2 of 100 mm, a large diameter outer diameter D0 of 0.180 mm, and a small diameter outer diameter D2 of 0.125 mm. From the two truncated cones of the first truncated cone 26A having a length L1 of 50 mm and a large outer diameter D2 of 0.125 mm and a small outer diameter D1 of 0.060 mm as viewed from the first truncated cone 26A. Become.
The tip small-diameter body 27 has a longitudinal length L4 of 15 mm, an outer diameter that is the same as the small outer diameter D1 of the first truncated cone 26A, and a circular cross-sectional shape of 0.060 mm. Further, the cross section having a circular outer cross-section with an outer diameter of 0.060 mm may be rectangular, and the cross-section with an aspect ratio (long side / short side) of 1.676 or more and 3.958 or less may be rectangular by pressing or cutting. .
Then, by arranging the outer first coil 31 having a dense winding in which the initial tension acts and a loose winding in which the initial tension does not act on the outside of the distal end small-diameter body 27, another advantageous effect described later is exhibited.

そして、第3実施形態の外側第1コイル31の中間テーパ部312は、外径が0.330mmから0.260mmへ徐変減少し、コイル線の線直径t1が0.060mmであることから、ばね指数C1は、径大側の4.5から径小側の約3.3へ徐変減少する。
かかる場合のねじり応力τ1は、径大側から径小側へ約138.6N/mmから約189.0N/mmへ徐変増大する。
径大側のねじり応力τ1が約138.6N/mmで、ばね指数C1が4.5であることから、前記関係式(4)へ代入すると、ねじり応力τ1の範囲は、約124.9N/mm以上196.5N/mm以下となり、前記関係式(6)へ代入すると、ねじり応力τ1の範囲は、約124.9N/mm以上182.4N/mm以下となり、いずれの場合も前記関係式(4)(6)を満たしている。
そして、径大側のねじり応力が約138.6N/mmのときの初張力は、前記関係式(8)を用いると約4.35×10−2Nとなり、又径小側のねじり応力が約189.0N/mmのときの初張力は前記関係式(8)を用いると約8.0×10−2Nとなる。
従って、第3実施形態の外側第1コイル31の中間テーパ部312は、第1截頭円錐体26Aの外径が先端側へ細径化するのに伴って、中間テーパ部312の初張力は、後端側から先端側へ約4.35×10−2Nから約8.0×10−2Nとなって、コイル線間の圧縮力(密着力)を後端側から先端側へ高めている。
Then, since the intermediate tapered portion 312 of the first outer coil 31 0 of the third embodiment, the outer diameter of gradual change reduced to 0.260mm from 0.330 mm, the line diameter t1 of the coil wire is 0.060mm The spring index C1 gradually decreases from 4.5 on the large diameter side to about 3.3 on the small diameter side.
Torsional stress τ1 of such a case, gradual change increases from the large-diameter side to about 138.6N / mm 2 to the small diameter side about 189.0N / mm 2.
Since the torsional stress τ1 on the large diameter side is about 138.6 N / mm 2 and the spring index C1 is 4.5, the range of the torsional stress τ1 is about 124.9 N when substituted into the relational expression (4). / Mm 2 or more and 196.5 N / mm 2 or less, and when substituted into the relational expression (6), the range of the torsional stress τ1 is about 124.9 N / mm 2 or more and 182.4 N / mm 2 or less. Satisfies the relational expressions (4) and (6).
When the torsional stress on the large diameter side is about 138.6 N / mm 2 , the initial tension is about 4.35 × 10 −2 N using the relational expression (8), and the torsional stress on the small diameter side. When the relational expression (8) is used, the initial tension at about 189.0 N / mm 2 is about 8.0 × 10 −2 N.
Therefore, the intermediate tapered portion 312 of the first outer coil 31 0 of the third embodiment, the outer diameter of the first truncated cone 26A is accompanied to reduce the diameter of the distal end side, the initial tension of the intermediate tapered portion 312 Is about 4.35 × 10 −2 N to about 8.0 × 10 −2 N from the rear end side to the front end side, and the compression force (adhesion force) between the coil wires is increased from the rear end side to the front end side. It is increasing.

次に、図8は、第4実施形態のガイドワイヤ111を示し、前記第3実施形態のガイドワイヤ11と異なるところは、外側コイル30の内側に、長手方向の長さが短く、かつ、同心状で、後端側から先端側へ向かって先細り形状の内側コイル4を配置していることである。尚、ふっ素樹脂被膜6と親水性樹脂被膜7は省略している。
内側コイル4は、芯線先端部2Bが貫挿し、接合部材等を用いて外側コイル30の先端と内側コイル4の先端と芯線先端部2Bの先端と接合して先丸形状の先端接合部5Aを形成し、内側コイル4の後端と芯線先端部2Bと接合して内側コイル後端接合部5Cを形成する。中間接合部5Eは、内側コイル4と外側コイル30と芯線先端部2Bと一体接合している。尚、中間接合部5Eは、内側コイル4と芯線先端部2Bとの接合、又は、内側コイル4と外側コイル30との接合としてもよい。
Next, FIG. 8 shows a guide wire 111 according to the fourth embodiment. The difference from the guide wire 11 according to the third embodiment is that the length in the longitudinal direction is short and concentric inside the outer coil 30. In other words, the tapered inner coil 4 is disposed from the rear end side toward the front end side. Note that the fluorine resin film 6 and the hydrophilic resin film 7 are omitted.
Inner coil 4 is inserted through the core wire distal end portion 2B, distal joint portion 5A of previous round shape by joining a leading end of the tip and the core wire distal end portion 2B of the tip and the inner coil 4 of the outer coil 30 by using a bonding member such as And the rear end of the inner coil 4 and the core wire front end portion 2B are joined to form the inner coil rear end joint portion 5C. Intermediate joint 5E are integrally joined to the inner coil 4 and the outer coil 30 and the core wire distal end portion 2B. The intermediate joint 5E may be a joint between the inner coil 4 and the core wire tip 2B or a joint between the inner coil 4 and the outer coil 30.

このように、内側コイル4は、ステンレス鋼から成る放射線透過性の線材を用いて後端径大等径部411と中間テーパ部412が密巻きで、先端径小等径部413は、先端側が疎巻きを有して巻回して成る。連接截頭円錐体26の第1截頭円錐体26Aの外側に、内側コイルの密巻きの中間テーパ部412と外側第1コイル31の密巻きの中間テーパ部312とを共に配置する。
そして、第1截頭円錐体26Aの外径が、後端側から先端側へ徐変減少するのに伴って、外側第1コイル31の中間テーパ部312の密巻きの初張力と内側コイル4の密巻きの中間テーパ部412の初張力とが共に後端側から先端側へ徐変増大する。
これにより、後端から先端へ徐変増大する外側コイル30の中間テーパ部312と内側コイル4の中間テーパ部412は、後端から先端へコイル線間の密着力(圧縮力)が徐変増大する。
そして、後端から先端へコイル線間の密着力(圧縮力)が徐変増大する2つの中間テーパ部312、412を、後端から先端へ外径が徐変減少する第1截頭円錐体26Aの外側へ配置することにより、第1截頭円錐体26Aの外径が先端側へ細径化するのに伴って、2つの中間テーパ部312、412のコイル線間の密着力(圧縮力)が先端側へ高められることとなり、細径の第1截頭円錐体26Aでありながら先端側への回転伝達性能の向上を、高めた初張力を用いてさらに補完することができる。
As described above, the inner coil 4 is formed by using a radiolucent wire made of stainless steel, the rear end diameter large equal diameter portion 411 and the intermediate taper portion 412 are tightly wound, and the tip diameter small equal diameter portion 413 is formed on the front end side. It has a loose winding and is wound . Outside the first truncated cones 26A of continuous contact truncated cones 26, together arranged a close coiled intermediate tapered portion 312 of the intermediate tapered portion 412 and the outer first coil 31 0 tightly wound inner coil.
The outer diameter of the first truncated cone 26A is accompanied to gradual change decreases distally from the rear end side, the initial tension of the closed winding of the first outer coil 31 0 intermediate tapered portion 312 and the inner coil 4 and the initial tension of the closely wound intermediate taper 412 gradually increase from the rear end side to the front end side.
As a result, the intermediate taper portion 312 of the outer coil 30 and the intermediate taper portion 412 of the inner coil 4 that gradually increase from the rear end to the front end gradually increase the adhesion force (compression force) between the coil wires from the rear end to the front end. To do.
Then, the two intermediate taper portions 312 and 412 in which the adhesion force (compression force) between the coil wires gradually increases from the rear end to the front end, and the first truncated cone in which the outer diameter gradually decreases from the rear end to the front end. As a result of the outer diameter of the first truncated cone 26A being reduced to the distal end side by arranging it outside the 26A, the adhesion force between the coil wires of the two intermediate taper portions 312 and 412 (compressive force) ) Is increased to the tip side, and the improvement of the rotation transmission performance to the tip side can be further supplemented by using the increased initial tension while being the first truncated cone 26A having a small diameter.

本発明の外側コイル3、30内の芯線先端部2Bの連接截頭円錐体26、260は、連接する截頭円錐体の個数は、外側コイル3、30の全長に影響されるが外側コイル3、30の全長が20mm以上350mm以下の場合には、少なくとも2個以上で20個以下であることが好ましい。The number of the connecting truncated cones 26 and 260 of the core wire tip 2B in the outer coils 3 and 30 of the present invention is affected by the total length of the outer coils 3 and 30, although the number of the connected truncated cones is affected by the total length of the outer coils 3 and 30. , in the case of a total length of 30 20mm or more 350mm or less, preferably 20 or hereinafter by at least two or more.

そして、前記第1〜4実施形態において、芯線先端部2Bは、後端側から先端側へ徐変縮径する少なくとも2個以上の截頭円錐体を連接した連接截頭円錐体26、260として説明したが、本発明の内容は、芯線先端部2Bの截頭円錐体が1個(第1截頭円錐体26Aに相当する場合)で、コイルのねじり応力が一定範囲の場合についても、前記同様の考え方が適用できる。
つまり、
後端側から先端側へ徐変縮径する部分を有する芯線の芯線先端部を外側コイルへ貫挿し、芯線先端部は、後端側から先端側へ徐変縮径する少なくとも1個の截頭円錐体を有し、
前記外側コイルは、先端側が放射線不透過性の線材を螺旋状に巻回した外側第1コイルと、後端側が放射線透過性の線材を螺旋状に巻回した外側第2コイルから成り、
前記外側第1コイルの先端と前記芯線先端部の先端と接合して先端接合部とし、
前記外側第2コイルの後端と前記芯線先端部の後端と接合して外側第2コイル後端接合部とした医療用ガイドワイヤであって、
前記外側第1コイルは、白金とニッケルの合金から成る放射線不透過性の線材を、後端側が密巻きで先端側が疎巻きに巻回し、
前記外側第2コイルは、ステンレス鋼から成る放射線透過性の線材を密巻きに巻回し、
前記外側第1コイルと前記外側第2コイルは、ばね指数が2.8以上6.8以下で、
記外側第1コイルの密巻きの初張力によるねじり応力をτ1とし、前記外側第2コイルの密巻きの初張力によるねじり応力をτ2とした場合に、前記外側第1コイルのねじり応力τ1は、
0.62τ2≦τ1≦1.02τ2
の関係式を満たすことを特徴とする。
又、前記截頭円錐体の径大外径D2と径小外径D1との外径比D2/D1は、外側コイルの外径比B1/B2よりも大きい{(D2/D1)>(B1/B2)}。
そして又、前記截頭円錐体の外径比D2/D1と外側コイルの外径比B1/B2と内側コイルの外径比A1/A2とは、(D2/D1)>(A1/A2)>(B1>B2)の関係式を満たすことを特徴とする。
And in the said 1st-4th embodiment, the core wire front-end | tip part 2B is as the connection truncated cones 26 and 260 which connected the at least 2 or more truncated cones which carry out a diameter change gradually from the rear end side to the front end side. As described above, the content of the present invention is also the case where the number of truncated cones of the core wire tip 2B is one (when corresponding to the first truncated cone 26A) and the torsional stress of the coil is in a certain range. A similar idea can be applied.
That means
The core wire tip having a portion that gradually changes in diameter from the rear end side to the tip side is inserted into the outer coil, and the core wire tip portion has at least one wharf that gradually changes in diameter from the rear end side to the tip side. Having a cone,
The outer coil is composed of an outer first coil in which a distal end side is spirally wound with a radiopaque wire, and an outer second coil in which a rear end side is spirally wound with a radiolucent wire,
A tip joint by joining a leading end of the core wire distal end and the distal end of the outer first coil,
A medical guide wire that joins a rear end of the outer second coil and a rear end of the core wire front end portion to form an outer second coil rear end joint portion,
The outer first coil is a radiopaque wire made of an alloy of platinum and nickel, with the rear end side wound closely and the front end side loosely wound,
The outer second coil is formed by winding a radiolucent wire made of stainless steel in close winding,
The outer first coil and the outer second coil have a spring index of 2.8 to 6.8 ,
The torsional stress caused by the initial tension of the closely coiled before Kisotogawa first coil and .tau.1, the torsional stress due to the initial tension of the closed winding of said outer second coil when the .tau.2, torsional stress .tau.1 of the outer first coil ,
0.62τ2 ≦ τ1 ≦ 1.02τ2
The above relational expression is satisfied.
The outer diameter ratio D2 / D1 between the large outer diameter D2 and the small outer diameter D1 of the truncated cone is larger than the outer diameter ratio B1 / B2 of the outer coil {(D2 / D1)> (B1 / B2)}.
Further, the outer diameter ratio D2 / D1 of the truncated cone, the outer diameter ratio B1 / B2 of the outer coil, and the outer diameter ratio A1 / A2 of the inner coil are (D2 / D1)> (A1 / A2)> The relational expression (B1> B2) is satisfied.

そして、本発明の内容は、外側コイル3、30が放射線不透過性の線材から成る外側第1コイル31のみから成る場合であっても前記同様に適用でき、外側コイル3、30が放射線不透過性の線材から成る外側第1コイルと芯線先端部が連接截頭円錐体26、260を有する構造の場合と、さらに、外側コイル3、30が放射線不透過性の線材のみから成る外側第1コイルと芯線先端部が1個の截頭円錐体を有する場合である。
後者の適用例として、
後端側から先端側へ徐変縮径する部分を有する芯線の芯線先端部を外側第1コイルへ貫挿し、前記芯線先端部は、後端側から先端側へ徐変縮径する少なくとも1個の截頭円錐体を有し、前記外側第1コイルは、前記外側第1コイルの先端と前記芯線先端部の先端と接合して先端接合部とし、前記外側第1コイルの後端と前記芯線先端部の後端と接合して外側第1コイル後端接合部とした医療用ガイドワイヤであって、
前記外側第1コイルは、白金が90重量%以上99重量%以下で残部がニッケルの放射線不透過性の線材を螺旋状に巻回し、後端側が密巻きで先端側は疎巻きから成り、
ばね指数をC1、密巻きの初張力によるねじり応力をτ1(N/mm)とすると、ばね指数C1が2.8以上6.8以下で、密巻きの初張力によるねじり応力τ1(N/mm)は、
−17.2C1+165.7≦τ1≦−35.3C1+341.2
の関係式を満たすことを特徴とする。
又、前記截頭円錐体の径大外径D2と径小外径D1との外径比D2/D1は、外側コイルの外径比B1/B2よりも大きい{(D2/D1)>(B1/B2)}。
そして又、前記截頭円錐体の外径比D2/D1と外側コイルの外径比B1/B2と内側コイルの外径比A1/A2とは、(D2/D1)>(A1/A2)>(B1>B2)の関係式を満たすことを特徴とする。又、外側第1コイルは、全長に亘って初張力が作用する密巻きとしてもよい。
The contents of the present invention can also be applied to the case where the outer coils 3 and 30 are composed of only the first outer coil 31 made of a radiopaque wire, and the outer coils 3 and 30 are radiopaque. The outer first coil made of a conductive wire and the structure in which the core tip has the connecting truncated cones 26 and 260, and the outer first coil made of only the radiopaque wire. And the core wire tip has one truncated cone.
As an application example of the latter,
The core wire tip having a portion gradually changing from the rear end side to the tip end side is inserted into the outer first coil, and the tip end portion of the core wire has at least one diameter gradually changing from the rear end side to the tip end side. It has a truncated cone, the outer first coil, the distal joint by joining a leading end of the tip and the core wire distal end portion of the outer first coil, wherein a rear end of said outer first coil A medical guide wire that joins the rear end of the core wire front end portion to form the outer first coil rear end joint portion,
The outer first coil is formed by spirally winding a radiopaque wire rod of platinum of 90 wt% or more and 99 wt% or less of the nickel, and the rear end side is closely wound and the front end side is loosely wound,
Assuming that the spring index is C1 and the torsional stress due to the initial tension of dense winding is τ1 (N / mm 2 ), the spring index C1 is 2.8 to 6.8 and the torsional stress τ1 (N / N mm 2 )
−17.2C1 + 165.7 ≦ τ1 ≦ −35.3C1 + 341.2
The above relational expression is satisfied.
The outer diameter ratio D2 / D1 between the large outer diameter D2 and the small outer diameter D1 of the truncated cone is larger than the outer diameter ratio B1 / B2 of the outer coil {(D2 / D1)> (B1 / B2)}.
Further, the outer diameter ratio D2 / D1 of the truncated cone, the outer diameter ratio B1 / B2 of the outer coil, and the outer diameter ratio A1 / A2 of the inner coil are (D2 / D1)> (A1 / A2)> The relational expression (B1> B2) is satisfied. Further, the outer first coil may be a tight winding in which the initial tension acts over the entire length.

Claims (4)

後端側から先端側へ徐変縮径する部分を有する芯線の芯線先端部を外側コイルへ貫挿し、
前記外側コイルは、先端側が放射線不透過性の線材を螺旋状に巻回した外側第1コイルと、後端側が放射線透過性の線材を螺旋状に巻回した外側第2コイルから成り、
前記外側第1コイルの先端と前記芯線先端部の先端と接合して先端接合部とし、
前記外側第2コイルの後端と前記芯線先端部の後端と接合して外側第2コイル後端接合部とした医療用ガイドワイヤであって、
前記外側第1コイルは、白金とニッケルの合金から成る放射線不透過性の線材を、後端側が密巻きで先端側が疎巻きに巻回し、
前記外側第2コイルは、ステンレス鋼から成る放射線透過性の線材を密巻きに巻回し、
前記外側第1コイルと前記外側第2コイルは、ばね指数が2.8以上6.8以下で、前記外側第1コイルと前記外側第2コイルとのコイル平均径の差が10%以内のとき、前記外側第1コイルの密巻きの初張力によるねじり応力をτ1とし、前記外側第2コイルの密巻きの初張力によるねじり応力をτ2とした場合に、前記外側第1コイルのねじり応力τ1は、
0.62τ2≦τ1≦1.02τ2
の関係式を満たし、
前記芯線先端部は、少なくとも2個以上の截頭円錐体を長手方向に連接した連接截頭円錐体で、1個の截頭円錐体は、長手方向の長さが後端側の截頭円錐体から先端側の截頭円錐体へ向かって徐変減少し、かつ、後端の径大外径と先端の径小外径との外径比(後端の径大外径/先端の径小外径)が、後端側の截頭円錐体から先端側の截頭円錐体へ向かって徐変増大し、
前記連接截頭円錐体の最大外径がD0で、最小外径をD1、全長がL、最大外径D0の横断面の中心位置から先端へ、任意の位置Xにおける前記連接截頭円錐体の外径をDmとし、任意の位置Xが0<X<Lの関係にある場合に、前記連接截頭円錐体の外径Dmは、Dm>{D0−(D0−D1)X/L}の関係式を満たし、
前記連接截頭円錐体の外側に、初張力が作用する前記外側第1コイルの密巻きと前記外側第2コイルの密巻きとを備えたことを特徴とする医療用ガイドワイヤ。
Inserting the core wire tip portion of the core wire having a gradually changing diameter from the rear end side to the tip side into the outer coil,
The outer coil is composed of an outer first coil in which a distal end side is spirally wound with a radiopaque wire, and an outer second coil in which a rear end side is spirally wound with a radiolucent wire,
Joining the tip of the outer first coil and the tip of the core wire tip to form a tip joint,
A medical guide wire that joins the rear end of the outer second coil and the rear end of the core wire tip part to form the outer second coil rear end joint part,
The outer first coil is a radiopaque wire made of an alloy of platinum and nickel, with the rear end side wound closely and the front end side loosely wound,
The outer second coil is formed by winding a radiolucent wire made of stainless steel in close winding,
The outer first coil and the outer second coil have a spring index of 2.8 or more and 6.8 or less, and a difference in coil average diameter between the outer first coil and the outer second coil is within 10%. When the torsional stress due to the initial tension of the outer first coil is τ1, and the torsional stress due to the initial tension of the outer second coil is τ2, the torsional stress τ1 of the outer first coil is ,
0.62τ2 ≦ τ1 ≦ 1.02τ2
Satisfy the relational expression of
The leading end of the core wire is an articulated truncated cone having at least two truncated cones connected in the longitudinal direction, and one truncated cone is a truncated cone having a longitudinal length on the rear end side. The outer diameter ratio of the outer diameter of the rear end to the outer diameter of the rear end and the outer diameter of the tip is smaller (the diameter of the rear end is larger than the outer diameter of the tip). Small outer diameter) gradually increases from the truncated cone on the rear end side toward the truncated cone on the distal end side,
From the center position to the tip of the cross-section of the connecting truncated cone having a maximum outer diameter D0, a minimum outer diameter D1, a total length L, and a maximum outer diameter D0. When the outer diameter is Dm and the arbitrary position X is in the relationship of 0 <X <L, the outer diameter Dm of the connecting truncated cone is Dm> {D0− (D0−D1) X / L}. Satisfy the relational expression,
A medical guide wire comprising: a tight winding of the outer first coil on which an initial tension acts and a dense winding of the outer second coil on the outside of the connecting truncated cone.
前記外側コイルは、後端側から先端側へ向かって後端径大等径部と中間テーパ部と先端径小部を備え、後端径大等径部と中間テーパ部は密巻きで、先端径小等径部は先端側に疎巻きを有し、
後端径大等径部の前記外側第2コイルと、中間テーパ部と先端径小等径部との前記外側第1コイルから成り、又は、
後端径大等径部と中間テーパ部の後端側との前記外側第2コイルと、中間テーパ部の先端側と先端径小等径部との前記外側第1コイルから成り、
前記連接截頭円錐体は、先端の截頭円錐体を第1截頭円錐体とし、前記第1截頭円錐体の外側に、前記外側コイルの中間テーパ部を配置し、
前記第1截頭円錐体の外径が、後端から先端へ徐変減少するのに伴って、前記外側コイルの中間テーパ部の密巻きの初張力が、後端から先端へ徐変増大したことを特徴とする請求項1記載の医療用ガイドワイヤ。
The outer coil includes a rear end diameter large equal diameter portion, an intermediate taper portion, and a small tip diameter portion from the rear end side toward the front end side, and the rear end large diameter equal diameter portion and the intermediate taper portion are closely wound, The small diameter equal diameter part has a loose winding on the tip side,
The outer second coil of the rear end diameter large equal diameter portion and the outer first coil of the intermediate taper portion and the tip diameter small equal diameter portion, or
The outer second coil on the rear end side of the rear end diameter large diameter portion and the intermediate taper portion, and the outer first coil of the front end side of the intermediate taper portion and the smaller end diameter portion of the intermediate taper portion,
The connecting truncated cone has a truncated cone at the tip as a first truncated cone, and an intermediate taper portion of the outer coil is disposed outside the first truncated cone.
As the outer diameter of the first truncated cone decreased gradually from the rear end to the tip, the initial tension of the tight winding of the intermediate taper portion of the outer coil gradually increased from the rear end to the tip. The medical guide wire according to claim 1.
請求項2記載の医療用ガイドワイヤであって、
前記外側コイルの後端径大等径部の外径をB1、先端径小等径部の外径をB2、前記連接截頭円錐体の前記第1截頭円錐体の後端の径大外径をD2とした場合に、
前記第1截頭円錐体の先端の径小外径がD1であることから、前記第1截頭円錐体の径大外径D2と径小外径D1との外径比(D2/D1)は、前記外側コイルの外径比(B1/B2)よりも大きい{(D2/D1)>(B1/B2)}ことを特徴とする請求項1記載の医療用ガイドワイヤ。
A medical guidewire according to claim 2,
The outer diameter of the outer diameter of the outer coil is B1, the outer diameter of the smaller tip of the outer diameter is B2, and the outer diameter of the rear end of the first truncated cone of the connecting truncated cone is larger. When the diameter is D2,
Since the small outer diameter at the tip of the first truncated cone is D1, the outer diameter ratio (D2 / D1) between the larger outer diameter D2 and the smaller outer diameter D1 of the first truncated cone. 2 is larger than the outer diameter ratio (B1 / B2) of the outer coil {(D2 / D1)> (B1 / B2)}.
後端側から先端側へ向かって後端径大等径部と中間テーパ部と先端径小等径部とを備えた内側コイルを、前記芯線先端部の外側で前記外側コイルの内側に、前記外側コイルよりも長手方向の長さが短く同心状に配置して、
前記外側コイルの先端と前記内側コイルの先端径小等径部の先端と前記芯線先端部の先端と接合して先端接合部とし、前記内側コイルの後端径大等径部の後端と前記芯線先端部と接合して内側コイル後端接合部とした請求項2〜3のいずれか一つに記載の医療用ガイドワイヤであって、
前記内側コイルは、ステンレス鋼から成る放射線透過性の線材を用いて、後端径大等径部と中間テーパ部は密巻きで、先端径小等径部の先端側が疎巻きに巻回し、
前記第1截頭円錐体の外側に、前記内側コイルの中間テーパ部と前記外側コイルの中間テーパ部とを配置し、
前記第1截頭円錐体の外径が、後端側から先端側へ徐変減少するのに伴って、前記外側第1コイルの中間テーパ部の密巻きの初張力と前記内側コイルの中間テーパ部の初張力とが共に、後端側から先端側へ徐変増大したことを特徴とする医療用ガイドワイヤ。
From the rear end side toward the front end side, an inner coil having a rear end diameter large equal diameter portion, an intermediate taper portion, and a front end diameter small equal diameter portion is disposed outside the core wire front end portion and inside the outer coil. The length in the longitudinal direction is shorter than the outer coil and is arranged concentrically.
Joining the tip of the outer coil, the tip of the tip of the inner coil with a small diameter of the tip, and the tip of the tip of the core wire to form a tip joint, The medical guide wire according to any one of claims 2 to 3, wherein the inner end of the inner coil is joined to the leading end portion of the core wire,
The inner coil uses a radiolucent wire made of stainless steel, the rear end diameter large-diameter portion and the intermediate taper portion are closely wound, the front end side of the small diameter end portion is wound loosely,
Outer side of the first truncated cone, an intermediate taper portion of the inner coil and an intermediate taper portion of the outer coil,
As the outer diameter of the first truncated cone gradually decreases from the rear end side to the front end side, the initial winding tension of the intermediate taper portion of the outer first coil and the intermediate taper of the inner coil are increased. A medical guide wire characterized by a gradual increase in both initial tension and rear end side from the rear end side to the front end side.
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