JP5517274B1 - Medical guidewire - Google Patents

Medical guidewire Download PDF

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JP5517274B1
JP5517274B1 JP2013214214A JP2013214214A JP5517274B1 JP 5517274 B1 JP5517274 B1 JP 5517274B1 JP 2013214214 A JP2013214214 A JP 2013214214A JP 2013214214 A JP2013214214 A JP 2013214214A JP 5517274 B1 JP5517274 B1 JP 5517274B1
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剛 寺師
誠司 志村
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株式会社エフエムディ
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A61M2025/09091—Basic structures of guide wires having a coil around a core where a sheath surrounds the coil at the distal part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip

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Abstract

【課題】血管病変部での通過性を向上させることができる医療用ガイドワイヤを提供する。
【解決手段】コイルは、後端側の第一コイル１３と先端側の第二コイル１４とを有する。第一コイル１３は、後端側に外径Ｄ１の径大部、先端側に外径Ｄ２の径小部を有する外径比増大構造である。径小部の先端と、芯線１１の先端と、第二コイル１４の先端とは接合されて先端接合部１５Ａを形成する。径大部の後端は芯線１１と接合されて後端接合部１５Ｂを形成する。少なくとも径大部は第一密巻き部を有する。第一コイル１３が第一密巻き部を有し、外径比（Ｄ１／Ｄ２）が増大する外径比増大構造とされることにより、血管病変部での通過性がより向上する。
【選択図】図６The present invention provides a medical guide wire capable of improving the passage through a vascular lesion.
The coil includes a first coil on the rear end side and a second coil on the front end side. The first coil 13 is an outer diameter ratio increasing structure having a large diameter portion with an outer diameter D1 on the rear end side and a small diameter portion with an outer diameter D2 on the distal end side. The tip of the small-diameter portion, the tip of the core wire 11, and the tip of the second coil 14 are joined to form a tip joint 15A. The rear end of the large diameter portion is joined to the core wire 11 to form a rear end joined portion 15B. At least the large diameter portion has a first densely wound portion. Since the first coil 13 has a first densely wound portion and has an outer diameter ratio increasing structure in which the outer diameter ratio (D1 / D2) is increased, the permeability at the vascular lesion is further improved.
[Selection] Figure 6

Description

この発明は、血管病変部治療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 vascular lesion treatment and the like.

従来、血管閉塞部及び狭窄部等の血管病変部の治療に際して、医療用ガイドワイヤ（以下、ガイドワイヤという）が用いられている。このガイドワイヤには、芯線の先端部に単一のコイルを有するものや、芯線の先端部に、同心状で外径が異なる内側コイル及び外側コイルを有するもの等がある。これらガイドワイヤを用いて、先端部を血管内に挿入し、先端部を病変部まで到達させて血管病変部の拡径治療を行っている。   Conventionally, medical guidewires (hereinafter referred to as guidewires) have been used in the treatment of vascular lesions such as vascular occlusions and stenosis. This guide wire includes one having a single coil at the distal end portion of the core wire, and one having an inner coil and an outer coil that are concentric and have different outer diameters at the distal end portion of the core wire. Using these guide wires, the distal end portion is inserted into the blood vessel, and the distal end portion reaches the lesioned portion to perform diameter expansion treatment of the vascular lesioned portion.

かかる場合において、血管病変部でのガイドワイヤの通過性の向上を図る為、回転伝達、塑性変形、任意選択等の性能の向上が必要になる。回転伝達とは、手元側（後端側）の回転を先端側へ伝達して先端部を回転させることをいう。塑性変形とは、最先端部を「ヘ」の字形に屈曲して術者の所望の形状に塑性変形させることをいう。任意選択とは、血管分岐部で任意の方向を選択して病変血管へ進行させることをいう。   In such a case, in order to improve the passability of the guide wire at the vascular lesion site, it is necessary to improve performance such as rotational transmission, plastic deformation, and optional selection. The rotation transmission means that the rotation on the proximal side (rear end side) is transmitted to the distal end side to rotate the distal end portion. The plastic deformation means that the most distal portion is bent into a “f” shape and is plastically deformed into a shape desired by the operator. Optional selection refers to selecting an arbitrary direction at the blood vessel bifurcation and advancing to the diseased blood vessel.

特許文献１には、隣接したコイルの端部どうしを直接接続し、複数のコイルを直列状に配置したガイドワイヤが記載されている。   Patent Document 1 describes a guide wire in which ends of adjacent coils are directly connected and a plurality of coils are arranged in series.

特許文献２には、コイルの両端部の線材間に隙間を設け、中央部が密巻き部で両端部が疎巻き部のガイドワイヤ及びその製造方法が記載されている。   Patent Document 2 describes a guide wire in which a gap is provided between wire rods at both ends of a coil, a center portion is a densely wound portion, and both ends are loosely wound portions, and a manufacturing method thereof.

特許第４１８６６８９号公報Japanese Patent No. 4186689 特開２０１０−２２２号公報JP 2010-222 A

特許文献１には、コイルどうしの接続作業を容易にし、先端部の柔軟性と自在性等を確保する技術思想が記載されている。又、特許文献２には、コイルの外周に樹脂被覆する際の樹脂被膜の偏りを防止しつつ、先端部に柔軟性を付与する技術思想が記載されている。   Patent Document 1 describes a technical idea that facilitates the connection work between coils and ensures the flexibility and flexibility of the tip. Patent Document 2 describes a technical idea of imparting flexibility to the tip while preventing unevenness of the resin coating when the outer periphery of the coil is coated with resin.

特許文献１，２は、血管壁損傷防止、及び、成形加工時の変形防止等の技術課題の解決手段は記載されているが、先端側への回転伝達性能、最先端部の塑性変形性能、及び、分岐血管部での任意選択性能等の技術課題に対する解決手段については、何ら記載されていない。これらの性能は、血管病変部でのガイドワイヤの通過性を向上させる為の重要な技術課題である。   Patent Documents 1 and 2 describe means for solving technical problems such as vessel wall damage prevention and deformation prevention during molding processing, but rotation transmission performance to the tip side, plastic deformation performance of the most advanced part, In addition, there is no description of any means for solving technical problems such as optional performance in the branch blood vessel. These performances are important technical issues for improving the passage of the guide wire at the vascular lesion.

本発明は上記課題を鑑みてなされたものであり、血管病変部での通過性をより向上させることができる医療用ガイドワイヤを提供することを目的とする。   This invention is made | formed in view of the said subject, and it aims at providing the medical guide wire which can improve the permeability | transmittance in a vascular lesion part more.

上記目的を達成する為に、本発明のガイドワイヤは、芯線の先端部をコイルに貫挿して形成される。芯線は、後端側は太径であり、先端側は先端へ向かって徐々に直径が小さく変化する。コイルは、第一コイル、第二コイルを有する。第一コイルは、線直径が０．０２０ｍｍ以上０．０７０ｍｍ以下で、引張強さが２２００Ｍｐａ以上３５００Ｍｐａ以下で、外観が鏡面状のオーステナイト系ステンレス鋼のコイル線を螺旋状に巻いて形成され、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有し、後端径大等径部と中間テーパ部、及び先端径小等径部の後端側が第一密巻き部で、先端径小等径部の先端側がコイルピッチを疎にした第一疎巻き部である。又、第一コイルは、先端径小等径部の先端と、芯線の先端と、第二コイルの先端とを接合して先端接合部を形成し、後端径大等径部の後端を芯線と接合して後端接合部を形成する。又、第一コイルは、ばね指数Ｃが２．８以上６．８以下で、後端径大等径部の外径Ｄ１と先端径小等径部の外径Ｄ２との外径比（Ｄ１／Ｄ２）が１．３０以上５．８０以下である。
第一密巻き部は、ばね指数がＣで、初張力によるねじり応力をτ（Ｎ／ｍｍ 2 ）とすると、
ねじり応力τは、−１１．２Ｃ＋１１１．７≦τ≦−３８．７Ｃ＋３７０．６の関係式を満たす。
第二コイルは、放射線不透過性のコイル線を螺旋状に巻いて形成され、中間テーパ部と先端径小等径部の外側に同心状に配置される。又、第二コイルは、後端が第一コイルの中間部に接合して中間接合部を形成し、少なくとも先端側にコイルピッチを疎にした第二疎巻き部を有する。
又、第一疎巻き部は、コイルピッチが線直径の１．０５倍以上３．５０倍以下とし、第二疎巻き部は、少なくとも第一疎巻き部の外側に同心状に設けられ、コイルピッチが線直径の１．０５倍以上１．９０倍以下とし、第一疎巻き部と第二疎巻き部のコイルピッチが異なる。 In order to achieve the above object, the guide wire of the present invention is formed by inserting the tip of the core wire into the coil. The core wire has a large diameter at the rear end side, and the diameter gradually decreases toward the front end side toward the front end side. The coil has a first coil and a second coil. The first coil is formed by spirally winding an austenitic stainless steel coil wire having a wire diameter of 0.020 mm to 0.070 mm , a tensile strength of 2200 Mpa to 3500 Mpa, and a mirror-like appearance. From the end side toward the front end side , it has a rear end diameter large equal diameter portion, an intermediate taper portion, and a tip diameter small equal diameter portion, and the rear end diameter large equal diameter portion, the intermediate taper portion, and the tip diameter small equal diameter portion. The rear end side is the first densely wound portion, and the distal end side of the small diameter end portion is the first loosely wound portion with a sparse coil pitch. Further, the first coil and the tip of the distal end small diameter such as diameter, and the tip of the core wire, by joining a leading end of the second coil to form a distal joint, the rear end of the rear end a large diameter such as diameter Join the core wire to form the rear end joint . The first coil has a spring index C of 2.8 or more and 6.8 or less, and an outer diameter ratio (D1) between the outer diameter D1 of the rear end diameter larger equal diameter portion and the outer diameter D2 of the smaller tip diameter equal diameter portion. / D2) is 1.30 or more and 5.80 or less.
The first densely wound portion has a spring index of C, and a torsional stress due to initial tension is τ (N / mm 2 ).
The torsional stress τ satisfies the relational expression of −11.2C + 111.7 ≦ τ ≦ −38.7C + 370.6.
The second coil is formed by spirally winding a radiopaque coil wire, and is concentrically disposed outside the intermediate taper portion and the small-diameter portion having a small tip diameter . The second coil has a second loosely wound portion with a rear end joined to an intermediate portion of the first coil to form an intermediate joined portion, and at least a distal end side with a sparse coil pitch .
The first sparsely wound portion has a coil pitch of 1.05 times to 3.50 times the wire diameter, and the second sparsely wound portion is provided concentrically at least outside the first sparsely wound portion. The pitch is 1.05 times or more and 1.90 times or less of the wire diameter, and the coil pitches of the first sparsely wound portion and the second sparsely wound portion are different .

第一コイルのコイル線の横断面形状が、コイルの径方向の長さｂよりも芯線長手方向の長さａが長く、アスペクト比（ａ／ｂ）が１．２０以上２．７５以下の矩形であることを特徴とする。 The transverse cross-sectional shape of the coil wire of the first coil is a rectangle having a length a in the longitudinal direction of the core wire longer than a length b in the radial direction of the coil and an aspect ratio (a / b) of 1.20 or more and 2.75 or less. It is characterized by being.

第一コイルは、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有し、後端径大等径部の外径Ｄ１１と、先端径小等径部の外径Ｄ２２と、第二コイルの外径Ｄ３とが、Ｄ１１＞Ｄ３＞Ｄ２２の関係式を満たすことを特徴とする。   The first coil has 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, and an outer diameter D11 of the rear end diameter large equal diameter portion; The outer diameter D22 of the tip portion having a small equal diameter and the outer diameter D3 of the second coil satisfy the relational expression D11> D3> D22.

第一コイルは、中間テーパ部の後端側から先端側へ向けて、線直径が太線から細線へ徐変縮径したロングテーパのコイル線を用いることを特徴とする。 The first coil uses a long taper coil wire whose diameter gradually changes from a thick line to a thin line from the rear end side to the front end side of the intermediate taper portion .

本発明のガイドワイヤは、第一コイルの後端側と先端側との外径比を最大限に確保した外径比増大構造によるねじりモーメント増大作用と、コイル線の外観が鏡面状とし隣接線相互の摩擦抵抗増大作用と、高強度の引張強さをもつコイル線を得て、少なくとも後端側に設けた密巻き部に初張力を働かせてコイル線間の密着力を高め、コイルのばね指数と初張力によるねじり応力との相関関係に基づくねじり応力の向上により、先端側への高度の回転伝達性能が向上する。
さらに、第一コイルの後端側の密巻き部にコイル線間の密着力を高めたことと、第二コイルの疎巻き部のコイル線間の隙間がコイル線の線直径を下回る寸法とすることとの併用により、後述するパラレルワイヤ手技における２本のガイドワイヤの噛み込み現象を防ぐことができる。 The guidewire of the present invention, the torsional and the moment increasing effect that by the outer diameter ratio increases structures ensure maximum outer diameter ratio between the rear end and the front end side of the first coil, the appearance of the coil wire is a mirror-like A coil wire having a frictional resistance increasing action between adjacent wires and a high tensile strength is obtained, and an initial tension is applied to at least the tightly wound portion provided on the rear end side to increase the adhesion between the coil wires, thereby increasing the coil strength. By improving the torsional stress based on the correlation between the spring index and the torsional stress due to the initial tension, a high degree of rotation transmission performance to the tip side is improved.
Further, the tightness between the coil wires is increased at the densely wound portion on the rear end side of the first coil, and the gap between the coil wires of the loosely wound portion of the second coil is set to a dimension that is smaller than the wire diameter of the coil wire. In combination with this, it is possible to prevent the two guide wires from biting in a parallel wire procedure to be described later.

従来例のガイドワイヤは、外径の大きい外側コイルの内側に、外径の小さい内側コイルを設けた二層構造であるのに対して、本発明では、後端側が後端径大等径部で先端側が先端径小等径部の第一コイルと、第一コイルの先端径小等径部の外側で同心状の第二コイルとを有することにより、後端側の後端径大等径部が従来例の外側コイルとして働き、先端側の先端径小等径部が従来例の内側コイルとして働く。従って、１つの第一コイルで、外側コイルと内側コイルとの２つのコイルの機能を有する。更に、第一コイルは後端側の後端径大等径部と先端側の先端径小等径部の外径比を従来のコイル二層構造の限界を超えて外径比を最大限に確保した外径比増大構造となっており、かつ先端側へのねじりモーメントは、後端側と先端側との外径比に比例する為、先端側への回転伝達性能が向上する。 Guidewire conventional example, inside of large outer coil outer diameter, whereas the two-layer structure in which a small inner coil outer diameter, in the present invention, the rear end side of the rear end large diameter such as the radial section a first coil distal end side of the tip small-diameter such diameter portion in, by having a concentric second coil outside of the tip small-diameter such diameter portion of the first coil, the rear end the rear end large diameter such as diameter Department acts as an outer coil of the conventional example, the tip small-diameter like the diameter of the distal end side serves as the inner coil of the prior art. Therefore, one first coil has the function of two coils, an outer coil and an inner coil. Further, the first coil to maximize the outer diameter ratio of the outer diameter ratio of the rear end large diameter such as the diameter of the rear end side and distal end side of the tip small-diameter such diameter portion beyond the limits of conventional coil two-layer structure Since the outer diameter ratio is increased and the torsional moment toward the front end is proportional to the outer diameter ratio between the rear end and the front end, the rotation transmission performance to the front end is improved.

第一コイルは、高強度の引張強さと外観が鏡面状のオーステナイト系ステンレス鋼線が用いられ、線直径と引張強さとばね指数と外径比が一定範囲であることを特徴とする。この理由は、縮径伸線加工により高強度の引張強さが得やすい材質を用いて、コイル成形の加工容易性と、高いねじり応力と、高いコイル線間の摩擦抵抗と、高い外径比を得て先端側への高度の回転伝達性能とを併せ考慮したからである。又、第一コイルは、後端径大等径部と中間テーパ部、及び先端径小等径部の後端側が密巻き部で、先端径小等径部の先端側がコイルピッチを疎にした第一疎巻き部であり、第一疎巻き部は、コイルピッチが線直径の１．０５倍以上３．５０倍以下である。第二コイルの第二疎巻き部は、少なくとも第一疎巻き部の外側に同心状に設けられ、コイルピッチが線直径の１．０５倍以上１．９０倍以下である。そして、第一疎巻き部と第二疎巻き部のコイルピッチが異なることを特徴とする。この理由は、第一コイルの先端側と第二コイルが重なり合う部分が存在しても双方の同一位置に設けたコイルの疎巻き部の存在により、術者による最先端部の塑性変形性能を向上させ、更に、第二コイルの疎巻き部の隣接線の隙間が線直径を下回る寸法とすることにより、第一コイルの後端側の、初張力を有して隣接線の密着力の高い密巻き部と併せて、後述するパラレルワイヤ手技における２本のガイドワイヤのコイル線どうしの噛み合い現象を防ぐことができるからである。そして又、第一コイルは、密巻き部が初張力による一定範囲のねじり応力をもつことを特徴とする。この理由は、第一コイルの密巻き部に初張力を働かせて、コイルのばね指数と初張力によるねじり応力との相関関係に基づいて高いねじり応力を得て、コイル線間の密着力を向上させて先端側への高度の回転伝達性能の向上を図る為である。そして、内側コイルと外側コイルの２つのコイルから成る従来のものと比べて、この２つのコイルの機能を兼備した外径比増大構造の第一コイルを用いることにより、より大きな外径比を確保してねじりモーメント増大作用を図り、更に、第一コイルの密巻き部に初張力を働かせて高いねじり応力を得て、コイル線間の密着力を向上させて、第一コイルの外径比増大構造と初張力とを働かせて密着力を向上させた第一コイルの密巻き部との併用により、先端側への高度の回転伝達性能の向上を飛躍的に向上させることができる。 The first coil is made of austenitic stainless steel wire having a high tensile strength and a mirror-like appearance , and the wire diameter, tensile strength, spring index, and outer diameter ratio are in a certain range. The reason for this is that, using a material that is easy to obtain high tensile strength by reduced diameter drawing, coil forming processability, high torsional stress, high frictional resistance between coil wires, and high outer diameter ratio This is because the high rotational transmission performance to the tip side was taken into consideration. Also, the first coil has a tightly wound portion at the rear end side of the large rear end diameter and intermediate taper portion, and a small tip diameter constant diameter portion, and a sparse coil pitch at the front end side of the small tip diameter constant diameter portion. The first sparsely wound portion has a coil pitch of 1.05 times to 3.50 times the wire diameter. The second sparsely wound portion of the second coil is provided concentrically at least outside the first sparsely wound portion, and the coil pitch is 1.05 times or more and 1.90 times or less of the wire diameter. And the coil pitch of a 1st sparsely wound part and a 2nd sparsely wound part differs, It is characterized by the above-mentioned. The reason for this is that even if there is a portion where the tip of the first coil and the second coil overlap, the presence of the coiled portion of the coil provided at the same position on both sides improves the plastic deformation performance of the most advanced part by the surgeon. In addition, by setting the gap between adjacent wires of the sparsely wound portion of the second coil to be smaller than the wire diameter, the denseness of the first coil on the rear end side with the initial tension and high adhesion of the adjacent wires This is because, together with the winding portion, it is possible to prevent the meshing phenomenon between the coil wires of the two guide wires in the parallel wire procedure described later. The first coil is characterized in that the closely wound portion has a certain range of torsional stress due to the initial tension. The reason for this is that the initial tension is applied to the tightly wound portion of the first coil, and a high torsional stress is obtained based on the correlation between the coil spring index and the torsional stress due to the initial tension, thereby improving the adhesion between the coil wires. This is for the purpose of improving the advanced rotation transmission performance to the tip side. And, compared with the conventional one consisting of two coils, the inner coil and the outer coil, a larger outer diameter ratio is secured by using the first coil of the outer diameter ratio increasing structure that combines the functions of these two coils. In order to increase the torsional moment, the initial tension is applied to the tightly wound portion of the first coil to obtain a high torsional stress, and the adhesion between the coil wires is improved to increase the outer diameter ratio of the first coil. The combined use with the tightly wound portion of the first coil, which improves the adhesion by using the structure and the initial tension, can dramatically improve the high rotation transmission performance to the tip side.

第一コイルのコイル線の横断面形状は、コイルの径方向の長さｂよりも芯線長手方向への長さａが長く、アスペクト比（ａ／ｂ）が１．２０以上２．７５以下の矩形であることを特徴とする。この理由は、極細線の芯線を貫挿する第一コイルの内径を確保しながら、かつ第一コイルの後端側と先端側の外径比をより増大させ、先端側への回転伝達性能を向上させる為である。 Cross-sectional shape of the coil wire of the first coil, the length a of the radial direction of the coil to the core wire longitudinal direction than the length b is rather long, the aspect ratio (a / b) is 1.20 or more 2.75 or less It is characterized by a rectangle. The reason for this is that while securing the inner diameter of the first coil that penetrates the core wire of the fine wire, the outer diameter ratio between the rear end side and the front end side of the first coil is further increased, and the rotation transmission performance to the front end side is improved. It is for improving.

第一コイルは、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有し、後端径大等径部の外径Ｄ１１と、先端径小等径部の外径Ｄ２２と、第二コイルの外径Ｄ３とが、Ｄ１１＞Ｄ３＞Ｄ２２の関係式を満たすことを特徴とする。この理由は、先細り形状による先端側へのねじりモーメント増大作用により、先端側への回転伝達性能をより向上させる為であり、又、狭窄病変内等での通過性をより向上させる為である。   The first coil has 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, and an outer diameter D11 of the rear end diameter large equal diameter portion; The outer diameter D22 of the tip portion having a small equal diameter and the outer diameter D3 of the second coil satisfy the relational expression D11> D3> D22. This is because the rotation transmission performance to the distal end side is further improved by the action of increasing the torsional moment toward the distal end due to the tapered shape, and the passage through the stenotic lesion or the like is further improved.

第一コイルは、中間テーパ部の後端側から先端側へ向けて、線直径が太線から細線へ徐変縮径したロングテーパのコイル線を用いることを特徴とする。この理由は、剛性が変化する中間接合部を無くして後端側から先端側への左右回転をより円滑にし、回転操作性の向上を図る為である。 The first coil uses a long taper coil wire whose diameter gradually changes from a thick line to a thin line from the rear end side to the front end side of the intermediate taper portion . The reason for this is to eliminate the intermediate joint portion where the rigidity changes, to make the left-right rotation from the rear end side to the front end side smoother, and to improve the rotational operability.

第１実施形態のガイドワイヤの一部を切り欠いて示す側面図である。It is a side view which cuts and shows a part of guide wire of 1st Embodiment. 第１実施形態のガイドワイヤの要部の寸法を示す側面図である。It is a side view which shows the dimension of the principal part of the guide wire of 1st Embodiment. ガイドワイヤを評価する為に用いた評価装置の断面図である。It is sectional drawing of the evaluation apparatus used in order to evaluate a guide wire. コイルのばね指数とねじり応力との相関関係を示すグラフである。It is a graph which shows the correlation with the spring index of a coil, and torsional stress. 第２実施形態のガイドワイヤの要部の寸法を示す側面図である。It is a side view which shows the dimension of the principal part of the guide wire of 2nd Embodiment. 第３実施形態のガイドワイヤの要部の寸法を示す側面図である。It is a side view which shows the dimension of the principal part of the guide wire of 3rd Embodiment. 第４実施形態のガイドワイヤの要部の寸法を示す側面図である。It is a side view which shows the dimension of the principal part of the guide wire of 4th Embodiment. 従来例のガイドワイヤの要部の寸法を示す側面図である。It is a side view which shows the dimension of the principal part of the guide wire of a prior art example.

図１は、第１実施形態のガイドワイヤ１０を示し、芯線１１と、第一コイル１３と、第二コイル１４と、接合部１５Ａ、１５Ｂ、１５Ｃ、１５Ｄとを有する。尚、本発明のガイドワイヤ１０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、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 a guide wire 10 according to the first embodiment, which includes a core wire 11, a first coil 13, a second coil 14, and joint portions 15A, 15B, 15C, and 15D. Note that the guide wire 10 of the present invention has a very small diameter compared to the length. For this reason, if the vertical and horizontal scale ratios are the same, it becomes difficult to show in a predetermined area, and therefore, a part is exaggerated or omitted.

芯線１１の先端部は、第一コイル１３と第二コイル１４とが接合された状態で、第一コイル１３と第二コイル１４へ挿通される。第一コイル１３と第二コイル１４とは、接合部１５Ｄ（以下、第一・第二コイル接合部１５Ｄという）によって接合される。第一コイル１３は、後端第一コイル２１と先端第一コイル２２とを有し、後端第一コイル２１は、芯線１１の先端部と後端部との間の接合部１５Ｃ（以下、中間接合部１５Ｃという）によって、先端第一コイル２２と接合され、後端第一コイル２１の後端は、芯線１１の後端部側の接合部１５Ｂ（以下、後端接合部１５Ｂという）によって、芯線１１と接合される。第二コイル１４は、先端第一コイル２２の外側に同心状に設けられる。芯線１１の先端、第二コイル１４の先端、及び先端第一コイル２２の先端は、ガイドワイヤ１０の最先端部分の接合部１５Ａ（以下、先端接合部１５Ａという）で、ろう材等を用いて接合される。先端接合部１５Ａは、先端が、例えば半球状のように縦断面の先端が円弧状に丸くされた先丸形状である。   The distal end portion of the core wire 11 is inserted into the first coil 13 and the second coil 14 with the first coil 13 and the second coil 14 being joined. The first coil 13 and the second coil 14 are joined by a joint 15D (hereinafter referred to as a first / second coil joint 15D). The first coil 13 includes a rear end first coil 21 and a front end first coil 22, and the rear end first coil 21 is a joint portion 15 </ b> C (hereinafter, referred to as a joint portion 15 </ b> C) between the front end portion and the rear end portion of the core wire 11. The first end coil 21 is joined to the front end first coil 22 by the intermediate joint portion 15C), and the rear end of the rear end first coil 21 is joined to the rear end portion side joint portion 15B (hereinafter referred to as the rear end joint portion 15B). The core wire 11 is joined. The second coil 14 is provided concentrically outside the first distal coil 22. The tip of the core wire 11, the tip of the second coil 14, and the tip of the tip first coil 22 are joint portions 15 </ b> A (hereinafter referred to as tip joint portions 15 </ b> A) at the most distal portion of the guide wire 10, using brazing material or the like. Be joined. 15 A of front-end | tip junction parts are the tip round shape by which the front-end | tip of the longitudinal section was rounded by circular arc shape, for example like a hemisphere.

芯線１１の手元側の太径部分の外周には、ふっ素樹脂被膜１６が形成されている。第一コイル１３及び第二コイル１４の外周には、親水性樹脂被膜１７が形成されている。図２に示すように、第一コイル１３は、後端側から順に、後端径大等径部（径大部）３１と、中間テーパ部３２と、先端径小等径部（径小部）３３とを有する。   A fluororesin film 16 is formed on the outer periphery of the large-diameter portion on the proximal side of the core wire 11. A hydrophilic resin film 17 is formed on the outer periphery of the first coil 13 and the second coil 14. As shown in FIG. 2, the first coil 13 includes, in order from the rear end side, a rear end diameter large equal diameter portion (large diameter portion) 31, an intermediate taper portion 32, and a tip diameter small equal diameter portion (small diameter portion). 33).

芯線１１は、手元側から順に、第１等径部１１Ａ、第１テーパ部１１Ｂ、第２等径部１１Ｃ、第２テーパ部１１Ｄ、第３等径部１１Ｅ、第３テーパ部１１Ｆ、第４等径部１１Ｇ、第４テーパ部１１Ｈ、第５等径部１１Ｉを有する。芯線１１は、手元側から先端側へ向かうに従い、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。第一コイル１３の後端接合部１５Ｂは、外径が０．１６０ｍｍ以上０．２１０ｍｍ以下の第３等径部１１Ｅで芯線１１と接合する。   The core wire 11 includes, in order from the hand side, a first equal diameter portion 11A, a first taper portion 11B, a second equal diameter portion 11C, a second taper portion 11D, a third equal diameter portion 11E, a third taper portion 11F, and a fourth. It has an equal diameter portion 11G, a fourth taper portion 11H, and a fifth equal diameter portion 11I. As the core wire 11 moves from the proximal side to the distal end side, the outer diameter gradually decreases from 0.3556 mm (0.014 inch for cardiovascular treatment) to 0.060 mm. The rear end joint portion 15B of the first coil 13 is joined to the core wire 11 by a third constant diameter portion 11E having an outer diameter of 0.160 mm to 0.210 mm.

芯線１１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２００３−２５３３９９号公報に記載の伸線加工と熱処理を繰り返して得られる高強度のステンレス鋼線や、特開２００２−６９５５５号公報に記載の所定条件下で熱処理を施して得られるＮｉ−Ｔｉ合金線が用いられる。   As the core wire 11, a stainless steel wire, a Ni-Ti alloy wire, or the like is used. For example, a high-strength stainless steel wire obtained by repeating the wire drawing and heat treatment described in Japanese Patent Application Laid-Open No. 2003-253399 or obtained by performing heat treatment under predetermined conditions described in Japanese Patent Application Laid-Open No. 2002-69555. Ni-Ti alloy wire is used.

第一コイル１３は、手元側から先端側へ向かって後端径大等径部３１、中間テーパ部３２、先端径小等径部３３の順に外径が徐変縮径する。後端第一コイル２１は、太径のコイル線８Ａを用いたコイルで、先端第一コイル２２は、細径のコイル線８Ｂを用いたコイルである。これら後端第一コイル２１と先端第一コイル２２は、中間接合部１５Ｃによって、ろう材等を用いて接合される。   The outer diameter of the first coil 13 is gradually changed from the proximal side toward the distal end side in the order of the rear end diameter large equal diameter portion 31, the intermediate taper portion 32, and the front end diameter small equal diameter portion 33. The rear end first coil 21 is a coil using a thick coil wire 8A, and the tip first coil 22 is a coil using a thin coil wire 8B. The rear end first coil 21 and the front end first coil 22 are joined together with a brazing material or the like by the intermediate joint portion 15C.

第一コイル１３の芯線長手方向の長さ（全長）Ｌ１０は約１５６ｍｍである。後端径大等径部３１の外径Ｄ１１（後端径大等径部３１を径大部としたときの外径Ｄ１）は０．３５５６ｍｍで、コイル平均径Ｄａ１１は０．２９５６ｍｍで、芯線長手方向の長さＬ１１は１２０ｍｍである。中間テーパ部３２の外径は０．３５５６ｍｍから０．１２０ｍｍへ徐変縮径し、芯線長手方向の長さＬ１２は２０ｍｍである。先端径小等径部３３の外径Ｄ２２（先端径小等径部３３を径小部としたときの外径Ｄ２）は０．１２０ｍｍで、コイル平均径Ｄａ２２は０．０９０ｍｍで、芯線長手方向の長さＬ１３は１６ｍｍである。後端第一コイル２１のコイル線の線直径ｄ１は０．０４０ｍｍ以上０．０７０ｍｍ以下であり、本実施形態では０．０６０ｍｍである。先端第一コイル２２のコイル線の線直径ｄ２は０．０２０ｍｍ以上０．０４０ｍｍ以下であり、本実施形態では０．０３０ｍｍである。   The length (full length) L10 of the first coil 13 in the longitudinal direction of the core wire is about 156 mm. The outer diameter D11 of the rear end diameter large equal diameter portion 31 (outer diameter D1 when the rear end diameter large equal diameter portion 31 is the large diameter portion) is 0.3556 mm, the coil average diameter Da11 is 0.2956 mm, and the core wire The length L11 in the longitudinal direction is 120 mm. The outer diameter of the intermediate taper portion 32 is gradually changed from 0.3556 mm to 0.120 mm, and the length L12 in the longitudinal direction of the core wire is 20 mm. The outer diameter D22 (the outer diameter D2 when the tip diameter small equal diameter portion 33 is a small diameter portion) of the tip diameter small equal diameter portion 33 is 0.120 mm, the coil average diameter Da22 is 0.090 mm, and the core wire longitudinal direction The length L13 is 16 mm. The wire diameter d1 of the coil wire of the rear end first coil 21 is 0.040 mm or more and 0.070 mm or less, and is 0.060 mm in this embodiment. The wire diameter d2 of the coil wire of the tip first coil 22 is 0.020 mm or more and 0.040 mm or less, and is 0.030 mm in this embodiment.

第一コイル１３を構成する後端第一コイル２１と先端第一コイル２２は、１本又は複数本のコイル線を巻回成形したコイルで、手元側の第一密巻き部１３Ａと、先端部側の第一疎巻き部１３Ｂとを有する。第一密巻き部１３Ａは、少なくとも後端径大等径部３１に設けられ、本実施形態では後端径大等径部３１、中間テーパ部３２、及び先端径小等径部３３の後端側に設けられる。   The rear end first coil 21 and the front end first coil 22 constituting the first coil 13 are coils in which one or a plurality of coil wires are wound and formed. Side first sparsely wound portion 13B. The first densely wound portion 13A is provided at least in the rear end diameter large equal diameter portion 31, and in this embodiment, the rear end large diameter equal diameter portion 31, the intermediate taper portion 32, and the rear end small diameter equal diameter portion 33 are rear ends. Provided on the side.

第一疎巻き部１３Ｂは、先端径小等径部３３の先端側に、先端接合部１５Ａの内側から手元側へ少なくとも３ｍｍの範囲に設けられ、コイルピッチＰ１は線直径ｄ２の１．０５倍以上３．５０倍以下であり、本実施形態では２．５倍である。コイルピッチＰ１は、線直径ｄ２が０．０３０ｍｍである為、その２．５倍の０．０７５ｍｍである。尚、第一コイル１３の手元側から先端側への回転伝達性能（特に先端接合部１５Ａへの回転伝達性能）を重視する場合には、第一コイル１３の全長に亘って第一密巻き部１３Ａとするのが好ましい。又、先端側への回転伝達性能と塑性変形性能とを併せて重視する場合には、本実施形態のように後端径大等径部３１、中間テーパ部３２、及び先端径小等径部３３の後端側を第一密巻き部１３Ａとし、先端径小等径部３３の先端側は第一疎巻き部１３Ｂとするのが好ましい。この第一疎巻き部１３Ｂは、先端径小等径部３３の第一密巻き部１３Ａよりも芯線長手方向の長さが短く、例えば先端径小等径部３３の芯線長手方向の全長に対して１／２以下の３ｍｍ以上８ｍｍ以下とする。尚、第一疎巻き部１３Ｂを形成するか否かは、病変部の状態による。   The first sparsely wound portion 13B is provided on the distal end side of the small-diameter portion 33 having a small distal end diameter within a range of at least 3 mm from the inside of the distal end joint portion 15A to the proximal side, and the coil pitch P1 is 1.05 times the wire diameter d2. It is 3.50 times or less and 2.5 times in the present embodiment. The coil pitch P1 is 0.075 mm, which is 2.5 times as long as the wire diameter d2 is 0.030 mm. In addition, when importance is attached to the rotation transmission performance from the hand side of the first coil 13 to the distal end side (particularly, the rotation transmission performance to the distal end joint portion 15A), the first densely wound portion extends over the entire length of the first coil 13. 13A is preferred. In addition, when emphasizing both the rotation transmission performance to the tip side and the plastic deformation performance, the rear end diameter large equal diameter portion 31, the intermediate taper portion 32, and the tip diameter small equal diameter portion as in this embodiment. It is preferable that the rear end side of 33 is the first densely wound portion 13A and the distal end side of the small diameter end portion 33 is the first loosely wound portion 13B. The first loosely wound portion 13B has a shorter length in the core wire longitudinal direction than the first densely wound portion 13A of the tip diameter small equal diameter portion 33, for example, with respect to the total length of the tip diameter small equal diameter portion 33 in the core wire longitudinal direction. And ½ or less of 3 mm or more and 8 mm or less. Whether or not the first loosely wound portion 13B is formed depends on the state of the lesioned portion.

第一コイル１３の後端第一コイル２１と先端第一コイル２２は、線直径ｄ１とｄ２が０．０２０ｍｍ以上０．０７０ｍｍ以下で、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で形成され、ばね指数は２．８以上６．８以下である。第１実施形態では、後端径大等径部３１のばね指数Ｃ１は約４．９３、先端径小等径部３３のばね指数Ｃ２は３．０である。ここで、脳血管閉塞部治療用等の細血管治療用を考慮すると、線直径の下限値は０．０２０ｍｍである。又、脳用よりも血管内径が比較的大きい下肢血管閉塞部治療用等の太血管治療用を考慮すると、線直径の上限値は０．０７０ｍｍである。   The rear end first coil 21 and the front end first coil 22 of the first coil 13 are austenitic stainless steel wires having wire diameters d1 and d2 of 0.020 mm to 0.070 mm and a tensile strength of 2200 MPa to 3500 MPa. The spring index is 2.8 or more and 6.8 or less. In the first embodiment, the spring index C1 of the rear end diameter large equal diameter part 31 is about 4.93, and the spring index C2 of the small tip diameter equal diameter part 33 is 3.0. Here, in consideration of the treatment of fine blood vessels such as for the treatment of cerebral vascular occlusion, the lower limit of the line diameter is 0.020 mm. In consideration of treatment for large blood vessels such as for treatment of a lower limb occlusion with a relatively larger blood vessel inner diameter than that for the brain, the upper limit of the line diameter is 0.070 mm.

第一コイル１３のコイル線にオーステナイト系ステンレス鋼線を用いる理由は、縮径伸線加工、又は縮径伸線加工と熱処理とを組み合わせることにより引張強さを容易に向上させることができ、かつ高い横弾性係数を得て高いねじり応力を得ることができるからである。又、引張強さが２２００ＭＰａ以上３５００ＭＰａ以下の線材は、特開２００２−６９５８６号公報、特開２００２−２４１８３６号公報等にみられるような公知の方法により、冷間伸線加工と熱処理を繰り返すことにより得ることができる。   The reason why an austenitic stainless steel wire is used for the coil wire of the first coil 13 is that the tensile strength can be easily improved by reducing diameter drawing, or by combining reduced diameter drawing and heat treatment, and This is because a high torsional stress can be obtained by obtaining a high transverse elastic modulus. Further, a wire having a tensile strength of 2200 MPa or more and 3500 MPa or less is repeatedly subjected to cold wire drawing and heat treatment by a known method such as those disclosed in JP-A-2002-69586, JP-A-2002-241836, etc. Can be obtained.

第一コイル１３のばね指数Ｃ（Ｃ１、Ｃ２）を２．８以上６．８以下とした理由は以下の通りである。ばね指数Ｃが２．８を下回れば巻回成形時にコイル線の表面に鱗紋、ひび割れ等が発生し易くなる。一方、ばね指数Ｃが６．８を上回れば、例えば、図３に示すような評価装置１８を用いた評価試験において、コイル部が塑性変形し、変形不良の発生率が急激に増大する。これにより、後述するばね指数とねじり応力との相関関係において、ねじり応力を向上させ、第一コイル１３の外径比増大構造によるねじりモーメント増大作用と併用して、先端側への高度の回転伝達性能を飛躍的に向上させることができる。尚、評価試験では、評価装置１８を用いて、挿入と回転と引抜とを１回として２０回繰り返し行う。図３に示すように、評価装置１８は、入口部１８ａと、屈曲蛇行部１８ｂとを有する。入口部１８ａは、内径ＩＤ１が２ｍｍである。屈曲蛇行部１８ｂは、内径ＩＤ２が０．５ｍｍであり、半径ｒ１が５ｍｍの１８０度曲げ部１８ｃが６箇所に設けられる。評価装置１８は、樹脂チューブによって形成される。   The reason why the spring index C (C1, C2) of the first coil 13 is 2.8 or more and 6.8 or less is as follows. If the spring index C is less than 2.8, scales, cracks, and the like are likely to occur on the surface of the coil wire during winding forming. On the other hand, if the spring index C exceeds 6.8, for example, in an evaluation test using the evaluation device 18 as shown in FIG. 3, the coil portion is plastically deformed, and the rate of occurrence of deformation failure increases rapidly. Thereby, in the correlation between the spring index and the torsional stress, which will be described later, the torsional stress is improved, and in combination with the torsional moment increasing action by the outer diameter ratio increasing structure of the first coil 13, a high degree of rotational transmission to the tip side. Performance can be improved dramatically. In the evaluation test, the evaluation device 18 is used, and insertion, rotation, and extraction are performed once and repeated 20 times. As shown in FIG. 3, the evaluation device 18 includes an inlet portion 18a and a bent meandering portion 18b. The inlet portion 18a has an inner diameter ID1 of 2 mm. The bent meandering portion 18b is provided with six 180-degree bent portions 18c having an inner diameter ID2 of 0.5 mm and a radius r1 of 5 mm. The evaluation device 18 is formed of a resin tube.

第二コイル１４は、金、白金、又は白金とニッケルの合金等の放射線不透過性のコイル線９で形成され、コイル線９の巻き方向は、ねじ込み接合法を考慮すると第一コイル１３と同一方向が好ましく、例えば、第一コイル１３がＺ巻の場合は、第二コイル１４もＺ巻である。又、点溶接法であれば、いずれの巻き方向であってもよい。第二コイル１４は、芯線長手方向の長さ（全長）Ｌ２０が約４０ｍｍで、外径Ｄ３は０．３５５６ｍｍ（０．０１４インチ）で、線直径ｄ３は０．０６０ｍｍである。第二コイル１４の後端側と、後端第一コイル２１の後端径大等径部３１の先端側とは、それぞれのコイル線どうしをねじ込んだ状態で、第一・第二コイル接合部１５Ｄによって、ろう材等を用いて接合されている。第二コイル１４の先端は、芯線１１の先端と先端第一コイル２２の先端と共に、先端接合部１５Ａによって、ろう材等を用いて接合されている。   The second coil 14 is formed of a radiopaque coil wire 9 such as gold, platinum, or an alloy of platinum and nickel, and the winding direction of the coil wire 9 is the same as that of the first coil 13 in consideration of the screw-in joining method. The direction is preferable. For example, when the first coil 13 is Z-turned, the second coil 14 is also Z-turned. Further, any winding direction may be used as long as it is a spot welding method. The second coil 14 has a length (total length) L20 in the longitudinal direction of the core wire of about 40 mm, an outer diameter D3 of 0.3556 mm (0.014 inch), and a wire diameter d3 of 0.060 mm. The rear end side of the second coil 14 and the front end side of the rear end first large-diameter portion 31 of the rear end first coil 21 are the first and second coil joint portions in a state where the respective coil wires are screwed together. 15D is joined using brazing material or the like. The distal end of the second coil 14 is joined together with the distal end of the core wire 11 and the distal end of the distal end first coil 22 by a distal end joining portion 15A using a brazing material or the like.

第二コイル１４は、第二密巻き部１４Ａと第二疎巻き部１４Ｂを有し、第二コイル１４の後端側に、第二疎巻き部１４Ｂは第二コイル１４の先端側に設けられ、少なくとも第一コイル１３の第一疎巻き部１３Ｂと芯線長手方向で同一位置に設けられる。第二コイル１４の第二疎巻き部１４Ｂは、好ましくはコイル線の線間間隙ｔ４を、線直径ｄ３を下回る寸法とし、コイルピッチＰ４は、線直径ｄ３の１．０５倍以上１．９０倍以下とする。   The second coil 14 includes a second densely wound portion 14 </ b> A and a second loosely wound portion 14 </ b> B, and the second loosely wound portion 14 </ b> B is provided on the distal end side of the second coil 14. At least the first loosely wound portion 13B of the first coil 13 is provided at the same position in the core wire longitudinal direction. The second sparsely wound portion 14B of the second coil 14 preferably has a gap t4 between the coil wires that is smaller than the wire diameter d3, and the coil pitch P4 is 1.05 times or more and 1.90 times the wire diameter d3. The following.

本発明のガイドワイヤ１０と、後述する従来例のガイドワイヤ１００（図８参照）とを比較する。本発明のガイドワイヤ１０の後端側の径大部（後端径大等径部３１）が、従来例の外側第一コイル１３０Ａに対応し、先端側の径小部（先端径小等径部３３）が、従来例の内側コイル１４０に対応し、後端側の径大部と先端側の径小部の外径比を従来例の限界を超えて増大させることができる。このように、本発明のガイドワイヤ１０の第一コイル３０は、従来例のガイドワイヤ１００の外側第一コイル１３０Ａと内側コイル１４０の２つのコイルの機能を兼備した外径比増大構造を有する。   The guide wire 10 of the present invention will be compared with a conventional guide wire 100 (see FIG. 8) described later. The rear diameter side large diameter portion (rear end diameter large equal diameter portion 31) of the guide wire 10 of the present invention corresponds to the outer first coil 130A of the conventional example, and the distal end side small diameter portion (small distal end diameter equal diameter). The portion 33) corresponds to the inner coil 140 of the conventional example, and the outer diameter ratio of the large diameter portion on the rear end side and the small diameter portion on the front end side can be increased beyond the limit of the conventional example. Thus, the first coil 30 of the guide wire 10 of the present invention has an outer diameter ratio increasing structure that combines the functions of the two coils of the outer first coil 130 </ b> A and the inner coil 140 of the conventional guide wire 100.

先端側へのねじりモーメントは、外径比（径大部の外径／径小部の外径、つまり後端径大等径部３１の外径Ｄ１１／先端径小等径部３３の外径Ｄ２２）に比例する為、本発明は、従来例よりも先端側へのねじりモーメントを約１．６５倍以上増大させることができる。従って、本発明のガイドワイヤ１０は、従来例のガイドワイヤ１００よりも先端側への回転伝達性能をより向上させることができる。   The torsional moment toward the front end is determined by the outer diameter ratio (outer diameter of the larger diameter / outer diameter of the smaller diameter, that is, outer diameter D11 of the rear end diameter larger equal diameter section 31 / outer diameter of the smaller distal diameter section 33). Since it is proportional to D22), the present invention can increase the torsional moment toward the tip side by about 1.65 times or more than the conventional example. Therefore, the guide wire 10 of the present invention can further improve the performance of transmitting rotation to the distal end side as compared with the guide wire 100 of the conventional example.

本発明のガイドワイヤ１０の外径比と従来例のガイドワイヤ１００の外径比とを比較する。図８に示すように、従来例のガイドワイヤ１００の外側コイル１３０は、後端側に外側第一コイル１３０Ａ、先端側に外側第二コイル１３０Ｂを有する。外側第一コイル１３０Ａは、線直径０．０６０ｍｍのステンレス鋼線の放射線透過性のコイル線１５１を用いて巻回して形成される。外側第二コイル１３０Ｂは、線直径０．０６０ｍｍの金、白金等の放射線不透過性のコイル線１５２を用いて巻回して形成される。外側第一コイル１３０Ａの先端と外側第二コイル１３０Ｂの後端とは、それぞれのコイル線どうしをねじ込んだ状態で、中間接合部１５Ｃによって接合されている。又は、コイル線どうしが溶接接合されていてもよい。   The outer diameter ratio of the guide wire 10 of the present invention is compared with the outer diameter ratio of the guide wire 100 of the conventional example. As shown in FIG. 8, the outer coil 130 of the conventional guidewire 100 has an outer first coil 130A on the rear end side and an outer second coil 130B on the distal end side. The outer first coil 130A is formed by winding using a radiolucent coil wire 151 of a stainless steel wire having a wire diameter of 0.060 mm. The outer second coil 130B is formed by winding using a radiopaque coil wire 152 such as gold or platinum having a wire diameter of 0.060 mm. The front end of the outer first coil 130A and the rear end of the outer second coil 130B are joined by an intermediate joint 15C in a state where the respective coil wires are screwed together. Alternatively, the coil wires may be welded together.

外側コイル１３０の内側には、芯線長手方向の長さが外側コイル１３０よりも短い同心状の内側コイル１４０が設けられ、後端側に径大部、先端側に径小部を有する。内側コイル１４０には、芯線１１の先端部が貫挿され、後端は、後端接合部１５Ｅによって芯線１１と接合され、先端は、芯線１１の先端と外側第二コイル１３０Ｂの先端と共に先端接合部１５Ａにて接合される。   Inside the outer coil 130, a concentric inner coil 140 whose length in the longitudinal direction of the core wire is shorter than that of the outer coil 130 is provided, and has a large-diameter portion on the rear end side and a small-diameter portion on the front end side. The inner coil 140 has the tip end of the core wire 11 inserted therein, the rear end is joined to the core wire 11 by the rear end joint 15E, and the tip is joined to the tip together with the tip of the core wire 11 and the tip of the outer second coil 130B. Joined at the portion 15A.

従来例の内側コイル１４０の径小部の外径ｄ２２は、本発明の第１実施形態の先端径小等径部３３の外径Ｄ２２と同じ寸法の０．１２０ｍｍで、径大部の外径ｄ１１は、外側コイル１３０の内側にある為、組付性を考慮すると、外側コイル１３０の内径寸法からクリアランスを差し引いた０．２１５ｍｍが最大外径となる。かかる場合、従来例の内側コイル１４０の外径比（ｄ１１／ｄ２２）は、約１．７９となる。これに対して、本発明の第一コイル１３の外径比（Ｄ１１／Ｄ２２）は、約２．９６となり、従来例に対して外径比を約１．６５倍以上増大させることができる。本発明の第一コイル１３は、後端側の径大部と先端側の径小部の外径比を従来例の限界を超えた外径比増大構造とすることによりねじりモーメント増大作用を図り、先端側への回転伝達性能をより向上させることができる。   The outer diameter d22 of the small-diameter portion of the inner coil 140 of the conventional example is 0.120 mm which is the same size as the outer diameter D22 of the small-diameter tip portion 33 of the first embodiment of the present invention, and the outer diameter of the large-diameter portion. Since d11 is inside the outer coil 130, in consideration of assembly, the maximum outer diameter is 0.215 mm obtained by subtracting the clearance from the inner diameter dimension of the outer coil 130. In such a case, the outer diameter ratio (d11 / d22) of the inner coil 140 of the conventional example is about 1.79. In contrast, the outer diameter ratio (D11 / D22) of the first coil 13 of the present invention is about 2.96, and the outer diameter ratio can be increased by about 1.65 times or more compared to the conventional example. The first coil 13 of the present invention achieves a torsional moment increasing action by adopting an outer diameter ratio increasing structure in which the outer diameter ratio between the large diameter portion on the rear end side and the small diameter portion on the front end side exceeds the limit of the conventional example. The performance of transmitting rotation to the tip side can be further improved.

第一コイル１３の後端径大等径部３１の外径Ｄ１１が、０．３５５６ｍｍ（０．０１４インチ、心臓血管治療用）の場合と、０．４５７２ｍｍ（０．０１８インチ、下肢血管治療用）の場合とにおいて、外径比Ｄ１１／Ｄ２２の好ましい範囲について説明する。   When the outer diameter D11 of the rear end large diameter portion 31 of the first coil 13 is 0.3556 mm (0.014 inch, for cardiovascular treatment) and 0.4572 mm (0.018 inch, for lower limb blood vessel treatment) ), The preferable range of the outer diameter ratio D11 / D22 will be described.

後端径大等径部３１の外径Ｄ１１が０．３５５６ｍｍの場合、先端径小等径部３３の線直径が０．０２０ｍｍで、ばね指数が３のとき、先端径小等径部３３の外径Ｄ２２が０．０８０ｍｍで、外径比Ｄ１１／Ｄ２２は約４．４４となる。又、先端径小等径部３３の線直径が０．０７０ｍｍで、ばね指数が２．８のとき、先端径小等径部３３の外径Ｄ２２が０．２６６ｍｍで、外径比Ｄ１１／Ｄ２２は約１．３３となる。従って、外径Ｄ１１が０．３５５６ｍｍ、線直径が０．０２０ｍｍ以上０．０７０ｍｍ以下の場合には、バラツキを考慮すると、外径比Ｄ１１／Ｄ２２（又はＤ１／Ｄ２）は１．３０以上４．４５以下の範囲が好ましい。   When the outer diameter D11 of the rear end diameter large equal diameter portion 31 is 0.3556 mm, when the wire diameter of the small tip diameter constant diameter portion 33 is 0.020 mm and the spring index is 3, the tip diameter small equal diameter portion 33 The outer diameter D22 is 0.080 mm, and the outer diameter ratio D11 / D22 is about 4.44. When the wire diameter of the small tip diameter constant diameter portion 33 is 0.070 mm and the spring index is 2.8, the outer diameter D22 of the small tip diameter constant diameter portion 33 is 0.266 mm and the outer diameter ratio D11 / D22. Is about 1.33. Therefore, when the outer diameter D11 is 0.3556 mm and the wire diameter is 0.020 mm or more and 0.070 mm or less, the outer diameter ratio D11 / D22 (or D1 / D2) is 1.30 or more and 4. A range of 45 or less is preferred.

後端径大等径部３１の外径Ｄ１１が０．４５７２ｍｍの場合、先端径小等径部３３の線直径が０．０２０ｍｍで、ばね指数が３のとき、先端径小等径部３３の外径Ｄ２２が０．０８０ｍｍで、外径比Ｄ１１／Ｄ２２は約５．７１となる。又、先端径小等径部３３の線直径が０．０７０ｍｍで、ばね指数が２．８のとき、先端径小等径部３３の外径Ｄ２２が０．２６６ｍｍで、外径比Ｄ１１／Ｄ２２は約１．７２となる。従って、外径Ｄ１１が０．４５７２ｍｍで、線直径が０．０２０ｍｍ以上０．０７０ｍｍ以下の場合には、バラツキを考慮すると、外径比Ｄ１１／Ｄ２２（又はＤ１／Ｄ２）は１．７０以上５．８０以下の範囲が好ましい。   When the outer diameter D11 of the rear end diameter large equal diameter portion 31 is 0.4572 mm, when the wire diameter of the small tip diameter constant diameter portion 33 is 0.020 mm and the spring index is 3, the tip diameter small equal diameter portion 33 The outer diameter D22 is 0.080 mm, and the outer diameter ratio D11 / D22 is about 5.71. When the wire diameter of the small tip diameter constant diameter portion 33 is 0.070 mm and the spring index is 2.8, the outer diameter D22 of the small tip diameter constant diameter portion 33 is 0.266 mm and the outer diameter ratio D11 / D22. Is approximately 1.72. Therefore, when the outer diameter D11 is 0.4572 mm and the wire diameter is 0.020 mm or more and 0.070 mm or less, the outer diameter ratio D11 / D22 (or D1 / D2) is 1.70 or more and 5 in consideration of variation. A range of .80 or less is preferred.

前記したように、第一コイル１３の外径Ｄ１１が０．０１４インチと０．０１８インチの双方の場合を考慮すると、外径比Ｄ１１／Ｄ２２（又はＤ１／Ｄ２）は１．３０以上５．８０以下の範囲が好ましい。   As described above, the outer diameter ratio D11 / D22 (or D1 / D2) is 1.30 or more considering the case where the outer diameter D11 of the first coil 13 is both 0.014 inch and 0.018 inch. A range of 80 or less is preferred.

第一コイル１３の外径Ｄ１１が０．０１４インチと０．０１８インチの双方の場合であり、線直径が０．０２５ｍｍ以上０．０６０ｍｍ以下のとき、外径比Ｄ１１／Ｄ２２（又はＤ１／Ｄ２）は１．５０以上４．００以下の範囲が好ましく、又、線直径が０．０３０ｍｍ以上０．０５０ｍｍ以下のとき、外径比Ｄ１１／Ｄ２２（又はＤ１／Ｄ２）は１．７５以上３．９０以下の範囲が好ましい。いずれの場合も、本発明の第１実施形態と従来例とにおいて、コイルの外径、及び、線直径を同一条件としたときには、本発明の第１実施形態は、従来例よりも外径比を大幅に増大させることができる。従って、この外径比増大構造によるねじりモーメント増大作用によって、先端側への回転伝達性能をより向上させることができる。   This is the case where the outer diameter D11 of the first coil 13 is both 0.014 inch and 0.018 inch, and when the wire diameter is 0.025 mm or more and 0.060 mm or less, the outer diameter ratio D11 / D22 (or D1 / D2). ) Is preferably in the range of 1.50 to 4.00, and when the wire diameter is 0.030 mm to 0.050 mm, the outer diameter ratio D11 / D22 (or D1 / D2) is 1.75 to 3. A range of 90 or less is preferred. In any case, in the first embodiment of the present invention and the conventional example, when the outer diameter of the coil and the wire diameter are the same, the first embodiment of the present invention has an outer diameter ratio than the conventional example. Can be greatly increased. Therefore, the rotation transmission performance to the tip end side can be further improved by the action of increasing the torsional moment by the outer diameter ratio increasing structure.

径大部と径小部とは、それぞれ後端径大等径部３１と先端径小等径部３３とを示す形態をさすのではなく、例えば、第一コイル１３が後端径大等径部３１と中間テーパ部３２の２つの形状から成る場合であってもよい。かかる場合は、径大部が後端径大等径部３１で、径小部が中間テーパ部３２である。そして、径大部の外径は、後端径大等径部３１の外径に対応し、径小部の外径は、中間テーパ部３２の先端外径に対応する。又、かかる場合、後述するロングテーパのコイル線４１を用いる場合には、径小部（中間テーパ部３２）の後端側から先端側へ向けて徐変縮径したコイル線４１を用いた第一コイル１３とする。   The large-diameter portion and the small-diameter portion do not refer to the forms of the rear-end-diameter large-diameter portion 31 and the front-end-diameter small-diameter portion 33, respectively. It may be the case where it consists of two shapes of the part 31 and the intermediate | middle taper part 32. FIG. In such a case, the large diameter portion is the rear end diameter large equal diameter portion 31, and the small diameter portion is the intermediate taper portion 32. The outer diameter of the larger diameter portion corresponds to the outer diameter of the rear end diameter larger equal diameter portion 31, and the outer diameter of the smaller diameter portion corresponds to the outer end diameter of the intermediate taper portion 32. In such a case, when using a long taper coil wire 41, which will be described later, a coil wire 41 having a diameter that gradually changes from the rear end side toward the front end side of the small diameter portion (intermediate taper portion 32) is used. One coil 13 is used.

第一コイル１３の第一密巻き部１３Ａには、高い初張力を働かせて一定範囲のねじり応力をもつコイルを用いることを特徴とする。   As the first closely wound portion 13A of the first coil 13, a coil having a predetermined range of torsional stress by using a high initial tension is used.

図４を参照しながら、ばね指数とねじり応力との相関関係について説明する。ねじり応力をτ（Ｎ／ｍｍ2）とすると、後端径大等径部３１の第一密巻き部１３Ａのねじり応力はτ１（Ｎ／ｍｍ2）で、先端径小等径部３３の第一密巻き部１３Ａのねじり応力はτ２（Ｎ／ｍｍ2）である。ばね指数をＣとすると、後端径大等径部３１のばね指数はＣ１で、先端径小等径部３３のばね指数はＣ２である。このばね指数Ｃ（Ｃ１、Ｃ２）が２．８以上６．８以下のとき、第一密巻き部１３Ａのねじり応力τ（τ１、τ２）（Ｎ／ｍｍ2）は、以下の関係式（１）を満たすことが好ましい（図示符号Ｌ１とＬ３）。尚、Ｌ１は上限値を示し、Ｌ３は下限値を示している。
−１１．２Ｃ＋１１１．７≦τ≦−３８．７Ｃ＋３７０．６ ・・・（１） The correlation between the spring index and the torsional stress will be described with reference to FIG. Assuming that the torsional stress is τ (N / mm 2 ), the torsional stress of the first close winding portion 13A of the rear end diameter large equal diameter portion 31 is τ1 (N / mm 2 ) and The torsional stress of the closely packed portion 13A is τ2 (N / mm 2 ). Assuming that the spring index is C, the spring index of the rear end diameter large equal diameter part 31 is C1, and the spring index of the small tip diameter equal diameter part 33 is C2. When the spring index C (C1, C2) is 2.8 or more and 6.8 or less, the torsional stress τ (τ1, τ2) (N / mm 2 ) of the first densely wound portion 13A is expressed by the following relational expression (1 ) Is preferably satisfied (indicated symbols L1 and L3). L1 represents an upper limit value, and L3 represents a lower limit value.
−11.2C + 111.7 ≦ τ ≦ −38.7C + 370.6 (1)

関係式（１）において、下限値Ｌ３未満になると、第一コイル１３の外径比増大構造によるねじりモーメント増大作用と、密巻き部に高い初張力を働かせた密着力向上作用との双方の作用による先端側への回転伝達性能向上効果が低減する。上限値Ｌ１を超えると、第一密巻き部１３Ａと第一疎巻き部１３Ｂとの境界部等で生じた剛性差から、境界部等で急激な折れ曲がりが発生しやすくなり、先端側への回転伝達性能向上効果が低減する。これらを考慮すると、関係式（１）を満たすことが好ましい。   In the relational expression (1), when the value is less than the lower limit L3, both the action of increasing the torsional moment due to the structure of increasing the outer diameter ratio of the first coil 13 and the action of improving the adhesion force by applying a high initial tension to the densely wound portion. This reduces the effect of improving the rotation transmission performance to the tip side. If the upper limit value L1 is exceeded, sudden bending is likely to occur at the boundary portion due to the difference in rigidity generated at the boundary portion between the first densely wound portion 13A and the first loosely wound portion 13B. The transmission performance improvement effect is reduced. Considering these, it is preferable to satisfy the relational expression (1).

ばね指数Ｃ（Ｃ１、Ｃ２）が２．８以上６．８以下のとき、第一密巻き部１３Ａのねじり応力τ（τ１、τ２）（Ｎ／ｍｍ2）は、以下の関係式（２）を満たすことがより好ましい（図示符号Ｌ１とＬ２）。尚、Ｌ１は上限値を示し、Ｌ２は下限値を示している。
−２１．８Ｃ＋１９８．１≦τ≦−３８．７Ｃ＋３７０．６ ・・・（２）
尚、コイル線の線直径をｄ、ねじり応力をτ、コイル平均径をＤとすると、初張力Ｆは、以下の関係式（３）で表すことができる。図４は多くの試験結果からこれら関係式を導いた。
Ｆ＝πｄ3τ／（８Ｄ） ・・・（３） When the spring index C (C1, C2) is 2.8 or more and 6.8 or less, the torsional stress τ (τ1, τ2) (N / mm 2 ) of the first densely wound portion 13A is expressed by the following relational expression (2) It is more preferable to satisfy (illustrated symbols L1 and L2). L1 indicates an upper limit value, and L2 indicates a lower limit value.
−21.8C + 198.1 ≦ τ ≦ −38.7C + 370.6 (2)
The initial tension F can be expressed by the following relational expression (3), where d is the wire diameter of the coil wire, τ is the torsional stress, and D is the average coil diameter. FIG. 4 derived these relational expressions from many test results.
F = πd 3 τ / (8D) (3)

そして、外径比増大構造を有する第一コイル１３の第一密巻き部１３Ａには、高い初張力を働かせて前記関係式（１），（２）を満たす一定範囲のねじり応力をもつコイルを用いることを特徴とする。この理由は、第一密巻き部１３Ａの初張力を高めることにより、第一密巻き部１３Ａのコイル線間に圧縮力（密着力）が加わり、この密着力を高めたコイルを後端側に用いることにより、更に、外径比増大構造との併用により、後端側から先端側への回転伝達性能を飛躍的に向上させることができるからである。   A coil having a certain range of torsional stress satisfying the relational expressions (1) and (2) by applying a high initial tension to the first densely wound portion 13A of the first coil 13 having the outer diameter ratio increasing structure. It is characterized by using. The reason for this is that by increasing the initial tension of the first densely wound portion 13A, a compressive force (adhesive force) is applied between the coil wires of the first densely wound portion 13A, and the coil that has enhanced this adhesive force is placed on the rear end side. This is because, by using it together with the outer diameter ratio increasing structure, it is possible to dramatically improve the rotation transmission performance from the rear end side to the front end side.

この初張力は、コイル成形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。この理由は、コイル線が巻回成形時に自由に回転することができずに捩じられた形で巻回成形される為である。従って、負のコイルピッチの負の量を増減することにより、初張力を増減させることができる。これにより、第一疎巻き部１３Ｂとの相関関係から、第一密巻き部１３Ａの初張力のねじり応力τを高く設定したり、低く設定したりして調整することができる。   This initial tension can be obtained by providing a negative coil pitch and performing winding forming during coil forming. The reason for this is that the coil wire cannot be freely rotated at the time of the winding forming and is wound in a twisted form. Therefore, the initial tension can be increased or decreased by increasing or decreasing the negative amount of the negative coil pitch. Thereby, from the correlation with the first loosely wound portion 13B, the initial tension torsional stress τ of the first densely wound portion 13A can be set higher or lower.

後端径大等径部３１の第一密巻き部１３Ａのねじり応力τ１は、第１実施形態の後端径大等径部３１の外径Ｄ１１が０．３５５６ｍｍのとき、約１４９．３Ｎ／ｍｍ2である。ばね指数Ｃ１は約４．９３であることから、この値を前記関係式（２）へ代入すると、ねじり応力τの上下限値の範囲は、約９０．６Ｎ／ｍｍ2以上１７９．８Ｎ／ｍｍ2以下となる。従って、ねじり応力τ１は、前記上下限値の範囲内であり、前記関係式（１）も満たしている。又、このねじり応力τ１が１４９．３Ｎ／ｍｍ2のとき、後端径大等径部３１の第一密巻き部１３Ａの初張力をＦ１とすると、初張力Ｆ１は約４．２８×１０−2Ｎである。これは、第一コイル１３の第一密巻き部１３Ａに引張力が加わると隣接コイル線が離間するまで（隙間が開くまで）の間に、この引張力に対する抵抗力として初張力Ｆ１が働き、予めコイル線間に圧縮力が加わり密着力を高めているこの初張力Ｆ１の作用により、手元側を回転操作したとき先端側への回転伝達性能をより向上させることができる。 The torsional stress τ1 of the first densely wound portion 13A of the rear end diameter large equal diameter portion 31 is about 149.3 N / when the outer diameter D11 of the rear end large diameter equal diameter portion 31 of the first embodiment is 0.3556 mm. a mm 2. Since the spring index C1 is about 4.93, when this value is substituted into the relational expression (2), the range of the upper and lower limit values of the torsional stress τ is about 90.6 N / mm 2 or more and 179.8 N / mm. 2 or less. Accordingly, the torsional stress τ1 is within the range of the upper and lower limit values, and the relational expression (1) is also satisfied. Further, when the torsional stress τ1 is 149.3 N / mm 2 , the initial tension F1 is about 4.28 × 10 − when the initial tension of the first close winding portion 13A of the rear end diameter large equal diameter portion 31 is F1. 2 N. This is because, when a tensile force is applied to the first closely wound portion 13A of the first coil 13, the initial tension F1 acts as a resistance force against the tensile force until the adjacent coil wire is separated (until the gap is opened). Due to the action of this initial tension F1 in which a compressive force is applied in advance between the coil wires to increase the adhesion force, the rotation transmission performance to the distal end side can be further improved when the proximal side is rotated.

第一コイル１３のコイル線に、高強度の引張強さをもつオーステナイト系ステンレス鋼線を用いると、高いねじり応力が得られ、更に、外観が鏡面状のコイル線を用いることにより、隣接線相互に摩擦抵抗力が作用する。これら高いねじり応力と摩擦抵抗力とを併用することにより、先端側への回転伝達性能をより一層向上させることができる。   When an austenitic stainless steel wire having a high tensile strength is used for the coil wire of the first coil 13, a high torsional stress is obtained. Friction resistance acts on By using these high torsional stress and frictional resistance in combination, the rotation transmission performance to the tip side can be further improved.

第１実施形態の後端径大等径部３１の外径Ｄ１１が０．４５７２ｍｍのとき、後端径大等径部３１の第一密巻き部１３Ａのねじり応力τ１は、約１１１．１Ｎ／ｍｍ2である。ねじり応力τの上下限値の範囲は、約５３．８Ｎ／ｍｍ2以上１１４．４Ｎ／ｍｍ2以下となる。従って、ねじり応力τ１は、前記上下限値の範囲内であり、前記関係式（１）も満たしている。又、このねじり応力τ１が１１１．１Ｎ／ｍｍ2のとき、初張力Ｆ１は、約２．３７×１０−2Ｎである。この初張力Ｆ１の作用効果については、前記同様、手元側を回転操作したときに、先端側への回転伝達性能をより向上させることができる。 When the outer diameter D11 of the rear end large diameter portion 31 of the first embodiment is 0.4572 mm, the torsional stress τ1 of the first closely wound portion 13A of the rear end large diameter portion 31 is about 111.1 N / a mm 2. The range of the upper and lower limit values of the torsional stress τ is about 53.8 N / mm 2 to 114.4 N / mm 2 . Accordingly, the torsional stress τ1 is within the range of the upper and lower limit values, and the relational expression (1) is also satisfied. When the torsional stress τ1 is 111.1 N / mm 2 , the initial tension F1 is about 2.37 × 10 −2 N. About the effect of this initial tension F1, the rotation transmission performance to the front end side can be further improved when the hand side is rotated as described above.

第１実施形態の後端径大等径部３１の外径Ｄ１１が０．３５５６ｍｍのとき、先端径小等径部３３の第一密巻き部１３Ａのねじり応力τ２は、約２４５．２Ｎ／ｍｍ2である。ばね指数Ｃ２は３．０であることから、この値を前記関係式（２）へ代入すると、ねじり応力τの上下限値の範囲は、約１３２．７Ｎ／ｍｍ2以上２５４．５Ｎ／ｍｍ2以下となる。従って、ねじり応力τ２は、前記上下限値の範囲内であり、前記関係式（１）も満たしている。又、このねじり応力τ２が２４５．２Ｎ／ｍｍ2のとき、先端径小等径部３３の第一密巻き部１３Ａの初張力をＦ２とすると、初張力Ｆ２は、約２．８９×１０−2Ｎである。この初張力Ｆ２の作用効果については、前記初張力Ｆ１と同様である。 When the outer diameter D11 of the rear end large-diameter portion 31 of the first embodiment is 0.3556 mm, the torsional stress τ2 of the first closely wound portion 13A of the small tip diameter constant-diameter portion 33 is about 245.2 N / mm. 2 . Since the spring index C2 is 3.0, when this value is substituted into the relational expression (2), the range of the upper and lower limit values of the torsional stress τ is about 132.7 N / mm 2 or more and 254.5 N / mm 2. It becomes as follows. Therefore, the torsional stress τ2 is within the range of the upper and lower limit values, and the relational expression (1) is also satisfied. Further, when the torsional stress τ2 is 245.2 N / mm 2 , the initial tension F2 is about 2.89 × 10 − when the initial tension of the first close winding portion 13A of the small diameter end portion 33A is F2. 2 N. The effect of the initial tension F2 is the same as that of the initial tension F1.

先端径小等径部３３の第一密巻き部１３Ａのねじり応力τ２は、後端径大等径部３１の外径Ｄ１１に影響されない為、ねじり応力τ２は、第１実施形態の後端径大等径部３１の外径Ｄ１１が０．４５７２ｍｍの場合であっても、前記外径Ｄ１１が０．３５５６ｍｍの場合と同様である。   Since the torsional stress τ2 of the first densely wound portion 13A of the tip end small diameter portion 33 is not affected by the outer diameter D11 of the rear end large diameter equal diameter portion 31, the torsional stress τ2 is the rear end diameter of the first embodiment. Even when the outer diameter D11 of the large diameter portion 31 is 0.4572 mm, it is the same as when the outer diameter D11 is 0.3556 mm.

第１実施形態のように第一コイル１３の径小部の先端側に第一疎巻き部１３Ｂを設ける場合には、後端径大等径部３１と中間テーパ部３２は全て第一密巻き部１３Ａとし、先端径小等径部３３の後端側を第一密巻き部１３Ａとし、先端径小等径部３３の先端側を第一疎巻き部１３Ｂとする。第二コイル１４の第二疎巻き部１４Ｂは、少なくとも先端径小等径部３３の第一疎巻き部１３Ｂと芯線長手方向で同一位置に設ける。第一疎巻き部１３ＢのコイルピッチＰ１は、線直径ｄ２の１．０５倍以上３．５０倍以下とし、第二疎巻き部１４ＢのコイルピッチＰ４は、線直径ｄ３の１．０５倍以上１．９０倍以下とする。このように、芯線長手方向で同一位置に設けられて重複した第一疎巻き部１３Ｂと第二疎巻き部１４Ｂとは、それぞれのコイルピッチＰ１とＰ４が異なることを特徴とする。   When the first loosely wound portion 13B is provided on the distal end side of the small diameter portion of the first coil 13 as in the first embodiment, the rear end diameter large-diameter portion 31 and the intermediate taper portion 32 are all first densely wound. The rear end side of the tip diameter small equal diameter portion 33 is referred to as a first densely wound portion 13A, and the front end side of the tip diameter small equal diameter portion 33 is referred to as a first loosely wound portion 13B. The second sparsely wound portion 14B of the second coil 14 is provided at the same position in the longitudinal direction of the core wire as at least the first sparsely wound portion 13B of the tip diameter small equal diameter portion 33. The coil pitch P1 of the first sparsely wound portion 13B is 1.05 times or more and 3.50 times or less of the wire diameter d2, and the coil pitch P4 of the second sparsely wound portion 14B is 1.05 times or more and 1 of the wire diameter d3. .90 times or less. As described above, the first sparsely wound portion 13B and the second sparsely wound portion 14B that are provided at the same position in the longitudinal direction of the core wire and have the same coil pitches P1 and P4 are different.

第１実施形態において、第一疎巻き部１３ＢのコイルピッチＰ１は、線直径ｄ２の２．５倍で０．０７５ｍｍとなり、又、第二疎巻き部１４ＢのコイルピッチＰ４は、線直径ｄ３の１．５０倍で約０．０９０ｍｍとなる。いずれも前記コイルピッチＰ１、Ｐ４の範囲を満たし、かつコイルピッチＰ１とＰ４とは異なっている。   In the first embodiment, the coil pitch P1 of the first loosely wound portion 13B is 0.075 mm, which is 2.5 times the wire diameter d2, and the coil pitch P4 of the second loosely wound portion 14B is of the wire diameter d3. It becomes about 0.090 mm at 1.50 times. Both satisfy the range of the coil pitches P1 and P4 and are different from the coil pitches P1 and P4.

第二疎巻き部１４Ｂは、少なくとも第一疎巻き部１３Ｂと芯線長手方向で同一位置に設けることにより、コイルが重複する構造であっても、重複する部位（先端側）の剛直化が防止される。この為、先端側の柔軟性が担保されるので、血管壁とのソフトタッチを可能とし、又、術者による最先端部の「へ」の字形等の屈曲変形を容易にさせ、塑性変形性能を向上させることができる。   By providing the second sparsely wound portion 14B at least at the same position in the longitudinal direction of the core wire as the first sparsely wound portion 13B, even if the coil overlaps, stiffening of the overlapping portion (tip side) is prevented. The For this reason, the flexibility on the tip side is ensured, so soft touch with the blood vessel wall is possible, and the surgeon can easily bend and deform the leading edge of the hem, etc., plastic deformation performance Can be improved.

第一疎巻き部１３ＢのコイルピッチＰ１と第二疎巻き部１４ＢのコイルピッチＰ４とを異ならせることにより、コイル線どうしの噛み込み現象を防ぐことができる。噛み込み現象とは、例えば、第二コイル１４のコイル線９が第一コイル１３の第一疎巻き部１３Ｂの線間間隙ｔ１へ食い込んだり、逆に、第一コイル１３の第一疎巻き部１３Ｂのコイル線８Ｂが第二コイル１４の第二疎巻き部１４Ｂの線間間隙ｔ４へ食い込んだりすることをいう。   By making the coil pitch P1 of the first sparsely wound portion 13B different from the coil pitch P4 of the second sparsely wound portion 14B, it is possible to prevent the coil wire from being caught. The biting phenomenon means that, for example, the coil wire 9 of the second coil 14 bites into the inter-line gap t1 of the first loosely wound portion 13B of the first coil 13, or conversely, the first loosely wound portion of the first coil 13 That is, the coil wire 8B of 13B bites into the inter-line gap t4 of the second loosely wound portion 14B of the second coil 14.

第一密巻き部１３Ａに初張力を働かせることにより、コイル線間に圧縮力（密着力）が働き、更に、第二疎巻き部１４ＢのコイルピッチＰ４が線直径ｄ３の２倍の寸法を下回る（つまり、線間間隙ｔ４の寸法は線直径ｄ３の寸法を下回る）ことを特徴とする。これにより、先端側への回転伝達性能の向上を図ると共に、術者の「パラレルワイヤ法」の手技時の噛み込み現象を防ぐことができる。尚、ここでいう「パラレルワイヤ法」とは、病変部内へ１本目のガイドワイヤを挿入した後、その１本目のガイドワイヤを道案内として、後からもう１本のガイドワイヤを導入し、２本目のガイドワイヤで病変部内の本来通るべき血液通路（真腔）を捕えて、閉塞部の穿通を図る手技のことをいう。従って、１本目のガイドワイヤ１０と、２本目のガイドワイヤ１０との間で、コイル部（第一コイル１３の後端径大等径部３１のコイルと第二コイル１４のコイル）が接触しても、後端側は、初張力による圧縮力（密着力）を働かせた第一密巻き部１３Ａである為、コイル線が食い込むことはなく、又、先端側は、第二疎巻き部１４Ｂの線間間隙ｔ４が線直径ｄ３よりも小さい為、コイル線が食い込むことはない。このように、本発明のガイドワイヤ１０は、このコイル線どうしの線間間隙への食い込み、噛み込み現象を防ぐことができる。   By applying an initial tension to the first densely wound portion 13A, a compressive force (adhesion force) is exerted between the coil wires, and the coil pitch P4 of the second loosely wound portion 14B is less than twice the wire diameter d3. (That is, the dimension of the inter-line gap t4 is smaller than the dimension of the line diameter d3). As a result, it is possible to improve the performance of transmitting rotation to the distal end side, and to prevent the biting phenomenon during the operator's “parallel wire method” procedure. The “parallel wire method” here refers to a method in which a first guide wire is inserted into a lesion, and then the first guide wire is used as a route guide to introduce another guide wire later. This refers to a technique for capturing the blood passage (true lumen) that should be passed through the lesioned part with the first guide wire, and trying to penetrate the blocked part. Therefore, between the first guide wire 10 and the second guide wire 10, the coil portion (the coil of the rear end diameter large-diameter portion 31 of the first coil 13 and the coil of the second coil 14) comes into contact. However, since the rear end side is the first densely wound portion 13A that exerts the compressive force (adhesion force) due to the initial tension, the coil wire does not bite, and the front end side is the second loosely wound portion 14B. Since the inter-wire gap t4 is smaller than the wire diameter d3, the coil wire does not bite. As described above, the guide wire 10 of the present invention can prevent the coil wires from being bitten into the inter-line gap and the biting phenomenon.

後端側の後端径大等径部３１（又は径大部）には、太径のコイル線８Ａを用い、先端側の先端径小等径部３３（又は径小部）には、細径のコイル線８Ｂを用い、第一コイル１３は、これら太径のコイル線８Ａと細径のコイル線８Ｂとの２つのコイル線を接合して成ることを特徴とする。例えば、第一コイル１３は、第１実施形態のように線直径が０．０６０ｍｍの太径のコイル線８Ａと、線直径が０．０４０ｍｍの細径のコイル線８Ｂとの接合、又は、線直径が０．０６０ｍｍの太径のコイル線８Ａと、線直径が０．０３０ｍｍの細径のコイル線８Ｂとの接合、又は、線直径が０．０６０ｍｍの太径のコイル線８Ａと、線直径が０．０２０ｍｍの細径のコイル線８Ｂとを接合して成る。これにより、先端側への回転伝達性能を「高、中、低」と異ならせたガイドワイヤ１０を数種類準備することにより、病変形態（完全閉塞の硬質、軟質等）に応じてガイドワイヤを提供することができ、術者の迅速な病変部治療が可能となる。   A large-diameter coil wire 8A is used for the rear end side large diameter portion 31 (or large diameter portion) on the rear end side, and a small diameter portion 33 (or small diameter portion) on the front end side is thin. The first coil 13 is formed by joining two coil wires of the large diameter coil wire 8A and the small diameter coil wire 8B. For example, the first coil 13 is formed by joining a thick coil wire 8A having a wire diameter of 0.060 mm and a thin coil wire 8B having a wire diameter of 0.040 mm as in the first embodiment, or a wire Joining of a thick coil wire 8A having a diameter of 0.060 mm and a thin coil wire 8B having a wire diameter of 0.030 mm, or a thick coil wire 8A having a wire diameter of 0.060 mm and a wire diameter Is formed by joining a coil wire 8B having a small diameter of 0.020 mm. As a result, by providing several types of guide wire 10 with different rotation transmission performance to the tip side, “high, medium, low”, a guide wire can be provided according to the lesion form (hard, soft, etc.) This makes it possible for the surgeon to quickly treat the lesion.

図５は第２実施形態のガイドワイヤ４０を示し、第一コイル１３に、後端側から先端側に向けて線直径が太線から細線へ徐変縮径したロングテーパのコイル線４１を用いたことを特徴とする。後端径大等径部３１のコイル線４１の線直径ｄ１は０．０６０ｍｍで、先端径小等径部３３のコイル線４１の線直径ｄ２は０．０３０ｍｍである。中間テーパ部３２は後端側から先端側に向けて０．０６０ｍｍから０．０３０ｍｍへ徐変縮径する。この理由は、前記第１実施形態のような剛性が変化する中間接合部１５Ｃを無くすことにより、後端側の径大部（又は後端径大等径部３１）から先端側の径小部（先端径小等径部３３）へ向けて剛性を徐変減少させ、手元側から先端側への左右回転の円滑性を向上させることができ、又、中間接合部１５Ｃを設ける為の接合作業を無くして組立性を向上させることができるからである。又、第一コイル１３は、中間テーパ部３２の後端側から先端径小等径部３３の先端側へ向けて徐変縮径したロングテーパのコイル線４１を用いてもよい。かかる場合、手元側から先端側への円滑な回転伝達性能をより向上させることができる。尚、第二コイル１４の線直径ｄ４は、第１実施形態の第二コイル１４の線直径ｄ３と同様である。   FIG. 5 shows a guide wire 40 of the second embodiment, and a long taper coil wire 41 whose wire diameter is gradually changed from a thick line to a thin line from the rear end side to the front end side is used for the first coil 13. It is characterized by that. The wire diameter d1 of the coil wire 41 of the rear end large diameter portion 31 is 0.060 mm, and the wire diameter d2 of the coil wire 41 of the small tip diameter constant portion 33 is 0.030 mm. The intermediate taper portion 32 gradually changes in diameter from 0.060 mm to 0.030 mm from the rear end side toward the front end side. The reason for this is that by eliminating the intermediate joint portion 15C whose rigidity changes as in the first embodiment, the large diameter portion on the rear end side (or the large rear end diameter constant diameter portion 31) to the small diameter portion on the front end side. Rigidity is gradually reduced and reduced toward the tip end small diameter portion 33, the smoothness of the left-right rotation from the hand side to the tip end side can be improved, and the joining work for providing the intermediate joint 15C This is because assemblability can be improved by eliminating the above. Alternatively, the first coil 13 may use a long taper coil wire 41 that gradually changes in diameter from the rear end side of the intermediate taper portion 32 toward the front end side of the small diameter constant diameter portion 33. In such a case, smooth rotation transmission performance from the hand side to the tip side can be further improved. The wire diameter d4 of the second coil 14 is the same as the wire diameter d3 of the second coil 14 of the first embodiment.

図６は第３実施形態のガイドワイヤ５０を示し、第２実施形態と異なるところは、第二コイル１４の外径Ｄ３は０．２５４ｍｍで、第一コイル１３の後端径大等径部３１の外径Ｄ１１の０．３５５６ｍｍより小さく、先端径小等径部３３の外径Ｄ２２の０．１２０ｍｍより大きくなっていることであり、第二コイル１４の外径Ｄ３は、第一コイル１３の後端径大等径部３１の外径Ｄ１１と先端径小等径部３３の外径Ｄ２２とは、Ｄ１１＞Ｄ３＞Ｄ２２の関係式を満たすことを特徴とする。この理由は、第二コイル１４の外径Ｄ３を後端径大等径部３１の外径Ｄ１１よりも小さくして、第一コイル１３の先端側への先細り形状と同様に、第一コイル１３と第二コイル１４の双方の先細り形状による先端側へのねじりモーメント増大作用により、先端側への回転伝達性能をより向上させる為であり、又、狭窄病変内等での先端部の通過性をより向上させる為である。尚、第二コイル１４の線直径ｄ４は、第１実施形態の第二コイル１４の線直径ｄ３と同様である。   FIG. 6 shows a guide wire 50 according to the third embodiment. The difference from the second embodiment is that the outer diameter D3 of the second coil 14 is 0.254 mm and the rear end diameter large-diameter portion 31 of the first coil 13 is shown. The outer diameter D11 of the second coil 14 is smaller than 0.3556 mm of the outer diameter D11 and larger than 0.120 mm of the outer diameter D22 of the small-diameter portion 33 having a small tip diameter. The outer diameter D11 of the rear end diameter larger equal diameter part 31 and the outer diameter D22 of the smaller distal end diameter equal diameter part 33 satisfy the relational expression D11> D3> D22. The reason for this is that the outer diameter D3 of the second coil 14 is made smaller than the outer diameter D11 of the large-diameter portion 31 of the rear end diameter, and the first coil 13 is similar to the tapered shape toward the front end side of the first coil 13. This is to increase the rotational transmission performance to the distal end side by increasing the torsional moment to the distal end side due to the tapered shape of both the first coil 14 and the second coil 14, and also to improve the passage of the distal end portion within the stenotic lesion. This is for further improvement. The wire diameter d4 of the second coil 14 is the same as the wire diameter d3 of the second coil 14 of the first embodiment.

図７は第４実施形態のガイドワイヤ６０を示し、第１実施形態と異なるところは、第１実施形態が第一コイル１３の線直径が異なる後端第一コイル２１と先端第一コイル２２とを中間接合部１５Ｃで２つのコイルを接合した構造に対して、線直径が同一で、かつ１つのコイルから成ることを特徴とする。つまり第一コイル１３は、後端径大等径部３１から先端径小等径部３３に至るまで、線直径ｄ１が０．０６０ｍｍのコイル線６１から成っている。そして、第一コイル１３の後端径大等径部３１の外径Ｄ１１は０．３５５６ｍｍ、先端径小等径部３３は、ばね指数が２．８で、外径Ｄ２２が０．２２８ｍｍである。この為、第一コイル１３の外径比Ｄ１１／Ｄ２２は約１．５６となる。後端径大等径部３１の外径Ｄ１１が０．４５７２ｍｍの場合は、外径比Ｄ１１／Ｄ２２は約２．００となる。後端径大等径部３１の外径Ｄ１１が０．３５５６ｍｍ（０．０１４インチ）の場合と０．４５７２ｍｍ（０．０１８インチ）の双方の場合を考慮すると、外径比Ｄ１１／Ｄ２２は１．５６以上２．００以下となる。尚、第二コイル１４の線直径ｄ４は、第１実施形態の第二コイル１４の線直径ｄ３と同様である。   FIG. 7 shows a guide wire 60 according to the fourth embodiment, which is different from the first embodiment in that the first embodiment has a rear end first coil 21 and a front end first coil 22 in which the wire diameter of the first coil 13 is different. In contrast to the structure in which two coils are joined by the intermediate joint 15C, the wire diameter is the same and the coil is composed of one coil. That is, the first coil 13 includes a coil wire 61 having a wire diameter d1 of 0.060 mm from the rear end diameter larger equal diameter portion 31 to the front end diameter smaller equal diameter portion 33. And the outer diameter D11 of the rear end diameter large equal diameter portion 31 of the first coil 13 is 0.3556 mm, and the small distal end diameter equal diameter portion 33 has a spring index of 2.8 and an outer diameter D22 of 0.228 mm. . For this reason, the outer diameter ratio D11 / D22 of the first coil 13 is about 1.56. When the outer diameter D11 of the rear end diameter equal-diameter portion 31 is 0.4572 mm, the outer diameter ratio D11 / D22 is about 2.00. Considering both the case where the outer diameter D11 of the rear end diameter large equal diameter portion 31 is 0.3556 mm (0.014 inch) and 0.4572 mm (0.018 inch), the outer diameter ratio D11 / D22 is 1. .56 or more and 2.00 or less. The wire diameter d4 of the second coil 14 is the same as the wire diameter d3 of the second coil 14 of the first embodiment.

そして、先端径小等径部３３の第一密巻き部１３Ａのねじり応力τ２は、約２６２Ｎ／ｍｍ2であり、このときの初張力Ｆ２は、約１３．２６×１０−2Ｎとなり、従来例に対して約１３．２６×１０−2Ｎの初張力が働き（従来例は初張力が働いていない）、又、第４実施形態のガイドワイヤ６０は、第１実施形態のガイドワイヤ１０よりも約４．６倍の初張力が働き、コイル線間の密着力をより高めている。これは主に、コイル線の線直径の差が、第１実施形態は０．０３０ｍｍであるのに対して、第４実施形態では０．０６０ｍｍであることによると考えられる。 Then, the torsional stress τ2 of the first close winding portion 13A of the tip diameter small equal diameter portion 33 is about 262 N / mm 2 , and the initial tension F2 at this time is about 13.26 × 10 −2 N. An initial tension of about 13.26 × 10 −2 N works for the example (the initial tension is not working in the conventional example), and the guide wire 60 of the fourth embodiment is the guide wire 10 of the first embodiment. The initial tension is about 4.6 times that of the coil, and the adhesion between the coil wires is further increased. This is presumably due to the difference in the wire diameters of the coil wires being 0.030 mm in the fourth embodiment compared to 0.030 mm in the first embodiment.

ガイドワイヤ６０は、芯線１１の外径が後端側から先端側へ向けて徐変縮径（例えば、０．３５５６ｍｍから０．０６０ｍｍへ）し、この縮径により、引張破断力（最大強度点）が低下（例えば２７７．９Ｎから７．９Ｎへ）した芯線１１の先端側の外側に、初張力によるねじり応力を最も高めた第一密巻き部１３Ａを有する第一コイル１３を設けたことを特徴とする。この理由は、先端側へ徐変縮径し、先端側での引張力に対する抵抗力が低下している極細線の芯線１１の先端側の外側に、高い初張力を働かせてコイル線間の密着力を高めた第一コイル１３を設けることにより、極細線の芯線１１に加わる引張力に対する抵抗力を補完し、かつ第一疎巻き部１３Ｂを有する第一コイル１３であっても、隣接する第一密巻き部１３Ａのコイル線間の密着力を高めて、先端側への回転伝達性能をより一層向上させることができるからである。   The guide wire 60 has an outer diameter of the core wire 11 that gradually changes from the rear end to the front end (for example, from 0.3556 mm to 0.060 mm). ) That the first coil 13 having the first closely wound portion 13A having the highest torsional stress due to the initial tension is provided on the outer side of the distal end side of the core wire 11 where the lowering (for example, from 277.9N to 7.9N) is provided. Features. The reason for this is that a high initial tension is applied to the outer side of the tip side of the ultrathin wire core 11 that gradually changes in diameter toward the tip side and the resistance to the pulling force on the tip side is reduced, and the coil wires are in close contact with each other. By providing the first coil 13 with increased force, even the first coil 13 that complements the resistance to the tensile force applied to the core wire 11 of the ultrafine wire and has the first loosely wound portion 13B is adjacent to the first coil 13. This is because the adhesion between the coil wires of the tightly wound portion 13A can be increased, and the rotation transmission performance to the tip side can be further improved.

芯線１１の先端側へ加わる引張力に対する抵抗力の補完をより高めることを考慮すると、第一コイル１３は、径小部の第一密巻き部１３Ａを芯線長手方向へより長く設ける構成、又は、全体に亘って初張力を発生させた第一密巻き部１３Ａとする構成が望ましい。   In consideration of further increasing the complement of resistance to the tensile force applied to the distal end side of the core wire 11, the first coil 13 has a configuration in which the first densely wound portion 13 </ b> A having a small diameter is provided longer in the core wire longitudinal direction, or The first densely wound portion 13A that generates the initial tension throughout is desirable.

尚、第１〜第４実施形態で用いたコイル線は、横断面形状が円形のコイル線であったが、芯線１１の外側に第一コイル１３を設けた状態で、横断面形状が、コイルの径方向の長さ（短辺ｂ）よりも、芯線長手方向への長さ（長辺ａ）が長い矩形のコイル線を用いてもよい。具体的には、アスペクト比（ａ／ｂ）が１．２０以上２．７５以下であることが好ましい。アスペクト比が１．２０のとき、短辺ｂは０．０４８ｍｍであり、長辺ａは約０．０５８ｍｍである。アスペクト比が２．７５のとき、短辺ｂは０．０３２ｍｍであり、長辺ａは約０．０８８ｍｍである。この為、極細線の芯線を貫挿する第一コイル１３の内径と同一にしながら外径を小さくすることができる（特に先端径小等径部３３の外径Ｄ２２）。これにより、外径比Ｄ１１／Ｄ２２を更に増大させて先端側へのねじりモーメント増大作用を高めることができる。   In addition, although the coil wire used in the first to fourth embodiments was a coil wire having a circular cross-sectional shape, the cross-sectional shape is a coil with the first coil 13 provided outside the core wire 11. A rectangular coil wire having a longer length (long side a) in the longitudinal direction of the core wire than a length in the radial direction (short side b) may be used. Specifically, the aspect ratio (a / b) is preferably 1.20 or more and 2.75 or less. When the aspect ratio is 1.20, the short side b is 0.048 mm, and the long side a is about 0.058 mm. When the aspect ratio is 2.75, the short side b is 0.032 mm and the long side a is about 0.088 mm. For this reason, it is possible to reduce the outer diameter while making it the same as the inner diameter of the first coil 13 that penetrates the core wire of the ultrafine wire (particularly, the outer diameter D22 of the tip diameter small equal diameter portion 33). As a result, the outer diameter ratio D11 / D22 can be further increased to enhance the action of increasing the torsional moment toward the tip.

横断面形状が矩形のコイル線と横断面形状が円形のコイル線とを比較すると、円形断面のコイル線は隣接線との接触が点接触であるのに対し、矩形断面のコイル線は、隣接線との接触が面接触となる。従って、矩形断面のコイル線は、円形断面のコイル線よりも、摩擦抵抗増大作用による先端側への回転伝達性能を高めることができる。又、円形断面のコイル線を用いたコイルの場合は、外部から過大な圧縮力が加わると隣接線が浮き上がったり、沈み込んだりして凸凹変形が発生しやすくなるといった問題がある。しかし、矩形断面のコイル線を用いたコイルでは、隣接線が面接触する為、この問題を防ぐことができる。そして、芯線長手方向の長さ（長辺ａ）が円形断面の場合よりも長くなることにより、コイル成形時の生産性を向上させることができる。   Comparing a coil wire with a rectangular cross section with a circular coil wire with a circular cross section, the coil wire with a circular cross section is a point contact with the adjacent line, whereas the coil wire with a rectangular cross section is adjacent Contact with the line is surface contact. Therefore, the coil wire having the rectangular cross section can enhance the rotation transmission performance to the tip side due to the frictional resistance increasing action than the coil wire having the circular cross section. In addition, in the case of a coil using a coil wire having a circular cross section, there is a problem that when an excessive compressive force is applied from the outside, the adjacent wire is lifted or submerged, and uneven deformation is likely to occur. However, in a coil using a rectangular cross-section coil wire, this problem can be prevented because adjacent wires are in surface contact. And the length (long side a) of a core wire longitudinal direction becomes longer than the case where it is a circular cross section, Therefore The productivity at the time of coil shaping | molding can be improved.

尚、第一コイル１３のコイル線に用いるオーステナイト系ステンレス鋼線は、外観が鏡面状であることが望ましい。この理由は、初張力を働かせて巻回成形した第一密巻き部１３Ａは、隣接線どうしが初張力による圧縮力を受け、更に隣接線が鏡面状で、かつ同一材料である為、隣接線相互に強い凝着力が作用して摩擦抵抗が増大し、手元側を回転操作したとき、この増大した摩擦抵抗力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。鏡面状とは、目視及び触感により凸凹が感知できない状態、又は光が反射できる状態であり、必ずしも鏡のように物が明白に映る状態を意味するのではない。   The austenitic stainless steel wire used for the coil wire of the first coil 13 is preferably mirror-like in appearance. The reason for this is that the first densely wound portion 13A formed by winding using the initial tension is subjected to a compressive force due to the initial tension between the adjacent wires, and the adjacent wires are mirror-like and made of the same material. This is because a strong adhesion force acts on each other to increase the frictional resistance, and when the proximal side is rotated, the increased frictional resistance can improve the rotation transmission performance to the tip side. The specular shape is a state where unevenness cannot be detected by visual and tactile sensation, or a state where light can be reflected, and does not necessarily mean a state where an object is clearly reflected like a mirror.

尚、第一コイル１３の第一疎巻き部１３Ｂを容易に形成する為には、複数本のコイル線を用いて巻回成形するよりも、１本のコイル線を用いて巻回成形したほうが望ましい。この理由は以下の通りである。複数本のコイル線を巻回成形したコイルを用いて疎巻き部を形成する場合には、巻回成形した方向とは逆方向へコイル線を巻き戻してコイル線間に隙間を空けなければならず、複数本のそれぞれのコイル線間に均一な線間間隙を確保することは加工上困難であり、特にコイルの芯線長手方向の中間部で、ろう材等を用いて芯線と接合する場合には、コイルの中間部で均一な線間間隙を設けなければならず、加工が極めて困難となる。これに対して、１本のコイル線を巻回成形したコイルであれば、芯線長手方向へ引張力を加えるのみで隣接線に隙間を空けて疎巻き部を設けることができ、コイルの端部であっても、中間部であっても、いずれの部位であっても疎巻き部を容易に形成することができるからである。   In order to easily form the first sparsely wound portion 13B of the first coil 13, it is better to perform winding molding using one coil wire than to perform winding molding using a plurality of coil wires. desirable. The reason is as follows. When forming a sparsely wound portion using a coil formed by winding a plurality of coil wires, the coil wires must be rewound in a direction opposite to the direction of the winding forming to leave a gap between the coil wires. It is difficult to secure a uniform gap between each coil wire, especially when joining the core wire with brazing material at the middle part of the coil core wire in the longitudinal direction. In this case, a uniform inter-line gap must be provided at the middle part of the coil, which makes processing extremely difficult. On the other hand, if the coil is formed by winding one coil wire, it is possible to provide a sparsely wound portion with a gap between adjacent wires by simply applying a tensile force in the longitudinal direction of the core wire. This is because the sparsely wound portion can be easily formed at any part of the intermediate portion.

１０、４０、５０、６０、１００ ガイドワイヤ
１１ 芯線
１３ 第一コイル
１３Ａ 第一密巻き部
１３Ｂ 第一疎巻き部
１４ 第二コイル
１４Ｂ 第二疎巻き部
１５Ａ 先端接合部
１６ ふっ素樹脂被膜
１７ 親水性樹脂被膜 10, 40, 50, 60, 100 Guide wire 11 Core wire 13 First coil 13A First densely wound part 13B First loosely wound part 14 Second coil 14B Second loosely wound part 15A Tip joint 16 Fluoropolymer coating 17 Hydrophilic Resin coating

Claims (4)

後端側は太径で、先端側は徐変縮径する細径の芯線の先端部をコイルに貫挿した医療用ガイドワイヤにおいて、
前記コイルは、後端側の第一コイルと先端側の第二コイルとを有し、
前記第一コイルは、
線直径が０．０２０ｍｍ以上０．０７０ｍｍ以下で、引張強さが２２００ＭＰａ以上３５００ＭＰａ以下で、外観が鏡面状のオーステナイト系ステンレス鋼のコイル線を巻回して構成され、
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有し、前記後端径大等径部、前記中間テーパ部、及び前記先端径小等径部の後端側が第一密巻き部で、前記先端径小等径部の先端側がコイルピッチを疎にした第一疎巻き部であり、
前記先端径小等径部の先端と、前記芯線の先端と、前記第二コイルの先端とを接合して先端接合部を形成し、
前記後端径大等径部の後端を前記芯線と接合して後端接合部を形成し、ばね指数Ｃが２．８以上６．８以下で、前記後端径大等径部の外径Ｄ１と、前記先端径小等径部の外径Ｄ２との外径比（Ｄ１／Ｄ２）が１．３０以上５．８０以下であり、
前記第一密巻き部は、ばね指数がＣで、初張力によるねじり応力をτ（Ｎ／ｍｍ 2 ）とすると、
前記ねじり応力τは、
−１１．２Ｃ＋１１１．７≦τ≦−３８．７Ｃ＋３７０．６の関係式を満たし、
前記第二コイルは、
放射線不透過性のコイル線を巻回して構成され前記中間テーパ部と前記先端径小等径部の外側に同心状に配され、後端が前記第一コイルの中間部に接合して中間接合部を形成し、少なくとも先端側にコイルピッチを疎にした第二疎巻き部を有し、
前記第一疎巻き部は、コイルピッチが線直径の１．０５倍以上３．５０倍以下とし、
前記第二疎巻き部は、少なくとも前記第一疎巻き部の外側に同心状に設けて、コイルピッチが線直径の１．０５倍以上１．９０倍以下とし、
前記第一疎巻き部と前記第二疎巻き部のコイルピッチが異なることを特徴とする医療用ガイドワイヤ。 In the medical guide wire in which the distal end side is a large diameter, the distal end side is inserted into the coil the distal end portion of a thin core wire gradually changing in diameter,
The coil has a first coil on the rear end side and a second coil on the front end side,
The first coil is
The wire diameter is 0.020 mm or more and 0.070 mm or less , the tensile strength is 2200 MPa or more and 3500 MPa or less, and the outer appearance is configured by winding a coil wire of austenitic stainless steel having a mirror surface shape ,
A rear end large diameter portion, an intermediate taper portion, and a small tip diameter constant diameter portion from the rear end side toward the front end side, the rear end diameter large equal diameter portion, the intermediate taper portion, and the tip diameter The rear end side of the small equal diameter portion is the first densely wound portion, and the front end side of the tip diameter small equal diameter portion is the first loosely wound portion with a sparse coil pitch,
Joining the tip of the tip diameter small equal diameter portion, the tip of the core wire, and the tip of the second coil to form a tip joint portion,
The rear end of the rear large-diameter such diameter portion joined to the core to form a rear end joint, a spring index C is 2.8 or more 6.8 or less, out of the rear end large diameter such as the radial section the diameter D1, an outer diameter ratio (D1 / D2) between the outer diameter D2 of the tip small-diameter like diameter portion is 1.30 or more 5.80 or less,
The first densely wound portion has a spring index of C, and a torsional stress due to initial tension is τ (N / mm 2 ).
The torsional stress τ is
−11.2C + 111.7 ≦ τ ≦ −38.7C + 370.6
The second coil is
Constructed by winding a radiopaque coil wire, concentrically arranged outside the intermediate taper portion and the small-diameter portion of the tip diameter, and the rear end joined to the intermediate portion of the first coil. Forming a portion, having a second sparsely wound portion with a sparse coil pitch at least on the tip side,
The first loosely wound portion has a coil pitch of 1.05 times to 3.50 times the wire diameter,
The second sparsely wound portion is provided concentrically outside at least the first sparsely wound portion, and the coil pitch is 1.05 times or more and 1.90 times or less of the wire diameter,
A medical guide wire, wherein the first sparsely wound portion and the second sparsely wound portion have different coil pitches . 前記第一コイルのコイル線の横断面形状が、コイルの径方向の長さｂよりも芯線長手方向の長さａが長く、アスペクト比（ａ／ｂ）が１．２０以上２．７５以下の矩形である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 cross-sectional shape of the coil wire of the first coil is such that the length a in the longitudinal direction of the core wire is longer than the length b in the radial direction of the coil , and the aspect ratio (a / b) is 1.20 or more and 2.75 or less. The medical guide wire according to claim 1 , wherein the medical guide wire is rectangular. 前記第一コイルは、前記後端径大等径部の外径がＤ１１と、前記先端径小等径部の外径をＤ２２と、前記第二コイルの外径Ｄ３とが、
Ｄ１１＞Ｄ３＞Ｄ２２の関係式を満たすことを特徴とする請求項１または２記載の医療用ガイドワイヤ。 The first coil has an outer diameter of the rear end diameter large equal diameter portion of D11, an outer diameter of the distal end small diameter equal diameter portion of D22, and an outer diameter D3 of the second coil.
The medical guide wire according to claim 1 or 2, wherein a relational expression of D11>D3> D22 is satisfied. 前記第一コイルは、前記中間テーパ部の後端側から先端側へ向けて、太線から細線へ徐変縮径したロングテーパのコイル線が用いられることを特徴とする請求項１から３のいずれか一つに記載の医療用ガイドワイヤ。 Said first coil, either from the rear end side of the intermediate tapered portion toward the distal end side, that the coil wire of the long taper and gradual change diameter from a thick line to a thin line is used from claim 1, wherein 3 of A medical guide wire according to any one of the above.
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