JP2020199025A - Guide wire and manufacturing method for the same - Google Patents

Guide wire and manufacturing method for the same Download PDF

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JP2020199025A
JP2020199025A JP2019107404A JP2019107404A JP2020199025A JP 2020199025 A JP2020199025 A JP 2020199025A JP 2019107404 A JP2019107404 A JP 2019107404A JP 2019107404 A JP2019107404 A JP 2019107404A JP 2020199025 A JP2020199025 A JP 2020199025A
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coil
coil portion
wire
guide wire
folded
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伊藤　悟
Satoru Ito
悟 伊藤
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Piolax Medical Devices Inc
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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

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  • Life Sciences & Earth Sciences (AREA)
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  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

To provide a guide wire and a manufacturing method for the same capable of improving the torque transmission property.SOLUTION: This guide wire 10 includes a core wire 20 and a coil member 30 fitted to an outer periphery of the core wire 20. The coil member 30 has a multi-coil structure, in which is included at least a first coil portion 40 arranged on the outer periphery of the core wire 20 and a second coil portion 50 arranged outside the first coil portion 40. The second coil portion 50 is folded back at a folding-back portion R on a one end 41 side of the first coil portion 40 to extend toward the other end 43 side of the first coil portion 40 so as to overlap the outside of the first coil portion 40. The first coil portion 40, the second coil portion 50, and the folding-back portion R are formed of the same continuous wire material W.SELECTED DRAWING: Figure 2

Description

本発明は、例えば、胆管、膵管、血管、尿管、気管等の人体の管状器官や、体腔等の人体組織の所定位置に、カテーテル等を挿入する際に用いられるガイドワイヤ、及び、その製造方法に関する。 The present invention provides, for example, a guide wire used when inserting a catheter or the like into a predetermined position of a tubular organ of the human body such as a bile duct, a pancreatic duct, a blood vessel, a ureter, or a trachea, or a human body tissue such as a body cavity, and manufacturing thereof. Regarding the method.

以前から、胆管や膵管、血管、尿管、気管等の人体の管状器官に、カテーテルを挿入して薬液を注入したり、バルーンカテーテルで閉塞した管状器官を拡径したり、或いは、ステントを留置したりすることが行われている。これらの作業の際には、まず、ガイドワイヤを管状器官に挿入して所定位置まで到達させ、その外周に沿ってカテーテルやバルーンカテーテル、ステントを保持したチューブ等を移動させている。 For some time, catheters have been inserted into tubular organs of the human body such as the bile duct, pancreatic duct, blood vessels, ureters, and trachea to inject drug solutions, the diameter of tubular organs occluded by balloon catheters has been expanded, or stents have been placed. Is being done. In these operations, first, a guide wire is inserted into a tubular organ to reach a predetermined position, and a catheter, a balloon catheter, a tube holding a stent, or the like is moved along the outer circumference thereof.

すなわち、カテーテル等に先行させて、ガイドワイヤを管状器官に挿入していくが、管状器官が分岐した分岐部では、所定の分岐管を選択する必要がある。その際には、ガイドワイヤの手元側を回転させて、そのトルクをガイドワイヤ先端まで伝達させて、ガイドワイヤ先端を所望の分岐管に向けた後、ガイドワイヤを挿入していく。そのため、ガイドワイヤ手元側からのトルクを、ガイドワイヤ先端側に伝達させるための、トルク伝達性が重要となる。 That is, the guide wire is inserted into the tubular organ in advance of the catheter or the like, but it is necessary to select a predetermined branch tube at the branch portion where the tubular organ is branched. At that time, the hand side of the guide wire is rotated, the torque is transmitted to the tip of the guide wire, the tip of the guide wire is directed to a desired branch pipe, and then the guide wire is inserted. Therefore, torque transmissibility is important for transmitting the torque from the guide wire hand side to the guide wire tip side.

このようなトルク伝達性を高めたガイドワイヤとして、例えば、下記特許文献１には、コアシャフトの先端側外周に配置された内側コイルと、該内側コイルの外周に配置された外側コイルとを有する、二重コイル構造をなした、医療用ガイドワイヤが記載されている。また、内側コイル及び外側コイルの各基端側は、ロウ付け等によりコアシャフト外周に固着されており、一方、内側コイル及び外側コイルの各先端側は、半球状をなした先端チップを介して、コアシャフト最先端に固着されている。 As a guide wire with enhanced torque transmission, for example, Patent Document 1 below includes an inner coil arranged on the outer periphery of the tip end side of the core shaft and an outer coil arranged on the outer periphery of the inner coil. , A medical guide wire having a double coil structure is described. Further, each base end side of the inner coil and the outer coil is fixed to the outer periphery of the core shaft by brazing or the like, while each tip side of the inner coil and the outer coil is interposed via a hemispherical tip. , Is fixed to the tip of the core shaft.

特許第５００４２５６号公報Japanese Patent No. 5004256

上記特許文献１の医療用ガイドワイヤでは、内側コイル及び外側コイルの先端側は、先端チップを介して連結されているが、両コイルが別体であるため、ガイドワイヤ手元側からトルクが作用した場合に、両コイルを相互に作用させにくく、トルク伝達性を高めにくい傾向にある。 In the medical guide wire of Patent Document 1, the tip side of the inner coil and the outer coil are connected via the tip tip, but since both coils are separate bodies, torque acts from the guide wire hand side. In some cases, it is difficult for both coils to interact with each other, and it tends to be difficult to improve torque transmission.

したがって、本発明の目的は、トルク伝達性を高めることができる、ガイドワイヤ及びその製造方法を提供することにある。 Therefore, an object of the present invention is to provide a guide wire and a method for manufacturing the guide wire, which can enhance torque transmissibility.

上記目的を達成するため、本発明の一つであるガイドワイヤは、芯線と、該芯線の外周に取付けられるコイル部材とを有しており、前記コイル部材は、前記芯線の外周に配置される第１コイル部と、該第１コイル部の外側に配置される第２コイル部とを少なくとも有する、多重コイル構造をなしており、前記第２コイル部は、前記第１コイル部の一端側に位置する折返し部を介して、前記第１コイル部の他端側に向けて折返されて延び、同第１コイル部の外側に重なるように配置されており、前記第１コイル部、前記第２コイル部、前記折返し部は、連続した同じ線材で形成されていることを特徴とする。 In order to achieve the above object, the guide wire, which is one of the present inventions, has a core wire and a coil member attached to the outer periphery of the core wire, and the coil member is arranged on the outer periphery of the core wire. It has a multi-coil structure having at least a first coil portion and a second coil portion arranged outside the first coil portion, and the second coil portion is located on one end side of the first coil portion. The first coil portion and the second coil portion are arranged so as to be folded and extended toward the other end side of the first coil portion and overlap the outside of the first coil portion via the positioned folded portion. The coil portion and the folded portion are characterized in that they are formed of the same continuous wire rod.

一方、本発明のもう一つは、延出部を有するガイドワイヤを製造する製造方法であって、基部及び該基部よりも縮径した縮径部を有する芯金を用い、該芯金の、前記縮径部の外周に、線材を巻き付けて前記第１コイル部を形成する第１工程と、前記線材を、前記第１コイル部の一端側で折返して前記折返し部を形成すると共に、前記第１コイル部の他端側に向けて、前記第１コイル部の外側に巻き付けて前記第２コイル部を形成する第２工程と、前記線材を、前記芯金の基部の外周に巻き付けて、前記延出部を形成する第３工程とを有することを特徴とする。 On the other hand, the other of the present invention is a manufacturing method for manufacturing a guide wire having an extending portion, in which a core metal having a base portion and a diameter-reduced portion smaller than the base portion is used, and the core metal has a diameter reduced. The first step of winding a wire around the outer periphery of the reduced diameter portion to form the first coil portion, and folding the wire rod at one end side of the first coil portion to form the folded portion, and the first step. The second step of winding the second coil portion on the outside of the first coil portion toward the other end side of the one coil portion, and winding the wire rod around the outer periphery of the base portion of the core metal to form the second coil portion. It is characterized by having a third step of forming an extension portion.

本発明によれば、第１コイル部と第２コイル部とが連続した同じ線材で形成されており、第２コイル部が折返し部を介して第１コイル部の外側に重なるように配置されているので、ガイドワイヤの先端の方向を変えるべく、ガイドワイヤの基端側（手元側）で回転させたとき（捩ったとき）のトルク伝達性を高めることができる。 According to the present invention, the first coil portion and the second coil portion are formed of the same continuous wire rod, and the second coil portion is arranged so as to overlap the outside of the first coil portion via the folded portion. Therefore, in order to change the direction of the tip of the guide wire, it is possible to improve the torque transmission when the guide wire is rotated on the base end side (hand side) (when twisted).

本発明に係るガイドワイヤの第１実施形態を示しており、その側面図である。A first embodiment of the guide wire according to the present invention is shown, and is a side view thereof. 同ガイドワイヤの断面図である。It is sectional drawing of the guide wire. 同ガイドワイヤを構成するコイル部材の他形状を示しており、（ａ）は第１他形状の側面図、（ｂ）は第２他形状の側面図である。Other shapes of the coil members constituting the guide wire are shown, (a) is a side view of the first other shape, and (b) is a side view of the second other shape. 本発明に係るガイドワイヤの製造方法の一実施形態を示しており、（ａ）は第１工程を示す説明図、（ｂ）は第２工程を示す説明図、（ｃ）は第３工程を示す説明図である。An embodiment of a method for manufacturing a guide wire according to the present invention is shown, in which (a) is an explanatory diagram showing a first step, (b) is an explanatory diagram showing a second step, and (c) is a third step. It is explanatory drawing which shows. 本発明に係るガイドワイヤの第２実施形態を示しており、その側面図である。A second embodiment of the guide wire according to the present invention is shown, and is a side view thereof. 同ガイドワイヤの断面図である。It is sectional drawing of the guide wire. 本発明に係るガイドワイヤの第３実施形態を示しており、その断面図である。A third embodiment of the guide wire according to the present invention is shown, and is a cross-sectional view thereof. 本発明に係るガイドワイヤの第４実施形態を示しており、その断面図である。A fourth embodiment of the guide wire according to the present invention is shown, and is a cross-sectional view thereof. 本発明に係るガイドワイヤの第５実施形態を示しており、その断面図である。A fifth embodiment of the guide wire according to the present invention is shown, and is a cross-sectional view thereof.

以下、図面を参照して、本発明に係るガイドワイヤの一実施形態について説明する。図１〜３には、本発明に係るガイドワイヤの第１実施形態が示されている。 Hereinafter, an embodiment of the guide wire according to the present invention will be described with reference to the drawings. 1 to 3 show a first embodiment of the guide wire according to the present invention.

図１に示すように、この実施形態のガイドワイヤ１０は、所定長さで延びる芯線２０と、この芯線２０の外周に取付けられるコイル部材３０とを有している。 As shown in FIG. 1, the guide wire 10 of this embodiment has a core wire 20 extending with a predetermined length and a coil member 30 attached to the outer periphery of the core wire 20.

前記芯線２０は、円形断面の丸線であって、一定の外径にて所定長さで伸びる基部２１と、この基部２１の先端側に設けられ、該基部２１よりも小径の先端部２３とを有している。また、先端部２３は、前記基部２１の先端から、芯線先端に向かって次第に縮径しつつ延びる、先細テーパ形状をなしている。なお、芯線２０の先端部２３の最先端を、先端２３ａ（ガイドワイヤ操作者の手元側から最も離れた遠位端）とし、基部２１の最基端を、基端２１ａ（ガイドワイヤ操作者の手元側に最も近い近位端）とする。 The core wire 20 is a round wire having a circular cross section, and has a base portion 21 extending with a predetermined outer diameter and a predetermined length, and a tip portion 23 provided on the tip end side of the base portion 21 and having a diameter smaller than that of the base portion 21. have. Further, the tip portion 23 has a tapered tapered shape extending from the tip of the base portion 21 toward the tip of the core wire while gradually reducing its diameter. The tip of the tip 23 of the core wire 20 is the tip 23a (the distal end farthest from the hand side of the guide wire operator), and the most proximal end of the base 21 is the base end 21a (the guide wire operator's). Proximal end closest to the hand side).

また、先端部２３としては、例えば、基部先端から芯線先端に向かって次第に縮径しつつ延びるテーパ部と、同テーパ部先端から一定外径で直線状に伸びる細径部とを有する形状としたり、或いは、芯線先端に向かって段階的に縮径して段状をなす形状としたりしてもよく、特に限定されない。 Further, the tip portion 23 may have, for example, a shape having a tapered portion extending from the tip of the base portion toward the tip of the core wire while gradually reducing the diameter, and a small diameter portion extending linearly from the tip of the tapered portion with a constant outer diameter. Alternatively, the diameter may be gradually reduced toward the tip of the core wire to form a stepped shape, and the shape is not particularly limited.

なお、上記芯線２０としては、例えば、Ｎｉ−Ｔｉ系合金，Ｎｉ−Ｔｉ−Ｘ（Ｘ＝Ｆｅ，Ｃｕ，Ｖ，Ｃｏ，Ｃｒ，Ｍｎ，Ｎｂ等）合金、Ｃｕ−Ｚｎ−Ｘ（Ｘ＝Ａｌ，Ｆｅ等）合金等の超弾性合金や、ステンレス、ピアノ線材などを用いることができ、或いは、Ｗ、Ｐｔ、Ｔｉ、Ｐｄ、Ｒｈ、Ａｕ、Ａｇ、Ｂｉ、Ｔａ及びこれらの合金等からなるＸ線不透過性金属を用いることもできる。 The core wire 20 includes, for example, a Ni—Ti alloy, a Ni—Ti—X (X = Fe, Cu, V, Co, Cr, Mn, Nb, etc.) alloy, or Cu—Zn—X (X = Al). , Fe, etc.) Superelastic alloys such as alloys, stainless steel, piano wire, etc. can be used, or X composed of W, Pt, Ti, Pd, Rh, Au, Ag, Bi, Ta and alloys thereof, etc. A line opaque metal can also be used.

図２に示すように、前記コイル部材３０は、芯線２０の外周に配置される第１コイル部４０と、この第１コイル部４０の外側に配置される第２コイル部５０とを少なくとも有する、多重コイル構造をなしている。この実施形態のコイル部材３０は、第１コイル部４０及び第２コイル部５０からなる、二重コイル構造をなしている。ただし、第２コイル部５０の更に外側に、一個又は複数個のコイル部を配置してもよく、特に限定はされない（三重コイル構造については、後述の第４，第５実施形態で説明する）。 As shown in FIG. 2, the coil member 30 has at least a first coil portion 40 arranged on the outer periphery of the core wire 20 and a second coil portion 50 arranged outside the first coil portion 40. It has a multi-coil structure. The coil member 30 of this embodiment has a double coil structure including a first coil portion 40 and a second coil portion 50. However, one or a plurality of coil portions may be arranged further outside the second coil portion 50, and is not particularly limited (the triple coil structure will be described in the fourth and fifth embodiments described later). ..

また、第２コイル部５０は、第１コイル部４０の一端４１側に位置する折返し部Ｒを介して、第１コイル部４０の他端４３側に向けて折返されて延び、第１コイル部４０の外側に重なるように配置されており、第１コイル部４０、第２コイル部５０、折返し部Ｒは、連続した同じ線材Ｗで形成されている。なお、第１コイル部４０と、第２コイル部５０とは、折返し部Ｒを介して折返されるので、各コイル部４０，５０における、線材Ｗの巻き方向が、互いに逆向きとなる。 Further, the second coil portion 50 is folded back toward the other end 43 side of the first coil portion 40 via the folded portion R located on the one end 41 side of the first coil portion 40, and extends toward the other end 43 side of the first coil portion 40. The first coil portion 40, the second coil portion 50, and the folded-back portion R are arranged so as to overlap the outside of the 40, and are formed of the same continuous wire rod W. Since the first coil portion 40 and the second coil portion 50 are folded back via the folded-back portion R, the winding directions of the wire rods W in the coil portions 40 and 50 are opposite to each other.

また、コイル部材３０を連続して一体形成するための線材Ｗとしては、例えば、Ｎｉ−Ｔｉ系合金，Ｎｉ−Ｔｉ−Ｘ（Ｘ＝Ｆｅ，Ｃｕ，Ｖ，Ｃｏ，Ｃｒ，Ｍｎ，Ｎｂ等）合金、Ｃｕ−Ｚｎ−Ｘ（Ｘ＝Ａｌ，Ｆｅ等）合金等の超弾性合金や、ステンレス、ピアノ線材などを用いることができ、或いは、Ｗ、Ｐｔ、Ｔｉ、Ｐｄ、Ｒｈ、Ａｕ、Ａｇ、Ｂｉ、Ｔａ及びこれらの合金等からなるＸ線不透過性金属を用いることもできる。 Further, examples of the wire rod W for continuously integrally forming the coil member 30 include a Ni—Ti alloy, Ni—Ti—X (X = Fe, Cu, V, Co, Cr, Mn, Nb, etc.). Superelastic alloys such as alloys, Cu-Zn-X (X = Al, Fe, etc.) alloys, stainless steel, piano wire, etc. can be used, or W, Pt, Ti, Pd, Rh, Au, Ag, An X-ray opaque metal composed of Bi, Ta, an alloy thereof, or the like can also be used.

図２に示すように、この実施形態における第１コイル部４０は、断面円形状の線材Ｗを巻回して形成されたものであって、芯線２０の先端部２３の外周に配置されている。なお、この実施形態での第１コイル部４０は、一端４１から他端４３に至る全長に亘って、線材Ｗどうしが密着するように巻回された密着巻き構造となっている。また、第１コイル部４０は、その一端４１が、芯線２０の先端部２３の先端２３ａ側に配置され、他端４３が、芯線２０の先端部２３の、基部２１寄りの箇所に配置されている。なお、第１コイル４０の一端４１及び他端４３を、上記の配置向きとは逆向きに配置してもよい。すなわち、第１コイル部４０の一端４１を、芯線２０の先端部２３の、基部寄りの箇所に配置し、第１コイル部４０の他端を、芯線２０の先端部２３の先端２３ａ側に配置してもよい。 As shown in FIG. 2, the first coil portion 40 in this embodiment is formed by winding a wire rod W having a circular cross section, and is arranged on the outer periphery of the tip portion 23 of the core wire 20. The first coil portion 40 in this embodiment has a close contact winding structure in which the wire rods W are wound so as to be in close contact with each other over the entire length from one end 41 to the other end 43. Further, one end 41 of the first coil portion 40 is arranged on the tip 23a side of the tip portion 23 of the core wire 20, and the other end 43 is arranged on the tip portion 23 of the core wire 20 near the base portion 21. There is. The one end 41 and the other end 43 of the first coil 40 may be arranged in the direction opposite to the above arrangement direction. That is, one end 41 of the first coil portion 40 is arranged at a position closer to the base of the tip portion 23 of the core wire 20, and the other end of the first coil portion 40 is arranged on the tip 23a side of the tip portion 23 of the core wire 20. You may.

なお、この実施形態の線材は、断面円形状となっているが、例えば、断面角形状の線材であってもよい。また、線材Ｗの線径は、０．０３〜０．１０ｍｍであることが好ましく、０．０５〜０．０８ｍｍであることがより好ましい。 The wire rod of this embodiment has a circular cross section, but may be, for example, a wire rod having a square cross section. The wire diameter of the wire rod W is preferably 0.03 to 0.10 mm, more preferably 0.05 to 0.08 mm.

更に図２に示すように、第１コイル部４０の内径は、一端４１側から他端４３側に至るまで一定径で形成されており、かつ、芯線２０の先端部２３の、先端２３ａ側の部分の外径よりも、大きくなるように形成されている。そのため、第１コイル部４０を芯線２０の先端部２３の外周に配置した状態では、第１コイル部４０の一端４１の内周と、芯線２０の先端部２３の外周との間に、所定の隙間が形成されるようになっている。 Further, as shown in FIG. 2, the inner diameter of the first coil portion 40 is formed to have a constant diameter from one end 41 side to the other end 43 side, and the tip portion 23 of the core wire 20 is on the tip 23a side. It is formed so as to be larger than the outer diameter of the portion. Therefore, in a state where the first coil portion 40 is arranged on the outer circumference of the tip portion 23 of the core wire 20, a predetermined value is provided between the inner circumference of one end 41 of the first coil portion 40 and the outer circumference of the tip portion 23 of the core wire 20. A gap is formed.

また、第１コイル部４０の外径Ｄ１は、０．１２〜０．２６ｍｍであることが好ましく、０．１６〜０．２２ｍｍであることがより好ましい。更に、第１コイル部４０の軸方向長さＬ１（一端４１から他端４３までの距離）は、２５〜１００ｍｍであることが好ましく、５０〜７５ｍｍであることがより好ましい。 The outer diameter D1 of the first coil portion 40 is preferably 0.12 to 0.26 mm, more preferably 0.16 to 0.22 mm. Further, the axial length L1 (distance from one end 41 to the other end 43) of the first coil portion 40 is preferably 25 to 100 mm, more preferably 50 to 75 mm.

一方、第２コイル部５０は、第１コイル部４０の一端４１に対して、線材Ｗを第１コイル部４０の他端４３側に向けて折返されてなる折返し部Ｒを介して延びて、第１コイル部４０の外側に重なるように配置されている。 On the other hand, the second coil portion 50 extends from one end 41 of the first coil portion 40 via a folded portion R formed by folding the wire rod W toward the other end 43 side of the first coil portion 40. It is arranged so as to overlap the outside of the first coil portion 40.

図２に示すように、前記折返し部Ｒは、一本の連続する線材Ｗで第１コイル部４０と第２コイル部５０とを一体形成するのに際し、第１コイル部４０の外側に第２コイル部５０を重ねて配置するために、不可欠な折返し部分を提供するものであって、第１コイル部４０の一端４１と、第２コイル部５０の一端５１とが含まれる構造となっている。また、この折返し部Ｒは、芯線２０の先端部２３の、先端２３ａ側に配置されている。 As shown in FIG. 2, the folded-back portion R is a second coil portion 40 outside the first coil portion 40 when the first coil portion 40 and the second coil portion 50 are integrally formed by one continuous wire rod W. It provides an indispensable folded-back portion for arranging the coil portions 50 in an overlapping manner, and has a structure including one end 41 of the first coil portion 40 and one end 51 of the second coil portion 50. .. Further, the folded-back portion R is arranged on the tip 23a side of the tip 23 of the core wire 20.

更に、第１コイル部４０の、折返し部Ｒ側の一端４１と、第２コイル部５０の、折返し部Ｒ側の一端５１とは、いずれ一方が他方に比べて軸方向に突出した構造となっている。この実施形態では、第２コイル部５０の一端５１に対して、第１コイル部４０の一端４１が、芯線２０の先端２３ａ側に向けて軸方向に突出している。また、ここでは、線材Ｗの半径程度の突出量で、第１コイル部４０の一端４１が、第２コイル部５０の一端５１に対して、芯線２０の先端２３ａ側に突出しており、第１コイル部４０と第２コイル部５０とは、半ピッチ位置ずれしたような二重コイル構造となっている。 Further, one end 41 of the first coil portion 40 on the folded-back portion R side and one end 51 of the second coil portion 50 on the folded-back portion R side have a structure in which one of them protrudes in the axial direction as compared with the other. ing. In this embodiment, one end 41 of the first coil portion 40 projects axially toward the tip 23a side of the core wire 20 with respect to one end 51 of the second coil portion 50. Further, here, one end 41 of the first coil portion 40 projects toward the tip 23a side of the core wire 20 with respect to one end 51 of the second coil portion 50 with an amount of protrusion about the radius of the wire rod W. The coil portion 40 and the second coil portion 50 have a double coil structure in which the positions are shifted by half a pitch.

なお、第１コイル部４０の一端４１に対して、第２コイル部５０の一端５１が、芯線２０の先端２３ａ側に突出してもよく、更に、第１コイル部４０の一端４１と第２コイル部５０の一端５１とを、芯線２０の軸方向で揃えて（軸方向同一箇所に）配置してもよい。 One end 51 of the second coil portion 50 may protrude toward the tip 23a side of the core wire 20 with respect to one end 41 of the first coil portion 40, and further, one end 41 of the first coil portion 40 and the second coil. One end 51 of the portion 50 may be aligned (at the same position in the axial direction) with the core wire 20 in the axial direction.

また、この実施形態においては、上述したように、第１コイル部４０と第２コイル部５０とが、半ピッチ位置ずれしたような二重コイル構造となっている関係上、図２の部分拡大図に示すように、第１コイル部４０を形成する線材Ｗ，Ｗの間に、第２コイル部５０を形成する線材Ｗの一部が入り込んで当接するようになっている。 Further, in this embodiment, as described above, since the first coil portion 40 and the second coil portion 50 have a double coil structure in which the positions of the first coil portion 40 and the second coil portion 50 are displaced by half a pitch, the partial enlargement of FIG. As shown in the figure, a part of the wire rod W forming the second coil portion 50 enters between the wire rods W and W forming the first coil portion 40 and comes into contact with each other.

更に、第２コイル部５０は、折返し部Ｒをなす一端５１から第１コイル部４０の他端４３側に向けて所定長さで延びると共に、この他端４３を超えて、芯線２０の基端２１ａに向けて延びており、第２コイル部５０のみが単独で配置されてなる延出部５５を有している。図２に示すように、この実施形態における延出部５５は、その内径Ｄ２´が、第２コイル部５０の内径と同一内径で形成されており、また、延出部５５の内径Ｄ２´は、第１コイル部４０の内径Ｄ１´よりも大きくなるように設けられている。上記のように、この実施形態におけるコイル部材３０は、第１コイル部４０よりも第２コイル部５０が長く延びた形状となっているが、第１コイル部の方が、第２コイル部よりも長く延びたり、或いは、第１コイル部及び第２コイル部が同一長さで延びていたりしても、特に限定はされない（これらについては、後述の実施形態で説明する）。 Further, the second coil portion 50 extends from one end 51 forming the folded-back portion R toward the other end 43 side of the first coil portion 40 by a predetermined length, and extends beyond the other end 43 to the base end of the core wire 20. It has an extension portion 55 extending toward 21a and in which only the second coil portion 50 is independently arranged. As shown in FIG. 2, the extension portion 55 in this embodiment has an inner diameter D2'formed by the same inner diameter as the inner diameter of the second coil portion 50, and the inner diameter D2'of the extension portion 55 is formed. , It is provided so as to be larger than the inner diameter D1'of the first coil portion 40. As described above, the coil member 30 in this embodiment has a shape in which the second coil portion 50 is longer than the first coil portion 40, but the first coil portion is larger than the second coil portion. There is no particular limitation even if the first coil portion and the second coil portion extend with the same length (these will be described in the embodiments described later).

また、芯線２０の先端２３ａと、第１コイル部４０の一端４１と、第２コイル部５０の一端５１と、両コイル部４０，５０の一端４１，５１からなる折返し部Ｒは、金属ロウや接着剤等の固着材料からなる、丸みを帯びた形状をなした頭部３５を介して、互いに固着されている。この際、折返し部Ｒをなす第１コイル部４０の一端４１の軸方向先端側、及び、第２コイル部５０の一端５１の軸方向先端側に、前記固着材料が付着する。また、第１コイル部４０の一端４１の内周と、芯線２０の先端部２３の外周との間の隙間に、頭部３５を形成する前記固着材料が入り込んで、折返し部Ｒを構成する第１コイル部４０の一端４１が、芯線２０の先端部２３の先端２３ａ寄りの箇所で固着される。すなわち、折返し部Ｒは、芯線２０に固着されている。 Further, the folded-back portion R including the tip 23a of the core wire 20, one end 41 of the first coil portion 40, one end 51 of the second coil portion 50, and one ends 41, 51 of both coil portions 40, 50 is formed of metal wax or the like. The heads 35, which are made of a fixing material such as an adhesive and have a rounded shape, are fixed to each other. At this time, the fixing material adheres to the axial tip side of one end 41 of the first coil portion 40 forming the folded-back portion R and the axial tip side of one end 51 of the second coil portion 50. Further, the fixing material forming the head portion 35 is inserted into the gap between the inner circumference of one end 41 of the first coil portion 40 and the outer circumference of the tip portion 23 of the core wire 20 to form the folded-back portion R. One end 41 of 1 coil portion 40 is fixed at a position near the tip 23a of the tip portion 23 of the core wire 20. That is, the folded-back portion R is fixed to the core wire 20.

なお、芯線２０にコイル部材３０を固着するための、上記の固着材料としては、例えば、ＳｎやＡｇロウ等のロウ材を用いることができるが、それ以外にも、例えば、紫外線硬化型のアクリレート樹脂や、シリコーン系接着剤、変性シリコーン系接着剤、エポキシ樹脂系接着剤、アクリレート系接着剤、ウレタン樹脂系接着剤等を用いることができる。 As the fixing material for fixing the coil member 30 to the core wire 20, for example, a brazing material such as Sn or Ag wax can be used, but in addition to this, for example, an ultraviolet curable acrylate can be used. Resins, silicone-based adhesives, modified silicone-based adhesives, epoxy resin-based adhesives, acrylate-based adhesives, urethane resin-based adhesives, and the like can be used.

更に、第１コイル部４０の他端４３が、芯線２０の先端部２３の、基部２１寄りの箇所に、前記の固着材料からなる固着部４５を介して固着されている。また、第２コイル部５０の他端５３側、すなわち、延出部５５の、芯線２０の他端２３ａ側に位置する他端５３側は、芯線２０の先端部２３の、基部２１寄りの箇所に、前記の固着材料からなる固着部５７を介して固着されている。このように、この実施形態におけるコイル部材３０は、複数の固着部４５，５７や、頭部３５を介して、芯線２０の外周に取付けられている。なお、コイル部材としては、両コイル部４０，５０の両端以外にも、軸方向途中の所定箇所で、芯線２０に固着してもよい。 Further, the other end 43 of the first coil portion 40 is fixed to the tip portion 23 of the core wire 20 near the base portion 21 via the fixing portion 45 made of the fixing material. Further, the other end 53 side of the second coil portion 50, that is, the other end 53 side of the extending portion 55 located on the other end 23a side of the core wire 20 is a portion of the tip portion 23 of the core wire 20 near the base portion 21. Is fixed via the fixing portion 57 made of the fixing material. As described above, the coil member 30 in this embodiment is attached to the outer periphery of the core wire 20 via a plurality of fixing portions 45, 57 and the head portion 35. The coil member may be fixed to the core wire 20 at a predetermined position in the middle of the axial direction in addition to both ends of both coil portions 40 and 50.

また、この実施形態での第２コイル部５０は、第１コイル部４０と同様に、一端５１から他端５３に至る全長に亘って、線材Ｗどうしが密着するように巻回された密着巻き構造となっている。ただし、両コイル部４０，５０は、線材Ｗ間に所定隙間を向けた疎巻きとしたり、或いは、軸方向一部を密巻きにしたり疎巻きにしたりしてもよく、特に限定はされない。 Further, in the second coil portion 50 in this embodiment, similarly to the first coil portion 40, the wire rods W are wound in close contact with each other over the entire length from one end 51 to the other end 53. It has a structure. However, both coil portions 40 and 50 may be loosely wound with a predetermined gap directed between the wire rods W, or may be tightly wound or loosely wound in a part in the axial direction, and are not particularly limited.

図３には、そのような他形状のコイル部材が図示されている。図３（ａ）のコイル部材３０Ａは、第１コイル部４０の一端４１から他端４３手前に至る範囲が、密巻き部分Ｍとなっており、この密巻き部分Ｍの他端４３寄りの端部から他端４３に至る範囲が、疎巻き部分Ｓとなっている。また、第２コイル部５０の軸方向中間部分が、密巻き部分Ｍとなっており、軸方向両端部分に疎巻き部分Ｓ，Ｓが設けられている。更に、第２コイル部５０の方が、第１コイル部４０よりも長く延びている。 FIG. 3 shows such a coil member having another shape. In the coil member 30A of FIG. 3A, the range from one end 41 of the first coil portion 40 to the front of the other end 43 is a tightly wound portion M, and the end of the tightly wound portion M near the other end 43. The range from the portion to the other end 43 is the loosely wound portion S. Further, the axially intermediate portion of the second coil portion 50 is a tightly wound portion M, and loosely wound portions S and S are provided at both end portions in the axial direction. Further, the second coil portion 50 extends longer than the first coil portion 40.

一方、図３（ｂ）のコイル部材３０Ｂは、第１コイル部４０の一端４１から他端４３手前に至る範囲が密巻き部分Ｍとなっており、密巻き部分Ｍの他端４３寄りの端部から他端４３に至る範囲が疎巻き部分となっている。また、第２コイル部５０の一端５１から他端５３手前に至る範囲が密巻き部分Ｍとなっており、密巻き部分Ｍの他端５３寄りの端部から他端５３に至る範囲が疎巻き部分Ｓとなっている。更に、第１コイル部４０の方が、第２コイル部５０よりも長く延びている。 On the other hand, in the coil member 30B of FIG. 3B, the range from one end 41 of the first coil portion 40 to the front of the other end 43 is the tightly wound portion M, and the end of the tightly wound portion M near the other end 43. The range from the portion to the other end 43 is a loosely wound portion. Further, the range from one end 51 of the second coil portion 50 to the front of the other end 53 is the tightly wound portion M, and the range from the end near the other end 53 of the tightly wound portion M to the other end 53 is loosely wound. It is a part S. Further, the first coil portion 40 extends longer than the second coil portion 50.

なお、上記のようなコイル部材３０Ａ，Ｂでは、疎巻き部分Ｓを有するので、この疎巻き部分Ｓを構成する線材Ｗ，Ｗの間に、金属ロウ等の固着材料が入り込みやすくなり、芯線２０に対するコイル部材の取付け強度を高めることができるという利点がある。 Since the coil members 30A and B as described above have the loosely wound portion S, the fixing material such as metal wax easily enters between the wire rods W and W constituting the loosely wound portion S, and the core wire 20 There is an advantage that the mounting strength of the coil member can be increased.

また、第２コイル部５０の外径Ｄ２は、０．１８〜０．４６ｍｍであることが好ましく、０．２６〜０．３８ｍｍであることがより好ましい。更に、第２コイル部５０の軸方向長さＬ２（一端５１から他端５３までの距離）は、５０〜５００ｍｍであることが好ましく、１００〜３００ｍｍであることがより好ましい。 The outer diameter D2 of the second coil portion 50 is preferably 0.18 to 0.46 mm, more preferably 0.26 to 0.38 mm. Further, the axial length L2 (distance from one end 51 to the other end 53) of the second coil portion 50 is preferably 50 to 500 mm, more preferably 100 to 300 mm.

また、コイル部材３０を構成する第１コイル部４０や第２コイル部５０に、Ｘ線不透過性のマーカーを設けてもよい。なお、このようなＸ線不透過性マーカーは、芯線２０側に設けてもよい。更に、コイル部材３０の外周に、樹脂層を被着させてもよい。なお、この樹脂層は、コイル部材３０のみならず、芯線２０も含めてガイドワイヤ全体を覆うようにしてもよい。 Further, an X-ray opaque marker may be provided on the first coil portion 40 and the second coil portion 50 constituting the coil member 30. In addition, such an X-ray opaque marker may be provided on the core wire 20 side. Further, a resin layer may be adhered to the outer periphery of the coil member 30. The resin layer may cover the entire guide wire including not only the coil member 30 but also the core wire 20.

次に、上記実施形態のガイドワイヤ（延出部５５を有するガイドワイヤ１０）を製造するための、本発明のガイドワイヤの製造方法の一実施形態について説明する。 Next, one embodiment of the guide wire manufacturing method of the present invention for manufacturing the guide wire of the above embodiment (guide wire 10 having the extending portion 55) will be described.

図４に示すように、このガイドワイヤの製造方法は、基部３及びこの基部３よりも縮径した縮径部５を有する芯金１を用い、この芯金１の、縮径部５の外周に、線材Ｗを巻き付けて第１コイル部４０を形成する第１工程（図４（ａ）参照）と、線材Ｗを、第１コイル部４０の一端４１側で折返して折返し部Ｒを形成すると共に、第１コイル部４０の他端４３側に向けて、第１コイル部４０の外側に巻き付けて第２コイル部５０を形成する第２工程（図４（ｂ）参照）と、線材Ｗを、芯金１の基部３の外周に巻き付けて、延出部５５を形成する第３工程（図４（ｃ）参照）とを有するものである。 As shown in FIG. 4, the method for manufacturing the guide wire uses a core metal 1 having a base portion 3 and a reduced diameter portion 5 having a diameter smaller than that of the base portion 3, and the outer circumference of the reduced diameter portion 5 of the core metal 1. In the first step (see FIG. 4A) in which the wire W is wound around the wire W to form the first coil portion 40, the wire W is folded back at one end 41 side of the first coil portion 40 to form the folded portion R. At the same time, the second step (see FIG. 4B) of winding the wire W around the outside of the first coil 40 toward the other end 43 side of the first coil 40 to form the second coil 50, and the wire W are It has a third step (see FIG. 4C) of winding the core metal 1 around the outer periphery of the base portion 3 to form the extending portion 55.

より具体的に説明すると、この製造方法における芯金１は、一定外径で延びる基部３と、該基部３の一端側から延出し、基部３よりも小径の一定外径で延びる縮径部５とを有している。なお、この実施形態では、第１コイル部４０を形成する線材Ｗ，Ｗの間に、第２コイル部５０を形成する線材Ｗの一部が入り込んで当接する関係上（図２の部分拡大図参照）、基部３の外径は、縮径部５の外周に巻き付けた線材Ｗの外径よりも、やや小さい外径（第２コイル部５０を形成した状態の線材Ｗの内径に適合する外径）で形成されている（図４（ｂ）参照）。 More specifically, the core metal 1 in this manufacturing method has a base portion 3 extending with a constant outer diameter and a reduced diameter portion 5 extending from one end side of the base portion 3 and extending with a constant outer diameter smaller than the base portion 3. And have. In this embodiment, a part of the wire rod W forming the second coil portion 50 enters between the wire rods W and W forming the first coil portion 40 and comes into contact with each other (partially enlarged view of FIG. 2). (Refer to), the outer diameter of the base 3 is slightly smaller than the outer diameter of the wire W wound around the outer diameter of the reduced diameter portion 5 (outer diameter matching the inner diameter of the wire W in the state where the second coil portion 50 is formed). (Diameter) (see FIG. 4 (b)).

そして、図４（ａ）の矢印Ｆ１に示すように、線材Ｗを、縮径部５の他端５ｂ側から一端５ａ側に向けて巻き付けていき、芯金１の縮径部５の一端５ａまで巻き付けることで、第１コイル部４０が形成される（以上、第１工程）。 Then, as shown by the arrow F1 in FIG. 4A, the wire rod W is wound from the other end 5b side of the reduced diameter portion 5 toward one end 5a side, and one end 5a of the reduced diameter portion 5 of the core metal 1 is wound. The first coil portion 40 is formed by winding up to (the above is the first step).

その後、線材Ｗを、第１コイル部４０の一端４１側で折返して、図４の矢印Ｆ２に示すように、第１コイル部４０の他端４３側に向けて、第１コイル部４０の外側に巻き付けていく。すると、第１コイル部４０の外側に、第２コイル部５０が隙間なく重なり、二重コイル状をなしていく。更に線材Ｗを、芯金１の縮径部５の他端５ｂに至るまで巻き付けることで、第２コイル部５０の、延出部５５を除く部分が形成される（以上、第２工程）。 After that, the wire rod W is folded back at one end 41 side of the first coil portion 40, and as shown by an arrow F2 in FIG. 4, the outside of the first coil portion 40 is directed toward the other end 43 side of the first coil portion 40. I will wrap it around. Then, the second coil portion 50 overlaps the outside of the first coil portion 40 without a gap, forming a double coil shape. Further, by winding the wire rod W up to the other end 5b of the reduced diameter portion 5 of the core metal 1, a portion of the second coil portion 50 excluding the extending portion 55 is formed (the above is the second step).

その後、線材Ｗを、芯金１の基部３の外周に巻き付けて、芯金１の基部３の他端３ａに至るまで巻き付けることで、第１コイル部４０の他端４３を超えて延びる、延出部５５が形成される（以上、第３工程）。 After that, the wire rod W is wound around the outer periphery of the base portion 3 of the core metal 1 and wound up to the other end 3a of the base portion 3 of the core metal 1, so that the wire rod W extends beyond the other end 43 of the first coil portion 40. The protrusion 55 is formed (the above is the third step).

上記第１〜第３工程後、コイル部材３０から芯金１を引き抜き、同コイル部材３０を、芯線２０の先端部２３の外周に配置して、上述したように、複数の固着部４５，５７や、頭部３５を介して、芯線２０の外周に取付けることで、図１や図２に示すようなガイドワイヤ１０を製造することができる。 After the first to third steps, the core metal 1 is pulled out from the coil member 30, and the coil member 30 is arranged on the outer periphery of the tip portion 23 of the core wire 20, and as described above, a plurality of fixing portions 45, 57. Alternatively, the guide wire 10 as shown in FIGS. 1 and 2 can be manufactured by attaching it to the outer periphery of the core wire 20 via the head 35.

このように、このガイドワイヤの製造方法においては、上記の第１工程、第２工程、第３工程とを有するので、一本の線材Ｗでもって、第１コイル部４０、折返し部Ｒ、第２コイル部５０を連続して一体形成することができると共に、第２コイル部５０に、第１コイル部４０の内径Ｄ１´よりも大きい内径Ｄ２´を有する延出部５５を設けることができる。 As described above, since the guide wire manufacturing method includes the above-mentioned first step, second step, and third step, the first coil portion 40, the folded portion R, and the first wire rod W are used together. The two coil portions 50 can be continuously integrally formed, and the second coil portion 50 can be provided with an extension portion 55 having an inner diameter D2'larger than the inner diameter D1'of the first coil portion 40.

次に、上記構造からなる本発明のガイドワイヤの使用方法等について説明する。 Next, a method of using the guide wire of the present invention having the above structure and the like will be described.

この実施形態におけるガイドワイヤ１０は、例えば、血管や、胆管、膵管、尿管、気管等の各種の管状器官や、体腔等の人体組織の所定位置に、カテーテルを配置したりステントを留置したりする際に用いることができ、使用箇所については特に限定されない。 The guide wire 10 in this embodiment can be used to place a catheter or a stent at a predetermined position in a blood vessel, various tubular organs such as a bile duct, a pancreatic duct, a ureter, a trachea, or a human body tissue such as a body cavity. It can be used when performing, and the place of use is not particularly limited.

使用に際しては、ガイドワイヤ１０を先端側（コイル部材３０側）から、管状器官内に挿入していき、所望の箇所に至るまで押し込んでいく。その際、管状器官の分岐部において、所望の分岐管を選択することがある。この場合には、分岐部において、ガイドワイヤ１０の基端側（手元側）で回転させて、所望の分岐管を選択する。 At the time of use, the guide wire 10 is inserted into the tubular organ from the tip side (coil member 30 side) and pushed in until it reaches a desired position. At that time, a desired bifurcation tube may be selected at the bifurcation of the tubular organ. In this case, at the branch portion, the guide wire 10 is rotated on the base end side (hand side) to select a desired branch pipe.

このとき、このガイドワイヤ１０においては、図２に示すように、第１コイル部４０と第２コイル部５０とが連続した同じ線材Ｗで形成されており、第２コイル部５０が折返し部Ｒを介して第１コイル部４０の外側に重なるように配置されているので、ガイドワイヤ１０の先端の方向を変えるべく、ガイドワイヤ１０の基端側で回転させたとき（捩ったとき）のトルク伝達性を高めることができる。すなわち、芯線２０の基端２１ａ側に付与されたトルクは、芯線２０の外周の第１コイル部４０や、折返し部Ｒ、第２コイル部５０に伝達されるが、第１コイル部４０、第２コイル部５０、折返し部Ｒは、一本の線材Ｗで連続して一体形成されているため、折返し部が別体の構造と比べて、芯線基端側からのトルクを、両コイル部４０，５０にスムーズに伝達させて、両コイル部４０，５０を相互に作用させやすくなり、その結果、トルク伝達性を高めることができる。 At this time, in the guide wire 10, as shown in FIG. 2, the first coil portion 40 and the second coil portion 50 are formed of the same continuous wire W, and the second coil portion 50 is a folded portion R. Since it is arranged so as to overlap the outside of the first coil portion 40 via the above, when it is rotated (twisted) on the base end side of the guide wire 10 in order to change the direction of the tip of the guide wire 10. Torque transmission can be improved. That is, the torque applied to the base end 21a side of the core wire 20 is transmitted to the first coil portion 40, the folded-back portion R, and the second coil portion 50 on the outer periphery of the core wire 20, but the first coil portion 40 and the second coil portion 50. Since the two coil portions 50 and the folded-back portion R are continuously and integrally formed by one wire rod W, the torque from the core wire base end side can be increased by the two coil portions 40 as compared with the structure in which the folded-back portion is a separate body. , 50 can be smoothly transmitted, and both coil portions 40, 50 can easily interact with each other, and as a result, torque transmission can be improved.

なお、上記の特許文献１の医療用ガイドワイヤのように、互いに別体とされた内側コイルと外側コイルとが、ロウ付けを介してコアシャフトに固着されている場合には、内側コイルと外側コイルとの、ロウ付けが不十分であったり不良であったりした場合には、トルク伝達性が低下するおそれがある。これに対して、このガイドワイヤ１０では、上述したように、両コイル部４０，５０が折返し部Ｒを介して一体形成されているので、両コイル部４０，５０どうしのロウ付け等がそもそも不要となり、それによるトルク伝達性の低下を確実に防止することができる。 When the inner coil and the outer coil, which are separated from each other, are fixed to the core shaft via brazing as in the medical guide wire of Patent Document 1, the inner coil and the outer coil are separated from each other. If brazing with the coil is insufficient or defective, torque transmission may decrease. On the other hand, in the guide wire 10, since both coil portions 40 and 50 are integrally formed via the folded-back portion R as described above, brazing of both coil portions 40 and 50 is unnecessary in the first place. Therefore, it is possible to reliably prevent a decrease in torque transmissibility due to this.

また、この実施形態においては、図２に示すように、折返し部Ｒは、芯線２０に固着された構造となっている（ここでは、第１コイル部４０の一端４１の内周と、芯線２０の先端部２３の外周との間の隙間に、頭部３５を形成する固着材料が入り込み、折返し部Ｒを構成する第１コイル部４０の一端４１及び第２コイル部５０の一端５１が、芯線２０に固着されるようになっている）。そのため、ガイドワイヤ１０を回転させたときの、芯線２０からのトルクが、折返し部Ｒに直接伝達されるので、トルク伝達性をより高めることができる。 Further, in this embodiment, as shown in FIG. 2, the folded-back portion R has a structure fixed to the core wire 20 (here, the inner circumference of one end 41 of the first coil portion 40 and the core wire 20). The fixing material forming the head 35 enters the gap between the tip portion 23 and the outer periphery of the tip portion 23, and one end 41 of the first coil portion 40 and one end 51 of the second coil portion 50 constituting the folded-back portion R are core wires. It is designed to be fixed to 20). Therefore, the torque from the core wire 20 when the guide wire 10 is rotated is directly transmitted to the folded-back portion R, so that the torque transmission property can be further improved.

更にこの実施形態においては、図２に示すように、折返し部Ｒは、芯線２０の先端２３ａ側に配置されている。そのため、ガイドワイヤ１０を基端側で回転させたときのトルクを、芯線２０の基端２１ａ側から先端２３ａ側に至るまで、伝達させやすくすることができ、トルク伝達性をより一層高めることができる。 Further, in this embodiment, as shown in FIG. 2, the folded-back portion R is arranged on the tip 23a side of the core wire 20. Therefore, the torque when the guide wire 10 is rotated on the base end side can be easily transmitted from the base end 21a side to the tip end 23a side of the core wire 20, and the torque transmission property can be further improved. it can.

また、この実施形態においては、図２に示すように、第１コイル部４０の、折返し部Ｒ側の一端４１と、第２コイル部５０の、折返し部Ｒ側の一端５１とは、いずれ一方が他方に比べて軸方向に突出した構造となっている。すなわち、第１コイル部４０の、折返し部Ｒ側の一端４１と、第２コイル部５０の、折返し部Ｒ側の一端５１とが軸方向にずれる構成となるので、芯線２０の外周にコイル部材３０を取付けるべく、折返し部Ｒに、例えば、金属ロウや接着剤等の固着剤を付着する際に、それらを付着させやすくすることができ、芯線２０に対するコイル部材３０の取付け強度を高めることでき、芯線２０に対してコイル部材３０を位置ずれしにくくすることができる。 Further, in this embodiment, as shown in FIG. 2, one end 41 of the first coil portion 40 on the folded portion R side and one end 51 of the second coil portion 50 on the folded portion R side are either one. Has a structure that protrudes in the axial direction compared to the other. That is, since one end 41 of the first coil portion 40 on the folded-back portion R side and one end 51 of the second coil portion 50 on the folded-back portion R side are displaced in the axial direction, the coil member is formed on the outer periphery of the core wire 20. When attaching a fixing agent such as a metal wax or an adhesive to the folded-back portion R in order to attach the 30, it is possible to easily attach them, and it is possible to increase the attachment strength of the coil member 30 to the core wire 20. , The coil member 30 can be prevented from being displaced with respect to the core wire 20.

更にこの実施形態においては、第２コイル部５０は、第１コイル部４０の他端４３を超えて延び、第２コイル部５０のみが単独で配置されてなる延出部５５を有しており、この延出部５５の内径Ｄ２´は、第１コイル部４０の内径Ｄ１´よりも大きくなるように設けられている（図２参照）。そのため、コイル部材３０について、その基端側から先端側に向けて、剛性を比較的滑らかに変化させて、キンクしにくくさせることができると共に、コイル部材３０と芯線２０との間に段差を生じにくくさせることができるため、ガイドワイヤ１０の表面を滑らかに形成することができ、各種の管状器官や体腔等へスムーズに挿入することができる。 Further, in this embodiment, the second coil portion 50 has an extension portion 55 extending beyond the other end 43 of the first coil portion 40 and in which only the second coil portion 50 is independently arranged. The inner diameter D2'of the extending portion 55 is provided so as to be larger than the inner diameter D1'of the first coil portion 40 (see FIG. 2). Therefore, the rigidity of the coil member 30 can be changed relatively smoothly from the base end side to the tip end side to make it difficult to kink, and a step is generated between the coil member 30 and the core wire 20. Since it can be made difficult, the surface of the guide wire 10 can be formed smoothly, and it can be smoothly inserted into various tubular organs, body cavities, and the like.

図５及び図６には、本発明に係るガイドワイヤの第２実施形態が示されている。なお、前記実施形態と実質的に同一部分には同符号を付してその説明を省略する。 5 and 6 show a second embodiment of the guide wire according to the present invention. The same parts as those in the above embodiment are designated by the same reference numerals, and the description thereof will be omitted.

図５及び図６に示すように、この第２実施形態のガイドワイヤ１０Ａは、第１実施形態のガイドワイヤ１０と同様に、第１コイル部４０及び第２コイル部５０からなる二重コイル構造をなしているが、芯線２０の外周に配置される第１コイル部４０の他端４３が、その外側に重なって配置される第２コイル部５０の他端５３よりも長く延びた形状となっている。なお、図６に示すように、第２コイル部５０の他端５３と、第１コイル部４０の軸方向途中部分が、芯線２０の先端部２３の軸方向途中において、前記固着材料からなる固着部４５を介して互いに固着されている。このような構成のガイドワイヤ１０Ａにおいても、上記第１実施形態のガイドワイヤ１０と同様の作用効果を得ることができる。 As shown in FIGS. 5 and 6, the guide wire 10A of the second embodiment has a double coil structure including a first coil portion 40 and a second coil portion 50, similarly to the guide wire 10 of the first embodiment. However, the other end 43 of the first coil portion 40 arranged on the outer periphery of the core wire 20 has a shape extending longer than the other end 53 of the second coil portion 50 arranged so as to overlap the outside thereof. ing. As shown in FIG. 6, the other end 53 of the second coil portion 50 and the axially intermediate portion of the first coil portion 40 are fixed by the adhesive material in the axially intermediate portion of the tip portion 23 of the core wire 20. They are fixed to each other via the portion 45. Even with the guide wire 10A having such a configuration, the same effect as that of the guide wire 10 of the first embodiment can be obtained.

図７には、本発明に係るガイドワイヤの第３実施形態が示されている。なお、前記実施形態と実質的に同一部分には同符号を付してその説明を省略する。 FIG. 7 shows a third embodiment of the guide wire according to the present invention. The same parts as those in the above embodiment are designated by the same reference numerals, and the description thereof will be omitted.

図７に示すように、この第３実施形態のガイドワイヤ１０Ｂは、第１実施形態のガイドワイヤ１０のコイル部材先端側に、更に別のコイルが連設された構造をなしている。 As shown in FIG. 7, the guide wire 10B of the third embodiment has a structure in which another coil is continuously provided on the tip end side of the coil member of the guide wire 10 of the first embodiment.

すなわち、このガイドワイヤ１０Ｂは、第１コイル部４０及び第２コイル部５０からなる二重コイル構造をなしたコイル部材３０を有すると共に、芯線２０の先端部２３の、コイル部材３０よりも先端２３ａ側には、コイル部材３０を構成する線材Ｗよりも大径の線材Ｗ´で密巻きしてなり、コイル部材３０とは別体とされたコイル部材３７が配置されている。このコイル部材３７の一端３７ａが、前記固着材料からなる頭部３５を介して芯線２０の先端２３ａに固着されている。また、コイル部材３７の他端３７ｂは、コイル部材３０の第２コイル部５０の一端５１に当接しており、このコイル部材３７の他端３７ｂと、第１コイル部４０の一端４１と、第２コイル部５０の一端５１とが、芯線２０の先端部２３の軸方向途中において、前記固着材料からなる固着部４７を互いに介して固着されている。 That is, the guide wire 10B has a coil member 30 having a double coil structure including a first coil portion 40 and a second coil portion 50, and the tip portion 23 of the core wire 20 has a tip 23a rather than the coil member 30. On the side, a coil member 37 which is tightly wound with a wire W'having a diameter larger than that of the wire W constituting the coil member 30 and is separate from the coil member 30 is arranged. One end 37a of the coil member 37 is fixed to the tip 23a of the core wire 20 via a head 35 made of the fixing material. Further, the other end 37b of the coil member 37 is in contact with one end 51 of the second coil portion 50 of the coil member 30, and the other end 37b of the coil member 37, one end 41 of the first coil portion 40, and the first one. One end 51 of the two coil portions 50 is fixed to each other via a fixing portion 47 made of the fixing material in the middle of the tip portion 23 of the core wire 20 in the axial direction.

このような構成のガイドワイヤ１０Ｂにおいても、上記第１実施形態のガイドワイヤ１０と同様の作用効果を得ることができる。また、コイル部材３０に加えて、別体のコイル部材３７を有するので、コイル部材全体の軸方向長さを延長することができる。 Even with the guide wire 10B having such a configuration, the same effect as that of the guide wire 10 of the first embodiment can be obtained. Further, since the coil member 37 is separately provided in addition to the coil member 30, the axial length of the entire coil member can be extended.

図８には、本発明に係るガイドワイヤの第４実施形態が示されている。なお、前記実施形態と実質的に同一部分には同符号を付してその説明を省略する。 FIG. 8 shows a fourth embodiment of the guide wire according to the present invention. The same parts as those in the above embodiment are designated by the same reference numerals, and the description thereof will be omitted.

図８に示すように、この第４実施形態のガイドワイヤ１０Ｃは、コイル部材３０の構造が前記第１〜第３実施形態と異なっている。すなわち、この第４実施形態におけるコイル部材３０は、芯線２０の外周に配置される第１コイル部４０と、この第１コイル部４０の外側に配置される第２コイル部５０と、第２コイル部５０の外側に配置される第３コイル部６０とからなる、三重コイル構造となっている。 As shown in FIG. 8, in the guide wire 10C of the fourth embodiment, the structure of the coil member 30 is different from that of the first to third embodiments. That is, the coil member 30 in the fourth embodiment has a first coil portion 40 arranged on the outer periphery of the core wire 20, a second coil portion 50 arranged outside the first coil portion 40, and a second coil. It has a triple coil structure including a third coil portion 60 arranged outside the portion 50.

また、第１コイル部４０の一端４１及び第２コイル部５０の一端５１側に折返し部Ｒが位置すると共に、第２コイル部５０の他端５３及び第３コイル部６０の他端６３側にも折返し部Ｒが位置している。すなわち、第２コイル部５０は、第１コイル部４０の一端４１側に位置する折返し部Ｒを介して、第１コイル部４０の他端４３側に向けて折返されて延びて、第１コイル部４０の外側に重なるように配置されると共に、第３コイル部６０は、第２コイル部５０の他端５３側に位置する折返し部Ｒを介して、第２コイル部５０の一端５１側に向けて折返されて延びて、第２コイル部５０の外側に重なるように配置されており、第１コイル部４０、第２コイル部５０、第３コイル部６０、及び、２箇所の折返し部Ｒ，Ｒは、連続した同じ線材Ｗで形成されている。また、図８に示すように、芯線２０の外周に配置される第１コイル部４０の他端４３は、第２コイル部５０の他端５３や、第３コイル部５０の他端６３よりも長く延びた形状となっている。更に、第１コイル部４０の軸方向途中部分と、第２コイル部５０の他端５３と、第３コイル部６０の他端６３とが、芯線２０の先端部２３の軸方向途中において、前記固着材料からなる固着部４５を介して互いに固着されている。 Further, the folded-back portion R is located on the one end 41 side of the first coil portion 40 and the one end 51 side of the second coil portion 50, and on the other end 53 side of the second coil portion 50 and the other end 63 side of the third coil portion 60. The folding part R is also located. That is, the second coil portion 50 is folded back and extends toward the other end 43 side of the first coil portion 40 via the folded portion R located on the one end 41 side of the first coil portion 40, and the first coil portion 50 extends. The third coil portion 60 is arranged so as to overlap the outside of the portion 40, and the third coil portion 60 is placed on one end 51 side of the second coil portion 50 via a folded-back portion R located on the other end 53 side of the second coil portion 50. It is arranged so as to be folded back toward and extended so as to overlap the outside of the second coil portion 50, and the first coil portion 40, the second coil portion 50, the third coil portion 60, and the two folded portions R. , R are formed of the same continuous wire W. Further, as shown in FIG. 8, the other end 43 of the first coil portion 40 arranged on the outer periphery of the core wire 20 is larger than the other end 53 of the second coil portion 50 and the other end 63 of the third coil portion 50. It has a long elongated shape. Further, the axially intermediate portion of the first coil portion 40, the other end 53 of the second coil portion 50, and the other end 63 of the third coil portion 60 are located in the middle of the tip portion 23 of the core wire 20 in the axial direction. They are fixed to each other via a fixing portion 45 made of a fixing material.

このような構成のガイドワイヤ１０Ｃにおいても、上記第１実施形態のガイドワイヤ１０と同様の作用効果を得ることができる。また、コイル部材３０が三重コイル構造をなしているので、ガイドワイヤ１０Ｃの基端側を回転させたときのトルクを、２つの折返し部Ｒを介して、３つのコイル部４０，５０，６０に相互に作用させやすくして、トルク伝達性をより高めることができる。 Even with the guide wire 10C having such a configuration, the same effect as that of the guide wire 10 of the first embodiment can be obtained. Further, since the coil member 30 has a triple coil structure, the torque when the base end side of the guide wire 10C is rotated is applied to the three coil portions 40, 50, 60 via the two folding portions R. The torque transmission can be further enhanced by facilitating the interaction.

図９には、本発明に係るガイドワイヤの第５実施形態が示されている。なお、前記実施形態と実質的に同一部分には同符号を付してその説明を省略する。 FIG. 9 shows a fifth embodiment of the guide wire according to the present invention. The same parts as those in the above embodiment are designated by the same reference numerals, and the description thereof will be omitted.

図９に示すように、この第５実施形態のガイドワイヤ１０Ｄは、前記第４実施形態と同様に、第１コイル部４０、第２コイル部５０、第３コイル部６０からなる、三重コイル構造をなしたコイル部材３０を有している。また、第１コイル部４０の他端４３と、第２コイル部５０の他端５３と、第３コイル部６０の他端６３とが、ほぼ同じ位置となるように各コイル部４０，５０，６０がほぼ同じ長さで延びており、これらの他端４３，５３，６３が、前記固着材料からなる固着部４５を介して互いに固着されている。このような構成のガイドワイヤ１０Ｄでは、上記第１実施形態のガイドワイヤ１０と同様の作用効果を得ることができると共に、第４実施形態と同様に、コイル部材３０が三重コイル構造をなしているので、そのトルク伝達性をより高めることができる。 As shown in FIG. 9, the guide wire 10D of the fifth embodiment has a triple coil structure including a first coil portion 40, a second coil portion 50, and a third coil portion 60, as in the fourth embodiment. It has a coil member 30 made of the above. Further, the coil portions 40, 50, respectively, so that the other end 43 of the first coil portion 40, the other end 53 of the second coil portion 50, and the other end 63 of the third coil portion 60 are at substantially the same positions. 60 extends with substantially the same length, and the other ends 43, 53, 63 of these are fixed to each other via a fixing portion 45 made of the fixing material. In the guide wire 10D having such a configuration, the same action and effect as the guide wire 10 of the first embodiment can be obtained, and the coil member 30 has a triple coil structure as in the fourth embodiment. Therefore, the torque transmissibility can be further enhanced.

なお、本発明は、上述した実施形態に限定されるものではなく、本発明の要旨の範囲内で、各種の変形実施形態が可能であり、そのような実施形態も本発明の範囲に含まれる。 The present invention is not limited to the above-described embodiments, and various modified embodiments are possible within the scope of the gist of the present invention, and such embodiments are also included in the scope of the present invention. ..

１ 芯金
３ 基部
５ 縮径部
１０，１０Ａ，１０Ｂ，１０Ｃ，１０Ｄ ガイドワイヤ
２０ 芯線
２１ 基部
２３ 先端部
３０，３０Ａ，３０Ｂ コイル部材
３５ 頭部
４０ 第２コイル部
４１ 一端
４３ 他端
５０ 第２コイル部
５１ 一端
５１ 他端
５５ 延出部
Ｒ 折返し部 1 Core metal 3 Base 5 Reduced diameter parts 10, 10A, 10B, 10C, 10D Guide wire 20 Core wire 21 Base part 23 Tip part 30, 30A, 30B Coil member 35 Head 40 Second coil part 41 One end 43 One end 50 Second Coil part 51 One end 51 One end 55 Extension part R Folded part

Claims (6)

芯線と、該芯線の外周に取付けられるコイル部材とを有しており、
前記コイル部材は、前記芯線の外周に配置される第１コイル部と、該第１コイル部の外側に配置される第２コイル部とを少なくとも有する、多重コイル構造をなしており、
前記第２コイル部は、前記第１コイル部の一端側に位置する折返し部を介して、前記第１コイル部の他端側に向けて折返されて延び、同第１コイル部の外側に重なるように配置されており、前記第１コイル部、前記第２コイル部、前記折返し部は、連続した同じ線材で形成されていることを特徴とするガイドワイヤ。 It has a core wire and a coil member attached to the outer circumference of the core wire.
The coil member has a multi-coil structure having at least a first coil portion arranged on the outer periphery of the core wire and a second coil portion arranged on the outside of the first coil portion.
The second coil portion is folded back and extends toward the other end side of the first coil portion via a folded portion located on one end side of the first coil portion, and overlaps the outside of the first coil portion. The guide wire is arranged so as to be such that the first coil portion, the second coil portion, and the folded portion are formed of the same continuous wire rod. 前記折返し部は、前記芯線に固着されている請求項１記載のガイドワイヤ。 The guide wire according to claim 1, wherein the folded portion is fixed to the core wire. 前記折返し部は、前記芯線の先端側に配置されている請求項１又は２記載のガイドワイヤ。 The guide wire according to claim 1 or 2, wherein the folded portion is arranged on the tip end side of the core wire. 前記第１コイル部の一端と、前記第２コイル部の一端とは、いずれか一方が他方に対して軸方向に突出している、請求項１〜３のいずれか１つに記載のガイドワイヤ。 The guide wire according to any one of claims 1 to 3, wherein one end of the first coil portion and one end of the second coil portion protrude in the axial direction with respect to the other. 前記第２コイル部は、前記第１コイル部の他端を超えて延び、同第２コイル部のみが単独で配置される延出部を有しており、該延出部の内径は、前記第１コイル部の内径よりも大きくなるように設けられている請求項１〜４のいずれか１つに記載のガイドワイヤ。 The second coil portion extends beyond the other end of the first coil portion, and has an extension portion in which only the second coil portion is independently arranged, and the inner diameter of the extension portion is the above-mentioned. The guide wire according to any one of claims 1 to 4, which is provided so as to be larger than the inner diameter of the first coil portion. 前記請求項５に記載のガイドワイヤの製造方法であって、
基部及び該基部よりも縮径した縮径部を有する芯金を用い、
該芯金の、前記縮径部の外周に、線材を巻き付けて前記第１コイル部を形成する第１工程と、
前記線材を、前記第１コイル部の一端側で折返して前記折返し部を形成すると共に、前記第１コイル部の他端側に向けて、前記第１コイル部の外側に巻き付けて前記第２コイル部を形成する第２工程と、
前記線材を、前記芯金の基部の外周に巻き付けて、前記延出部を形成する第３工程とを有することを特徴とするガイドワイヤの製造方法。 The method for manufacturing a guide wire according to claim 5.
Using a core metal having a base portion and a diameter-reduced portion smaller than the base portion,
A first step of winding a wire rod around the outer circumference of the reduced diameter portion of the core metal to form the first coil portion.
The wire rod is folded back at one end side of the first coil portion to form the folded portion, and is wound around the outside of the first coil portion toward the other end side of the first coil portion to form the second coil portion. The second step of forming the part and
A method for manufacturing a guide wire, which comprises a third step of winding the wire rod around the outer periphery of a base portion of the core metal to form the extending portion.
JP2019107404A 2019-06-07 2019-06-07 Guide wire and manufacturing method for the same Pending JP2020199025A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012070853A (en) * 2010-09-28 2012-04-12 Asahi Intecc Co Ltd Guide wire
WO2017149843A1 (en) * 2016-02-29 2017-09-08 テルモ株式会社 Guide wire
US20180339139A1 (en) * 2015-11-18 2018-11-29 Heraeus Deutschland GmbH & Co. KG Torque coil and method

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012070853A (en) * 2010-09-28 2012-04-12 Asahi Intecc Co Ltd Guide wire
US20180339139A1 (en) * 2015-11-18 2018-11-29 Heraeus Deutschland GmbH & Co. KG Torque coil and method
WO2017149843A1 (en) * 2016-02-29 2017-09-08 テルモ株式会社 Guide wire

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