JP2016064068A

JP2016064068A - Guide wire

Info

Publication number: JP2016064068A
Application number: JP2014195744A
Authority: JP
Inventors: 豊田野; Yutaka Tano; 泰直大谷; Yasunao Otani
Original assignee: Terumo Corp
Current assignee: Terumo Corp
Priority date: 2014-09-25
Filing date: 2014-09-25
Publication date: 2016-04-28

Abstract

PROBLEM TO BE SOLVED: To provide a guide wire having excellent vessel followability and entry property into narrowed and occluded vessels.SOLUTION: A guide wire 1 includes a core part 2A composed of a long object having flexibility. The core part 2A includes, in order from a proximal end to a distal end: a body part 3 having a circular cross section; a flat plate part 5; and a distal end part 7 coaxially formed with the body part 3 and having a circular cross section. The guide wire 1 includes: a coil part 8 that is installed to cover the distal side of the core part 2A and is formed by spirally forming strands; and a fixing part 92 for fixing the distal end 7 to the coil part 8. Further, the guide wire 1 includes a resin coating part formed to cover the distal side of the core part 2A.SELECTED DRAWING: Figure 1

Description

本発明は、体腔内、特に血管内にカテーテルを誘導する際に使用されるガイドワイヤに関する。 The present invention relates to a guide wire for use in guiding a catheter into a body cavity, particularly into a blood vessel.

ガイドワイヤは、例えばＰＴＣＡ（Percutaneous Transluminal Coronary Angioplasty：経皮的冠状動脈血管形成術）のような外科的手術が困難な部位の治療、人体への低侵襲を目的とした治療、または、心臓血管造影などの検査に用いられるカテーテルを血管内に誘導する際に使用される。ＰＴＣＡは、冠状動脈の狭窄部位をバルーン等で拡張して、血液流路を確保する治療方法である。 The guide wire can be used for treatment of a site where surgical operation is difficult, such as PTCA (Percutaneous Transluminal Coronary Angioplasty), treatment for minimally invasive human body, or cardiac angiography. It is used when guiding a catheter used for examinations into the blood vessel. PTCA is a treatment method for securing a blood flow path by dilating a stenotic site of a coronary artery with a balloon or the like.

ＰＴＣＡでは、ガイドワイヤの先端部をバルーンカテーテルの先端部より突出させた状態で、ガイドワイヤを血管の狭窄部位付近まで挿入することによって、バルーンカテーテルを狭窄部位に誘導する。その際、ガイドワイヤは、蛇行または分岐した血管、狭窄した血管等を選択し、通過する必要があり、また、狭窄部位では、狭窄部位を構成するコレステロール等の堆積物をガイドワイヤの押し込み力によって押し広げる、または、貫通させる必要がある。したがって、ＰＴＣＡに用いられるガイドワイヤには、血管形状に追従でき、血管壁を傷つけないために、優れた柔軟性（血管追従性）が要求されると共に、手元部（基端部）の回転操作により先端部を狭窄および閉塞した血管に容易に進入させることが可能な優れたエントリー性が要求される。 In PTCA, the balloon catheter is guided to the stenosis site by inserting the guide wire to the vicinity of the stenosis site of the blood vessel with the tip of the guide wire protruding from the tip of the balloon catheter. At that time, it is necessary to select a meandering or branched blood vessel, a narrowed blood vessel, or the like for the guide wire, and in the stenotic site, the deposit such as cholesterol constituting the stenotic site is pushed by the pushing force of the guide wire. It is necessary to spread or penetrate. Therefore, the guide wire used for PTCA is required to have excellent flexibility (blood vessel followability) in order to follow the blood vessel shape and not damage the blood vessel wall, and to rotate the proximal portion (base end portion). Therefore, an excellent entry property capable of easily entering a blood vessel whose tip is narrowed and occluded is required.

また、ＰＴＣＡでは、ガイドワイヤを屈曲、分岐した血管へ追従させるために、ガイドワイヤを血管内に挿入する前に、先端形状付けが行われることがある。具体的には、ガイドワイヤの先端部を分岐血管等の形状に合わせて医師等が手指で所定の形状（例えば、Ｊ型）に曲げて形状付けを行う。したがって、ガイドワイヤには、前記のような先端形状付けも容易に行えることが要求される。 In PTCA, in order to follow a blood vessel that is bent and branched, the tip shape may be formed before the guide wire is inserted into the blood vessel. Specifically, a doctor or the like is bent with a finger into a predetermined shape (for example, J shape) with the distal end portion of the guide wire in accordance with the shape of a branch blood vessel or the like, and is shaped. Therefore, the guide wire is required to be able to easily shape the tip as described above.

従来、ＰＴＣＡに用いられるガイドワイヤとして、特許文献１には、以下のような構成を備えたガイドワイヤが提案されている。特許文献１のガイドワイヤは、長尺物からなるコア部と、コア部の先端側を覆うように設置されたコイルとを備え、コア部の先端側には板高さ（板厚）の２倍以上の板幅で形成された平板部を有する。 Conventionally, as a guide wire used for PTCA, Patent Document 1 has proposed a guide wire having the following configuration. The guide wire of Patent Document 1 includes a long core part and a coil installed so as to cover the tip side of the core part, and a plate height (plate thickness) of 2 at the tip side of the core part. It has the flat plate part formed with the board width more than double.

国際公開第２００９／１２６６５６号International Publication No. 2009/126656

特許文献１のガイドワイヤにおいては、板厚の薄い平板部をコア部の先端側に備えることによって、ガイドワイヤの先端部が柔軟となり、安全性および血管追従性の向上がある程度期待できる。しかしながら、このようなガイドワイヤでは、ガイドワイヤが蛇行または分岐した血管、狭窄および閉塞した血管等を通過するために、ガイドワイヤの基端部を回転操作した際に、平板部にねじれが発生する。その結果、ガイドワイヤの基端部の回転トルクが先端部に有効に伝わらないため、ガイドワイヤの先端部が意図した方向に向かず、ガイドワイヤの血管追従性およびエントリー性が低下するという問題がある。 In the guide wire of Patent Document 1, by providing a thin flat plate portion on the distal end side of the core portion, the distal end portion of the guide wire becomes flexible and safety and blood vessel followability can be expected to some extent. However, in such a guide wire, the guide wire passes through a meandering or branched blood vessel, a stenosis and a blocked blood vessel, etc., so that the flat plate portion is twisted when the proximal end portion of the guide wire is rotated. . As a result, since the rotational torque of the proximal end portion of the guide wire is not effectively transmitted to the distal end portion, the distal end portion of the guide wire is not directed in the intended direction, and the blood vessel followability and entry property of the guide wire are deteriorated. is there.

そこで、本発明は、このような問題を解決すべく創案されたもので、その課題は優れた血管追従性と、狭窄および閉塞した血管に対するエントリー性とを有するガイドワイヤを提供することにある。 Therefore, the present invention has been developed to solve such problems, and the object thereof is to provide a guide wire having excellent blood vessel followability and entry properties for a stenotic and occluded blood vessel.

前記課題を解決するために、本発明に係るガイドワイヤは、可撓性を有する長尺物からなるコア部を備えたガイドワイヤであって、前記コア部は、基端側から先端側に向かって順に、横断面が円形状の本体部と、平板部と、前記本体部と同軸上に形成された横断面が円形状の先端部とを備えていることを特徴とする。また、本発明に係るガイドワイヤは、前記コア部の先端側を覆うように設置され、素線を螺旋状に形成してなるコイル部と、前記先端部と前記コイル部とを固定する固定部とを備えていることが好ましい。また、本発明に係るガイドワイヤは、前記コア部の先端側を覆うように形成された樹脂材料からなる樹脂被覆部を備えていることが好ましい。 In order to solve the above-described problems, a guide wire according to the present invention is a guide wire including a core portion made of a flexible long object, and the core portion is directed from the proximal end side to the distal end side. The cross section includes a main body portion having a circular cross section, a flat plate portion, and a tip portion having a circular cross section formed coaxially with the main body portion. In addition, the guide wire according to the present invention is installed so as to cover the distal end side of the core portion, and a coil portion formed by forming a strand in a spiral shape, and a fixing portion that fixes the distal end portion and the coil portion Are preferably provided. Moreover, it is preferable that the guide wire which concerns on this invention is equipped with the resin coating part which consists of a resin material formed so that the front end side of the said core part may be covered.

前記構成によれば、コア部の先端側に平板部を備えることによって、コア部の先端側での柔軟性が向上するため、ガイドワイヤの先端部での柔軟性が向上する。また、ガイドワイヤの先端部での柔軟性が向上するため、分岐血管等の形状に合わせてガイドワイヤの先端部を形状付けることが容易なものとなる。また、コア部において先端側に横断面が円形状の先端部を備え、その先端部が基端側の横断面が円形状の本体部と同軸上にあることによって、ガイドワイヤの基端部を回転操作した際に、平板部を挟む本体部と先端部の横断面形状が円形状で同一であるため、平板部がねじれることが抑制される。その結果、ガイドワイヤの基端部の回転トルクを先端部に有効に伝えることが可能となるため、ガイドワイヤの先端部を意図した方向に制御できる。また、狭窄および閉塞した血管へのガイドワイヤ先端部の進入が容易となる。 According to the said structure, since the softness | flexibility in the front end side of a core part improves by providing a flat plate part in the front end side of a core part, the softness | flexibility in the front-end | tip part of a guide wire improves. Moreover, since the flexibility at the distal end portion of the guide wire is improved, it is easy to shape the distal end portion of the guide wire in accordance with the shape of the branch blood vessel or the like. In addition, the core portion has a distal end portion with a circular cross section on the distal end side, and the distal end portion is coaxial with the main body portion with a circular cross section on the proximal end side so that the proximal end portion of the guide wire is When the rotation operation is performed, the cross-sectional shape of the main body portion and the tip portion sandwiching the flat plate portion is circular and the same, so that the flat plate portion is prevented from being twisted. As a result, the rotational torque of the proximal end portion of the guide wire can be effectively transmitted to the distal end portion, so that the distal end portion of the guide wire can be controlled in the intended direction. In addition, the guide wire tip can easily enter the narrowed and blocked blood vessel.

本発明に係るガイドワイヤは、前記先端部が、前記固定部の先端面から突出する突出部を有し、前記突出部の外径が、前記平板部の板幅に比べて細いことが好ましい。 In the guide wire according to the present invention, it is preferable that the distal end portion has a projecting portion projecting from the distal end surface of the fixed portion, and an outer diameter of the projecting portion is narrower than a plate width of the flat plate portion.

前記構成によれば、細径の突出部が固定部の先端面から突出することによって、ガイドワイヤを回転操作した際、細径の突出部は回転半径が小さく小回りが利くため、狭窄および閉塞した血管へのガイドワイヤ先端部の進入もさらに容易となる。 According to the above configuration, when the guide wire is rotated by the protrusion of the small diameter protruding from the distal end surface of the fixed portion, the thin protrusion is narrowed and closed because the rotation radius is small and the short turn is good. It is easier to enter the distal end of the guide wire into the blood vessel.

本発明に係るガイドワイヤは、前記先端部が、前記樹脂被覆部の先端面から突出する突出部を有し、前記突出部の外径が、前記平板部の板幅に比べて細いことが好ましい。 In the guide wire according to the present invention, it is preferable that the distal end portion has a projecting portion projecting from the distal end surface of the resin coating portion, and an outer diameter of the projecting portion is narrower than a plate width of the flat plate portion. .

前記構成によれば、細径の突出部が樹脂被覆部の先端面から突出することによって、ガイドワイヤを回転操作した際、細径の突出部は回転半径が小さく小回りが利くため、狭窄および閉塞した血管へのガイドワイヤ先端部の進入もさらに容易となる。 According to the above configuration, when the guide wire is rotated by the protrusion of the small diameter protruding from the distal end surface of the resin coating portion, the small diameter protrusion has a small rotation radius and a small turn, so that the constriction and blockage occur. It is easier to enter the distal end of the guide wire into the blood vessel.

本発明に係るガイドワイヤによれば、ガイドワイヤの先端側での柔軟性が向上すると共に、先端形状付けも容易となるため、ガイドワイヤの血管追従性が優れたものとなる。また、コア部の平板部のねじれが抑制されるため、ガイドワイヤの基端部の回転トルクを先端部に有効に伝えることが可能となり、ガイドワイヤの血管追従性と、狭窄および閉塞した血管に対するエントリー性とが優れたものとなる。 According to the guide wire of the present invention, the flexibility at the distal end side of the guide wire is improved, and the distal end shaping is facilitated, so that the blood vessel followability of the guide wire is excellent. In addition, since the twist of the flat plate portion of the core portion is suppressed, it is possible to effectively transmit the rotational torque of the proximal end portion of the guide wire to the distal end portion. Entry is excellent.

本発明のガイドワイヤの第１実施形態を示す部分縦断面図である。It is a fragmentary longitudinal cross-section which shows 1st Embodiment of the guide wire of this invention. 図１に示すガイドワイヤのコア部の先端側での平面図である。It is a top view in the front end side of the core part of the guide wire shown in FIG. 図２に示すＡ−Ａ線におけるコア部の端面図である。FIG. 3 is an end view of a core portion taken along line AA shown in FIG. 2. 図２に示すＢ−Ｂ線におけるコア部の端面図である。It is an end view of the core part in the BB line shown in FIG. 図２に示すＣ−Ｃ線におけるコア部の端面図である。It is an end view of the core part in the CC line shown in FIG. 本発明のガイドワイヤの第２実施形態を示し、ワイヤの先端側での部分縦断面図である。The 2nd Embodiment of the guide wire of this invention is shown, and it is a fragmentary longitudinal cross-sectional view in the front end side of a wire. 本発明のガイドワイヤの第３実施形態を示す部分縦断面図である。It is a fragmentary longitudinal cross-section which shows 3rd Embodiment of the guide wire of this invention. 本発明のガイドワイヤの第４実施形態を示し、ワイヤの先端側での部分縦断面図である。The 4th Embodiment of the guide wire of this invention is shown, and it is the fragmentary longitudinal cross-section by the front end side of a wire.

本発明に係るガイドワイヤの第１実施形態について、図面を参照して詳細に説明する。なお、本発明において、先端側とはガイドワイヤの血管挿入側を言い、基端側とは医師等がガイドワイヤの操作を行う側を言う。 A first embodiment of a guide wire according to the present invention will be described in detail with reference to the drawings. In the present invention, the distal end side refers to the blood vessel insertion side of the guide wire, and the proximal end side refers to the side on which a doctor or the like operates the guide wire.

図１に示すように、ガイドワイヤ（以下、ワイヤと称す）１は、コア部２Ａを備えた長尺物であって、コア部２Ａは、本体部３と、平板部５と、先端部７とを備えている。また、ワイヤ１は、コイル部８と、固定部９２とを備えていることが好ましい。ワイヤ１の全長は、特に規定されず、例えば、２００〜５０００ｍｍが好ましい。以下、各構成について説明する。 As shown in FIG. 1, a guide wire (hereinafter referred to as a wire) 1 is a long object provided with a core portion 2A. The core portion 2A includes a main body portion 3, a flat plate portion 5, and a tip portion 7. And. The wire 1 preferably includes a coil portion 8 and a fixing portion 92. The total length of the wire 1 is not particularly limited, and is preferably 200 to 5000 mm, for example. Each configuration will be described below.

＜コア部＞
図１、図２に示すように、コア部２Ａは、可撓性を有する長尺物からなる。そして、コア部２Ａは、ワイヤ１の柔軟性および強度を考慮して、Ｎｉ−Ｔｉ合金、ステンレス鋼等の弾性金属材料からなることが好ましい。そして、コア部２Ａは、基端側から先端側に向かって順に、本体部３と、第１移行部４と、平板部５と、第２移行部６と、先端部７とを備える。なお、第１移行部４および第２移行部６は備えていなくてもよい。 <Core part>
As shown in FIGS. 1 and 2, the core portion 2 A is made of a long object having flexibility. The core portion 2A is preferably made of an elastic metal material such as a Ni—Ti alloy or stainless steel in consideration of the flexibility and strength of the wire 1. The core portion 2A includes a main body portion 3, a first transition portion 4, a flat plate portion 5, a second transition portion 6, and a distal end portion 7 in order from the proximal end side toward the distal end side. In addition, the 1st transfer part 4 and the 2nd transfer part 6 do not need to be provided.

（本体部）
図１、図２に示すように、本体部３は、丸棒状の長尺物から構成される。本体部３の横断面（ＹＺ軸平面であって、長さ方向に垂直な断面）は、円形状または略円形状であることが好ましい。また、本体部３は、基端側から先端側に向かって、一定の外径を有する大径部３１と、先端側に向かって外径が漸減する第１テーパ部３２と、一定の外径を有する中径部３３と、先端側に向かって外径が漸減する第２テーパ部３４と、一定の外径を有する小径部３５とを備えることが好ましい。 (Main body)
As shown in FIGS. 1 and 2, the main body 3 is composed of a round bar-like long object. The cross section of the main body 3 (the YZ axis plane and a cross section perpendicular to the length direction) is preferably circular or substantially circular. The main body 3 includes a large-diameter portion 31 having a constant outer diameter from the proximal end side toward the distal end side, a first taper portion 32 whose outer diameter gradually decreases toward the distal end side, and a constant outer diameter. It is preferable to include a middle diameter portion 33 having a second outer diameter, a second taper portion 34 whose outer diameter gradually decreases toward the distal end side, and a small diameter portion 35 having a constant outer diameter.

一定の外径を有する部分の間（大径部３１と中径部３３との間、および、中径部３３と小径部３５との間）に形成されるテーパ部として、前記では第１テーパ部３２と第２テーパ部３４の２つを記載したが、テーパ部は、２つに限定されず、少なくとも１つ形成すればよい。また、大径部３１と外径が同一で構成材料が異なる大径部３６を、接合部(溶接部）３７で大径部３１に接合してもよい。接合方法としては、特に規定されないが、摩擦圧接、レーザを用いたスポット溶接、アプセット溶接等の突き合わせ抵抗溶接、管状接合部材による接合等が挙げられる。 As the tapered portion formed between the portions having a constant outer diameter (between the large diameter portion 31 and the medium diameter portion 33 and between the medium diameter portion 33 and the small diameter portion 35), the first taper is used. Although two of the part 32 and the 2nd taper part 34 were described, the taper part is not limited to two, What is necessary is just to form at least 1 part. Further, a large diameter portion 36 having the same outer diameter as the large diameter portion 31 but having a different constituent material may be joined to the large diameter portion 31 by a joint portion (welded portion) 37. Although it does not prescribe | regulate especially as a joining method, Butt resistance welding, such as friction welding, spot welding using a laser, and upset welding, joining by a tubular joining member, etc. are mentioned.

（第１移行部）
図１、図２に示すように、第１移行部４は、本体部３と平板部５とを繋ぎ、基端側から先端側に向かって、円形の横断面（図３参照）から矩形の横断面（図４参照）に次第に変化する部分である。そして、第１移行部４の長さは１〜１０ｍｍが好ましい。なお、第１移行部４は、丸棒状の本体部３の先端側、好ましくは細径化された先端側を金型等によってプレスすることによって、平板部５、第２移行部６および先端部７と共に作製することが好ましい。また、本発明のワイヤ１では、第１移行部４を作製せずに、本体部３と平板部５とを直接繋げた形態であってもよい。 (First transition part)
As shown in FIGS. 1 and 2, the first transition portion 4 connects the main body portion 3 and the flat plate portion 5, and has a rectangular shape from a circular cross section (see FIG. 3) from the proximal end side toward the distal end side. This is a portion that gradually changes in the cross section (see FIG. 4). And as for the length of the 1st transition part 4, 1-10 mm is preferable. In addition, the 1st transition part 4 presses the front end side of the round-bar-shaped main-body part 3, Preferably the diameter-reduced front end side with a metal mold | die etc., The flat plate part 5, the 2nd transition part 6, and a front-end | tip part 7 is preferable. Moreover, in the wire 1 of this invention, the form which connected the main-body part 3 and the flat plate part 5 directly without producing the 1st transition part 4 may be sufficient.

（平板部）
図１、図２に示すように、平板部５は、ワイヤ１（コア部２Ａ）に柔軟性を持たせると共に、ワイヤ先端部の先端形状付けが容易となるように、矩形状または略矩形状の横断面を有する細長い板状の平板から構成されている。平板部５は、板長さが１〜３０ｍｍ、板幅Ｗが０．１〜０．５ｍｍ、板厚が０．０１〜０．０６ｍｍであることが好ましい。また、平板部５の板幅Ｗは先端側に向かって増大または減少してもよく、板厚も先端側に向かって増大または減少してもよい。なお、平板部５の横断面の形状は、プレスによって作製するため、横断面の両端は少し丸みが残り略矩形状となる。但し、説明の便宜上、図４では両端の丸みを省略する。 (Flat plate part)
As shown in FIGS. 1 and 2, the flat plate portion 5 has a rectangular shape or a substantially rectangular shape so that the wire 1 (core portion 2 A) has flexibility and the tip shape of the wire tip portion can be easily formed. It is comprised from the elongate plate-shaped flat plate which has the cross section of. The flat plate portion 5 preferably has a plate length of 1 to 30 mm, a plate width W of 0.1 to 0.5 mm, and a plate thickness of 0.01 to 0.06 mm. Further, the plate width W of the flat plate portion 5 may increase or decrease toward the front end side, and the plate thickness may increase or decrease toward the front end side. In addition, since the shape of the cross section of the flat plate part 5 is produced by pressing, both ends of the cross section are slightly rounded and become substantially rectangular. However, for convenience of explanation, rounding at both ends is omitted in FIG.

（第２移行部）
図１、図２に示すように、第２移行部６は、平板部５と先端部７とを繋ぎ、基端側から先端側に向かって、矩形の横断面（図４参照）から円形の横断面（図５参照）に次第に変化する部分である。そして、第２移行部６の長さは１〜１０ｍｍが好ましい。なお、本発明のワイヤ１においては、第２移行部６を作製せずに、平板部５と先端部７とを直接繋げた形態であってもよい。 (Second transition part)
As shown in FIGS. 1 and 2, the second transition portion 6 connects the flat plate portion 5 and the distal end portion 7 and is circular from a rectangular cross section (see FIG. 4) from the proximal end side toward the distal end side. This is a portion that gradually changes in the cross section (see FIG. 5). And as for the length of the 2nd transition part 6, 1-10 mm is preferable. In addition, in the wire 1 of this invention, the form which connected the flat plate part 5 and the front-end | tip part 7 directly without producing the 2nd transition part 6 may be sufficient.

（先端部）
図１、図２に示すように、先端部７は、丸棒状の長尺物から構成される。先端部７の横断面は、円形状または略円形状であることが好ましい。そして、先端部７は、本体部３と同軸上に形成され、固定部９２でコイル部８の先端側に固定されている。 (Tip)
As shown in FIGS. 1 and 2, the distal end portion 7 is composed of a round bar-like long object. The cross section of the tip 7 is preferably circular or substantially circular. The distal end portion 7 is formed coaxially with the main body portion 3, and is fixed to the distal end side of the coil portion 8 with a fixing portion 92.

先端部７の外径Ｄ１は０．０１〜０．３ｍｍ、長さＬ１は０．５〜１５ｍｍが好ましい。さらに、先端部７の外径Ｄ１は、先端側に向かって一定の外径を有することが好ましいが、先端側に向かって増大または減少してもよい。 The outer diameter D1 of the tip 7 is preferably 0.01 to 0.3 mm, and the length L1 is preferably 0.5 to 15 mm. Furthermore, the outer diameter D1 of the distal end portion 7 preferably has a constant outer diameter toward the distal end side, but may increase or decrease toward the distal end side.

本発明のワイヤ１においては、本体部３と同軸上に形成された先端部７を備えることによって、ワイヤ１が蛇行または分岐した血管、狭窄および閉塞した血管等を通過するために、ワイヤ１の基端部を回転操作した際に、平板部５を挟む本体部３と先端部７の横断面形状が円形状で同一であるため、コア部２Ａの平板部５がねじれることが抑制される。その結果、ワイヤ１の基端部の回転トルクを先端部７に有効に伝えることが可能となるため、ワイヤ１の先端部を意図した方向に制御できる。また、狭窄および閉塞した血管へのガイドワイヤ先端部の進入が容易となる。したがって、ワイヤ１の血管追従性およびエントリー性が向上する。 In the wire 1 of the present invention, the distal end portion 7 formed coaxially with the main body portion 3 is provided so that the wire 1 passes through meandering or branched blood vessels, stenotic and occluded blood vessels, and the like. When the base end portion is rotated, since the cross-sectional shape of the main body portion 3 and the distal end portion 7 sandwiching the flat plate portion 5 is the same in a circular shape, the flat plate portion 5 of the core portion 2A is suppressed from being twisted. As a result, the rotational torque of the proximal end portion of the wire 1 can be effectively transmitted to the distal end portion 7, so that the distal end portion of the wire 1 can be controlled in the intended direction. In addition, the guide wire tip can easily enter the narrowed and blocked blood vessel. Therefore, the blood vessel followability and entry property of the wire 1 are improved.

＜コイル部＞
図１に示すように、コイル部８は、コア部２Ａの先端側を覆うように設置され、素線を螺旋状に形成してなるコイルである。そして、コイルは、隣接する素線同士が接触したいわゆる密巻きしたものや、隣接する素線同士が離間したもののいずれでもよい。また、コイル部８は、その先端側が固定部９２でコア部２Ａ（先端部７）に固定されている。 <Coil part>
As shown in FIG. 1, the coil portion 8 is a coil that is installed so as to cover the distal end side of the core portion 2 A and is formed by forming a strand in a spiral shape. The coil may be a so-called densely wound coil in which adjacent strands are in contact with each other or a coil in which adjacent strands are separated from each other. The coil 8 is fixed to the core 2 A (tip 7) by a fixing portion 92 on the tip side.

素線を構成する材料は、特に規定されないが、ステンレス鋼、Ｐｔ−Ｎｉ合金等の金属材料であることが好ましい。また、コイル部８のサイズは、特に規定されず、ワイヤ１の使用目的によって異なる。ＰＴＣＡに使用されるワイヤ1では、コイル部８のコイル外径が０．２〜０．５ｍｍ、コイル長さが１０〜１０００ｍｍであることが好ましい。コイル外径は、ワイヤ１の長さ方向に同一径であることが好ましいが、ワイヤ１の先端側に向かって減少していてもよい。 Although the material which comprises a strand is not prescribed | regulated in particular, It is preferable that they are metal materials, such as stainless steel and a Pt-Ni alloy. Further, the size of the coil portion 8 is not particularly defined and varies depending on the purpose of use of the wire 1. In the wire 1 used for PTCA, it is preferable that the coil outer diameter of the coil portion 8 is 0.2 to 0.5 mm and the coil length is 10 to 1000 mm. The outer diameter of the coil is preferably the same diameter in the length direction of the wire 1, but may be decreased toward the distal end side of the wire 1.

コイル部８は、２種以上の金属材料を組み合わせたものであってもよい。例えば、コイル部８は、基端側にステンレス鋼製の素線からなる第１コイル部８１と、先端側にＸ線不透過材料であるＰｔ−Ｎｉ合金製の素線からなる第２コイル部８２とを備え、第１コイル部８１と第２コイル部８２との境界部８３で両コイル部８１、８２を溶接、接着等で接合したものであってもよい。これにより、ワイヤ１の先端側がＸ線透視下で視認しやすくなる。 The coil portion 8 may be a combination of two or more metal materials. For example, the coil portion 8 includes a first coil portion 81 made of a stainless steel wire on the proximal end side, and a second coil portion made of a Pt—Ni alloy wire made of a radiopaque material on the distal end side. 82, and the two coil portions 81 and 82 may be joined by welding, bonding or the like at the boundary portion 83 between the first coil portion 81 and the second coil portion 82. Thereby, the front end side of the wire 1 becomes easy to visually recognize under X-ray fluoroscopy.

＜固定部＞
固定部９２は、ワイヤ１の先端側で、先端部７とコイル部８とを固定する部分である。固定部９２は、半田(ろう材)、接着材等の固定材料で形成することが好ましいが、溶接で固定部９２を形成してもよい。 <Fixed part>
The fixing portion 92 is a portion that fixes the tip portion 7 and the coil portion 8 on the tip side of the wire 1. The fixing portion 92 is preferably formed of a fixing material such as solder (brazing material) or an adhesive, but the fixing portion 92 may be formed by welding.

次に、本発明のワイヤ１の第１実施形態の変形例について説明する。
図１に示すように、ワイヤ1は、コア部２Ａとコイル部８とが先端側の１箇所（固定部９２）で固定されていれば十分であるが、コア部２Ａとコイル部８とが複数個所で固定されていることが好ましい。 Next, the modification of 1st Embodiment of the wire 1 of this invention is demonstrated.
As shown in FIG. 1, it is sufficient for the wire 1 that the core portion 2A and the coil portion 8 are fixed at one point (fixed portion 92) on the distal end side. It is preferably fixed at a plurality of locations.

例えば、図１に示すように、ワイヤ１は、先端部７とコイル部８（第２コイル部８２）の先端側とが固定部９２で固定され、コア部２Ａの途中の部位（第１移行部４の基端側、小径部３５、および、第２テーパ部３４の先端側）とコイル部８の途中の部位(境界部８３)とが固定部９３で固定され、コア部２Ａの途中の部位(中径部３３の基端側、および、第１テーパ部３２の先端側)とコイル部８(第１コイル部８１)の基端側とが固定部９１で固定されている。 For example, as shown in FIG. 1, the wire 1 has a distal end portion 7 and a distal end side of the coil portion 8 (second coil portion 82) fixed by a fixing portion 92, and a portion in the middle of the core portion 2 A (first transition). The base end side of the portion 4, the small diameter portion 35, and the distal end side of the second taper portion 34) and a portion in the middle of the coil portion 8 (boundary portion 83) are fixed by the fixing portion 93, and are in the middle of the core portion 2 A. The portion (the base end side of the medium diameter portion 33 and the tip end side of the first taper portion 32) and the base end side of the coil portion 8 (first coil portion 81) are fixed by a fixing portion 91.

ここで、固定部９１、９２、９３は、半田(ろう材)、接着剤等の固定材料で形成されている。なお、コア部２Ａとコイル部８との固定方法は、前記のような固定材料によるものに限らず、溶接で固定部９１、９２、９３を形成してもよい。 Here, the fixing portions 91, 92, and 93 are formed of a fixing material such as solder (brazing material) or adhesive. The fixing method of the core portion 2A and the coil portion 8 is not limited to the fixing material as described above, and the fixing portions 91, 92, and 93 may be formed by welding.

図１に示すように、ワイヤ１は、コイル部８の少なくとも先端側の表面を覆うように形成された樹脂被覆部１０を備えることが好ましい。 As shown in FIG. 1, the wire 1 preferably includes a resin coating portion 10 formed so as to cover at least the surface of the coil portion 8 on the tip side.

具体的には、樹脂被覆部１０は、前記したワイヤの表面の一部または全部、すなわち、第２コイル部８２の全表面、コイル部８(第１コイル部８１、境界部８３および第２コイル部８２)の全表面、または、コイル部８とコア部２Ａの基端側部位の全表面を覆うことが好ましい。 Specifically, the resin coating portion 10 includes part or all of the surface of the wire, that is, the entire surface of the second coil portion 82, the coil portion 8 (the first coil portion 81, the boundary portion 83, and the second coil). It is preferable to cover the entire surface of the portion 82) or the entire surface of the proximal end portion of the coil 8 and the core 2A.

樹脂被覆部１０は、フッ素系樹脂、無水マレイン酸系高分子物質、ポリウレタン等の樹脂材料からなることが好ましく、フッ素系樹脂からなることがさらに好ましい。また、樹脂被覆部１０の厚みは０．００１〜０．０５ｍｍが好ましい。このような樹脂被覆部１０で覆われていることによって、ワイヤ１は、摩擦抵抗（摺動抵抗）が低減するため、血管内での操作性が向上する。 The resin coating portion 10 is preferably made of a resin material such as a fluorine resin, a maleic anhydride polymer material, or polyurethane, and more preferably a fluorine resin. The thickness of the resin coating 10 is preferably 0.001 to 0.05 mm. Since the wire 1 is covered with such a resin coating portion 10, the friction resistance (sliding resistance) of the wire 1 is reduced, so that the operability in the blood vessel is improved.

次に、本発明に係るガイドワイヤの第２実施形態について説明する。
図２、図６に示すように、ガイドワイヤ１は、第１実施形態の先端部７が、固定部９２の先端面９２ａから突出する突出部７ａを有し、突出部７ａの外径Ｄ２が平板部５の板幅Ｗに比べて細いものである。なお、突出部７ａ以外の構成については第１実施形態と同様であるので、突出部７ａについて説明し、それ以外の説明は省略する。 Next, a second embodiment of the guide wire according to the present invention will be described.
As shown in FIGS. 2 and 6, the guide wire 1 has a distal end portion 7 according to the first embodiment having a projecting portion 7 a projecting from the distal end surface 92 a of the fixing portion 92, and the outer diameter D2 of the projecting portion 7 a is It is thinner than the plate width W of the flat plate portion 5. In addition, since it is the same as that of 1st Embodiment about structures other than the protrusion part 7a, the protrusion part 7a is demonstrated and description other than that is abbreviate | omitted.

突出部７ａの長さＬ２は、０．１〜３.０ｍｍが好ましい。このとき、先端部７の長さＬ１は、０．５〜１５ｍｍが好ましい。なお、突出部７ａの長さＬ２の調整は、先端部７の長さＬ１で調整することが好ましいが、コア部２Ａの他の構成である本体部３、第１移行部４、平板部５および第２移行部６の長さで調整してもよい。 The length L2 of the protruding portion 7a is preferably 0.1 to 3.0 mm. At this time, the length L1 of the tip 7 is preferably 0.5 to 15 mm. The length L2 of the projecting portion 7a is preferably adjusted by the length L1 of the distal end portion 7, but the main body portion 3, the first transition portion 4, and the flat plate portion 5 which are other configurations of the core portion 2A. Further, the length of the second transition portion 6 may be adjusted.

突出部７ａの外径Ｄ２は、平板部５の板幅Ｗに比べて細いもの（Ｄ２＜Ｗ）であれば下記の効果を奏するが、Ｄ２＜０．５Ｗのものが好ましい。突出部７ａの外径Ｄ２の調整は、例えば、丸棒状のコア部２Ａから板状の平板部５をプレスによって作製することによって、平板部５の板幅Ｗより細い外径Ｄ１を有する先端部７を作製することができ、それによって、突出部７ａの外径Ｄ２も板幅Ｗよりも細いものに調整できる（図４、図５参照）。また、先端部７の作製の際に、先端側に向かって外径Ｄ１が減少するように作製してもよい。さらに、突出部７ａの先端側は丸みのある形状であることが好ましい。 The outer diameter D2 of the protruding portion 7a has the following effects if it is thinner than the plate width W of the flat plate portion 5 (D2 <W), but preferably has a D2 <0.5W. The adjustment of the outer diameter D2 of the projecting portion 7a is performed by, for example, producing the plate-like flat plate portion 5 from the round bar-shaped core portion 2A by pressing, and thereby the tip portion having an outer diameter D1 smaller than the plate width W of the flat plate portion 5 7 can be produced, and the outer diameter D2 of the protrusion 7a can be adjusted to be narrower than the plate width W (see FIGS. 4 and 5). Further, when the distal end portion 7 is manufactured, the outer diameter D1 may be decreased toward the distal end side. Furthermore, it is preferable that the front end side of the protrusion 7a has a round shape.

本発明のガイドワイヤ１においては、前記のような細径の突出部７ａを有する先端部７を備えることによって、ガイドワイヤ１を回転操作した際、細径の突出部７ａは回転半径が小さく小回りが利くため、狭窄および閉塞した血管へのガイドワイヤ先端部の進入もさらに容易となる。その結果、ガイドワイヤ１の血管追従性およびエントリー性が向上する。 In the guide wire 1 of the present invention, by providing the distal end portion 7 having the small-diameter protruding portion 7a as described above, when the guide wire 1 is rotated, the small-diameter protruding portion 7a has a small turning radius and a small turn. Therefore, it is easier to enter the distal end of the guide wire into a narrowed and occluded blood vessel. As a result, the blood vessel following property and entry property of the guide wire 1 are improved.

本発明のガイドワイヤの第２実施形態の変形例としては、第１実施形態と同様に、コア部２Ａとコイル部８とが複数個所で固定されている例、ワイヤ表面が樹脂被覆部１０で覆われている例が挙げられる。また、図６に示すように、樹脂被覆部１０の被覆は、ワイヤ表面だけでなく、突出部７ａの外径Ｄ２が太くならない程度（Ｄ２＜平板部５の板幅Ｗ）に、突出部７ａの表面に行ってもよい。 As a modification of the second embodiment of the guide wire of the present invention, as in the first embodiment, the core portion 2A and the coil portion 8 are fixed at a plurality of locations, the wire surface is the resin coating portion 10 Examples are covered. Further, as shown in FIG. 6, the coating of the resin coating portion 10 is performed not only on the wire surface but also on the protruding portion 7 a so that the outer diameter D 2 of the protruding portion 7 a does not increase (D2 <plate width W of the flat plate portion 5). You may go to the surface.

次に、本発明のガイドワイヤの第３実施形態について説明する。
図７に示すように、ガイドワイヤ１は、第１実施形態におけるコイル部８の代わりに樹脂被覆部１１を備えている。なお、樹脂被覆部１１以外の構成については第１実施形態と同様であるので、樹脂被覆部１１について説明し、それ以外の説明は省略する。 Next, a third embodiment of the guide wire of the present invention will be described.
As shown in FIG. 7, the guide wire 1 includes a resin coating portion 11 instead of the coil portion 8 in the first embodiment. In addition, since it is the same as that of 1st Embodiment about structures other than the resin coating part 11, the resin coating part 11 is demonstrated and description other than that is abbreviate | omitted.

樹脂被覆部１１は、コア部２Ａの先端側を覆うように形成され、樹脂材料からなる。樹脂材料としては、フッ素系樹脂、ポリウレタン等が挙げられ、ポリウレタンが好ましい。樹脂被覆部１１は、その厚さが基端側よりも先端側が厚く形成されていることが好ましく、０．００１〜０．０５ｍｍであることが好ましい。また、樹脂被覆部１１は、その先端側が丸く形成されていることが好ましい。 The resin coating portion 11 is formed so as to cover the distal end side of the core portion 2A and is made of a resin material. Examples of the resin material include a fluorine-based resin and polyurethane, and polyurethane is preferable. The resin coating portion 11 is preferably formed such that the distal end side is thicker than the proximal end side, and is preferably 0.001 to 0.05 mm. Moreover, it is preferable that the resin coating | coated part 11 is formed in the front end side roundly.

このような樹脂被覆部１１を備えることによって、ガイドワイヤ１を使用する際、コア部２Ａで血管壁を損傷することが抑制されるため、安全性が向上する。また、ガイドワイヤ１は、摩擦抵抗（摺動抵抗）が低減するため、血管内での操作性も向上する。 By providing such a resin coating portion 11, when the guide wire 1 is used, damage to the blood vessel wall by the core portion 2A is suppressed, so that safety is improved. Further, since the guide wire 1 has reduced frictional resistance (sliding resistance), the operability in the blood vessel is also improved.

次に、本発明に係るガイドワイヤの第４実施形態について説明する。
図８に示すように、ガイドワイヤ１は、第３実施形態の先端部７が、樹脂被覆部１１の先端面１１ａから突出する突出部７ａを有し、突出部７ａの外径Ｄ２が平板部５の板幅Ｗに比べて細いものである。なお、突出部７ａ以外の構成については第１実施形態と同様である。また、突出部７ａについては、突出する先端面１１ａが樹脂被覆部１１であって固定部９２でないこと以外は、第２実施形態と同様である。 Next, a fourth embodiment of the guide wire according to the present invention will be described.
As shown in FIG. 8, in the guide wire 1, the distal end portion 7 of the third embodiment has a protruding portion 7a protruding from the distal end surface 11a of the resin coating portion 11, and the outer diameter D2 of the protruding portion 7a is a flat plate portion. It is thinner than the plate width W of 5. The configuration other than the protruding portion 7a is the same as that of the first embodiment. Further, the protruding portion 7a is the same as that of the second embodiment except that the protruding tip surface 11a is the resin coating portion 11 and not the fixing portion 92.

次に、本発明のガイドワイヤの使用方法について、ＰＴＣＡを例にとって説明する。
ガイドワイヤの先端をガイディングカテーテルの先端から突出させ、その状態でセルジンガー法により大腿動脈内に挿入し、大動脈、大動脈弓、右冠状動脈開口部を経て右冠状動脈内に挿入する。ガイディングカテーテルを右冠状動脈開口部の位置に残したまま、ガイドワイヤのみを右冠状動脈内でさらに進めて血管狭窄部を通過させ、ガイドワイヤの先端が血管狭窄部を越えた位置で停止する。これにより、狭窄部拡張用のバルーンカテーテルの通路が確保される。 Next, a method for using the guide wire of the present invention will be described taking PTCA as an example.
The tip of the guide wire is protruded from the tip of the guiding catheter, and in that state, the guide wire is inserted into the femoral artery by the Seldinger method, and inserted into the right coronary artery through the aorta, aortic arch, and right coronary artery opening. With the guiding catheter left at the opening of the right coronary artery, only the guide wire is advanced further in the right coronary artery to pass through the vascular stenosis, and stops at the position where the tip of the guide wire exceeds the vascular stenosis. . Thereby, the passage of the balloon catheter for expanding the stenosis is secured.

次に、ガイドワイヤの基端側から挿通されたバルーンカテーテルの先端をガイディングカテーテルの先端から突出させ、さらにガイドワイヤに沿って進め、右冠状動脈開口部から右冠状動脈内に挿入し、バルーンカテーテルのバルーンが血管狭窄部の位置に到達したところで停止する。 Next, the tip of the balloon catheter inserted from the proximal end side of the guide wire is protruded from the tip of the guiding catheter, further advanced along the guide wire, inserted into the right coronary artery from the right coronary artery opening, and the balloon Stop when the balloon of the catheter reaches the position of the vascular stenosis.

次に、バルーンカテーテルの基端側からバルーン拡張用の流体を注入して、バルーンを拡張させ、血管狭窄部を拡張する。このようにすることによって、血管狭窄部に付着堆積しているコレステロール等の堆積物は物理的に押し広げられ、血流阻害が解消される。 Next, a balloon expansion fluid is injected from the proximal end side of the balloon catheter to expand the balloon and expand the vascular stenosis. By doing in this way, deposits, such as cholesterol deposited on the vascular stenosis, are physically expanded and the blood flow obstruction is eliminated.

バルーン内からバルーン拡張用の流体を抜き取り、バルーンを収縮させる。次いで、バルーンカテーテルをガイドワイヤと共に基端方向へ移動して、血管よりバルーンカテーテル、ガイドワイヤおよびガイディングカテーテルを抜き取る。以上により、ＰＴＣＡの手技が終了する。 The balloon expansion fluid is withdrawn from the balloon, and the balloon is deflated. Next, the balloon catheter is moved in the proximal direction together with the guide wire, and the balloon catheter, the guide wire and the guiding catheter are extracted from the blood vessel. Thus, the PTCA procedure is completed.

１ガイドワイヤ（ワイヤ）
２Ａコア部
３本体部
４第１移行部
５平板部
６第２移行部
７先端部
７ａ突出部
８コイル部
９１、９２、９３固定部
９２ａ先端面
１０、１１樹脂被覆部
１１ａ先端面 1 Guide wire (wire)
2A Core part 3 Body part 4 First transition part 5 Flat plate part 6 Second transition part 7 Tip part 7a Projection part 8 Coil part 91, 92, 93 Fixing part 92a Tip surface 10, 11 Resin coating part 11a Tip surface

Claims

A guide wire having a core portion made of a flexible long object,
The core portion includes, in order from the proximal end side to the distal end side, a main body portion having a circular cross section, a flat plate portion, and a front end portion having a circular cross section formed coaxially with the main body portion. A guide wire comprising the guide wire.

The guide wire is provided so as to cover the distal end side of the core portion, and includes a coil portion formed by forming a strand in a spiral shape, and a fixing portion that fixes the distal end portion and the coil portion. The guide wire according to claim 1.

3. The guide according to claim 2, wherein the distal end portion has a protruding portion that protrudes from a distal end surface of the fixed portion, and an outer diameter of the protruding portion is smaller than a plate width of the flat plate portion. Wire.

The guide wire according to claim 1, wherein the guide wire includes a resin coating portion made of a resin material so as to cover a tip side of the core portion.

The said front-end | tip part has a protrusion part which protrudes from the front-end | tip surface of the said resin coating | coated part, The outer diameter of the said protrusion part is thin compared with the board width of the said flat plate part. Guide wire.