JP2010259624A - Guide wire and manufacturing method thereof - Google Patents

Guide wire and manufacturing method thereof Download PDF

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JP2010259624A
JP2010259624A JP2009112839A JP2009112839A JP2010259624A JP 2010259624 A JP2010259624 A JP 2010259624A JP 2009112839 A JP2009112839 A JP 2009112839A JP 2009112839 A JP2009112839 A JP 2009112839A JP 2010259624 A JP2010259624 A JP 2010259624A
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guide wire
tip
joining
distal end
core portion
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Masaru Ito
賢 伊藤
Fumiyuki Miura
史之 三浦
Akihiro Ametani
彰洋 飴谷
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Hi Lex Corp
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Hi Lex Corp
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Abstract

<P>PROBLEM TO BE SOLVED: To provide guide wire, in which a core part and a tip member do not come off in introducing a catheter and which also has elasticity which can bear the operation of the guide wire, and moreover a manufacturing method which can simply manufacture the guide wire, does not take width in a longitudinal direction, enables the reduced diameter of a binding part, and raises operation. <P>SOLUTION: In the guide wire 1 comprising the core part 2 and the tip member 3, the core part and the tip member are joined by the binding part 4, and in the binding part, a coil spring 4b is arranged in an axial direction on the outsides of the core part, and the tip member in an overlapping part in which the proximal end side of the tip member overlaps the distal end side of the core part, and the core part, the tip member, and an adhesion resin part applied to the overlapping part of the coil spring are included. Moreover, the manufacturing method includes a process which inserts the tip member into the gap of the core part and the coil spring, and a process which performs adhesion with an adhesive agent. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

本発明は、ガイドワイヤおよびその製造方法に関する。さらに詳しくは、例えば経皮的冠状動脈血管形成術(PTCA)等に使用するバルーンカテーテル等のカテーテルを血管内に導入する際に使用されるガイドワイヤにおいて、そのコア部と先端部材とが簡単かつ強固に固定され、操作性にも優れたガイドワイヤおよびその製造方法に関する。   The present invention relates to a guide wire and a manufacturing method thereof. More specifically, for example, in a guide wire used when a catheter such as a balloon catheter used for percutaneous coronary artery angioplasty (PTCA) or the like is introduced into a blood vessel, the core portion and the tip member are simple and The present invention relates to a guide wire that is firmly fixed and excellent in operability, and a manufacturing method thereof.

ガイドワイヤは一般に、治療上の又はその他の装置を運ぶカテーテルを被験者の血管系における遠隔部位に誘導するために用いられている。例えば、血管が閉塞又は部分閉塞している場合には、ガイドワイヤを用いて、遠位端にバルーン又はステントを有することがあるカテーテルを誘導し、閉塞部位の間に貫通する通路を維持するために動脈内の閉塞部位に設置する。しかし、ステント又は他の同様の装置を挿入する前に、ステントを入れるための閉塞部位を貫通した通路を開通するために、閉塞部位を貫通しなければならない。ガイドワイヤは、ガイドワイヤ越しにカテーテルを挿入する前にこのような閉塞又は部分閉塞部位を貫通するために提供されるものである。   Guidewires are commonly used to guide catheters carrying therapeutic or other devices to a remote site in a subject's vasculature. For example, if a blood vessel is occluded or partially occluded, a guide wire is used to guide a catheter that may have a balloon or stent at the distal end to maintain a penetrating passage between the occluded sites Installed at the occlusion site in the artery. However, prior to insertion of a stent or other similar device, the occlusion site must be penetrated to open a passage through the occlusion site for placement of the stent. A guide wire is provided to penetrate such an occlusion or partial occlusion site prior to insertion of the catheter over the guide wire.

ガイドワイヤは、その性質上操作に耐え得るための充分な弾性を有する必要があるとともに、ガイドワイヤのコア部と先端部材とが不意に外れることのないよう強固に固着されていることも必要である。   The guide wire must have sufficient elasticity to withstand operation due to its nature, and it must also be firmly fixed so that the core portion of the guide wire and the tip member do not come off unexpectedly. is there.

たとえば、特許文献1には、潤滑性の向上したガイドワイヤについての技術が開示されている。また、その構成において、ハンダ接合部は、ガイドワイヤに密着する必要はないものの、内部コイル、リボンおよび外部の細いワイヤコイルはすべて、単一の一体化ユニットとして維持されていることが開示されている。   For example, Patent Document 1 discloses a technique for a guide wire with improved lubricity. Also, it is disclosed that the solder joint does not need to be in close contact with the guide wire, but the internal coil, ribbon and external thin wire coil are all maintained as a single integrated unit. Yes.

特開平8−238319号公報JP-A-8-238319

しかし、特許文献1のガイドワイヤ場合、リボンは、内部コイルの外側に、ハンダで接合されている。リボンとコアとを接合するためには、リボンとコアとが重なった状態を維持してハンダ付けの操作をする必要があり、その操作は難しく、流動性のある溶融状態のハンダをコア部の周方向に均一に付着させることを簡易に行うのは難しい。また、ハンダを使用している結果、ガイドワイヤの長手方向の垂直方向への応力に対して、弾性をほとんど有しておらず、その結果、ハンダの付着量が多い場合には、分岐した血管内を移動させる操作性に影響を与えることともなる。当該操作性を考慮してハンダ量を著しく減らした場合には、場合によっては、ハンダが剥離し、リボンが不意に抜け外れることも想定されるので、厳密な製品検査をし、外れる恐れのあるものを不良品として廃棄しなければならない。そのため、接着剤を用いて固定することが好ましく、通常、直径が0.1mm程度のコア部と先端部材とを接着剤で固着するには接着ズレを防止するためにシアノ系モノマーを含んだ瞬間接着剤を用いるのであるが、瞬間接着剤は粘性が低いために、コア部と先端部との間を流れてしまい十分な接着力を発揮する接着層を当該瞬間接着剤のみで得ることは難しい。   However, in the case of the guide wire of Patent Document 1, the ribbon is joined to the outside of the internal coil by solder. In order to join the ribbon and the core, it is necessary to perform the soldering operation while maintaining the ribbon and the core in an overlapped state. It is difficult to easily perform uniform adhesion in the circumferential direction. Also, as a result of using solder, there is almost no elasticity against stress in the vertical direction of the longitudinal direction of the guide wire, and as a result, when the amount of solder attached is large, branched blood vessels It also affects the operability of moving inside. When the amount of solder is remarkably reduced in consideration of the operability, in some cases, it is assumed that the solder will peel off and the ribbon may come off unexpectedly. Things must be discarded as defective. Therefore, it is preferable to fix using an adhesive. Usually, in order to fix the core portion having a diameter of about 0.1 mm and the tip member with the adhesive, the moment when the cyano monomer is included in order to prevent adhesive displacement. Adhesive is used, but since the instantaneous adhesive has low viscosity, it is difficult to obtain an adhesive layer that flows between the core part and the tip part and exerts sufficient adhesive force with only the instantaneous adhesive. .

本発明は、上記従来の問題に鑑みてなされたものであり、例えば経皮的冠状動脈血管形成術(PTCA)等に使用するカテーテルを血管内に導入する際に使用されるガイドワイヤにおいて、コア部と先端部材とが不意に外れる医療事故がなく、かつ、簡単に先端部材とコア部とを接合できるガイドワイヤを提供することを目的とする。   The present invention has been made in view of the above-described conventional problems. For example, in a guide wire used when a catheter used for percutaneous coronary angioplasty (PTCA) or the like is introduced into a blood vessel, a core It is an object of the present invention to provide a guide wire in which there is no medical accident in which the distal portion and the distal end member are unexpectedly detached, and the distal end member and the core portion can be easily joined.

本発明にかかわるガイドワイヤは、線状に延びるコア部と、先端部材とを備えたガイドワイヤであって、前記コア部と前記コア部の先端よりも基端が細径若しくは同径の前記先端部材とは接合部により接合され、前記接合部は、前記コア部の遠位端側と前記先端部材の基端側とが重複する重複部分において、前記コア部及び前記先端部材の外側に筒状若しくは概略形状が筒状である接合補助部材が軸方向に配され、前記接合部が、(a)前記接合補助部材が、熱収縮され若しくは加締められること、または(b)前記コア部、前記先端部材、及び前記接合補助部材の重複部分に、接合材による固定層が形成されること、により接合されて形成されたガイドワイヤである。   A guide wire according to the present invention is a guide wire including a linearly extending core portion and a distal end member, and the distal end has a proximal end smaller in diameter or the same diameter than the distal end of the core portion and the core portion. The member is joined by a joint portion, and the joint portion has a cylindrical shape outside the core portion and the tip member at an overlapping portion where the distal end side of the core portion and the base end side of the tip member overlap. Or the joining auxiliary member whose outline shape is cylindrical is arranged in the direction of an axis, and the above-mentioned joined part is (a) the above-mentioned joining auxiliary member is thermally contracted or crimped, or (b) the above-mentioned core part, the above-mentioned The guide wire is formed by bonding a distal end member and an overlapping portion of the bonding auxiliary member by forming a fixed layer of a bonding material.

また、本発明にかかわるガイドワイヤの製造方法は、線状に延びるコア部と、前記コア部の先端よりも基端が細径若しくは同径の先端部材とを備えたガイドワイヤの製造方法であって、前記コア部の先端側の外側に接合補助部材とを重複させ、前記先端部材を前記コア部と前記接合補助部材との間に挿入して嵌着させる嵌着工程と、前記コア部と前記先端部材と前記接合補助部材とを、(a)前記接合補助部材が、熱収縮され若しくは加締められること、または、(b)前記コア部、前記先端部材、及び前記接合補助部材の重複部分に、接合材による固定層が形成されること、により接合する接合工程とを含むガイドワイヤの製造方法である。   The guide wire manufacturing method according to the present invention is a guide wire manufacturing method including a linearly extending core portion and a distal end member having a proximal end smaller in diameter or the same diameter than the distal end of the core portion. A fitting step of overlapping a joining auxiliary member on the outer side of the distal end side of the core portion, and inserting and fitting the distal end member between the core portion and the joining auxiliary member; and the core portion, The tip member and the joining auxiliary member are either (a) the joining assistant member is thermally contracted or crimped, or (b) the overlapping portion of the core portion, the tip member, and the joining assistant member. And a bonding step of bonding by forming a fixed layer of a bonding material.

本発明にかかわるガイドワイヤによって、そのコア部とワイヤ材とが不意に外れ、医療事故の原因となることがなく、かつ、ガイドワイヤの操作性に優れた弾性をも有するガイドワイヤを提供することができる。また、本発明にかかわるガイドワイヤの製造方法によって、これらの効果を奏するガイドワイヤを簡便に製作することができ、さらに、従来の接着剤のみによる接合に比べて、長手方向に幅を取ることがなく、さらに接着部の縮径が可能となり、操作の利便性を向上させることができる。   A guide wire according to the present invention is provided with a guide wire having elasticity that is excellent in operability of a guide wire without causing a core accident and a wire material to be unexpectedly removed, causing a medical accident. Can do. In addition, the guide wire manufacturing method according to the present invention makes it possible to easily manufacture a guide wire that exhibits these effects, and moreover, it can take a width in the longitudinal direction as compared with conventional bonding using only an adhesive. In addition, the diameter of the bonded portion can be further reduced, and the convenience of operation can be improved.

本発明のガイドワイヤの一実施態様におけるガイドワイヤの側面からの部分拡大断面図である。It is a partial expanded sectional view from the side of the guide wire in one embodiment of the guide wire of the present invention. 従来のガイドワイヤの側面からの部分拡大断面図である。It is a partial expanded sectional view from the side of the conventional guide wire. 従来のガイドワイヤの側面からの部分拡大断面図である。It is a partial expanded sectional view from the side of the conventional guide wire. 本発明のガイドワイヤの一実施態様におけるガイドワイヤの部分拡大斜視図である。It is a partial expansion perspective view of the guide wire in one embodiment of the guide wire of the present invention. 図1のガイドワイヤの縦断面図である。It is a longitudinal cross-sectional view of the guide wire of FIG. 本発明の他の実施態様におけるガイドワイヤの断面図である。It is sectional drawing of the guide wire in the other embodiment of this invention.

以下、本発明のガイドワイヤを、図を用いて説明するが、これにより本発明のガイドワイヤを限定するものではない。図1は、本発明のガイドワイヤの一実施態様におけるガイドワイヤの側面からの部分拡大断面図である。図2は、従来のガイドワイヤの側面からの部分拡大側面断面図である。図3は、従来のガイドワイヤの側面からの部分拡大側面断面図である。図4は、図1のガイドワイヤにおけるガイドワイヤの模式的な部分拡大斜視図である。図5は、図1のガイドワイヤの縦断面図である。図6は、本発明の他の実施態様におけるガイドワイヤの断面図である。   Hereinafter, although the guide wire of this invention is demonstrated using figures, this does not limit the guide wire of this invention. FIG. 1 is a partially enlarged sectional view from the side of a guide wire in an embodiment of the guide wire of the present invention. FIG. 2 is a partially enlarged side sectional view from the side of a conventional guide wire. FIG. 3 is a partially enlarged side sectional view from the side of a conventional guide wire. FIG. 4 is a schematic partial enlarged perspective view of a guide wire in the guide wire of FIG. FIG. 5 is a longitudinal sectional view of the guide wire of FIG. FIG. 6 is a cross-sectional view of a guide wire in another embodiment of the present invention.

本発明のガイドワイヤ1は、図1に示すように、線状に延びるコア部2と、前記コア部の先端よりも基端が細径若しくは同径の先端部材3とを備えたガイドワイヤであり、コア部2と先端部材3とが接合部4により接合されている。接合部4では、コア部2の遠位端側と先端部材3の基端側とが重複する重複部分においては、コア部2及び先端部材3の外側に接合補助部材であるコイルバネ4aが軸方向に配されている。接合部4は、コア部2、先端部材3及び接合補助部材4aの重複部分に接合材である接着剤が塗布されてコア部2と先端部材3とコイルバネ4aとを接合する固定層4bが形成されることで、形成されている。   As shown in FIG. 1, the guide wire 1 of the present invention is a guide wire provided with a core portion 2 extending linearly and a distal end member 3 having a proximal end smaller in diameter or the same diameter than the distal end of the core portion. Yes, the core portion 2 and the tip member 3 are joined by the joint portion 4. In the joint portion 4, in the overlapping portion where the distal end side of the core portion 2 and the proximal end side of the tip member 3 overlap, the coil spring 4 a that is a joining auxiliary member is axially disposed outside the core portion 2 and the tip member 3. It is arranged in. The bonding portion 4 is formed with a fixed layer 4b for bonding the core portion 2, the tip member 3, and the coil spring 4a by applying an adhesive as a bonding material to the overlapping portion of the core portion 2, the tip member 3, and the joining auxiliary member 4a. Is formed.

コイルバネ4aは先端部材3をコア部2とで狭持して接合を補助する役割を担っているが、接合補助部材として接合を補助するために筒状若しくは概略形状が筒状であればよい。接続補助部材がコイルバネである場合には、接合材として接着剤またはハンダを用いて固定層4bが形成され、固定層4bが、コア部と先端部材との表面上に前記接合補助部材を内側に含むように形成される。コイルバネを接合補助部材として用いた際には、コイルバネの内側へ軸方向にコア部先端を挿入し、コア部挿入方向の反対方向から先端部材をコイルバネの内側に挿入することで、先端部材がコイルバネとコア部とで狭持されるので、コア部、先端部材及びコイルバネが係合した状態を簡単に形成することができる。前記コイルバネは、コイルバネをそのまま用いても良いが、前記コア部と前記先端部材との表面に線材を巻回してコイルバネ状としたものであってもよい。なお、コイルバネは、接着剤またはハンダで固定されるが、接合する部材がハンダのぬれ性が悪い材料(Ni−Tiなど)の場合、固定層の形成には接着剤を用いることが好ましい。 The coil spring 4a has a role of supporting the joining by holding the tip member 3 between the core portion 2 and may be cylindrical or a rough shape as a joining auxiliary member in order to assist the joining. When the connection auxiliary member is a coil spring, the fixing layer 4b is formed using an adhesive or solder as a bonding material, and the fixing layer 4b is disposed on the surface of the core portion and the tip member so that the bonding auxiliary member is placed inside. Formed to include. When the coil spring is used as a joining auxiliary member, the tip of the core is inserted into the coil spring in the axial direction, and the tip is inserted into the coil spring from the opposite direction of the core insertion direction. Therefore, it is possible to easily form a state in which the core portion, the tip member, and the coil spring are engaged with each other. Although the coil spring may be used as it is, the coil spring may be a coil spring formed by winding a wire around the surface of the core portion and the tip member. The coil spring is fixed with an adhesive or solder, but when the member to be joined is a material with poor solder wettability (Ni-Ti or the like), it is preferable to use an adhesive for forming the fixed layer.

コイルバネの材質としては特に限定されるものではなく、当業者に自明の各種素材を使用することができるが、塑性変形の観点から、ステンレス製が好ましいが、X線造影可能なようにプラチナ製を用いることもできる。プラチナ製のコイルバネを用いた際には、ステンレス製のコイルバネを用いた別のガイドワイヤと組み合わせて使うことにより、先端部に用いられる先端コイルと前記コイルバネとがX線不透過性金属製であるために2箇所が造影して標識となるので、カテーテルを複数本使用する治療において、マーキング効果を発揮し、誤操作防止がより簡易になる。接合補助部材としてのコイルバネは、コイルバネの巻数が特に限定されるものではなく、シェイピングに影響がない程度の大きさである。コイルバネは、線材の細さ、間隔によって、適宜設定されるものであるが、長さが0.5〜300mmであり、外径が0.2〜0.8mmである。   The material of the coil spring is not particularly limited, and various materials obvious to those skilled in the art can be used. From the viewpoint of plastic deformation, stainless steel is preferable, but platinum is used so that X-ray imaging can be performed. It can also be used. When a platinum coil spring is used, the tip coil used for the tip and the coil spring are made of a radiopaque metal by using in combination with another guide wire using a stainless steel coil spring. Therefore, since two places are contrasted and become a label, in a treatment using a plurality of catheters, a marking effect is exhibited and erroneous operation prevention becomes easier. The coil spring as the joining auxiliary member is not particularly limited in the number of turns of the coil spring, and has a size that does not affect the shaping. The coil spring is appropriately set according to the fineness and interval of the wire, but has a length of 0.5 to 300 mm and an outer diameter of 0.2 to 0.8 mm.

また、前記接合補助部材は、コイルバネに替えて、金属製若しくは樹脂製の円筒体であってもよい。前記接合補助部材が金属製若しくは樹脂製の円筒体である場合には、前記接着剤による接着での固定に換えて、樹脂製の円筒体を熱収縮すること、または金属若しくは樹脂製の円筒体を加締めることにより、前記接合部を形成しても良い。   Further, the joining auxiliary member may be a metal or resin cylindrical body instead of the coil spring. When the joining auxiliary member is a metal or resin cylindrical body, the resin cylindrical body is thermally shrunk instead of being fixed by bonding with the adhesive, or a metal or resin cylindrical body The joint may be formed by caulking.

接合補助部材に用いられる金属製若しくは樹脂製の円筒体としては、コア部と先端部材との重複部分を内側に収納し、かつ、加締め若しくは熱収縮によりコア部と先端部材とを固定することができる材質及びサイズであれば特に限定されるものではない。なかでも前記金属製若しくは樹脂製の円筒体の材質としては、生体適合性、加工性、コストの観点からステンレスが好ましい。   As a cylindrical body made of metal or resin used for the joining auxiliary member, the overlapping portion of the core portion and the tip member is accommodated inside, and the core portion and the tip member are fixed by caulking or heat shrinkage. There is no particular limitation as long as the material and size can be used. Among these, stainless steel is preferable as the material of the metal or resin cylindrical body from the viewpoint of biocompatibility, workability, and cost.

固定層4bは、前記コア部2と前記先端部材3と前記コイルバネ4aとを一体的に固着する。すなわち、前記接合材が接着剤である場合には、固定層4bは、コア部2と先端部材3とをコイルバネ4aにより係合した後に接着剤が塗布されて形成される。コイルバネ4aをも含む形で固定層4bが形成されるために、図2に示されるような、コイルバネ4aを用いずに接着剤のみを塗布した場合に比べて、接着剤の樹脂成分により形成される固定層4bがガイドワイヤ1の長手方向に広がることもない。これは、接合補助部材(コイルバネ4a)とコア部2・先端部材3との間隙によって生じる毛管力の作用に起因して接着剤の流動が阻害されることによる。かかる毛管力により、コア部2・先端部材3との間隙でガイドワイヤ1の長手方向に接着剤が広がることもなく、コア部と先端部材とに亘って存在する接着剤の樹脂層が一定以上の厚さを確保できるので、コア部と先端部材との固着強度の強い固定層4bを形成することができる。つまり、コア部2と先端部材3およびコイルバネ4aをすべて包む形で接着部が形成されるため、使用による先端部材の抜けを確実に防ぎ、より強固にコア部2と先端部材3とを接合することができる。   The fixed layer 4b integrally fixes the core portion 2, the tip member 3, and the coil spring 4a. That is, when the bonding material is an adhesive, the fixing layer 4b is formed by applying the adhesive after the core portion 2 and the tip member 3 are engaged by the coil spring 4a. Since the fixed layer 4b is formed so as to include the coil spring 4a, it is formed by the resin component of the adhesive as compared with the case where only the adhesive is applied without using the coil spring 4a as shown in FIG. The fixed layer 4b does not spread in the longitudinal direction of the guide wire 1. This is because the flow of the adhesive is hindered due to the action of the capillary force generated by the gap between the joining auxiliary member (coil spring 4a) and the core portion 2 / tip member 3. With this capillary force, the adhesive does not spread in the longitudinal direction of the guide wire 1 in the gap between the core portion 2 and the tip member 3, and the resin layer of the adhesive existing over the core portion and the tip member exceeds a certain level. Therefore, it is possible to form the fixed layer 4b having a strong fixing strength between the core portion and the tip member. That is, since the bonding portion is formed so as to enclose all of the core portion 2, the tip member 3, and the coil spring 4a, the tip portion is prevented from being pulled out by use, and the core portion 2 and the tip member 3 are joined more firmly. be able to.

前記接着剤の種類としては特に限定されないが、エポキシ系接着剤、シアノアクリレート系接着剤などを用いることができる。特に、ニッケルチタン合金等からなるコア部2とステンレス等からなる先端部材3とを強固に接着して、乾燥時のコア部と先端部材とのブレを生じにくく、作業性が良好なことから、前記接着剤はエポキシ系接着剤が好ましい。このように、コイルバネ4aで、コア部2と先端部材3とを狭持したのちに、接着剤4bで、コア部2と先端部材3とコイルバネ4aとを一体的に接着することにより、強固な固定層4を形成することができ、ガイドワイヤ1長手方向(図1のA1方向)の引張強度を顕著に向上させることができる。前記接着剤による固定層は、従来のハンダを用いた場合と比べて、ガイドワイヤ1の長手方向と垂直方向(図1のA2方向)における弾性をも有することが期待できるので、ガイドワイヤ1の長手方向と垂直な方向における曲げ効率を顕著に向上させることができるため、治療の際の操作性の向上が期待できる。また、変性による破壊や接着剤の剥離も生じない。   Although it does not specifically limit as a kind of said adhesive agent, An epoxy-type adhesive agent, a cyanoacrylate-type adhesive agent, etc. can be used. In particular, since the core part 2 made of nickel titanium alloy or the like and the tip member 3 made of stainless steel or the like are firmly bonded, the core part and the tip member during drying are less likely to be shaken, and the workability is good. The adhesive is preferably an epoxy adhesive. Thus, after sandwiching the core part 2 and the tip member 3 with the coil spring 4a, the core part 2, the tip member 3 and the coil spring 4a are integrally bonded with the adhesive 4b, so The fixed layer 4 can be formed, and the tensile strength in the longitudinal direction of the guide wire 1 (A1 direction in FIG. 1) can be remarkably improved. Since the fixing layer made of the adhesive can be expected to have elasticity in the direction perpendicular to the longitudinal direction of the guide wire 1 (A2 direction in FIG. 1) as compared with the case of using conventional solder, Since the bending efficiency in the direction perpendicular to the longitudinal direction can be remarkably improved, improvement in operability during treatment can be expected. Moreover, the destruction by the modification and the peeling of the adhesive do not occur.

ここで、接合部は、ガイドワイヤ1長手方向に0.5〜1.5mm形成されていることが好ましい。1.5mm以上の場合にはコア部2と先端部材3のとの接合作業が容易であるが曲がりにくい。0.5mm以下の場合には塑性変形が容易となるので曲がりやすく、用途に制限がないが、接合強度が弱くなる。   Here, it is preferable that the junction is formed in the longitudinal direction of the guide wire 1 by 0.5 to 1.5 mm. In the case of 1.5 mm or more, the joining operation between the core portion 2 and the tip member 3 is easy, but is difficult to bend. In the case of 0.5 mm or less, plastic deformation is easy, so that it is easy to bend and there is no limit to the application, but the bonding strength is weakened.

コア部2は、ガイドワイヤ1の大部分を占める部材であり、カテーテルを導入する際のガイドとなる部材である。その全長としては、特に制限はないが、一般的に50〜300cm程度であり、治療に応じて適宜用いられる。 図1、図4に示される実施態様では、コア部2は、体腔内を傷つけることなく柔軟に先進するために超弾性を有するニッケルチタン合金製であり、径の異なる3つの部位から構成されている。   The core portion 2 is a member that occupies most of the guide wire 1 and serves as a guide when a catheter is introduced. Although there is no restriction | limiting in particular as the full length, Generally, it is about 50-300 cm, and is used suitably according to a treatment. In the embodiment shown in FIG. 1 and FIG. 4, the core portion 2 is made of a nickel-titanium alloy having superelasticity so as to advance flexibly without damaging the body cavity, and is composed of three parts having different diameters. Yes.

先端部材3は、接合部4を介して前記ガイドワイヤ1の先端に接合されている。図1、図4に示される実施態様においては、先端部材3は、長さ方向を有し、コア部2の先端よりも基端が細径若しくは同径であり、前記コア部2に平行して接合されており、コア部2の先端よりもさらにガイドワイヤ1長手方向に突出するよう接合されている。コア部2のみでは治療に際して曲がり癖を付けることが困難であり、ガイドワイヤ1の先端を所望の形状にシェイピングすることが困難であったが、ガイドワイヤ1の先端に塑性変形しやすいステンレス製の先端部材3を用い、該先端部材が基端側は棒状形状とされ、先端側が平坦な板状とされていることから、シェイピングが容易であって、しかもより曲がった形状がしやすくなっている。   The distal end member 3 is joined to the distal end of the guide wire 1 via the joining portion 4. In the embodiment shown in FIGS. 1 and 4, the distal end member 3 has a length direction, the proximal end is narrower or the same diameter as the distal end of the core portion 2, and is parallel to the core portion 2. And joined so as to protrude further in the longitudinal direction of the guide wire 1 than the tip of the core portion 2. Although it is difficult to bend and wrinkle at the time of treatment with only the core portion 2 and it is difficult to shape the tip of the guide wire 1 into a desired shape, the tip of the guide wire 1 is made of stainless steel which is easily plastically deformed. Since the distal end member 3 is used and the distal end side has a rod-like shape on the proximal end side and a flat plate shape on the distal end side, it is easy to shape and more easily bend. .

図1のガイドワイヤは、図5に示すように、公知の方法によってウレタンコートが施されてウレタン系樹脂部7が形成され、先端部分が、先端コイル5と先端部材3のプレス部3bとを有する先端近傍領域と、円筒状ウレタン系樹脂部7の内部に先端コイル5と先端部材3の本体部3aとが埋設された基端領域とを備えたガイドワイヤ1とすることができる。ガイドワイヤ1は、先端部にステンレス製の先端部材3を備え、先端部は、先端部材3が先端コイル5の内側に配置されるように、先端部材3の先端と先端コイル5の先端とをガイドワイヤの先端に配されたチップ6で固定した先端構造を有している。また、コア2の先端部と前記先端コイルの端部とが、先端部材3を含んで固定部8が形成されるように接着される。先端部材は、先端のプレス部3bと線体である本体部3aとからなり、ガイドワイヤ1は、先端部の基端領域からコアの基端方向まで最外層となるようにウレタン系樹脂部7が形成され、さらに本発明の接合部4をも備えている。かかる実施形態とすることにより、先端部が3つの領域を持つことからシェイピング性が良く、しかもコア部と先端部材とが不意に外れる医療事故がなく、かつ、簡単に先端部材とコア部とを接合でき、しかも優れた操作性をも有するガイドワイヤとすることができる。   As shown in FIG. 5, the guide wire of FIG. 1 is urethane-coated by a known method to form a urethane-based resin portion 7, and the tip portion is connected to the tip coil 5 and the press portion 3 b of the tip member 3. The guide wire 1 can be provided with an area near the distal end and a proximal end area in which the distal end coil 5 and the main body portion 3a of the distal end member 3 are embedded in the cylindrical urethane-based resin portion 7. The guide wire 1 includes a tip member 3 made of stainless steel at the tip, and the tip is connected to the tip of the tip member 3 and the tip of the tip coil 5 so that the tip member 3 is disposed inside the tip coil 5. It has a tip structure fixed with a tip 6 arranged at the tip of the guide wire. Further, the distal end portion of the core 2 and the end portion of the distal end coil are bonded so that the fixing portion 8 including the distal end member 3 is formed. The distal end member is composed of a pressing portion 3b at the distal end and a main body portion 3a which is a linear body, and the guide wire 1 is a urethane-based resin portion 7 so as to be the outermost layer from the proximal end region of the distal end portion to the proximal end direction of the core. Is further provided with the joint 4 of the present invention. By adopting such an embodiment, since the tip portion has three regions, the shapeability is good, and there is no medical accident in which the core portion and the tip member are unexpectedly removed, and the tip member and the core portion can be easily connected. A guide wire that can be joined and has excellent operability can be obtained.

図5の実施態様例においては、ガイドワイヤ1は、チップ6の先端からコア部2の基端2fまでの長さが1800mmである。コア部2は、PTFEコーティングされた基部2eから縮径し、基端部2fからテーパー部2dを介して第一縮径部2cにつながり、段差部2gを介して外径0.11mmの第二縮径部2bへつながる。第二縮径部2bはさらに段差を介して第三縮径部2aへとつながる。コイルバネ4aは素線径0.06mmのSUSコイルで外径0.3mmに形成され、接着部4は長さ1.0mmで形成することができる。固定部8は、長さ1.2〜1.7mmとなるように、素線径0.07mmで外径0.30mmの先端コイルとの基端と先端部材3の外径0.06mmの本体部3aとコア部の第三縮径部2aとを含むように接着剤により形成されている。先端コイル5の先端と先端部材3のプレス部3bの先端とを固定するように、先端のチップはハンダにより形成されている。なお、プレス部は、先端部材において、線材の先端側プレス加工することにより薄い平板状とされた部分であり、シェイピングをより容易とした部分である。   In the embodiment shown in FIG. 5, the guide wire 1 has a length of 1800 mm from the tip end of the chip 6 to the base end 2 f of the core portion 2. The core portion 2 is reduced in diameter from the PTFE-coated base portion 2e, is connected from the base end portion 2f to the first reduced diameter portion 2c through the tapered portion 2d, and has a second diameter of 0.11 mm through the stepped portion 2g. It leads to the reduced diameter part 2b. The second reduced diameter portion 2b is further connected to the third reduced diameter portion 2a through a step. The coil spring 4a is a SUS coil having a strand diameter of 0.06 mm and is formed with an outer diameter of 0.3 mm, and the bonding portion 4 can be formed with a length of 1.0 mm. The fixed portion 8 has a base wire diameter of 0.07 mm and a distal end coil having an outer diameter of 0.30 mm and a main body of the distal end member 3 having an outer diameter of 0.06 mm so that the length is 1.2 to 1.7 mm. It is formed of an adhesive so as to include the portion 3a and the third reduced diameter portion 2a of the core portion. The tip of the tip is formed of solder so as to fix the tip of the tip coil 5 and the tip of the press part 3b of the tip member 3. In addition, a press part is a part made into thin flat plate shape by carrying out the front end side press process of a wire, and is a part which made shaping easier.

また、本発明のガイドワイヤは、図1の実施態様においては、前記接合部が前記先端部材の基端に設けられているが、他の実施態様として、図6に示す実施態様例を用いることができる。ガイドワイヤ11においては、コイルバネ14aが先端部材13の基端からコア部12の先端近傍まで延在し、前記接合部として、コイルバネの基端側に設けられた基端側接合部14と、コイルバネの先端側に設けられ、先端コイル15と先端部材13とコア12との固定部でもある先端側接合部18とが設けられたガイドワイヤとすることもできる。このように、接合補助部材であるコイルバネ14aが先端部材13の基端からコア部12の先端近傍まで延在することにより、コイルバネ14とコア2とによって、先端部材13をより強固に狭持することができるので接着の作業性が良く、しかも、先端コイルと先端部材とコア部との接合部としての形成も容易となり、先端部材の抜けの防止がより容易となる。なお、この実施態様例においては、接合補助部材としてコイルバネ若しくは熱収縮可能な樹脂製の筒状体を用い、コイルバネに接着剤を塗布することにより固定層を形成して接合部を設けるか、樹脂製の筒状体を熱収縮させることで接合部を設けるかでも良い。   Further, in the embodiment of FIG. 1, the guide wire of the present invention is provided with the joint portion at the proximal end of the distal end member. As another embodiment, the embodiment shown in FIG. 6 is used. Can do. In the guide wire 11, a coil spring 14 a extends from the proximal end of the distal end member 13 to the vicinity of the distal end of the core portion 12, and the proximal end side joint portion 14 provided on the proximal end side of the coil spring as the joint portion, and a coil spring It is also possible to provide a guide wire provided with a distal end side joint portion 18 which is provided on the distal end side of the first end coil 15 and is also a fixing portion for the distal end coil 15, the distal end member 13 and the core 12. As described above, the coil spring 14a, which is a joining auxiliary member, extends from the proximal end of the distal end member 13 to the vicinity of the distal end of the core portion 12, whereby the distal end member 13 is more firmly held by the coil spring 14 and the core 2. Therefore, the workability of the bonding is good, and the formation of the joining portion between the tip coil, the tip member, and the core portion is facilitated, and the tip member can be prevented from coming off more easily. In this embodiment, a coil spring or a heat-shrinkable resin tubular body is used as a joining auxiliary member, and a fixing layer is formed by applying an adhesive to the coil spring to provide a joint portion or resin. A joining part may be provided by heat shrinking a cylindrical body made of metal.

次に、本発明にかかわるガイドワイヤ1の製造方法について、説明する。まず、基端側が拡径したコア部2の段差部2gよりも先端側になるようにコイルバネ4がコア部2の外側に配置され、次いでコア部とコイルバネ4aとの間隙に先端部材3を挿通し、先端部材3の基端が段差部2gに当たったところで先端部材3の挿入が止まる。先端部材3の挿入が止まって、先端部材3がコア2とコイルバネ4aにより狭持された状態で嵌着され、接着剤を塗布することにより接着剤が固化し、接合部4が形成される。このように、コア部の先端側の外側にコイルバネとを重複させ、先端部材を前記コア部とコイルバネとの間に挿入して嵌着させる接合工程と、コア部と先端部材とコイルバネとを接着剤で接着する接着工程とを含むガイドワイヤの製造方法を用いることにより、そのコア部と先端部材とが不意に外れる医療事故がなく、かつ、簡単に先端部材とコア部とを接合でき、しかも優れた操作性をも有するガイドワイヤを容易に製造することができる。特に、先端部材の基端に接着部を設けることは、先端部材がコイルバネとコア部とに嵌着した状態を容易に形成できるので好ましい。コア部2と先端部材3とを線材で巻着し、巻着部であるコイルバネ4aを形成する工程とコア部2と先端部材3とコイルバネ4aとを接着剤で接着することにより接着剤による固定層を設けて接合部4を形成してもよい。なお、コア部2、先端部材3、コイルバネ4a、接着剤等の材質、形状等は前述と同様であるため説明を省略する。   Next, a method for manufacturing the guide wire 1 according to the present invention will be described. First, the coil spring 4 is disposed on the outer side of the core portion 2 so that the base end side is closer to the tip side than the stepped portion 2g of the core portion 2 whose diameter has been expanded, and then the tip member 3 is inserted into the gap between the core portion and the coil spring 4a. The insertion of the tip member 3 stops when the base end of the tip member 3 hits the stepped portion 2g. Insertion of the tip member 3 is stopped, the tip member 3 is fitted in a state of being held between the core 2 and the coil spring 4a, and the adhesive is solidified by applying the adhesive, whereby the joint portion 4 is formed. In this way, the coil spring is overlapped on the outer side of the distal end side of the core portion, the joining step of inserting and fitting the distal end member between the core portion and the coil spring, and bonding the core portion, the distal end member, and the coil spring. By using a guide wire manufacturing method including a bonding step of bonding with an agent, there is no medical accident in which the core portion and the tip member are unexpectedly detached, and the tip member and the core portion can be easily joined. A guide wire having excellent operability can be easily manufactured. In particular, it is preferable to provide an adhesive portion at the proximal end of the tip member because the tip member can be easily formed in a state of being fitted to the coil spring and the core portion. The core part 2 and the tip member 3 are wound with a wire, and the coil spring 4a that is the wound part is formed, and the core part 2, the tip member 3, and the coil spring 4a are bonded with an adhesive, thereby fixing with an adhesive. A layer may be provided to form the joint 4. The material, shape, and the like of the core portion 2, the tip member 3, the coil spring 4a, the adhesive, and the like are the same as described above, and a description thereof is omitted.

本発明において、図5のガイドワイヤ1においては、さらにコア部2の先端と先端部材3の中間部と先端コイルの基端部とを接着剤で接着することにより固定部8を公知の方法により形成し、先端部材3の先端と先端コイル5の先端とを固定するようにハンダによってチップ6を公知の方法により形成することができる。チップが形成されたガイドワイヤにウレタン系樹脂を押出しやディッピング等の公知の方法によりコーティングすることにより、ウレタン樹脂部系7が形成されたガイドワイヤを得ることができる。   In the present invention, in the guide wire 1 of FIG. 5, the fixing portion 8 is further bonded by a known method by bonding the distal end of the core portion 2, the intermediate portion of the distal end member 3, and the proximal end portion of the distal end coil with an adhesive. The tip 6 can be formed by a known method by soldering so that the tip of the tip member 3 and the tip of the tip coil 5 are fixed. By coating urethane guide resin on the guide wire on which the chip is formed by a known method such as extrusion or dipping, a guide wire on which the urethane resin portion system 7 is formed can be obtained.

また、図6の実施態様例については、図1のガイドワイヤの製造方法におけるコア部2の先端と先端部材3の中間部と先端コイル5の基端部とを接着剤で接着することにより固定部8を形成することに換えて、先端部材の基端からコアの先端近傍までの長さを有するコイルバネを用い、コア部12の先端と先端部材13の中間部と先端コイル15の基端部とコイルバネ14aの先端とを接着剤で接着して先端側接合部18を形成することにより、図6のガイドワイヤを得ることができる。   6 is fixed by adhering the distal end of the core portion 2, the intermediate portion of the distal end member 3, and the proximal end portion of the distal end coil 5 with an adhesive in the guide wire manufacturing method of FIG. Instead of forming the portion 8, a coil spring having a length from the proximal end of the distal end member to the vicinity of the distal end of the core is used, and the distal end of the core portion 12, the intermediate portion of the distal end member 13, and the proximal end portion of the distal end coil 15. The guide wire shown in FIG. 6 can be obtained by bonding the tip of the coil spring 14a to the tip of the coil spring 14a with an adhesive to form the tip side joint 18.

以上、本発明にかかわるガイドワイヤによれば、コア部と先端部材とを極めて容易に接合できることからコア部と先端部材とが不意に外れて医療事故となる恐れのある不良品の不良率を極めて低くすることができ、かつ、ガイドワイヤの操作に耐え得る充分な弾性をも有するガイドワイヤを提供することができる。また、本発明にかかるガイドワイヤの製造方法によって、これらの効果を奏するガイドワイヤを簡便に製作することができ、さらに、従来の接着剤のみによる接合に比べて、長手方向に幅を取ることがなく、さらに接着部の縮径が可能となり、操作の利便性を向上させることができる。   As described above, according to the guide wire according to the present invention, since the core portion and the tip member can be joined very easily, the defect rate of defective products that can cause the core portion and the tip member to come off unexpectedly and cause a medical accident is extremely high. It is possible to provide a guide wire that can be lowered and has sufficient elasticity to withstand the operation of the guide wire. In addition, the guide wire manufacturing method according to the present invention makes it possible to easily manufacture a guide wire that achieves these effects, and it can take a width in the longitudinal direction as compared with conventional bonding using only an adhesive. In addition, the diameter of the bonded portion can be further reduced, and the convenience of operation can be improved.

1 ガイドワイヤ
2 コア部
3 先端部材
4 接合部
4a コイルバネ
4b 固定層
5 先端コイル
6 チップ
7 ウレタン系樹脂部
8 固定部
11 ガイドワイヤ
12 コア部
13 先端部材
14 接合部
14a コイルバネ
15 先端コイル
16 チップ
17 ウレタン系樹脂部
18 先端側接合部(固定部)
DESCRIPTION OF SYMBOLS 1 Guide wire 2 Core part 3 Tip member 4 Joining part 4a Coil spring 4b Fixing layer 5 Tip coil 6 Tip 7 Urethane resin part 8 Fixing part 11 Guide wire 12 Core part 13 Tip member 14 Joining part 14a Coil spring 15 Tip coil 16 Tip 17 Urethane resin part 18 Tip side joint (fixed part)

Claims (7)

線状に延びるコア部と、前記コア部の先端よりも基端が細径若しくは同径の先端部材とを備えたガイドワイヤであって、
前記コア部と前記先端部材とは接合部により接合され、
前記接合部には、前記コア部の遠位端側と前記先端部材の基端側とが重複する重複部分において、前記コア部及び前記先端部材の外側に筒状若しくは概略形状が筒状である接合補助部材が軸方向に配され、
前記接合部は、
(a)前記接合補助部材が、熱収縮され若しくは加締められること、
または
(b)前記コア部、前記先端部材、及び前記接合補助部材の重複部分に、接合材による固定層が形成されること、
により接合されて形成されたガイドワイヤ。
A guide wire comprising a linearly extending core portion and a distal end member having a smaller diameter or the same diameter than the distal end of the core portion,
The core part and the tip member are joined by a joint part,
In the overlapping portion where the distal end side of the core portion and the proximal end side of the tip member overlap, the joint portion has a cylindrical shape or a cylindrical shape outside the core portion and the tip member. A joining auxiliary member is arranged in the axial direction,
The joint is
(A) the joining auxiliary member is thermally contracted or crimped;
Or (b) a fixed layer made of a bonding material is formed in an overlapping portion of the core portion, the tip member, and the bonding auxiliary member;
A guide wire formed by joining together.
前記接合補助部材がコイルバネであり、前記接合材が接着剤またはハンダであり、前記固定層が前記接合補助材を内部に含んで前記コア部と前記先端部材との表面上に形成されることにより接合部が形成された請求項1に記載のガイドワイヤ。   The bonding auxiliary member is a coil spring, the bonding material is an adhesive or solder, and the fixing layer includes the bonding auxiliary material inside and is formed on the surfaces of the core portion and the tip member. The guide wire according to claim 1, wherein a joint portion is formed. 前記接合補助部材が金属若しくは樹脂製の円筒体であり、樹脂製の円筒体を熱収縮すること、または金属若しくは樹脂製の円筒体を加締めることにより前記接合部が形成された請求項1に記載のガイドワイヤ。   2. The joining portion according to claim 1, wherein the joining auxiliary member is a metal or resin cylindrical body, and the joint portion is formed by heat shrinking the resin cylindrical body or caulking the metal or resin cylindrical body. Guide wire as described. 前記接合部が前記先端部材の基端に設けられた請求項1〜3のいずれかに記載のガイドワイヤ。   The guide wire according to claim 1, wherein the joint portion is provided at a proximal end of the distal end member. 前記接合補助部材が先端部材の基端からコア部の先端近傍まで延在し、前記接合部として、前記接合補助部材の先端側に設けられた先端側接合部と前記接合補助部材の基端側に設けられた基端側接合部とが設けられ、
前記接合補助部材が、熱収縮可能な合成樹脂製の円筒体かコイルバネである
請求項1〜3のいずれかに記載のガイドワイヤ。
The joining auxiliary member extends from the proximal end of the distal end member to the vicinity of the distal end of the core portion, and the distal end side joining portion provided on the distal end side of the joining assisting member and the proximal end side of the joining auxiliary member as the joining portion And a proximal end side joint provided in
The guide wire according to claim 1, wherein the joining auxiliary member is a heat-shrinkable synthetic resin cylindrical body or a coil spring.
先端部に用いられる先端コイルを備え、前記先端コイルと前記コイルとがX線不透過性金属製であることを特徴とする請求項1〜5のいずれかに記載のガイドワイヤ。   The guide wire according to any one of claims 1 to 5, further comprising a tip coil used for a tip portion, wherein the tip coil and the coil are made of a radiopaque metal. 線状に延びるコア部と、前記コア部の先端よりも基端が細径若しくは同径の先端部材とを備えたガイドワイヤの製造方法であって
前記コア部の先端側の外側に接合補助部材とを重複させ、前記先端部材を前記コア部と前記接合補助部材との間に挿入して嵌着させる嵌着工程と
前記コア部と前記先端部材と前記接合補助部材とを、
(a)前記接合補助部材が、熱収縮され若しくは加締められること、
または
(b)前記コア部、前記先端部材、及び前記接合補助部材の重複部分に、接合材による固定層が形成されること
により接合する接合工程とを含むガイドワイヤの製造方法。
A guide wire manufacturing method comprising: a core portion extending linearly; and a tip member having a base end smaller in diameter or the same diameter than the tip end of the core portion, and a joining auxiliary member outside the tip end side of the core portion And a fitting step of inserting and fitting the tip member between the core part and the joining auxiliary member, and the core part, the tip member, and the joining auxiliary member,
(A) the joining auxiliary member is thermally contracted or crimped;
Or (b) a guide wire manufacturing method including a joining step in which a fixing layer made of a joining material is formed at an overlapping portion of the core portion, the tip member, and the joining auxiliary member.
JP2009112839A 2009-05-07 2009-05-07 Guide wire and manufacturing method thereof Pending JP2010259624A (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013111404A1 (en) * 2012-01-26 2013-08-01 テルモ株式会社 Guide wire
JP2018524086A (en) * 2015-07-17 2018-08-30 コーニンクレッカ フィリップス エヌ ヴェKoninklijke Philips N.V. Intravascular devices, systems and methods using molded ribbons attached with adhesives
WO2018180929A1 (en) 2017-03-31 2018-10-04 富士フイルム株式会社 Resin molded body and blue light cut laminated body
JP2020137854A (en) * 2019-02-28 2020-09-03 朝日インテック株式会社 Guide wire

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Publication number Priority date Publication date Assignee Title
JPH08510394A (en) * 1993-03-12 1996-11-05 シー・アール・バード・インコーポレーテッド Anatomically steerable steerable PTCA guidewire
JP2003260140A (en) * 2002-03-12 2003-09-16 Tokusen Kogyo Co Ltd Medical guide wire core material and medical guide wire using the same
JP2005528126A (en) * 2001-10-05 2005-09-22 ボストン サイエンティフィック リミテッド Composite guidewire

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08510394A (en) * 1993-03-12 1996-11-05 シー・アール・バード・インコーポレーテッド Anatomically steerable steerable PTCA guidewire
JP2005528126A (en) * 2001-10-05 2005-09-22 ボストン サイエンティフィック リミテッド Composite guidewire
JP2003260140A (en) * 2002-03-12 2003-09-16 Tokusen Kogyo Co Ltd Medical guide wire core material and medical guide wire using the same

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013111404A1 (en) * 2012-01-26 2013-08-01 テルモ株式会社 Guide wire
JPWO2013111404A1 (en) * 2012-01-26 2015-05-11 テルモ株式会社 Guide wire
JP2018524086A (en) * 2015-07-17 2018-08-30 コーニンクレッカ フィリップス エヌ ヴェKoninklijke Philips N.V. Intravascular devices, systems and methods using molded ribbons attached with adhesives
WO2018180929A1 (en) 2017-03-31 2018-10-04 富士フイルム株式会社 Resin molded body and blue light cut laminated body
JP2020137854A (en) * 2019-02-28 2020-09-03 朝日インテック株式会社 Guide wire
JP7353043B2 (en) 2019-02-28 2023-09-29 朝日インテック株式会社 guide wire

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