JP4197961B2 - Manufacturing method of medical guide wire - Google Patents

Manufacturing method of medical guide wire Download PDF

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Publication number
JP4197961B2
JP4197961B2 JP2003012949A JP2003012949A JP4197961B2 JP 4197961 B2 JP4197961 B2 JP 4197961B2 JP 2003012949 A JP2003012949 A JP 2003012949A JP 2003012949 A JP2003012949 A JP 2003012949A JP 4197961 B2 JP4197961 B2 JP 4197961B2
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shaped
shaping
coil body
manufacturing
guide wire
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JP2004222880A (en
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富久 加藤
憲治 千田
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Asahi Intecc Co Ltd
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Asahi Intecc Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B21MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21FWORKING OR PROCESSING OF METAL WIRE
    • B21F1/00Bending wire other than coiling; Straightening wire
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B21MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21FWORKING OR PROCESSING OF METAL WIRE
    • B21F45/00Wire-working in the manufacture of other particular articles
    • B21F45/008Wire-working in the manufacture of other particular articles of medical instruments, e.g. stents, corneal rings
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B21MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21FWORKING OR PROCESSING OF METAL WIRE
    • B21F99/00Subject matter not provided for in other groups of this subclass
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09058Basic structures of guide wires
    • A61M2025/09083Basic structures of guide wires having a coil around a core
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09108Methods for making a guide wire

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pulmonology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Other Surface Treatments For Metallic Materials (AREA)

Description

【0001】
【発明の属する技術分野】
本発明は、血管や尿管・気管等の体腔内にカテーテルを挿入したり、血管の病変部に治療用留置具を挿入する等に用いる端部付形型の医療用ガイドワイヤの製造方法に関するものである。
【0002】
【従来の技術】
端部付形型の医療用ガイドワイヤは、特許文献1に示す公知例があり(図9参照)ステンレス・プラチナ・タングステン・金等の金属線を密着状にコイリングした可撓性線状体のコイル体1に、ステンレス線・炭素鋼線等の芯線2を挿入着してコイル体1の前端部分をU字状に曲成した付形部Fを設けた形態を有している。
【0003】
そして、その公知例の付形部Fつき医療用ガイドワイヤGは(図10参照)、安全ワイヤ3(コイル体1の伸び防止ワイヤ)と芯線2を並存させてコイル体1の中空部に内挿すると共に、安全ワイヤ3の両端をコイル体1の両端にロー材等によって形成した栓状の膨出端4と共に固定してセットされ、U字型の成形溝51を有するブロック体の「蓋板52つき成形型50」に付形すべき先端部分を圧入挿してU字型の付形部Fを形成し、続いてその成形型50と共に加熱装置(図示しない)に入れて、加工による残留応力除去の加熱処理を施して付形成形する製造方法に成っている。
【0004】
【特許文献1】
特許第3300155号公報(図1・図2、請求項)
【0005】
【発明が解決しようとする課題】
以上の公知例の製造方法は、コイル体1に内挿した安全ワイヤ3が芯線2と共存し、かつ、コイル体1の両端に固定された両端固定形態のままU字状に付形成形する工法となるので、下記の難点が存在する。
【0006】
即ち、コイル体1は密着コイル形態であることから、付形部F成形のために先端部分を曲げ変形させるときの曲げ中立面が、その曲げ内側のコイル体1の外周となり、コイル体1内に両端固定状態で存在する安全ワイヤ3は「その曲げ中立面より大なる曲率半径に強制曲げされるので異常な張力」が生ずる。
【0007】
しかし、安全ワイヤ3は容易に弾性伸びしない剛質であるので、その張力は成形溝51から突き出す自由状態のストレート状のコイル体1に該張力に基づく曲がりを生じた状態で付形することになるので、付形成形加熱処理後に、その曲がり部分にストレート状への復元応力を生ずる。従って、U字状の付形部Fがその曲がり復元応力の影響を受けてU字付形形状の崩れをもたらす品質上の難点がある。そして、前記のコイル体1の曲がり変形抵抗は、コイル体1の成形型50への挿入抗力としてあらわれるので、成形作業がしづらく非能率になる。
【0008】
さらに、加熱装置で加熱処理するとき、マスが大なるブロック状の成形型50に付形部Fを内蔵した形態で加熱処理するので、その成形型50の加熱昇温に時間を要し、付形部Fの加熱処理のためのカロリーロス・加熱時間が大にして、その上加熱後の付形部Fの外し作業が煩雑(成形型50自体の冷却に時間がかかる)になる等の加熱処理生産性上の不具合がある。
【0009】
本発明は、以上の従来技術の難点を解消する「医療用ガイドワイヤの製造方法」を提供するものである。
【0010】
【課題を解決するための手段】
以上の技術課題を解決する本発明は「可撓性線状体のコイル体の端部に曲成状の付形部を備えた医療用ガイドワイヤを製造するにおいて、該コイル体の端部を開口端から挿脱自在に受け入れる付形パイプ、または、付形溝を付形軸の外周に備えた付形型に、該コイル体の端部を挿入して前記付形部を形成し、しかるのち、該付形型に付形保持したまま加工による残留応力除去の加熱処理を施して成形することを特徴とする医療用ガイドワイヤの製造方法」の第1製造方法と、
【0011】
「可撓性線状体のコイル体の端部に曲成状の付形部を備えた医療用ガイドワイヤを製造するにおいて、開口端から該コイル体の端部を挿脱自在に受け入れるフレキシブルパイプの付形パイプを付形軸の外周に備えた付形型に、該コイル体の端部を挿入セットし、続いて該付形パイプを該付形軸の外周に沿わせ変形させて前記付形部を形成し、しかるのち、該付形型に付形保持したまま加工による残留応力除去の加熱処理を施して成形することを特徴とする医療用ガイドワイヤの製造方法」の第2製造方法と、
【0012】
「可撓性線状体のコイル体の端部に曲成状の付形部を備えた医療用ガイドワイヤを製造するにおいて、該コイル体の端部を突き出しセット可能にして、かつ、該突き出し部分を付形軸に沿わせ変形させる可撓性付形板を備えた付形冶具に、前記端部をセットして該可撓性付形板によって前記付形部を形成し、しかるのち、該付形冶具に付形保持したまま加工による残留応力除去の加熱処理を施して成形することを特徴とする医療用ガイドワイヤの製造方法」の第3製造方法と、
【0013】
「可撓性線状体のコイル体の端部に曲成状の付形部を備えた医療用ガイドワイヤを製造するにおいて、該コイル体の端部を、付形冶具の付形軸の外周に沿えてセットし、しかるのち、該付形軸の回転による変形または該付形軸外周への添着による変形によって前記付形部を形成し、しかるのち、該付形冶具に付形保持したまま加工による残留応力除去の加熱処理を施して成形することを特徴とする医療用ガイドワイヤの製造方法」の第4製造方法と、
【0014】
「可撓性線状体のコイル体の端部に曲成状の付形部を備えた医療用ガイドワイヤを製造するにおいて、該コイル体に安全ワイヤを挿通して、該安全ワイヤの先端を前記付形部にすべきコイル体前端に固定すると共に、該固定点以外を自由状態にして該コイル体から突き出してセットし、続いて、付形型または付形冶具によって前記付形部を形成し、しかるのち、該付形型または該付形冶具に付形保持したまま加工による残留応力除去の加熱処理を施し、続いて前記安全ワイヤの突き出し部分を切断して該切断端を該コイル体に溶着固定して製造することを特徴とする医療用ガイドワイヤの製造方法」の第5製造方法と、
【0015】
「可撓性線状体のコイル体の端部に曲成状の付形部を備えた医療用ガイドワイヤを製造するにおいて、段落0010〜段落0014のいずれかの成形方法によって該付形部の成形と該付形成形後の加熱処理を施し、しかるのち、コイル体内に所定長の芯線と安全ワイヤを後入れ挿着して該安全ワイヤの先端を該コイル体の先端に溶着固定すると共に、該芯線と該安全ワイヤのそれぞれの後端と該コイル体を溶着固定することを特徴とする医療用ガイドワイヤの製造方法」の第6製造方法の発明群によって構成されている。
【0016】
そして、以上の製造方法の態様として「付形部の外周に、電解研磨または電解研磨後の超音波洗浄」を施して樹脂被覆を設けたり、その樹脂被覆の上に「ポリビニルピロリドン・ヒアルロン酸等の公知の親水性ポリマーの被覆層」を設ける。
【0017】
【作用】
前記第1〜第4製造方法は、付形部Fの形成手段が付形パイプ・付形軸等を利用するので、付形すべきコイル体の端部が多数個並列自在にして単回の付形操作による多数個同時付形が可能になり、付形生産性が極めて向上する。
【0018】
さらに、付形部Fを成形するための付形型が、前記の付形パイプ・付形板等から成るので加熱装置内での付形部Fへの熱伝導性が極めて良く、少なる熱カロリー短時間で応分の加熱処理ができると共に、加熱処理後の冷却が迅速にして付形型・付形冶具からの外しが迅速かつ簡便にできる。
【0019】
そして、前記第5製造方法はコイル体に前端を固定して挿着する安全ワイヤがフリー形態となるので、段落0005〜0007に示す「付形部F形成のときに安全ワイヤに生ずる有害な引っ張り応力の発生がなく」付形成形が極めて円滑にできると共に、付形後の付形部F変形が無く付形品質が安定し向上する。
【0020】
そして、前記第6製造方法は、コイル体の付形部Fの成形加熱処理後に芯線・安全ワイヤをコイル体に挿着して、それ等を溶着固定する工法を特徴とするので、以下に詳述する特有作用がある。
【0021】
即ち、コイル体と安全ワイヤの体積比は「例えば通常形態の医療用ガイドワイヤにおいて、概ね35〜36倍」の特段の相違がある。従って、大なる体積のコイル体を基準にして残留応力除去の加熱処理を施すと、コイル体より特段に小なる体積の安全ワイヤ・芯線は過剰加熱処理となって機械的性質の劣化を生じて機能不全になるケースがある。しかし、前記第6製造方法はコイル体の付形加熱処理後に、芯線・安全ワイヤを後付け挿着固定する工法となるので、前記の機械的性質劣化のおそれがなく、芯線・安全ワイヤの機械的性質・機能が良好に維持できる。
【0022】
【発明の実施の形態】
まず、図1・図2を参照して第1製造方法の実施形態を説明する。即ち、図8に示す「付形部F付き医療用ガイドワイヤG」(以下、単にガイドワイヤGという)を製造するにおいて、コイル体1の先端部分を加熱装置Hに出入自在に成す付形冶具5(以下、単に冶具5という)に設けた付形型Rによって付形部Fの付形と付形部Fの加熱処理が行われる。
【0023】
詳しくは、冶具5は方形の台板11の前端部位に「形成すべき付形部Fの形状を有して開口すると共に先端を閉じた付形パイプ7群を、軸受12に支承して横設した付形軸6に巻装した付形型R」を主要部に成し、その付形型Rの後方にコイル体1をトレイ板8に載せて「上下の合せ型9」によってクランプ固定するクランプ部10を設けた構造を有している。そして、以下の工法によって付形し加熱処理する。なお、この実施形態のものは付形パイプ7が多数個並設連設され、かつ、曲成形状が大小異なる2種の付形パイプ7が層別して並設されている。
【0024】
即ち、まず端部を付形部Fに成す所要長にして安全ワイヤ3を挿通したコイル体1群の先端部分を付形パイプ7の開口部に1本づつ強制挿入してコイル体1の先端に付形部Fを付形成形する。続いて、その付形パイプ7の入口近傍のコイル体1をクランプ部10の下型にセットして保持し、上型によって挟着クランプする。
【0025】
しかるのち、冶具5を加熱装置H内に入れて所要の温度・時間(例えばステンレス材のときは800℃×90秒)の加熱処理を施してコイル体1の加工による残留応力の除去処理を施す。かくして、その加熱処理後に冶具5を加熱装置Hから取り出して、冷却後のコイル体1を冶具5から外す。
【0026】
続いて、安全ワイヤ3の突き出し部分のカット除去・芯線2の挿入固定と膨出端4の形成・樹脂被覆Cの形成等の後加工を施して付形部FつきガイドワイヤGに仕上げる。
【0027】
なお、この図1実施形態の冶具5は、付形軸6に加熱処理後の冷却を迅速にするための空冷・水冷用の冷却孔13が軸方向に貫設されており、そしてクランプ部10の後方の台板11上にコイル体1を個個に受け入れてコイル体1をストレート状に保持する案内トレイ14を設置する態様にすることがある。
【0028】
一方、図2は図1と同様な冶具5・付形型Rから成るものにおいて、クランプ部10を前端に積設して台板11上を前進後退可能にした車輪16・レール17つき付形台車15が台板11上に設けた構造を有し、この付形台車15を後退姿勢にしてコイル体1群をクランプ部10にクランプセットし、しかるのち、その付形台車15を前進移動させることによってクランプ部10にクランプセットしたコイル体1群の前端部分を付形パイプ7群に一括挿入して付形部Fの一括付形をするように成っている。
【0029】
なお、この図2の冶具5には、並設した付形パイプ7の開口部を閉鎖して掛け止めしたり外し自在の「付形加工すべきコイル体1の前端を位置決め規制して付形部7の形状安定を図るストッパー板18」を設けると共に、付形パイプ7には、挿入したコイル体1を視認するピープホール19が穿設されている。
【0030】
そして、図1実施形態と同一工法によって、付形加工・加熱処理して付形部FつきガイドワイヤGを量産成形する。この図2実施形態のものは付形部7の付形加工が一段と能率的にして、かつ、付形パイプ7への差し込み長さが一定化されて付形部Fの形状品質が一段と安定し向上する。
【0031】
なお、この第1製造方法の実施形態は、図示しないが付形パイプ7に代えて、付形軸6の外周に「コイル体1を付形軸6の外周に沿わせて案内変形させるパイプ機能の付形溝」の形態にする変化がある。
【0032】
続いて図3を参照して第2製造方法の実施形態を説明する。即ち、図1・図2実施形態と同様に「付形パイプ7と付形軸6から成る付形型R」とクランプ部10を台板11上に載置した冶具5から成るものにおいて、図示の付形パイプ7Aはフレキシブルパイプ(外力に応じて容易に曲直自在に変形し、自由状態でその変形姿勢を維持する公知のフレキシブルパイプ)から成ると共に、付形軸6の前半部は、付形パイプ7Aを外周に添設させることによって、「付形パイプ7Aを形成すべき付形部Fの形状に導く付形曲面20」を備えた構造を有し、この付形パイプ7Aと付形軸6によって付形型Rを構成している。
【0033】
そして、例えば付形パイプ7A群の上側に接合してカム22によって案内されて付形軸6の外周に沿って転動移動可能の成形ローラー21によって、または手動操作によって付形パイプ7A群を付形軸6の付形曲面20に沿わせて折り曲げ変形させることによって、コイル体1の先端部分に付形部Fを付形形成し、その付形形成後に前記実施形態と同様に加熱装置H内に挿入して必要な加熱処理を施し、付形部FつきガイドワイヤGを順次連続的に量産成形する構造と製造方法に成っている。
【0034】
続いて、図4・図5を参照して第3製造方法の実施形態を説明する。即ちこの製造方法は前記の付形パイプ7に代えて「コイル体1の前端部分を、冶具5に設けた弾性付形板Pによって付形軸6に巻き着け変形させて付形部Fを成形する工法」を特徴とするものにして、この第3製造方法の治具5は下記の構造を有している。
【0035】
即ち、冶具5は「上面がコイル体1の載置セット面27にして前端に弾性付形板P(以下、単に付形板Pという)を傾斜立設したレバー形態の付形台25」と、この付形台25の後端を支承ピン28で回転自在に支承した一対の冶具枠板30の間に設けた付形軸6と、付形軸6に巻き着けた付形板Pの先端を押え込む付形板ロック部26」によって構成され、付形板ロック部26は図示矢印の前後方向にスライドセット可能にして、付形軸6に巻き付けた付形板Pの先端を付形軸6の外周に挟着ロックできる。
【0036】
そして、冶具枠板30と付形台25を貫通連通するピン孔28とロックピン29から成る「前記挟着ロック姿勢をロックしたり解離するロック・解放手段」が設けてあり、以上の構造の冶具5によって付形部Fの付形成形を行う。
【0037】
即ち(図4(C)参照)まず前記のロック・解放手段を開放して、冶具枠板30を起立させて付形台25のセット面27を開放し、そのセット面27にコイル体1を任意ピッチで並設セットして付形部Fの展開長に当る前端部分を付形板Pの上面に添置する。
【0038】
続いて、その状態で冶具枠板30を倒してロックして、コイル体1をセット面27と付形軸6の下面との間に挟着してロックする。しかるのち、付形板Pを指先等で曲げて付形軸6外周に沿わせ変形させることによって、コイル体1の先端部分に付形部Fを形成する。続いて、その曲げ姿勢の付形板Pの先端を「付形ロック部26を前進させることによって、付形軸6と付形ロック部26の間に付形部Fの前端を挟着保持して」付形部Fを的確に付形ロックする。
【0039】
しかるのち、その形付けロック状態のまま前記実施形態と同様に加熱装置Hに入れて所定の加熱処理を施し、その処理後に取り出して付形ロック部26を後退させて前記ロック手段をルーズにして冶具枠板30を傾斜起立させてコイル体1を取り出し、図1実施形態のものと同様に付形部FつきガイドワイヤGを量産成増する。
【0040】
一方、図5に示すものは、図4のものと同様に付形軸6に巻き付ける付形板Pによって付形部Fを形成する製造方法にして、この図5のものは図1実施形態と同様に「台板11上に付形軸6とクランプ部10を備えた冶具5」の前端に付形軸6に巻き付け変位させる曲板状の付形板Pが付形軸6を包み込むように設けられると共に、その巻き着け折り曲げ姿勢の付形板Pのロック孔31にロックピン32を挿着して姿勢ロックする付形板ロック部33を設けた構造を有している。そして、以下の工法によって付形部Fの成形を行う。
【0041】
即ち、付形部Fを形成すべきコイル体1を並設して先端部分を所定長に突き出してクランプ部10でクランプセットし、続いて付形板Pを折り曲げて付形軸6に沿わせることによって付形部Fを形成し、付形板ロック部33によってロックする。しかるのち、そのロック姿勢のまま加熱処理して前記実施形態と同様に付形部FつきガイドワイヤGを量産成形する。
【0042】
次に、図6・図7を参照して第4製造方法の1実施形態を説明する。即ち、まず、図6に示す製造方法に用いる冶具5は台板11に「形成すべき付形部Fの内周形状を有する柱体形の付形軸6」を立設固定すると共に、その付形軸6の軸心6Aを中心として付形軸6の外周に沿って回転作動可能にして、かつ、付形軸6の周面との間にコイル体1を挟着する「回転作動用ハンドル35つき付形押型34」から成る構造を有している。
【0043】
そして、その付形押型34の内面には付形成形するコイル体1を保持するワイヤ溝36が設けられると共に、図1実施形態と同一のクランプ部10とコイル体1の位置決め用ストッパー板18が台板11上に立設され、さらに、付形押型34を付形軸6に添わせて回転移動させた最終位置(図示点線位置)をロックするためのロックピン孔31とロックピン32から成るロック手段が設けてある。
【0044】
以上の冶具5によって以下のように付形部Fを成形する。即ち、加工すべきコイル体1の先端部分を「クランプ部10から付形押型34のワイヤ溝36を通してストッパー板18で位置決めして」クランプ部10にクランプ固定する。
【0045】
しかるのち、ハンドル35で付形押型34を付形軸6の外周に沿って押えつけながら回転移動させることによって、付形部Fを付形成形すると共に、その付形最終位置でロックピン32をロックピン孔31に挿着して付形押型34と付形軸6の相対位置を固定ロックする。
【0046】
しかるのち、前記実施形態と同様に、その付形成形ロック状態のまま加熱装置Hに入れて所定の加熱処理を施し、しかるのち、冶具5から外して付形部FつきガイドワイヤGを順次量産成形する。
【0047】
続いて、図7を参照して第4製造方法の他の実施形態を説明する。即ちこの実施形態の冶具5は、台板11上に「形成すべき付形部Fの内周形状を有する横軸形態の付形軸6」を横置固定すると共に、この付形軸6の前半外周に沿って回転作動可能にして、かつ、付形軸6の外周との間にコイル体1を挟着する「回転ハンドル35つき付形押型34」と(図7(B)参照)付形軸6の後半外周に並設セットしたコイル体1の挟着スリット37を有するコイル体挟着固定部38を備えた構造を有している。
【0048】
そして、コイル体1の前端をストッパー板18に突き当ててセットしてコイル体挟着固定部38で挟着固定し、しかるのち、(図7(A)(C)参照)回転ハンドル35を付形軸6の前半外周に沿わせて図示点線位置に約180°回転させて付形押型34を付形軸6の前半外周に沿わせて転移することによって、ワイヤ体1のそれぞれに付形部Fを成形すると共に、その付形状態の付形押型34を「ロックピン32とロックピン孔31のロックピン手段」によって付形軸6に固定ロックして保持する。
【0049】
しかるのち、その固定ロック状態のまま加熱装置Fに入れて所定の加熱処理を施し、しかるのち、冶具5から外して付形部FつきガイドワイヤGを順次量産成形する。なお、図中のMは付形押型34の移動ガイド、39は立設支柱である。
【0050】
なお、以上の図1〜図7の各実施形態の製造方法は、コイル体1に安全ワイヤ3・芯線2のいずれか、またはいずれもを、コイル体1に先入れ装着して前記の付形加工したり、或は付形加工後に後入れ装着するいずれの工法であっても良く、前記の加熱処理はコイル体1の素線材質・サイズによって適宜設定する。
【0051】
次に、前記第6製造方法の実施態様を説明する。即ち、この実施態様は図1〜図6に示す付形部FつきガイドワイヤGの製造方法において、付形部Fの付形成形・加熱処理後に芯線2・安全ワイヤ3のいずれか、またはいずれもをコイル体1に後入れ挿着して芯線2・安全ワイヤ3のそれぞれの後端をコイル体1の後端に溶着固定し、図9例示の従来構造のようにコイル体1の後端に固定する工法でガイドワイヤGを付形成形する。
【0052】
以上の実施形態の製造方法は、コイル体1の多数本同時付形が可能にして、その上付形パイプ7・付形軸6の輪郭形状は任意にして真円円弧形以外の曲成形状や曲成度が180°以外の多様形状の付形部Fが高能率・低コストで量産できる。
【0053】
そして、加熱装置H内での付形部Fの加熱処理は、付形部7の加熱装置H内での保持姿勢が前記の形態(ブロック体内に挿着しない)であることから効率的熱伝導加熱が可能にして、その上付形軸6は冷却孔13を有して付形部Fの迅速冷却ができるので、例えば熱伝導率が少なるステンレス材質のコイル体1・付形軸6でも冷却が速く、極めて高効率・短時間に残留応力除去の加熱処理ができる。
【0054】
次に、図8を参照して第6製造方法の実施形態を説明する。即ち、図1〜図7に示すいずれかの製造方法で製造した「付形部Fつきコイル体1」を樹脂被覆CつきガイドワイヤGに仕上げる製造方法にして以下の手順・工法に成っている。
【0055】
即ち、所要長に切断したコイル体1に安全ワイヤ3を挿入して前端をコイル体1にロー付け溶着すると共に、その溶着ロー材によって略半球状に膨出する膨出端4を形成し、前端を固定した安全ワイヤ3はコイル体1の中空部を自由状態で貫挿して余剰部分をコイル体1から引き出した形態にセットされる。
【0056】
続いて、前記の第1〜第4製造方法のいずれかによって付形部Fを形成し、所要の加熱処理を施し、加工による残留応力除去の付形部Fつきコイル体1Aに成形する。
【0057】
しかるのち、そのコイル体1Aの付形部Fを電解液(リン酸)を入れた電解層40に浸漬して公知手段の電解研磨を施し、さらに、必要に応じてその電解研磨部分を洗浄槽41に浸漬して公知手段の超音波洗浄を施し、続いてコイル体1Aを架設冶具43に並設立設してセットし、スプレーガン44によってテフロン等を吹き付けて樹脂被覆Cの被覆処理を施す。
【0058】
なお、以上の被覆処理はテフロン吹付け塗装後に加熱炉45に入れて「約380℃×30分」処理してテフロンの焼成乾燥を施す。
【0059】
かくして、外周仕上げされたコイル体1Aは後端から突き出している安全ワイヤ3の突き出し部分を切断除去すると共に、芯線2を挿着し、続いてその安全ワイヤ3の切断端と芯線2の後端がコイル体1Aの後端にプラズマ溶着されると同時に後端外方に盛り上がる膨出端4が形成され、付形部FつきガイドワイヤGが成形できる。なお、この実施形態のコイル体1・芯線2・安全ワイヤ3はオーステナイト系ステンレス線材が用いてある。
【0060】
以上の図8実施形態の製造方法は前記の作用があり、付形部Fの形状が特段に安定向上した高品質のガイドワイヤGが低コスト高生産性で量産成形できる。なお、この図8実施形態は樹脂被覆Cの上に、必要に応じて親水性ポリマーの被覆層を設ける複層形態の態様にすることがある。
【0061】
そして、本実施形態の電解研磨・超音波洗浄を施したガイドワイヤGは以下の特有作用がある。即ち、コイル体1にオーステナイト系ステンレス線材を用いると、線材の冷間伸線加工によって加工誘起変態して磁性を帯びた表面鏡面状となるので、公知のファン・デル・ワールスの分子間吸着力が生ずると共に、コイル間の素線間隙存在の形態を呈するので、異物・微小鉄粉等が付着し易くして異物界面との「すきま腐食」「もらい錆」によって耐食性が低下する不良現象を生ずる難点がある。
【0062】
しかし、前記の電解研磨によって金属表面の酸化スケールを除去して線材表面のクロム濃度を回復させて不動態皮膜を形成するので前記の不良現状を防止してオーステナイト系ステンレス本来の性状を安定確保し、ガイドワイヤGの良好な表面形態が維持できる。
【0063】
【発明の効果】
以上の説明のとおり本発明の医療用ガイドワイヤの製造方法は、高品質の医療用ガイドワイヤを低コスト高生産性で多量生産提供し、当該医療分野の特段の便宜向上を図る効果がある。
【図面の簡単な説明】
【図1】本発明の第1製造方法の実施形態と、それに用いる付形冶具の説明図
【図2】本発明の第1製造方法の他の実施形態と、それに用いる付形冶具の説明図
【図3】本発明の第2製造方法の実施形態と、それに用いる付形冶具を示し、(A)は付形型の構造と用法説明図、(B)は付形冶具と用法の説明図
【図4】本発明の第3製造方法の実施形態と、それに用いる付形冶具を示し、(A)はその付形冶具の正面図、(B)は(A)の側面断面図、(C)は用法説明図
【図5】本発明の第3製造方法の他の実施形態と、それに用いる付形型の説明図
【図6】本発明の第4製造方法の実施形態を示し、(A)は付形冶具の構造と用法説明図、(B)(C)は(A)の部分説明図
【図7】本発明の第4製造方法に他の実施形態を示し、(A)は付形冶具の構造と用法説明図、(B)は(A)の部分説明図、(C)は付形部Fの成形説明図
【図8】本発明の第5製造方法の実施形態の説明図
【図9】(A)(B)(C)のいずれも付形部付き医療用ガイドワイヤの構造を例示した正面図
【図10】付形部付き医療用ガイドワイヤの従来の製造方法の説明図
【符号の説明】
1 コイル体
2 芯線
3 安全ワイヤ
5 付形冶具
6 付形軸
7 付形パイプ
9 合せ型
10 クランプ部
11 台板
15 付形台車
18 ストッパー板
20 付形曲面
21 成形ローラー
25 付形台
26 付形板ロック部
30 冶具枠板
33 付形板ロック部
40 電解研磨槽
41 超音波洗浄槽
C 樹脂被覆
F 付形部
G 医療用ガイドワイヤ
H 加熱装置
R 付形型
P 弾性付形板
[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a method for manufacturing a medical guide wire with an end, which is used for inserting a catheter into a body cavity such as a blood vessel, a ureter or a trachea, or inserting a treatment indwelling device into a lesioned portion of a blood vessel. Is.
[0002]
[Prior art]
There is a known example of a medical guide wire with an end portion as shown in Patent Document 1 (see FIG. 9), which is a flexible linear body in which metal wires such as stainless steel, platinum, tungsten, and gold are coiled in close contact. The coil body 1 has a configuration in which a core part 2 such as a stainless steel wire or a carbon steel wire is inserted and attached, and a shaped part F in which a front end portion of the coil body 1 is bent in a U shape is provided.
[0003]
And the medical guide wire G with the shaping part F of the well-known example (refer FIG. 10), the safety wire 3 (elongation prevention wire of the coil body 1), and the core wire 2 coexist in the hollow part of the coil body 1. In addition, the both ends of the safety wire 3 are fixed and set together with the plug-like bulging ends 4 formed of brazing material or the like at both ends of the coil body 1, and the “lid” of the block body having the U-shaped forming groove 51 The tip portion to be shaped is press-fitted into the “molding die 50 with plate 52” to form a U-shaped shaping portion F, which is then placed in a heating device (not shown) together with the shaping die 50 and remains due to processing. This is a manufacturing method in which a heat treatment for removing stress is applied to form a shape.
[0004]
[Patent Document 1]
Japanese Patent No. 3300155 (FIGS. 1 and 2, claim)
[0005]
[Problems to be solved by the invention]
In the manufacturing method of the above known example, the safety wire 3 inserted in the coil body 1 coexists with the core wire 2 and is formed in a U shape while being fixed at both ends of the coil body 1. Since it is a construction method, the following difficulties exist.
[0006]
That is, since the coil body 1 is in the form of a contact coil, the bending neutral surface when the tip portion is bent and deformed for forming the shaped part F becomes the outer periphery of the coil body 1 inside the bend. The safety wire 3 existing in a state in which both ends are fixed inside is “abnormally tensioned because it is forcibly bent to a radius of curvature larger than the bending neutral surface”.
[0007]
However, since the safety wire 3 is rigid and does not easily stretch elastically, its tension is formed on the straight coil body 1 in a free state protruding from the forming groove 51 in a state where the bending based on the tension is generated. As a result, after the heat forming process, a restoring stress to a straight shape is generated at the bent portion. Therefore, the U-shaped shaped part F is affected by the bending restoring stress, and there is a difficulty in quality that causes the U-shaped shaped part to collapse. The bending deformation resistance of the coil body 1 appears as an insertion resistance of the coil body 1 to the molding die 50, which makes it difficult to perform the molding operation.
[0008]
Further, when the heat treatment is performed by the heating device, the heat treatment is performed in a form in which the shaping portion F is incorporated in the block-shaped mold 50 having a large mass, so that it takes time to raise the temperature of the mold 50. Heating such that the calorie loss and heating time for the heat treatment of the shape part F are increased, and the removal work of the shaped part F after heating becomes complicated (it takes time to cool the mold 50 itself). There is a defect in processing productivity.
[0009]
The present invention provides a “medical guide wire manufacturing method” that solves the above-mentioned problems of the prior art.
[0010]
[Means for Solving the Problems]
The present invention for solving the above technical problem is that, in manufacturing a medical guide wire having a curved shaped portion at the end of a coil body of a flexible linear body, the end of the coil body is The shaped part is formed by inserting the end of the coil body into a shaped pipe that is removably received from the open end or a shaped mold having a shaped groove on the outer periphery of the shaped shaft. After that, a first manufacturing method of “a manufacturing method of a medical guide wire, which is formed by performing a heat treatment for removing residual stress by processing while being shaped and held on the shaping die”,
[0011]
“A flexible pipe for removably receiving an end of a coiled body from an open end in manufacturing a medical guide wire having a curved shaped part at the end of a coiled body of a flexible linear body The end of the coil body is inserted and set in a shaping die having the shaping pipe provided on the outer circumference of the shaping shaft, and then the shaping pipe is deformed along the outer circumference of the shaping shaft. A second manufacturing method of "a manufacturing method of a medical guide wire characterized by forming a shape portion and then performing a heat treatment for removing a residual stress by processing while holding the shape on the shaping die" When,
[0012]
“In manufacturing a medical guide wire having a curved shaped portion at the end of a coiled body of a flexible linear body, the end of the coiled body can be projected and set, and the projected A shaping jig provided with a flexible shaping plate for deforming the portion along the shaping axis, and setting the end portion to form the shaping portion by the flexible shaping plate; A third manufacturing method of “a manufacturing method of a medical guide wire, which is formed by performing a heat treatment for removing residual stress by processing while being shaped and held on the shaping jig”;
[0013]
“In manufacturing a medical guide wire having a curved shaped portion at the end of a coiled body of a flexible linear body, the end of the coiled body is connected to the outer periphery of the shaped shaft of the shaped jig. Then, the shaped part is formed by deformation by rotation of the shaping shaft or by attachment to the outer periphery of the shaping shaft, and after that, the shaped jig is held in shape by the shaping jig. A fourth manufacturing method of “a manufacturing method of a medical guide wire, which is formed by performing heat treatment for removing residual stress by processing”;
[0014]
“When manufacturing a medical guide wire having a curved shaped portion at the end of a coil body of a flexible linear body, a safety wire is inserted into the coil body, and the tip of the safety wire is Fixing to the front end of the coil body to be the shaping part, and setting the protruding part from the coil body in a free state except for the fixing point, and subsequently forming the shaping part by a shaping die or a shaping jig After that, heat treatment for removing residual stress is performed by processing while holding the shaped mold or the shaping jig, and then the protruding portion of the safety wire is cut to connect the cut end to the coil body. A fifth method for producing a medical guide wire characterized by being welded and fixed to
[0015]
“In manufacturing a medical guide wire having a curved shaped portion at the end of a coiled body of a flexible linear body, the shaped portion is formed by any one of the forming methods of paragraphs 0010 to 0014. After the molding and the heat treatment after the forming, the core wire and the safety wire having a predetermined length are inserted into and inserted into the coil body, and the tip of the safety wire is welded and fixed to the tip of the coil body. It is constituted by a group of inventions of a sixth manufacturing method of “a manufacturing method of a medical guide wire, wherein the core wire, the rear ends of the safety wires, and the coil body are welded and fixed”.
[0016]
And, as an aspect of the above manufacturing method, the outer periphery of the shaped part is subjected to electrolytic polishing or ultrasonic cleaning after electrolytic polishing to provide a resin coating, or “polyvinylpyrrolidone / hyaluronic acid or the like on the resin coating” A known hydrophilic polymer coating layer ”.
[0017]
[Action]
In the first to fourth manufacturing methods, since the means for forming the shaped part F uses a shaped pipe, a shaped shaft, and the like, a large number of end portions of the coil body to be shaped can be arranged in parallel and single-ended. A large number of parts can be formed at the same time by the forming operation, which greatly improves the forming productivity.
[0018]
Further, since the shaping mold for forming the shaping portion F is composed of the above-described shaping pipe, shaping plate, etc., the heat conductivity to the shaping portion F in the heating device is extremely good and less heat is required. The heat treatment can be performed in a short time with a short calorie, and the cooling after the heat treatment can be quickly performed, and the removal from the shaping die / shaped jig can be performed quickly and easily.
[0019]
In the fifth manufacturing method, since the safety wire to be fixed and inserted into the coil body is free, the “harmful pulling that occurs in the safety wire when the shaped part F is formed” shown in the paragraphs 0005 to 0007. There is no generation of stress, and the forming form can be made very smoothly, and the forming part F is not deformed after forming, and the forming quality is stabilized and improved.
[0020]
The sixth manufacturing method is characterized by a construction method in which a core wire / safety wire is inserted into the coil body after forming heat treatment of the shaped part F of the coil body, and these are welded and fixed. There are special effects to describe.
[0021]
That is, the volume ratio between the coil body and the safety wire has a special difference of “for example, approximately 35 to 36 times in a normal medical guide wire”. Therefore, when heat treatment for removing residual stress is performed on the basis of a large volume coil body, the safety wire / core wire having a volume that is particularly smaller than the coil body is excessively heated, resulting in deterioration of mechanical properties. There are cases of malfunction. However, since the sixth manufacturing method is a method of attaching and fixing the core wire / safety wire after the coil body is heat-treated, there is no risk of deterioration of the mechanical properties, and the mechanical properties of the core wire / safety wire Good properties and functions can be maintained.
[0022]
DETAILED DESCRIPTION OF THE INVENTION
First, an embodiment of the first manufacturing method will be described with reference to FIGS. That is, in manufacturing the “medical guide wire G with the shaping portion F” (hereinafter simply referred to as the guide wire G) shown in FIG. 8, the shaping jig that allows the distal end portion of the coil body 1 to freely enter and exit the heating device H. The shaping of the shaping part F and the heat treatment of the shaping part F are performed by the shaping mold R provided in 5 (hereinafter simply referred to as the jig 5).
[0023]
In detail, the jig 5 is provided at the front end portion of the square base plate 11 with a shape of the shaping portion F to be formed and opened, and the shaping pipe 7 group whose end is closed is supported by the bearing 12 and is laterally mounted. A shaping die R "wound around the shaping shaft 6 is formed in the main part, and the coil body 1 is placed on the tray plate 8 behind the shaping die R and clamped by the" upper and lower mating die 9 ". The clamp portion 10 is provided. And it shapes and heat-processes with the following construction methods. In this embodiment, a large number of shaped pipes 7 are arranged side by side, and two types of shaped pipes 7 having different bending shapes are arranged in layers.
[0024]
That is, first, the distal end portion of the coil body 1 group in which the end portion has a required length formed into the shaped portion F and the safety wire 3 is inserted is forcibly inserted into the opening portion of the shaped pipe 7 one by one. The shaped part F is formed and formed. Subsequently, the coil body 1 in the vicinity of the inlet of the shaped pipe 7 is set and held in the lower mold of the clamp portion 10 and clamped by the upper mold.
[0025]
After that, the jig 5 is placed in the heating device H and subjected to a heat treatment at a required temperature and time (for example, 800 ° C. × 90 seconds for a stainless steel material) to remove the residual stress by processing the coil body 1. . Thus, the jig 5 is taken out of the heating device H after the heat treatment, and the coil body 1 after cooling is removed from the jig 5.
[0026]
Subsequently, post-processing such as cut removal of the protruding portion of the safety wire 3, insertion and fixing of the core wire 2 and formation of the bulging end 4 and formation of the resin coating C is performed to finish the guide wire G with the shaped portion F.
[0027]
In the jig 5 according to the embodiment shown in FIG. 1, a cooling hole 13 for air cooling and water cooling for swiftly cooling after the heat treatment is formed in the shaped shaft 6 so as to penetrate in the axial direction. The guide tray 14 that receives the coil bodies 1 individually and holds the coil bodies 1 in a straight shape may be installed on the base plate 11 on the rear side of the base plate 11.
[0028]
On the other hand, FIG. 2 is composed of a jig 5 and a shaping die R similar to those in FIG. 1, and is equipped with a wheel 16 and a rail 17 in which a clamp portion 10 is stacked at the front end so as to be able to move forward and backward on the base plate 11. The carriage 15 has a structure provided on the base plate 11. The shaped carriage 15 is set in the retracted posture, and the coil body 1 group is clamped and set in the clamp portion 10. Thereafter, the shaped carriage 15 is moved forward. Accordingly, the front end portion of the coil body 1 group clamped and set in the clamp portion 10 is collectively inserted into the shaped pipe 7 group to form the shaped portion F in a lump.
[0029]
Note that the jig 5 shown in FIG. 2 is formed by closing the opening of the side-by-side shaped pipes 7 so that it can be hooked or removed and the front end of the coil body 1 to be shaped is positioned and regulated. A stopper plate 18 ”for stabilizing the shape of the portion 7 is provided, and a peep hole 19 for visually recognizing the inserted coil body 1 is formed in the shaped pipe 7.
[0030]
Then, the guide wire G with the shaping part F is mass-produced and molded by the shaping process and heat treatment by the same method as the embodiment of FIG. In the embodiment of FIG. 2, the shaping process of the shaping part 7 is made more efficient, and the length of insertion into the shaping pipe 7 is made constant, and the shape quality of the shaping part F is further stabilized. improves.
[0031]
Although the embodiment of the first manufacturing method is not shown in the drawing, the pipe function for guiding and deforming the coil body 1 along the outer circumference of the shaping shaft 6 is provided on the outer circumference of the shaping shaft 6 instead of the shaping pipe 7. There is a change in the form of “shaped groove”.
[0032]
Next, an embodiment of the second manufacturing method will be described with reference to FIG. That is, as in the embodiment shown in FIGS. 1 and 2, the “shaped die R comprising the shaped pipe 7 and the shaped shaft 6” and the jig 5 having the clamp portion 10 placed on the base plate 11 are illustrated. The shaped pipe 7A is composed of a flexible pipe (a well-known flexible pipe that can be easily bent in response to an external force and maintains its deformed posture in a free state), and the front half of the shaped shaft 6 is shaped. By attaching the pipe 7A to the outer periphery, the pipe 7A has a structure having a "shaped curved surface 20 that leads to the shape of the shaped part F to form the shaped pipe 7A". The shaped pipe 7A and the shaped shaft 6 forms a shaping mold R.
[0033]
Then, for example, the shaped pipe 7A group is attached to the upper side of the shaped pipe 7A group, guided by the cam 22, and rollable along the outer periphery of the shaped shaft 6 or manually. By bending and deforming along the shaped curved surface 20 of the shaft 6, a shaped part F is shaped at the tip of the coil body 1, and after the shaping is formed, the inside of the heating device H is the same as in the previous embodiment. The guide wire G with the shaping part F is sequentially and continuously mass-produced and manufactured by performing the necessary heat treatment.
[0034]
Subsequently, an embodiment of the third manufacturing method will be described with reference to FIGS. That is, in this manufacturing method, instead of the above-described shaped pipe 7, “the front end portion of the coil body 1 is wound around the shaped shaft 6 by the elastic shaped plate P provided on the jig 5 to deform the shaped part F. The jig 5 of this third manufacturing method has the following structure.
[0035]
In other words, the jig 5 is “a shaped base 25 in the form of a lever in which the upper surface is the mounting set surface 27 of the coil body 1 and an elastic shaped plate P (hereinafter simply referred to as a shaped plate P) is inclined and erected at the front end”. The shaping shaft 6 provided between a pair of jig frame plates 30 whose rear ends are rotatably supported by the support pins 28 and the tip of the shaping plate P wound around the shaping shaft 6. The shaped plate lock portion 26 is configured to be slidable in the front-rear direction of the illustrated arrow, and the tip of the shaped plate P wound around the shaped shaft 6 is attached to the shaped shaft. 6 can be clamped to the outer periphery.
[0036]
And, there is provided a “lock / release means for locking or disengaging the clamping lock posture” which comprises a pin hole 28 and a lock pin 29 which penetrate the jig frame plate 30 and the shaping base 25 and communicate with each other. The shaping part F is formed by the jig 5.
[0037]
That is, (see FIG. 4 (C)) First, the lock / release means is opened, the jig frame plate 30 is erected to open the set surface 27 of the shaping table 25, and the coil body 1 is placed on the set surface 27. The front end portion corresponding to the unfolded length of the shaped portion F is placed on the upper surface of the shaped plate P after being set in parallel at an arbitrary pitch.
[0038]
Subsequently, the jig frame plate 30 is tilted and locked in that state, and the coil body 1 is clamped between the set surface 27 and the lower surface of the shaping shaft 6 to be locked. Thereafter, the shaped plate F is formed at the tip of the coil body 1 by bending the shaped plate P with a fingertip or the like and deforming it along the outer periphery of the shaped shaft 6. Subsequently, the front end of the shaping part F is sandwiched and held between the shaping shaft 6 and the shaping lock part 26 by advancing the shaping lock part 26 at the tip of the shaping plate P in the bending posture. "Take the shaped part F precisely and lock it."
[0039]
After that, it is put into the heating device H in the same manner as in the above-mentioned embodiment while being in its shape-locked state, and is subjected to a predetermined heat treatment. After that treatment, it is taken out and the shaped lock portion 26 is retracted to loosen the locking means. The jig frame plate 30 is tilted up and the coil body 1 is taken out, and the guide wire G with the shaped portion F is mass-produced and increased as in the embodiment of FIG.
[0040]
On the other hand, what is shown in FIG. 5 is a manufacturing method in which the shaped portion F is formed by the shaped plate P wound around the shaped shaft 6 as in FIG. Similarly, a curved plate-shaped shaped plate P wound around the shaped shaft 6 and wrapped around the front end of “the jig 5 provided with the shaped shaft 6 and the clamp portion 10 on the base plate 11” wraps around the shaped shaft 6. It has a structure in which a shaped plate locking portion 33 for locking the posture by inserting the lock pin 32 into the lock hole 31 of the shaped plate P in the winding and bending posture is provided. And the shaping part F is shape | molded with the following construction methods.
[0041]
That is, the coil bodies 1 to be formed with the shaped part F are juxtaposed, the tip part is protruded to a predetermined length and clamped and set by the clamp part 10, and then the shaped plate P is bent along the shaped shaft 6. Thus, the shaped portion F is formed and locked by the shaped plate lock portion 33. Thereafter, heat treatment is performed in the locked posture, and the guide wire G with the shaped portion F is mass-produced and molded as in the above embodiment.
[0042]
Next, an embodiment of the fourth manufacturing method will be described with reference to FIGS. That is, first, the jig 5 used in the manufacturing method shown in FIG. 6 vertically stands and fixes the “columnar shaped shaping shaft 6 having the inner peripheral shape of the shaping portion F to be formed” on the base plate 11 and attaches it. Rotation operation is possible along the outer periphery of the shaping shaft 6 about the axis 6A of the shaping shaft 6 and the coil body 1 is sandwiched between the outer circumference of the shaping shaft 6 It has a structure consisting of a 35-shaped embossing die 34 ".
[0043]
A wire groove 36 for holding the coil body 1 to be formed is provided on the inner surface of the shaping die 34, and the clamp portion 10 and the positioning stopper plate 18 for the coil body 1 are the same as those in the embodiment of FIG. Further, the lock plate 31 includes a lock pin hole 31 and a lock pin 32 for locking a final position (a dotted line position in the drawing) where the shaping die 34 is rotated along the shaping shaft 6 while standing on the base plate 11. Locking means are provided.
[0044]
The shaped part F is formed by the above jig 5 as follows. That is, the distal end portion of the coil body 1 to be processed is clamped and fixed to the clamp portion 10 by “positioning with the stopper plate 18 from the clamp portion 10 through the wire groove 36 of the shaping die 34”.
[0045]
After that, by rotating the shaping die 34 while pressing it along the outer periphery of the shaping shaft 6 with the handle 35, the shaping portion F is formed and the lock pin 32 is moved at the final shape position. The relative position between the shaping die 34 and the shaping shaft 6 is fixedly locked by being inserted into the lock pin hole 31.
[0046]
Thereafter, in the same manner as in the above-described embodiment, it is put into the heating device H while being in its formed-form lock state and subjected to a predetermined heat treatment. After that, it is removed from the jig 5 and the guide wire G with the shaped portion F is sequentially mass-produced. Mold.
[0047]
Next, another embodiment of the fourth manufacturing method will be described with reference to FIG. That is, the jig 5 of this embodiment horizontally fixes the “shaping shaft 6 in the form of a horizontal axis having the inner peripheral shape of the shaping portion F to be formed” on the base plate 11, and A “shaped stamp 34 with a rotating handle 35” (see FIG. 7 (B)) that can rotate along the outer circumference of the first half and sandwich the coil body 1 between the outer circumference of the shaping shaft 6 The coil body sandwiching and fixing portion 38 having the sandwiching slits 37 of the coil body 1 set side by side on the outer periphery of the rear half of the shape shaft 6 is provided.
[0048]
Then, the front end of the coil body 1 is set so as to abut against the stopper plate 18 and is fixed by being clamped by the coil body clamping / fixing portion 38, and then the rotation handle 35 is attached (see FIGS. 7A and 7C). By rotating the shaped pressing die 34 along the outer circumference of the first half of the shaping shaft 6 by rotating it about 180 ° along the outer circumference of the first half of the shaping shaft 6 to the illustrated dotted line position, In addition to molding F, the shaping die 34 in the shaping state is fixedly locked to the shaping shaft 6 by the “lock pin means of the lock pin 32 and the lock pin hole 31” and held.
[0049]
After that, it is put into the heating device F in the fixed lock state and subjected to a predetermined heat treatment. After that, it is removed from the jig 5 and the guide wire G with the shaped part F is sequentially mass-produced. In the figure, M is a movement guide for the shaped pressing die 34, and 39 is a standing support column.
[0050]
In addition, the manufacturing method of each embodiment of the above FIGS. 1-7 WHEREIN: Either the safety wire 3 and the core wire 2 are attached to the coil body 1 in advance, and the said shaping is carried out. Any method of processing or post-mounting after shaping may be used, and the heat treatment is appropriately set according to the material and size of the coil body 1.
[0051]
Next, an embodiment of the sixth manufacturing method will be described. That is, in this embodiment, in the method of manufacturing the guide wire G with the shaped part F shown in FIGS. 1 to 6, either the core wire 2 or the safety wire 3 after the shaping process or the heat treatment of the shaped part F, or 9 is inserted into the coil body 1 and the rear ends of the core wire 2 and the safety wire 3 are welded and fixed to the rear end of the coil body 1, and the rear end of the coil body 1 as in the conventional structure shown in FIG. A guide wire G is attached and formed by a method of fixing to the wire.
[0052]
The manufacturing method of the above embodiment enables simultaneous forming of a large number of coil bodies 1, and the contour shape of the upper pipe 7 and the shaping shaft 6 is arbitrarily curved other than a circular arc shape. Shaped parts F with various shapes and curvatures other than 180 ° can be mass-produced with high efficiency and low cost.
[0053]
The heat treatment of the shaping part F in the heating device H is an efficient heat conduction because the holding posture of the shaping part 7 in the heating device H is the above-described form (not inserted into the block body). Heating is possible, and the superposed shaft 6 has a cooling hole 13 so that the shaped portion F can be quickly cooled. Therefore, for example, the stainless steel coil body 1 and the shaped shaft 6 with low thermal conductivity can be used. Fast cooling, extremely high efficiency, and heat treatment for residual stress removal in a short time.
[0054]
Next, an embodiment of the sixth manufacturing method will be described with reference to FIG. In other words, the following procedure and method are used in which a “coil body 1 with a shaped part F” manufactured by any of the manufacturing methods shown in FIGS. 1 to 7 is finished into a guide wire G with a resin coating C. .
[0055]
That is, the safety wire 3 is inserted into the coil body 1 cut to a required length and the front end is brazed and welded to the coil body 1, and the bulging end 4 bulging into a substantially hemispherical shape by the welding brazing material is formed. The safety wire 3 with the front end fixed is set in a form in which a hollow portion of the coil body 1 is inserted in a free state and an excess portion is pulled out from the coil body 1.
[0056]
Subsequently, the shaped part F is formed by any one of the first to fourth manufacturing methods described above, subjected to necessary heat treatment, and formed into a coil body 1A with the shaped part F for removing residual stress by processing.
[0057]
Thereafter, the shaped part F of the coil body 1A is immersed in an electrolytic layer 40 containing an electrolytic solution (phosphoric acid) and subjected to electropolishing by a known means, and the electropolished part is cleaned as necessary. Then, the coil body 1A is set in parallel with the installation jig 43, and Teflon or the like is sprayed by the spray gun 44 to perform the coating process of the resin coating C.
[0058]
In the above coating treatment, Teflon spraying is applied and then placed in a heating furnace 45 to process “about 380 ° C. × 30 minutes” for baking and drying of Teflon.
[0059]
Thus, the outer peripherally finished coil body 1A cuts and removes the protruding portion of the safety wire 3 protruding from the rear end, and inserts the core wire 2, and then the cut end of the safety wire 3 and the rear end of the core wire 2 Is welded to the rear end of the coil body 1A, and at the same time, a bulging end 4 bulging outward from the rear end is formed, and a guide wire G with a shaped portion F can be formed. The coil body 1, the core wire 2, and the safety wire 3 of this embodiment are made of austenitic stainless wire.
[0060]
The manufacturing method of the above embodiment of FIG. 8 has the above-described action, and a high-quality guide wire G in which the shape of the shaped portion F is particularly stably improved can be mass-produced and molded at low cost and high productivity. The embodiment shown in FIG. 8 may be in the form of a multilayer form in which a hydrophilic polymer coating layer is provided on the resin coating C as required.
[0061]
The guide wire G subjected to the electrolytic polishing / ultrasonic cleaning according to the present embodiment has the following specific actions. That is, when an austenitic stainless steel wire is used for the coil body 1, the work is induced and transformed by the cold wire drawing of the wire. Tinged Since the surface is mirror-like, a known van der Waals intermolecular adsorption force is generated and a wire gap exists between the coils. “Crevice corrosion” and “rust rust” cause a problem that the corrosion resistance deteriorates.
[0062]
However, the electropolishing removes the oxide scale on the metal surface and restores the chromium concentration on the surface of the wire to form a passive film. A good surface morphology of the guide wire G can be maintained.
[0063]
【The invention's effect】
As described above, the method for producing a medical guide wire according to the present invention has the effect of providing high-quality medical guide wires in large quantities with low cost and high productivity, and improving special convenience in the medical field.
[Brief description of the drawings]
FIG. 1 is an explanatory view of an embodiment of a first manufacturing method of the present invention and a shaping jig used therefor.
FIG. 2 is an explanatory view of another embodiment of the first manufacturing method of the present invention and a shaping jig used therefor.
FIGS. 3A and 3B show an embodiment of a second manufacturing method of the present invention and a shaping jig used therefor, FIG. 3A is a drawing showing the structure and usage of the shaping mold, and FIG. 3B is an explanatory drawing of the shaping jig and usage.
FIG. 4 shows an embodiment of a third manufacturing method of the present invention and a shaping jig used therefor, (A) is a front view of the shaping jig, (B) is a side sectional view of (A), (C ) Is a usage illustration
FIG. 5 is an explanatory view of another embodiment of the third manufacturing method of the present invention and a shaping mold used therefor.
6A and 6B show an embodiment of a fourth manufacturing method according to the present invention, where FIG. 6A is a diagram illustrating the structure and usage of a shaping jig, and FIGS.
7A and 7B show another embodiment of the fourth manufacturing method of the present invention, in which FIG. 7A shows a structure and usage of a shaping jig, FIG. 7B shows a partial explanatory view of FIG. Molding illustration of shape part F
FIG. 8 is an explanatory view of an embodiment of the fifth manufacturing method of the present invention.
FIGS. 9A, 9B, and 9C are front views illustrating the structure of a medical guide wire with a shaped portion in any of FIGS.
FIG. 10 is an explanatory view of a conventional manufacturing method of a medical guide wire with a shaped part.
[Explanation of symbols]
1 Coil body
2 core wire
3 Safety wire
5 Shaped jigs
6 Shaped shaft
7 Shaped pipe
9 Matching type
10 Clamp part
11 Base plate
15 Attached cart
18 Stopper plate
20 Shaped curved surface
21 Forming roller
25 Shaping table
26 Shaped plate lock
30 Jig frame
33 Shaped plate lock
40 Electrolytic polishing tank
41 Ultrasonic cleaning tank
C resin coating
F Shaped part
G Medical guide wire
H Heating device
R Shaped type
P Elastic shaped plate

Claims (4)

可撓性線状体のコイル体の端部に曲成状の付形部を備えた医療用ガイドワイヤの製造方法において、
前記コイル体に安全ワイヤを挿通して
前記安全ワイヤの先端を前記付形部にすべきコイル体前端に固定すると共に、
前記固定点以外を自由状態にして前記コイル体から突き出してセットし、
形成すべき付形部の形状を有して開口するとともに先端を閉じた付形パイプを
多数個並列した付形パイプ群を、軸受に支承して横設した付形軸に巻装した付形型により前記付形部を形成し、
その後、前記付形型に付形保持したまま加工による残留応力除去の加熱処理を施して
前記安全ワイヤの突き出し部分を切断して
前記切断端を前記コイル体に溶着固定して製造することを特徴とする医療用ガイドワイヤの製造方法。
In a method for manufacturing a medical guide wire comprising a curved shaped portion at the end of a coil body of a flexible linear body,
Insert a safety wire through the coil body ,
While fixing the tip of the safety wire to the front end of the coil body to be the shaping part,
Set other than the fixed point in a free state protruding from the coil body,
A shaped pipe having the shape of the shaped part to be formed and opened and closed at the tip
The shaped part is formed by a shaped mold in which a large number of shaped pipe groups arranged in parallel are wound around a shaped shaft that is horizontally supported by a bearing.
Then, heat treatment for removing residual stress by processing is performed while holding the shape on the shaping die.
Cut the protruding part of the safety wire
A method of manufacturing a medical guide wire, wherein the cut end is manufactured by welding and fixing to the coil body.
請求項1に記載の医療用ガイドワイヤの製造方法において、前記付形軸の軸方向に冷却孔を貫設した付形軸を用いたことを特徴とする医療用ガイドワイヤの製造方法。2. The method for manufacturing a medical guide wire according to claim 1, wherein a shaping shaft having a cooling hole penetrating in the axial direction of the shaping shaft is used. 請求項1または2のいずれか1に記載の医療用ガイドワイヤの製造方法において、前記付形パイプが、曲成形状が大小異なる二種の層別して並設して成ることを特徴とする医療用ガイドワイヤの製造方法。3. The medical guide wire manufacturing method according to claim 1, wherein the shaped pipes are arranged side by side in two different layers having different bending shapes. 3. Guide wire manufacturing method. 請求項1〜3のいずれか1に記載の医療用ガイドワイヤの製造方法において、前記コイル体がオーステナイト系ステンレス線材の冷間伸線加工材から成り、前記コイル体の付形成形加熱処理後の付形部の外周に、電解研磨または電解研磨と電解研磨後に超音波洗浄を施すことを特徴とする医療用ガイドワイヤの製造方法。In the manufacturing method of the medical guide wire of any one of Claims 1-3, the said coil body consists of the cold wire drawing material of an austenitic stainless steel wire, and after the forming heat treatment of the said coil body A method for producing a medical guide wire, comprising subjecting an outer periphery of a shaped part to ultrasonic cleaning after electrolytic polishing or electrolytic polishing and electrolytic polishing.
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JP3931195B2 (en) * 2006-03-20 2007-06-13 朝日インテック株式会社 Baking mold and guide wire manufacturing method using the baking mold
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