JP4159777B2 - Medical guidewire - Google Patents

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Publication number
JP4159777B2
JP4159777B2 JP2001393026A JP2001393026A JP4159777B2 JP 4159777 B2 JP4159777 B2 JP 4159777B2 JP 2001393026 A JP2001393026 A JP 2001393026A JP 2001393026 A JP2001393026 A JP 2001393026A JP 4159777 B2 JP4159777 B2 JP 4159777B2
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Prior art keywords
guide wire
lubricant coating
catheter
wire
medical guide
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JP2003190290A5 (en
JP2003190290A (en
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富久 加藤
英員 池田
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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
    • 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
    • A61M2025/09133Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/02General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0222Materials for reducing friction

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

Description

【0001】
【発明の属する技術分野】
本発明は、心臓血管系内等にカテーテルを導入する際に用いる医療用ガイドワイヤに関するものである。
【0002】
【従来の技術】
血管造影を目的として、極細可撓管体のカテーテルを血管内に挿入したり、または、冠状動脈の閉塞部位の治療に、バルーンカテーテルを血管内に挿入するのに際し、そのカテーテルの挿入を安全確実にするために、可撓性線条体の医療用ガイドワイヤが用いられており、特公平4−25024号公報等に示される公知例がある。
【0003】
そして、この医療用ガイドワイヤ(以下、単にガイドワイヤという)は、(図6参照)可撓性の線条体2からなる線条形態にして曲りくねった複雑な径路の血管・分岐血管に前端部10から挿入して体外に位置する手元部11を回転させながら押し引きして血管内へ挿入し進行させると共に、術者(ガイドワイヤを操作する者)が手元部11によって感触する操作フィーリングを判断要素にして血管内への円滑な挿入セットを図るので、先端部分5は血管への良好な先導挿入性を有し、かつ前端部10の血管内挙動が手元部11で鋭敏に感触認知できる等の高度の機械的性質が要求される。
【0004】
そして、以上の要求特性に対応するものとして線条体2の先端部分5にコイルばね15を嵌装すると共に、そのコイルばね15の全長外周全面を親水性ポリマーから成る潤滑剤コーティング被覆16で包み込んで血管壁との滑り性の向上を図る構造のガイドワイヤ1Aと、金属製の可撓性線条体のコア線3の全体を樹脂被覆層7に埋め込んだ線条体2の全周面に前記の潤滑剤コーティング被覆16を設けた構造のガイドワイヤ1Bが普及している。
【0005】
【発明が解決しようとする課題】
以上の従来技術のガイドワイヤ1Aは、予め食塩水に浸漬して「大気中で乾燥状態になっているコーティング被膜16」を親水軟化して血管内挿入される。しかし、そのコーティング被膜16の形成時にコイル表面側のコイル線間谷間17を埋め込むと共に、コイル線間の微細隙間の毛細管現象によってコイル内側のコイル線間谷間18にも相当量がはみ出して埋め込んだ状態になる。
【0006】
さらに、前記の食塩水による親水軟化処理では、コーティング被膜16の表皮が速やかに親水状態となってフィルム状を呈して被膜下層への浸水を阻止するので、前記のコイル線間谷間17・18に存在する潤滑剤は固化状態または半固化状態を呈して、コイルばね15の可撓柔軟性を阻害した状態で血管内へ挿入される形態になり、湾曲血管への挿入先導性を妨げて、分岐血管へ導入すべき先端部分5が硬直姿勢を呈して、その導入を困難にしたり、可撓性柔軟性の低下によって血管壁との摩擦抵抗が増大して挿入・引き抜き性を悪くしたり、さらには、強い抵触抵抗によって血管壁の損傷をもたらすことがある。
【0007】
一方、前記のガイドワイヤ1Bは線条体の全長全周に潤滑剤コーティング被覆16が存在して、血管内壁に対する滑り性が過度になるので、例えば血管屈曲部位・血管分岐部位・病変部において前端部10に生ずる微妙な抵抗変動が血液脈動に打ち消されて手元部11で感知できないケースがあり、手元部11における前端部10の挙動情報伝達性に欠けて当該治療性の低下をもたらす不具合がある。
【0008】
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を提供するものである。
【0009】
【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「可撓性線条体から成る医療用ガイドワイヤにおいて、前記可撓性線条体は金属線撚線構造のワイヤロープの外周に樹脂被覆を備えると共に、該ワイヤロープは側ストランド線の一部が他の側ストランド線より太径に構成され、前記可撓性線条体の先端部分の外周に、スパイラル帯状の潤滑剤コーティング部とスパイラル帯状の該先端部分の外周露出部を交互配設し、さらに前記先端部分以外の本体部の外周に、環状帯状の潤滑剤コーティング部と環状帯状の該本体部の外周露出部を交互配設した構造」の医療用ガイドワイヤと、
【0010】
可撓性線条体から成る医療用ガイドワイヤにおいて、前記可撓性線条体は金属線撚線構造のワイヤロープの外周に樹脂被覆を備えると共に、該ワイヤロープは側ストランド線の一部が他の側ストランド線より太径に構成され、前記可撓性線条体の先端部分の外周に、スパイラル帯状の潤滑剤コーティング部とスパイラル帯状の該先端部分の外周露出部を交互配設し、さらに前記先端部分以外の本体部の外周に、前記可撓性線条体の長手方向に伸長するストライプ状の潤滑剤コーティング部を設けた構造」の医療用ガイドワイヤに成っている。
【0011】
即ち、前記構成の本発明の医療用ガイドワイヤは、可撓性線条体の線長方向に「潤滑性に富む帯状の潤滑剤コーティング部」と「潤滑剤不存在にして潤滑性に欠ける線条体の帯状の外周露出部」を交互配設して「血管壁に対する滑り性と摩擦性が調和共存した適正な滑り特性」を付与する思想から成るものである。
【0012】
そして、共通した態様として、前記の潤滑剤コーティング部の帯幅が前端から後端の方向へ漸減徐変する形態にしたり、前記の外周露出部の帯幅が同じく前端から後端の方向に漸増徐変する形態にする。
【0013】
【作用】
前記構成の本発明の医療用ガイドワイヤは、可撓性線条体の外周に「潤滑性に富む帯状の潤滑剤コーティング部」と「潤滑剤不存在にして摩擦抵抗力が存在する帯状の外周露出部」が長手方向に交互連続するので、全長の大半部分が血管内へ挿入される可撓性線条体の血管壁への摺動性が潤滑剤コーティング部の高摺動性と外周露出部の非摺動性の相殺に基づいて過大・過小に偏しない適性摺動性が確保できる。
【0014】
そして、血管挿入の先導部となる先端部分は「スパイラル状の潤滑剤コーティング部」であることから、血管壁に優先接触(潤滑剤層の厚さだけ外周露出部より膨径しているので外周露出部より原則的に優先接触する)する潤滑剤コーティング部のスパイラル形態と、体外に位置する手元部の術者による回転進退操作が概ねマッチングして、その接触ポイントによる滑り機能と外周露出部による滑りブレーキ機能が調和作用し、前記の適性摺動性を確保すると共に血管屈曲部や微細血管への良好な挿入進行性が確保できる。
【0015】
さらに、前記の適性摺動性に基づいて、血管内挿入状態の可撓性線条体は血管壁に対して素直な姿勢(無理曲げして過大な曲げ応力を生じない姿勢)を呈するので、先導する前端部と血管壁との接触抵抗変化や「ガリガリ・ゴツゴツ」の接触フィーリングの手元部への伝達性が向上し、血管分岐部・血管病変部等における前端部の挙動を把握するための前端部情報の感知把握性が向上する。
【0016】
さらに、先端部分以外の本体部には帯状環状の潤滑剤コーティング部と外周露出部が交互配設されているので、本体部を指先で回転させながら先端部分から順次に血管内へ挿入するとき、その露出外周部の直径方向を指先でクランプ把持して操作できるので、潤滑剤による指先滑りがなく、血管への挿入操作が的確にしてし易くなる。以上の主たる作用がある。
【0017】
【発明の実施の形態】
以下、図面に基づいて本発明ガイドワイヤ1を説明する。即ち、図1〜図4は本発明のガイドワイヤの主たる構成要素の「潤滑材コーティング部」の形態が示してあり、まず図1のものは金属製のコア線3を樹脂被覆7(ポリアミド・ポリウレタン等)で包み込んだ可撓性の線条体2から成るもにおいて、この線条体2の外周には帯状の潤滑剤コーティング部8A・8Bが隣接間間隔を有して、線長方向の概ね全長に並設されている。
【0018】
詳しくは、潤滑剤コーティング部8A・8Bは「無水マレイン酸共重合体・メチルビニルエーテル・ポリビニルピロドリン」等の潤滑時に潤滑性を有する潤滑性物質が樹脂被覆7の外周に沿って帯状にコーティングされて形成されている。そして、ガイドワイヤとして高柔軟性が不可欠になる先端部分5は同一帯幅B1の潤滑剤コーティング部8Aが連続するスパイラル帯状を成し、この潤滑剤コーティング部8Aの隣接間が同一幅C1のスパイラル帯状を成して線条体2の外周をあらわす外周露出部9に成っている。
【0019】
そして、その先端部分5以外の本体部6は同一帯幅B2の環状帯の潤滑剤コーティング部8Bが同一ピッチで後端方向に連設され、その潤滑剤コーティング部8Bの相互間が線条体2の外周をあらわした環状帯の外周露出部9に設定されている。
【0020】
なお、この図1のものは先端部分5を血管内に挿入するときの先導部として機能する前端部10が、潤滑剤コーティングしない露出頭(長さ=概ね8粍)に設定されており、コア線3はSUS材(ステンレス)またはNi(ニッケル)−Ti(チタン)材の公知の単線・撚線構造またはワイヤロープWの構造に成っている。
【0021】
そして、この図1のものは、先端部分5の長さ=約300粍、潤滑剤コーティング部8Aの帯幅B1=約5粍、外周露出部9の帯幅C1=約2粍・帯幅C2=約20粍、潤滑剤コーティング部8Bの帯幅B2=約60粍、のサイズ諸元である。
【0022】
以上の図1に示す潤滑剤コーティング部8A・8Bを有するものは前記の作用があり、以下これについて図示補足する。即ち(図1(C)〜(E)参照)血管20の分岐部分において高摺動性の従来のガイドワイヤ1Bは、容易に滑り移動して分岐血管21への導入案内が困難であるのに対し、図1実施例のものは潤滑剤コーティング部8A間の外周露出部9が血管壁に摺接してブレーキ機能するので分岐血管21への導入案内がし易くなる。
【0023】
そして、閉塞病変部Pの凹陥状壁の中心部分の膠原線維部位23へ前端部10を導入案内するとき、先端部分5が適性摺動性にして、かつ前端部10が潤滑剤不存在形態であることから、前端部10の血管内膜22への接合による「ガリガリ」「ゴツゴツ」感が手元部11へ高精度に伝達されて感触認知し易く、その先端部情報による操作によって図示実線に示す前端部10の真腔挿入が迅速にして的確にできる。
【0024】
そして、先端部分5・本体部6は潤滑剤コーティング部8A・8Bと外周露出部9が交互配設形態であることから(図1(E)参照)血管挿入状態のガイドワイヤ1にチューブ状のカテーテル24を外嵌し、カテーテル24とガイドワイヤ1との間隙に造影剤Lを注入送すると、造影剤Lの流速Vは接触抵抗の相違によって潤滑剤コーティング部8Aゾーンでは早速V1にして外周露出部9ゾーンでは遅速V2となり、そのV1・V2の接合部位では乱流を生じて造影剤Lの拡散効果をもたらし、造影剤Lの密度偏在を解消して造影効果の向上が促進できる。
【0025】
続いて、図2を参照して他の形態の潤滑剤コーティング部を説明する。即ち、図1のものと同様に線条体2の先端部分5の外周に「スパイラル帯状の潤滑剤コーティング部8A」を設け、本体部6の外周に潤滑剤コーティング部8Bを設けたものにおいて、この図2の潤滑剤コーティング部8Bは本体部6の一直径上に位置して対称形状の対となり、かつ、本体部6の前端から後端まで連続するストライプ状を成しており、図2(A)のものは同一ストライプ幅の連続、図2(B)のものは本体部6の前端から後端へストライプ幅が漸減徐変する形状を有し、そのストライプ以外の部分は長手方向に連続する外周露出部9に成っている。
【0026】
以上の図2のものも本体部6が「潤滑剤コーティング部8Bと外周露出部9が長手方向に共存混在する形態」であるので図1のものと同様な作用があり、さらに、術者が手元部11を指先で挟持して回転・押し引き操作して血管内挿入するとき、半円弧帯状の外周露出部9が上下一対に存在するので、その指先クランプが滑ることなく極めて容易にして血管内挿入作業がし易くなる。そして図2(B)のものはそのクランプスペースが本体部6の後端に向って広くなるので、大半部分を血管内へ挿入して操作難度が向上する本体部6の後半部分のクランプ操作が極めてし易くなる。以上の特有作用がある。なお、この実施例の潤滑剤コーティング部8Bの帯幅は「図2(A)のものが約0.8粍・図2(B)のものは最大幅=約1.0粍、最小幅=約0.3粍」である。
【0027】
次に図3を参照して他の形態を説明する。即ち、潤滑剤コーティング部8A・8Bを有するものにおいて、図3(A)に示す先端部分5のスパイラル帯状の潤滑剤コーティング部8Aは帯幅が前端から後端方向へB1・B2・B3と順次幅小になる漸減徐変する形態であり、図3(B)に示す先端部分5のスパイラル帯状の潤滑剤コーティング部8Aは同一帯幅B1を並設した相互間の外周露出部9の帯幅が前端部10から後端方向へC1・C2・C3と順次幅大になる漸増徐変形態を成している。
【0028】
そして、図3(C)に示す本体部6の環状帯状の潤滑剤コーティング部8Bは、後端方向へ帯幅B1・B2・B3が順次幅小になる漸減徐変にして、かつ外周露出部9の帯幅C1が一定になる形態であり、図3(D)に示す本体部6は同一幅C1の環状帯状の潤滑剤コーティング部8Bの並設において、相互間の外周露出部9の帯幅が後端方向へC1・C2・C3と順次幅大になる漸増徐変形態に成っている。
【0029】
以上の図3に示す形態のものは、線条体2の長さ方向の単位長当りの潤滑剤コーティング部8の表面積が、前端部10から後端方向へ漸減徐変する形態となるので、血管内壁の接触面積と血管屈曲部による総曲げ角度が前端部10から後端方向へ漸減徐変するガイドワイヤ1の使用特性と極めてマッチングし、ガイドワイヤ1の長手方向の各ゾーンにおける過大滑り性を防止して線長方向に概ね一様な前記適性滑り性を確保すると共に、潤滑剤のムダ防止ができる。
【0030】
続いて図4を参照して他の形態を説明する。即ち、この図4に示すものは前記の潤滑剤コーティング部8A・8Bを有するガイドワイヤ1の線条体2の形態変化を例示したものであり、図4に示す線条体2は芯ストランド線12に複数の側ストランド線13を撚合した公知のワイヤロープWから成る本体部6と、矩形断面のコア線3にコイルばね15を嵌装した先端部分5から成る形態にして、この先端部分5と本体部6の外周に「ポリウレタン等の樹脂薄膜コートC」が施され、その樹脂薄膜コートCの上に前記同様の潤滑材コーティング部8A・8Bが設定されている。
【0031】
続いて、図5を参照して前記説明の潤滑剤コーティング部8A・8Bを主要構成要素に成す本発明1実施例のガイドワイヤ1を説明する。即ち、このガイドワイヤ1は先端部分5・本体部6がワイヤロープWから成り、このワイヤロープWの側ストランド線13の一部が太径側ストランド線13Aに成っており、この側ストランド線13Aが突状スパイラルを成してロープ外周の全長に現れる構造に成っている。そして、ワイヤロープWの外周に「図4に示す樹脂薄膜コートCの上に潤滑剤コーティング部8A・8B」が設定されている。この実施例のガイドワイヤ1は線条体2の外周露出部9に側ストランド線13・13Aが成すスパイラル凹条14またはスパイラル凹条筋14A(側ストランド線13の隣接接合部位にあらわれる凹条筋)が現れるので、血管挿入時に回転操作されるガイドワイヤ1の凹条14・凹条筋14Aが注入する潤滑剤の溜り部・送出溝として機能する。
【0032】
さらに、この図5実施例のものは「スパイラル凹条筋14Aまたはスパイラル凹条14」が外周に存在するので、下記の特有作用がある。即ち(図5(B)参照)血管内挿入後にカテーテル24を外嵌セットして、ガイドワイヤ1の外周とカテーテル24の内周間に造影剤Lを注入送した場合、造影剤Lがスパイラル凹条筋14A・スパイラル凹条14に導かれてスパイラル流を生じ、かつ、図1(E)に示す流速V1・V2に基づく乱流を生ずるので、このスパイラル流と乱流の相乗効果によって段落0024に示した造影剤Lの拡散効果が一段と顕著になる。
【0033】
【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は血管内への挿入性と血管内で先端部分の屈曲血管・分岐血管・血管病変部への方向制御性・導入案内性が優れると共に、前端部の血管内接触挙動の手元部への情報伝達性に優れ、当該治療性の特段の向上を図る効果がある。
【図面の簡単な説明】
【図1】 本発明の主たる構成要素の潤滑剤コーティング部を備えた医療用ガイドワイヤを示し、(A)はその全体正面図、(B)は(A)の横断面図、(C)(D)(E)はその作用状態の説明図
【図2】 本発明の主たる構成要素の潤滑剤コーティング部を備えた医療用ガイドワイヤを示し、(A)(B)はその全体正面図、(C)は(A)(B)の横断面図
【図3】 本発明の主たる構成要素の潤滑剤コーティング部を備えた医療用ガイドワイヤを示し、(A)〜(D)はその部分正面図
【図4】 本発明の主たる構成要素の潤滑剤コーティング部を備えた医療用ガイドワイヤを示し、(A)はその全体正面図、(B)は(A)のEE断面図、(C)は(A)のFF断面図
【図5】 本発明1実施例の医療用ガイドワイヤを示し、(A)はその全体正面図、(B)は作用説明図
【図6】 従来の医療用ガイドワイヤ示し、(A)(B)はその全体正面図、(C)は(A)の部分断面図、(D)は(B)の横断面図
【符号の説明】
1 本発明の主たる構成要素の潤滑剤コーティング部を備えた医療用ガイドワイヤ
1A・1B 従来の医療用ガイドワイヤ
1C 本発明の医療用ガイドワイヤ
2 線条体
3 コア材
5 先端部分
6 本体部
7 樹脂被覆
8A・8B 潤滑剤コーティング部
9 外周露出部
10 前端部
11 手元部
14 スパイラル凹条
20 血管
P 血管閉塞部
W ワイヤロープ
[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a medical guide wire used when a catheter is introduced into a cardiovascular system or the like.
[0002]
[Prior art]
For the purpose of angiography, when inserting a catheter with a very thin flexible tube into a blood vessel, or when inserting a balloon catheter into a blood vessel for treatment of a coronary artery occlusion site, the catheter must be inserted safely. In order to achieve this, a medical guide wire of a flexible striate body is used, and there is a known example shown in Japanese Patent Publication No. 4-25024.
[0003]
This medical guide wire (hereinafter simply referred to as a guide wire) is (see FIG. 6) a front end of a complex path blood vessel / branch blood vessel that is wound in the form of a line consisting of a flexible line 2. Operation feeling that the operator (the person who operates the guide wire) feels with the hand portion 11 while pushing and pulling the hand portion 11 inserted from the portion 10 and rotating outside the body 10 to be inserted into the blood vessel and progressing. Therefore, the distal end portion 5 has a good leading insertion property into the blood vessel, and the behavior of the front end portion 10 in the blood vessel is sharply perceived by the hand portion 11. High mechanical properties such as being possible are required.
[0004]
A coil spring 15 is fitted to the tip portion 5 of the filament 2 so as to meet the above required characteristics, and the entire outer circumference of the coil spring 15 is wrapped with a lubricant coating 16 made of a hydrophilic polymer. The guide wire 1A having a structure for improving the slipperiness with the blood vessel wall and the entire core surface 3 of the metal flexible striated wire are embedded on the entire peripheral surface of the striated material 2 embedded in the resin coating layer 7. A guide wire 1B having a structure provided with the lubricant coating 16 is in widespread use.
[0005]
[Problems to be solved by the invention]
The above-described guide wire 1A according to the prior art is inserted into a blood vessel by hydrolyzing the “coating film 16 which is in a dry state in the atmosphere” by dipping in a saline solution in advance. However, when the coating film 16 is formed, the coil wire valleys 17 are embedded on the coil surface side, and a considerable amount protrudes and is embedded in the coil wire valleys 18 inside the coil due to the capillary phenomenon of the fine gaps between the coil wires. become.
[0006]
Further, in the hydrophilic softening treatment using the saline solution, the skin of the coating film 16 quickly becomes hydrophilic and forms a film to prevent water from entering into the lower layer of the coating film. The existing lubricant exhibits a solidified state or a semi-solidified state, and is configured to be inserted into the blood vessel in a state in which the flexible flexibility of the coil spring 15 is hindered. The distal end portion 5 to be introduced into the blood vessel has a rigid posture, which makes it difficult to introduce, reduces the flexibility and increases the frictional resistance with the blood vessel wall, and worsens the insertion and withdrawal properties. May cause vessel wall damage due to strong conflict resistance.
[0007]
On the other hand, the guide wire 1B has the lubricant coating 16 on the entire circumference of the striatum and becomes excessively slidable with respect to the inner wall of the blood vessel. There is a case where the delicate resistance fluctuation generated in the part 10 is canceled out by the blood pulsation and cannot be detected by the hand part 11, and there is a problem that the behavior information transmission property of the front end part 10 in the hand part 11 is lacking and the therapeutic property is lowered. .
[0008]
The present invention provides a medical guide wire that solves the above-mentioned problems of the prior art.
[0009]
[Means for Solving the Problems]
The present invention that solves the above technical problem is as follows: "In the medical guide wire made of a flexible wire, the flexible wire is provided with a resin coating on the outer periphery of a wire rope having a metal wire stranded structure, In the wire rope, a part of the side strand wire is configured to have a larger diameter than the other side strand wire, and a spiral belt-like lubricant coating portion and the spiral belt-like tip are formed on the outer periphery of the tip portion of the flexible linear body. The medical treatment of “the structure in which the outer peripheral exposed portions of the portions are alternately arranged, and the outer peripheral exposed portions of the annular belt-like lubricant coating portions and the annular belt-like main body portions are alternately arranged on the outer periphery of the main body portion other than the tip portion”. A guide wire for
[0010]
“In the medical guide wire comprising a flexible wire, the flexible wire is provided with a resin coating on the outer periphery of a wire rope having a stranded metal wire structure, and the wire rope is a part of a side strand wire. Is configured to have a diameter larger than that of the other side strand wire, and a spiral strip-shaped lubricant coating portion and an exposed portion of the outer periphery of the spiral strip-shaped tip portion are alternately disposed on the outer periphery of the distal end portion of the flexible linear body. Furthermore, the medical guide wire has a structure in which a stripe-like lubricant coating portion extending in the longitudinal direction of the flexible linear body is provided on the outer periphery of the main body portion other than the tip portion .
[0011]
That is, the medical guidewire of the present invention having the above-described structure is a wire lacking in lubricity due to the absence of a lubricant and a “lubricant-like strip-shaped lubricant coating portion” in the wire length direction of the flexible filament. The strip-shaped outer peripheral exposed portions of the strips are alternately arranged to provide “appropriate slip characteristics in which slipperiness and friction with respect to the blood vessel wall are harmoniously coexisting”.
[0012]
As a common aspect, the band width of the lubricant coating portion gradually decreases and gradually changes from the front end to the rear end, or the band width of the outer peripheral exposed portion gradually increases from the front end to the rear end. Use a gradually changing form.
[0013]
[Action]
The medical guide wire of the present invention having the above-described configuration is provided with a “strip-shaped lubricant coating portion rich in lubricity” and a “strip-shaped outer periphery where friction resistance is present in the absence of a lubricant” on the outer periphery of the flexible linear body. Since the "exposed part" is alternately continuous in the longitudinal direction, the sliding property of the flexible striatum that is inserted into the blood vessel for the most part of the entire length to the blood vessel wall is highly slidable and the outer periphery exposed to the lubricant coating part. Appropriate slidability that is not excessively or excessively biased can be secured based on the offset of the non-slidability of the part.
[0014]
And since the tip part that becomes the leading part of the blood vessel insertion is a “spiral-shaped lubricant coating part”, it has a preferential contact with the blood vessel wall (the diameter of the lubricant layer is expanded from the outer peripheral exposed part, so The spiral form of the lubricant coating part (which is in principle preferential contact with the exposed part) and the rotational advance / retreat operation by the surgeon of the hand part located outside the body generally match, and the sliding function by the contact point and the outer peripheral exposed part The sliding brake function works in harmony, ensuring the appropriate slidability as described above, and ensuring good insertion progress to the blood vessel bent portion and the fine blood vessel.
[0015]
Furthermore, based on the appropriate sliding property, the flexible striatum inserted into the blood vessel exhibits a straight posture with respect to the blood vessel wall (a posture in which excessive bending stress is not generated by excessive bending), To improve the contact resistance change between the leading front end and the vascular wall leading to the contact part of the contact feeling of "Garigari / Rugs", and to understand the behavior of the front end at the vascular bifurcation and vascular lesions The perception and graspability of the front edge information is improved.
[0016]
Furthermore, since the belt-like annular lubricant coating portion and the outer peripheral exposed portion are alternately arranged in the main body portion other than the tip portion, when inserting into the blood vessel sequentially from the tip portion while rotating the main body portion with the fingertip, Since the diameter direction of the exposed outer peripheral portion can be clamped and operated by the fingertip, there is no fingertip slip due to the lubricant, and the insertion operation into the blood vessel can be easily performed accurately. There are the above main effects.
[0017]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, the guide wire 1 of the present invention will be described based on the drawings. That is, FIGS. 1 to 4 show the form of the “lubricant coating portion” of the main component of the guide wire of the present invention. First, in FIG. 1, the metal core wire 3 is coated with a resin coating 7 (polyamide. In the case of the flexible linear member 2 wrapped with polyurethane or the like, strip-like lubricant coating portions 8A and 8B are provided on the outer periphery of the linear member 2 with an interval between adjacent ones in the line length direction. They are generally arranged along the entire length.
[0018]
Specifically, the lubricant coating portions 8A and 8B are coated with a lubricant material having lubricity during lubrication such as “maleic anhydride copolymer / methyl vinyl ether / polyvinyl pyrodrine” along the outer periphery of the resin coating 7. Is formed. The tip portion 5 where high flexibility is indispensable as a guide wire has a spiral band shape in which the lubricant coating portion 8A having the same band width B1 is continuous, and a spiral having the same width C1 is formed between adjacent lubricant coating portions 8A. The outer periphery exposed part 9 which comprises strip | belt shape and represents the outer periphery of the filament 2 is comprised.
[0019]
The main body portion 6 other than the front end portion 5 is formed by connecting the lubricant coating portions 8B of the annular belt having the same band width B2 in the rear end direction at the same pitch, and the lubricant coating portions 8B are connected to each other between the linear coating bodies. 2 is set to the outer periphery exposed portion 9 of the annular band representing the outer periphery of 2.
[0020]
In FIG. 1, the front end portion 10 that functions as a leading portion when the distal end portion 5 is inserted into a blood vessel is set to an exposed head (length = approximately 8 mm) that is not coated with a lubricant. The wire 3 has a known single wire / stranded wire structure of SUS material (stainless steel) or Ni (nickel) -Ti (titanium) material or a wire rope W structure.
[0021]
1, the length of the tip portion 5 = about 300 mm, the band width B1 of the lubricant coating portion 8A = about 5 mm, the band width C1 of the outer peripheral exposed portion 9 = about 2 mm / band width C2. The size is about 20 mm and the width B2 of the lubricant coating portion 8B is about 60 mm.
[0022]
Those having a lubricant coating portion 8A · 8B shown in FIG. 1 described above has an effect of the following this will be illustrated supplement. In other words (see FIGS. 1C to 1E), the conventional guide wire 1B having a high slidability at the branch portion of the blood vessel 20 easily slides and is difficult to guide to the branch blood vessel 21. On the other hand, in the embodiment of FIG. 1, the outer peripheral exposed portion 9 between the lubricant coating portions 8A slides against the blood vessel wall and functions as a brake, so that introduction guidance to the branch blood vessel 21 is facilitated.
[0023]
Then, when the front end portion 10 is introduced and guided to the collagen fiber portion 23 at the central portion of the concave wall of the occlusion lesion P, the front end portion 5 is appropriately slidable and the front end portion 10 is in the absence of lubricant. For this reason, the feeling of “crisp” and “lumpy” due to the joining of the front end portion 10 to the vascular intima 22 is transmitted to the hand portion 11 with high accuracy so that the touch can be easily recognized. The true cavity can be inserted into the front end portion 10 quickly and accurately.
[0024]
The tip portion 5 and the main body portion 6 are formed by alternately arranging the lubricant coating portions 8A and 8B and the outer peripheral exposed portion 9 (see FIG. 1E). When the catheter 24 is externally fitted and the contrast agent L is injected into the gap between the catheter 24 and the guide wire 1, the flow velocity V of the contrast agent L is quickly set to V 1 in the lubricant coating portion 8 A zone due to the difference in contact resistance. The zone 9 zone has a slow speed V2, and turbulence is generated at the joint portion of V1 and V2 to bring about the diffusion effect of the contrast agent L, and the density unevenness of the contrast agent L is eliminated to improve the contrast effect.
[0025]
Next, another form of the lubricant coating portion will be described with reference to FIG. That is, in the same manner as in FIG. 1 , the “spiral belt-like lubricant coating portion 8A” is provided on the outer periphery of the tip portion 5 of the linear member 2, and the lubricant coating portion 8B is provided on the outer periphery of the main body portion 6. The lubricant coating portion 8B of FIG. 2 is located on one diameter of the main body 6 and forms a symmetrical pair, and has a continuous stripe shape from the front end to the rear end of the main body 6. FIG. 2A has a shape in which the stripe width gradually decreases from the front end to the rear end of the main body 6, and the portions other than the stripe are in the longitudinal direction. It consists of a continuous outer periphery exposed portion 9.
[0026]
2 has the same operation as that of FIG. 1 because the main body 6 is “a form in which the lubricant coating portion 8B and the outer peripheral exposed portion 9 coexist in the longitudinal direction” . When the hand portion 11 is sandwiched between the fingertips and rotated and pushed and pulled to be inserted into the blood vessel, the semicircular arc strip-shaped outer peripheral exposed portions 9 exist in a pair in the upper and lower sides. It becomes easy to perform the internal insertion work. In FIG. 2B, the clamping space is widened toward the rear end of the main body 6, so that the clamping operation of the latter half of the main body 6 is improved by inserting the most part into the blood vessel and improving the operation difficulty. It becomes extremely easy to do. There are the above specific effects. The band width of the lubricant coating portion 8B of this embodiment is “0.8 mm for FIG. 2A and maximum width of about 1.0 mm for FIG. 2B, and minimum width = About 0.3cm ".
[0027]
Next, another embodiment will be described with reference to FIG . That is, in the one having the lubricant coating portions 8A and 8B, the spiral belt-like lubricant coating portion 8A of the front end portion 5 shown in FIG. 3A has a band width of B1, B2, and B3 sequentially from the front end toward the rear end. 3B, the spiral-band-like lubricant coating portion 8A of the tip portion 5 shown in FIG. 3B has a width of the outer peripheral exposed portion 9 between the same width B1. Is gradually increasing gradually changing from the front end portion 10 toward the rear end in the order of C1, C2, and C3.
[0028]
Then, the annular belt-like lubricant coating portion 8B of the main body portion 6 shown in FIG. 3 (C) has a gradually decreasing and gradually changing width of the band widths B1, B2, and B3 toward the rear end, and the outer peripheral exposed portion. 9 is a form in which the band width C1 is constant, and the main body 6 shown in FIG. 3 (D) is a band of the circumferentially exposed portion 9 between the annular belt-like lubricant coating portions 8B having the same width C1. The width gradually increases in the order of C1, C2, and C3 in the rear end direction.
[0029]
Since the surface area of the lubricant coating portion 8 per unit length in the length direction of the linear member 2 gradually decreases gradually from the front end portion 10 toward the rear end direction in the configuration shown in FIG. The contact area of the inner wall of the blood vessel and the total bending angle due to the blood vessel bending portion are extremely matched with the usage characteristics of the guide wire 1 that gradually decreases and gradually changes from the front end portion 10 toward the rear end direction, and the excessive slip in each zone in the longitudinal direction of the guide wire 1 This prevents the lubricant from being wasted while ensuring the appropriate slipperiness substantially uniform in the line length direction.
[0030]
Next, another embodiment will be described with reference to FIG. That is, what is shown in FIG. 4 is an example of a change in the shape of the filament 2 of the guide wire 1 having the lubricant coating portions 8A and 8B. The filament 2 shown in FIG. This tip portion is composed of a main body portion 6 made of a known wire rope W in which a plurality of side strand wires 13 are twisted to 12 and a tip portion 5 in which a coil spring 15 is fitted to a core wire 3 having a rectangular cross section. 5 and the outer periphery of the main body 6 are coated with “resin thin film coat C such as polyurethane”, and the same lubricant coating portions 8A and 8B are set on the resin thin film coat C.
[0031]
Next, the guide wire 1 according to the first embodiment of the present invention having the lubricant coating portions 8A and 8B described above as main components will be described with reference to FIG. That is, the guide wire 1 has a distal end portion 5 and a body portion 6 made of a wire rope W, and a part of the side strand wire 13 of the wire rope W is a large-diameter side strand wire 13A. Has a structure that appears in the entire length of the outer periphery of the rope in a protruding spiral. And, on the outer periphery of the wire rope W, “lubricant coating portions 8A and 8B on the resin thin film coat C shown in FIG. 4” are set. In this embodiment, the guide wire 1 has a spiral groove 14 or a spiral groove 14A formed by the side strand wires 13 and 13A on the outer peripheral exposed portion 9 of the wire body 2 (the groove wire appearing at the adjacent joint portion of the side strand wire 13). ) Appears, the concave strip 14 and the concave strip 14A of the guide wire 1 that is rotated when the blood vessel is inserted function as a reservoir and a feed groove for the lubricant to be injected.
[0032]
Further, since the “spiral groove streaks 14A or spiral grooves 14” are present on the outer periphery, the embodiment of FIG. 5 has the following specific effects. That is, (see FIG. 5 (B)) When the catheter 24 is fitted and set after insertion into the blood vessel, and the contrast agent L is injected between the outer periphery of the guide wire 1 and the inner periphery of the catheter 24, the contrast agent L is spirally recessed. A spiral flow is generated by being guided by the streak 14A and the spiral recess 14, and a turbulent flow based on the flow velocity V1 and V2 shown in FIG. 1E is generated. The diffusion effect of the contrast agent L shown in FIG.
[0033]
【The invention's effect】
As described above, the medical guide wire of the present invention has excellent insertion property into the blood vessel, direction control to the bent blood vessel / branch blood vessel / vascular lesioned portion of the blood vessel, and introduction guideability in the blood vessel, and the front end. It is excellent in information transmission to the proximal part of the intravascular contact behavior of the part, and has an effect of particularly improving the therapeutic property.
[Brief description of the drawings]
FIG. 1 shows a medical guide wire provided with a lubricant coating portion as a main component of the present invention , (A) is a front view thereof, (B) is a cross-sectional view of (A), and (C) ( D) (E) shows a medical guide wire with a lubricant coating of the main components of illustration the present invention; FIG its activated condition, (a) (B) is its overall front view, ( (C) is a cross-sectional view of (A) and (B). FIG. 3 shows a medical guide wire having a lubricant coating portion as a main component of the present invention , and (A) to (D) are partial front views thereof. 4A and 4B show a medical guide wire having a lubricant coating portion as a main component of the present invention, in which FIG. 4A is an overall front view, FIG. 4B is an EE cross-sectional view of FIG. FF sectional view of (a) [5] shows a medical guide wire according to the present invention one embodiment, (a) thereof Front view of body, (B) is an explanatory view of the action. FIG. 6 shows a conventional medical guide wire, (A) and (B) are front views of the whole, (C) is a partial sectional view of (A), and (D). Is a cross-sectional view of (B) [Explanation of symbols]
DESCRIPTION OF REFERENCE NUMERALS 1 Medical guide wire provided with lubricant coating portion as main component of the present invention 1A / 1B Conventional medical guide wire
1C Medical guide wire 2 of the present invention 2 striate body 3 core material 5 tip portion 6 body portion 7 resin coating 8A and 8B lubricant coating portion 9 outer peripheral exposed portion 10 front end portion 11 proximal portion 14 spiral groove 20 blood vessel P blood vessel occlusion Part W Wire rope

Claims (5)

可撓性線条体から成る医療用ガイドワイヤにカテーテルを外嵌セットした組立体において、前記医療用ガイドワイヤの前端部に、潤滑剤未コーティング部の露出頭を設けて、
前記可撓性線条体は金属線撚線構造のワイヤロープの外周に樹脂被覆を備えると共に、前記ワイヤロープは側ストランド線の一部が他の側ストランド線より太径に構成され、前記可撓性線条体の先端部分の外周に、スパイラル帯状の潤滑剤コーティング部とスパイラル帯状の前記先端部分の外周露出部を交互配設し、
さらに前記先端部分以外の本体部の外周に、環状帯状の潤滑剤コーティング部と環状帯状の前記本体部の外周露出部を交互配設した構造とし、
前記カテーテル内へ注入剤の注入時に、前記潤滑剤コーティング部と前記外周露出部とで前記注入剤に流速差を生じさせて拡散効果を高めたことを特徴とする医療用ガイドワイヤとカテーテルとの組立体
In an assembly in which a catheter is externally fitted and set on a medical guide wire made of a flexible striated body, an exposed head of a lubricant-uncoated portion is provided at the front end of the medical guide wire,
The flexible umbilical member is provided with a periphery in the resin coating of the wire rope of the metal wire stranded structure, the wire rope is constructed to a large diameter portion of the side strands line than the other side strands lines, wherein the outer periphery of the distal end portion of the flexible striatum, the outer peripheral exposed portion of the tip portion of the lubricant coating portion and the spiral strip of the spiral strip is alternately arranged,
Further, the the outer periphery of the body portion other than the tip portion, and alternately arranged with a structure in which the outer peripheral exposed portion of the main body portion of the lubricant coating portion and the annular band-shaped annular strip,
A medical guide wire and a catheter, wherein a diffusion effect is enhanced by causing a difference in flow rate in the infusate between the lubricant coating portion and the outer peripheral exposed portion when the infusate is injected into the catheter. Assembly .
請求項1に記載の医療用ガイドワイヤとカテーテルとの組立体において、前記環状帯状の潤滑剤コーティング部の帯幅が、前端から後端方向へ順次幅小になる漸減徐変形態、又は前記環状帯状の潤滑剤コーティング部と並設した外周露出部の帯幅が前端から後端方向へ順次幅大になる漸増徐変形態としたことを特徴とする医療用ガイドワイヤとカテーテルとの組立体 The assembly of the medical guide wire and the catheter according to claim 1, wherein a band width of the annular belt-like lubricant coating portion gradually decreases gradually from the front end toward the rear end, or the annular assembly of the medical guide wire and catheter, characterized in that the band width of the band-like lubricant coating portion juxtaposed the outer peripheral exposed portion has a gradually increasing gradual change form to be sequentially width size from the front end to the rear end direction. 可撓性線条体から成る医療用ガイドワイヤにカテーテルを外嵌セットした組立体において、
前記医療用ガイドワイヤの先端部に、潤滑剤未コーティング部の露出頭を設けて、
前記可撓性線条体は、金属線撚線構造のワイヤロープの外周に樹脂被覆を備えると共に、前記ワイヤロープは側ストランド線の一部が他の側ストランド線より太径に構成され、前記可撓性線条体の先端部分の外周にスパイラル帯状の潤滑剤コーティング部とスパイラル帯状の前記先端部分の外周露出部を交互配設し、
さらに、前記先端部分以外の本体部の外周に前記可撓性線条体の長手方向に伸長するストライプ状の潤滑剤コーティング部を設けた構造とし、
前記カテーテル内へ注入剤の注入時に、前記潤滑剤コーティング部と前記外周露出部とで前記注入剤に流速差を生じさせて拡散効果を高めたことを特徴とする医療用ガイドワイヤとカテーテルとの組立体
In an assembly in which a catheter is externally fitted to a medical guide wire made of a flexible striate body,
At the distal end portion of the medical guide wire, an exposed head of the lubricant uncoated portion is provided,
The flexible linear body is provided with a resin coating on the outer periphery of a wire rope having a metal wire twisted wire structure, and the wire rope is configured such that a part of the side strand wire has a larger diameter than the other side strand wire, The spiral strip-shaped lubricant coating portion and the outer peripheral exposed portion of the spiral strip-shaped tip portion are alternately disposed on the outer periphery of the distal end portion of the flexible linear body,
Furthermore, the outer periphery of the main body portion other than the tip portion is provided with a stripe-shaped lubricant coating portion extending in the longitudinal direction of the flexible linear body,
A medical guide wire and a catheter, wherein a diffusion effect is enhanced by causing a difference in flow rate in the infusate between the lubricant coating portion and the outer peripheral exposed portion when the infusate is injected into the catheter. Assembly .
請求項3に記載の医療用ガイドワイヤとカテーテルとの組立体において、前記ストライプ状の潤滑剤コーティング部のストライプ幅が、前端から後端方向へ漸減徐変形態としたことを特徴とする医療用ガイドワイヤとカテーテルとの組立体 4. The medical guide wire and catheter assembly according to claim 3, wherein the stripe width of the stripe-shaped lubricant coating portion gradually decreases from the front end toward the rear end. Guide wire and catheter assembly . 請求項1〜4のいずれか一つに記載の医療用ガイドワイヤとカテーテルとの組立体において、前記先端部分のストライプ帯状の潤滑剤コーティング部の帯幅が、前端から後端方向へ順次幅小になる漸減徐変形態、又は、前記スパイラル帯状の潤滑剤コーティング部と並設した外周露出部の帯幅が前端から後端方向へ順次幅大になる漸増徐変形態としたことを特徴とする医療用ガイドワイヤとカテーテルとの組立体。The assembly of the medical guide wire and the catheter according to any one of claims 1 to 4, wherein the band width of the strip-like lubricant coating portion at the front end portion is gradually reduced from the front end toward the rear end. Or a gradually increasing and changing shape in which the band width of the outer peripheral exposed portion arranged in parallel with the spiral belt-like lubricant coating portion is gradually increased from the front end toward the rear end. A medical guidewire and catheter assembly.
JP2001393026A 2001-12-26 2001-12-26 Medical guidewire Expired - Fee Related JP4159777B2 (en)

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JP5979879B2 (en) * 2012-01-06 2016-08-31 テルモ株式会社 Guide wire
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