JP4812932B2

JP4812932B2 - Catheter and balloon catheter

Info

Publication number: JP4812932B2
Application number: JP2000347567A
Authority: JP
Inventors: 正年渡辺; 真司福谷; 健志岩野
Original assignee: Kawasumi Laboratories Inc
Current assignee: SB Kawasumi Laboratories Inc
Priority date: 2000-11-15
Filing date: 2000-11-15
Publication date: 2011-11-09
Anticipated expiration: 2020-11-15
Also published as: JP2002143316A

Description

【０００１】
【発明の属する技術分野】
本発明はカテーテルチューブ（またはガイドワイヤー用チューブ）に装着されるＸ線不透過の金属マーカーの取付形態及び金属マーカーの形態の改良に関し、例えば脳カテーテル、マイクロカテーテル等のカテーテルやあるいは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の改良に関するものである。
【０００２】
【従来の技術及び発明が解決しようとする課題】
生体内へのカテーテルの挿入長の確認やカテーテル先端部の位置確認のため、例えば図９に示すようにＸ線不透過の金属マーカー６３がカテーテルチューブ６４に装着されて使用されている。これらの金属マーカー６３は、白金、タングステン、イリジウム等の金属材料より構成され、長さが０．５から２．０ｍｍで薄肉で管状の形態に形成されているため、柔軟性に乏しく、例えば図１０に示すようにガイドワイヤーＧＷに通しながら屈曲した血管に挿入した場合、ガイドワイヤーＧＷにつかえて血管の屈曲部を速やかに通過できないという課題が指摘されていた。
また前記金属マーカー６３は、カテーテルチューブ６４に固定する際に、例えば図１１（カテーテルチューブ６４の断面図）に示すように瞬間接着剤Ｓ等によって、接着したり、あるいは図１２（カテーテルチューブ６４Ａの断面図）に示すようスウェ−ジングマシンにより、カテーテルチューブ６４Ａをスウェ−ジングして凹部６５を形成し、凹部６５に金属マーカー６３を固定している。
しかしながら、接着剤等による固定では、金属マーカー６３とカテーテルチューブ６４の間に、段差ができ、カテーテルの血管通過性を損なうことがある。
またスウェ−ジングによる固定では、金属マーカー６３とカテーテルチューブ６４Ａの段差はなくなるが、カテーテルチューブ６４Ａの肉厚が凹部６５で薄くなるので、カテーテルチューブ６４Ａの強度低下やスウェ−ジング加工時のピンホール等の発生が懸念されていた。
そこで本発明者らは以上の課題を解決するために鋭意検討を重ねた結果次の発明に到達した。
【０００３】
【課題を解決するための手段】
［１］本発明は、可とう性を有するカテーテルチューブ（４）と、金属マーカー（１１）と、第１固定チューブ（１２．１）及び第２固定チューブ（１２．２）とを有し、
前記カテーテルチューブ（４）、前記金属マーカー（１１）、前記第１固定チューブ（１２．１）及び前記第２固定チューブ（１２．２）は、それぞれ管状で、長さ方向と、当該長さ方向に略垂直に交差する側部方向と、前記長さ方向に第１端部と第２端部とを有し、
前記金属マーカー（１１）、前記第１固定チューブ（１２．１）及び前記第２固定チューブ（１２．２）は、それぞれの側部方向の内径は、前記カテーテルチューブ（４）の側部方向の外周に装着できる大きさを有し、
前記金属マーカー（１１）、前記第１固定チューブ（１２．１）及び前記第２固定チューブ（１２．２）を、前記カテーテルチューブ（４）の外周に装着し、
前記金属マーカー（１１）の前記第１端部の近傍に第１固定チューブ（１２．１）を装着し、及び前記金属マーカー（１１）の前記第２端部の近傍に第２固定チューブ（１２．２）を装着し、
前記第１固定チューブ（１２．１）は、第２端部から第１端部、すなわち前記カテーテルチューブ（４）の第１端部に向けて下るテーパー部（１２．１Ｔ）を有し、
前記第２固定チューブ（１２．２）は、第１端部から第２端部、すなわち、前記カテーテルチューブ（４）の第２端部に向けて下るテーパー部（１２．２Ｔ）を有し、
前記第１固定チューブ（１２．１）及び前記第２固定チューブ（１２．２）は、前記金属マーカー（１１）の前記第１端部の近傍及び前記金属マーカー（１１）の前記第２端部の近傍に装着する以前においても、
管状で、長さ方向と、当該長さ方向に略垂直に交差する側部方向と、前記長さ方向に第１端部と第２端部とを有する形状を保持し、
側部方向の内径は、前記カテーテルチューブ（４）の側部方向の外周に装着できる大きさの形状を保持し、かつ前記カテーテルチューブ（４）の第１端部に向けて下るテーパー部（１２．１Ｔ）の形状及び前記カテーテルチューブ（４）の第２端部に向けて下るテーパー部（１２．２Ｔ）の形状を保持し、
さらに前記金属マーカー（１１）の前記第１端部の近傍及び前記金属マーカー（１１）の前記第２端部の近傍に装着する途中の段階、及び装着後の段階においても、前記装着する以前の前記形状を保持しているものであり、
前記金属マーカー（１１）の前記第１端部と前記カテーテルチューブ（４）の側部方向の外周面、及び前記金属マーカー（１１）の前記第２端部と前記カテーテルチューブ（４）の側部方向の外周面との間に、段差が生じないように形成した、カテーテル（１）を提供する。
［２］本発明は、［１］に記載のカテーテル（１）の前記管状の金属マーカー（１１）に代えて、コイル状のマーカー（１３）を有し、
前記コイル状のマーカー（１３）は、長さ方向と、当該長さ方向に略垂直に交差する側部方向と、前記長さ方向に第１端部と第２端部とを有し、
前記コイル状のマーカー（１３）は、金属線をコイル状に加工したものであり、
前記コイル状のマーカー（１３）、前記第１固定チューブ（１２．１）及び前記第２固定チューブ（１２．２）を、前記カテーテルチューブ（４）の外周に装着し、
前記コイル状のマーカー（１３）の前記第１端部の近傍に第１固定チューブ（１２．１）を装着し、及び前記コイル状のマーカー（１３）の前記第２端部の近傍に第２固定チューブ（１２．２）を装着し、
前記第１固定チューブ（１２．１）は、第２端部から第１端部、すなわち前記カテーテルチューブ（４）の第１端部に向けて下るテーパー部（１２．１Ｔ）を有し、
前記第２固定チューブ（１２．２）は、第１端部から第２端部、すなわち、前記カテーテルチューブ（４）の第２端部に向けて下るテーパー部（１２．２Ｔ）を有し、
前記コイル状のマーカー（１３）の前記第１端部と前記カテーテルチューブ（４）の側部方向の外周面、及び前記コイル状のマーカー（１３）の前記第２端部と前記カテーテルチューブ（４）の側部方向の外周面との間に、段差が生じないように形成した、カテーテル（１ａ）を提供する。
［３］本発明は、可とう性を有するガイドワイヤー用チューブ（４Ａ、１４）と、金属マーカー（１１）と、第１固定チューブ（１２．１）及び第２固定チューブ（１２．２）とを有し、
前記ガイドワイヤー用チューブ（４Ａ、１４）、前記金属マーカー（１１）、前記第１固定チューブ（１２．１）及び前記第２固定チューブ（１２．２）は、それぞれ管状で、長さ方向と、当該長さ方向に略垂直に交差する側部方向と、前記長さ方向に第１端部と第２端部とを有し、
前記金属マーカー（１１）、前記第１固定チューブ（１２．１）及び前記第２固定チューブ（１２．２）は、それぞれの側部方向の内径は、前記ガイドワイヤー用チューブ（４Ａ、１４）の側部方向の外周に装着できる大きさを有し、
前記金属マーカー（１１）、前記第１固定チューブ（１２．１）及び前記第２固定チューブ（１２．２）を、前記ガイドワイヤー用チューブ（４Ａ、１４）の外周に装着し、
前記金属マーカー（１１）の前記第１端部の近傍に第１固定チューブ（１２．１）を装着し、及び前記金属マーカー（１１）の前記第２端部の近傍に第２固定チューブ（１２．２）を装着し、
前記第１固定チューブ（１２．１）は、第２端部から第１端部、すなわち前記ガイドワイヤー用チューブ（４Ａ、１４）の第１端部に向けて下るテーパー部（１２．１Ｔ）を有し、
前記第２固定チューブ（１２．２）は、第１端部から第２端部、すなわち、前記ガイドワイヤー用チューブ（４Ａ、１４）の第２端部に向けて下るテーパー部（１２．２Ｔ）を有し、
前記第１固定チューブ（１２．１）及び前記第２固定チューブ（１２．２）は、前記金属マーカー（１１）の前記第１端部の近傍及び前記金属マーカー（１１）の前記第２端部の近傍に装着する以前においても、
管状で、長さ方向と、当該長さ方向に略垂直に交差する側部方向と、前記長さ方向に第１端部と第２端部とを有する形状を保持し、
側部方向の内径は、前記カテーテルチューブ（４）の側部方向の外周に装着できる大きさの形状を保持し、かつ前記カテーテルチューブ（４）の第１端部に向けて下るテーパー部（１２．１Ｔ）の形状及び前記カテーテルチューブ（４）の第２端部に向けて下るテーパー部（１２．２Ｔ）の形状を保持し、
さらに前記金属マーカー（１１）の前記第１端部の近傍及び前記金属マーカー（１１）の前記第２端部の近傍に装着する途中の段階、及び装着後の段階においても、前記装着する以前の前記形状を保持しているものであり、
前記金属マーカー（１１）の前記第１端部と前記ガイドワイヤー用チューブ（４Ａ、１４）の側部方向の外周面、及び前記金属マーカー（１１）の前記第２端部と前記ガイドワイヤー用チューブ（４Ａ、１４）の側部方向の外周面との間に、段差が生じないように形成した、バルーンカテーテル（１Ａ、１Ｂ、１Ｃ）を提供する。
［４］本発明は、シャフト（２）とバルーン（５）とを有し、前記シャフト（２）と前記バルーン（５）は、それぞれ長手方向と、当該長手方向と略垂直に交わる側部方向とを有し、
前記長手方向の前方から後方に向けて、前記バルーン（５）、前記シャフト（２）の順に配置し、
前記シャフト（２）と前記バルーン（５）は、それぞれ前記長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有し、
前記シャフト（２）は、可とう性の前方部（２Ｆ）と、剛性の基端部（２Ｂ）とを有し、
前記前方部（２Ｆ）と前記基端部（２Ｂ）は、それぞれ長手方向と、当該長手方向と略垂直に交わる側部方向とを有し、
前記前方部（２Ｆ）と前記基端部（２Ｂ）とは、それぞれ前記長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有し、
前記前方部（２Ｆ）の近位端に、前記基端部（２Ｂ）の遠位端を装着し、
前記前方部（２Ｆ）の遠位端に、前記バルーン（５）の近位端を装着し、
前記シャフト（２）の前方部（２Ｆ）の内腔に、可とう性を有するガイドワイヤー用チューブ（４Ａ）を配置し、当該ガイドワイヤー用チューブ（４Ａ）は、内腔にガイドワイヤールーメン（６）を有し、
当該ガイドワイヤールーメン（６）は、先端開口部（９Ｆ）と、後端開口部（９Ｂ）とを有し、
前記先端開口部（９Ｆ）は、前記バルーン（５）の内腔を経て前記バルーン（５）の遠位端に配置され、
前記後端開口部（９Ｂ）は、前記前方部（２Ｆ）の内腔を経て当該前方部（２Ｆ）の側部に配置され、
前記前方部（２Ｆ）の内壁面と前記ガイドワイヤー用チューブ（４Ａ）の外壁面との間に形成される流体ルーメン（７）内に、補強体（３）を配置し、
当該補強体（３）は、長手方向と、当該長手方向と略垂直に交わる側部方向とを有し、
前記長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有し、
前記ガイドワイヤー用チューブ（４Ａ）に、前記［３］に記載の前記金属マーカー（１
１）と、前記第１固定チューブ（１２．１）及び前記第２固定チューブ（１２．２）とを装着し、
前記金属マーカー（１１）の前記第１端部と前記ガイドワイヤー用チューブ（４Ａ）の側部方向の外周面、及び前記金属マーカー（１１）の前記第２端部と前記ガイドワイヤー用チューブ（４Ａ）の側部方向の外周面との間に、段差が生じないように形成した、バルーンカテーテル（１Ａ、１Ｂ）を提供する。
［５］本発明は、シャフト（１２Ａ）とバルーン（１５）とを有し、前記シャフト（１２Ａ）と前記バルーン（１５）は、それぞれ長手方向と、当該長手方向と略垂直に交わる側部方向とを有し、
前記長手方向の前方から後方に向けて、前記バルーン（１５）、前記シャフト（１２Ａ）の順に配置し、
前記シャフト（１２Ａ）と前記バルーン（１５）は、それぞれ前記長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有し、
前記シャフト（１２Ａ）は、長手方向と、当該長手方向と略垂直に交わる側部方向とを有し、
前記長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有し、
前記シャフト（１２Ａ）の内腔に、可とう性を有するガイドワイヤー用チューブ（１４）を配置し、当該ガイドワイヤー用チューブ（１４）は、内腔にガイドワイヤールーメン（１６）を有し、
当該ガイドワイヤールーメン（１６）は、先端開口部（１９Ｆ）と、後端開口部（１９Ｂ）とを有し、
前記先端開口部（１９Ｆ）は、前記バルーン（１５）の内腔を経て前記バルーン（１５）の遠位端に配置され、
前記後端開口部（１９Ｂ）は、前記シャフト（１２Ａ）の内腔を経て、当該シャフト（１２Ａ）の近位端に装着されたコネクタ（１８）の近位端に配置され、
前記ガイドワイヤー用チューブ（１４）に、前記［３］に記載の前記金属マーカー（１
１）と、前記第１固定チューブ（１２．１）及び前記第２固定チューブ（１２．２）とを装着し、
前記金属マーカー（１１）の前記第１端部と前記ガイドワイヤー用チューブ（１４）の側部方向の外周面、及び前記金属マーカー（１１）の前記第２端部と前記ガイドワイヤー用チューブ（１４）の側部方向の外周面との間に、段差が生じないように形成した、バルーンカテーテル（１Ｃ）を提供する。
［６］本発明は、前記管状の金属マーカー（１１）に代えて、コイル状のマーカー（１３）を装着した［３］から［５］のいずれか１項に記載のバルーンカテーテル（１Ａ、１Ｂ、１Ｃ）を提供する。
【０００４】
【発明の実施の形態】
図１は本発明のカテーテル１の概略図で、図２は図１のＡ―Ａ断面図である。本発明のカテーテル１は、カテーテルチューブ４の外周に金属マーカー１１を装着するとともに、該金属マーカー１１の両側に外周がテーパーに形成された一対の第１固定チューブ１２．１と第２固定チューブ１２．２とを装着し、前記金属マーカー１１と前記第１固定チューブ１２．１と第２固定チューブ１２．２との間に、段差が生じないように形成している。
さらに詳述すれば、本発明のカテーテル１は、カテーテルチューブ４と、金属マーカー１１と、第１固定チューブ１２．１及び第２固定チューブ１２．２とを有する。
前記カテーテルチューブ４、前記金属マーカー１１、前記第１固定チューブ１２．１及び前記第２固定チューブ１２．２は、それぞれ管状で、長さ方向と、当該長さ方向に略垂直に交差する側部方向と、前記長さ方向に第１端部と第２端部とを有する。
金属マーカー１１、前記第１固定チューブ１２．１及び前記第２固定チューブ１２．２は、それぞれの側部方向の内径は、前記カテーテルチューブ４の側部方向の外周に装着できる大きさを有する。
前記金属マーカー１１、前記第１固定チューブ１２．１及び前記第２固定チューブ１２．２を、前記カテーテルチューブ４の外周に装着している。
前記金属マーカー１１の前記第１端部の近傍に第１固定チューブ１２．１を装着し、及び前記金属マーカー１１の前記第２端部の近傍に第２固定チューブ１２．２を装着している。
前記第１固定チューブ１２．１は、第２端部から第１端部、すなわち前記カテーテルチューブ４の第１端部に向けて下るテーパー部１２．１Ｔを有し、前記第２固定チューブ１２．２は、第１端部から第２端部、すなわち、前記カテーテルチューブ４の第２端部に向けて下るテーパー部１２．２Ｔを有している。
前記金属マーカー１１の前記第１端部と前記カテーテルチューブ４の側部方向の外周面、及び前記金属マーカー１１の前記第２端部と前記カテーテルチューブ４の側部方向の外周面との間に、段差が生じないように形成している。
本発明で「金属マーカー１１」とは、白金、タングステン、イリジウム等の金属材料より構成され、長さが０．５から３．０ｍｍで薄肉で管状の形態のものやコイル状の形態も含む。本発明で、「固定チューブ１２」とは、管状で、その外周は、金属マーカー１１側の端部からこれと反対側のカテーテルチューブ４の外周方向へ向けて、なだらかなテーパーに形成されている。このため金属マーカー１１とこれの両側に配置された固定チューブ１２の間並びに固定チューブ１２とカテーテルチューブ４の間には、段差がなく、血管への通過性を損なうことがない。
さらに補足すれば、第１固定チューブ１２．１及び第２固定チューブ１２．２は、金属マーカー１１の第１端部の近傍及び金属マーカー１の第２端部の近傍に装着する以前においても、管状で、長さ方向と、当該長さ方向に略垂直に交差する側部方向と、前記長さ方向に第１端部と第２端部とを有する形状を保持している。
側部方向の内径は、カテーテルチューブ４の側部方向の外周に装着できる大きさの形状を保持し、かつ前記カテーテルチューブ４の第１端部に向けて下るテーパー部１２．１Ｔの形状及びカテーテルチューブ４の第２端部に向けて下るテーパー部１２．２Ｔの形状を保持している。
さらに金属マーカー１１の第１端部の近傍及び金属マーカー１１の第２端部の近傍に装着する途中の段階、及び装着後の段階においても、前記装着する以前の前記形状を保持している。
【０００５】
図３は図１のカテーテルのその他の実施例を示す拡大図で、図４は図３の使用状態図である。
本発明のカテーテル１ａではカテーテルチューブ４の外周にコイル状のマーカー１３を装着している。
すなわちコイル状のマーカー１３は、長さ方向と、当該長さ方向に略垂直に交差する側部方向と、前記長さ方向に第１端部と第２端部とを有している。
コイル状のマーカー１３は、金属線をコイル状に加工したものであり、コイル状のマーカー１３、前記第１固定チューブ１２．１及び前記第２固定チューブ１２．２を、前記カテーテルチューブ４の外周に装着している。
コイル状のマーカー１３の前記第１端部の近傍に第１固定チューブ１２．１を装着し、及び前記コイル状のマーカー１３の前記第２端部の近傍に第２固定チューブ１２．２を装着している。
前記第１固定チューブ１２．１は、第２端部から第１端部、すなわち前記カテーテルチューブ４の第１端部に向けて下るテーパー部１２．１Ｔを有し、前記第２固定チューブ１２．２は、第１端部から第２端部、すなわち、前記カテーテルチューブ４の第２端部に向けて下るテーパー部１２．２Ｔを有している。
前記コイル状のマーカー１３の前記第１端部と前記カテーテルチューブ４の側部方向の外周面、及び前記コイル状のマーカー１３の前記第２端部と前記カテーテルチューブ４の側部方向の外周面との間に、段差が生じないように形成している。
本発明で「コイル状のマーカー１３」とは、線径１０μｍから３００μｍの例えば白金、タングステン、イリジウム等の金属材料からなる線径１０μｍから３００μｍの金属線をコイル状に加工したもので、コイルの形状は、カテーテルチューブ４の外径に合わせて加工することができる。本発明のカテーテル１ａは、図４に示すように、コイル状のマーカー１３自体が柔軟に屈曲することで、ガイドワイヤーＧＷに通しながら血管の屈曲部にカテーテルチューブ４を挿入しても、コイル状のマーカー１３が容易に変形するので、血管の屈曲部に止まることなく、速やかに通過することができる。
以上説明したカテーテル１、１ａの金属マーカー１１（コイル状のマーカ１３を含む）を装着したカテーテルチューブ４は、以下に説明するバルーンカテーテル１Ａ、１Ｂ、１Ｃのガイドワイヤー用チューブ４Ａに、置き換えて使用することができる。すなわちガイドワイヤー用チューブ４Ａの外周に前記金属マーカー１１（コイル状のマーカー１３も含む）と前記固定チューブ１２を装着する。
前記金属マーカー１１（コイル状のマーカー１３）と固定チューブ１２のカテーテルチューブ４、ガイドワイヤー用チューブ４Ａへの装着位置は、カテーテルチューブ４、ガイドワイヤー用チューブ４Ａの外周であれば、同チューブ４、４Ａの中間、先端、後端のいずれの位置でも良い。後述するバルーンカテーテル１Ａ、１Ｂ、１Ｃのガイドワイヤー用チューブ４Ａ、１４へ装着する場合は、バルーン５（１５）内もしくはその先端または前方部２Ｆ（シャフト１２Ａの前方部）内のいずれの位置でも良い。
【０００６】
図５〜図６は本発明のバルーンカテーテル（１Ａ、１Ｂ）の一例を示す概略図（断面図）、図７は本発明のバルーンカテーテルの一例を示す概略図、図８は図７のＢ付近の断面図である。
バルーンカテーテル（１Ａ、１Ｂ、１Ｃ）は、ガイドワイヤー用チューブ（４Ａ、１４）と、金属マーカー１１と、第１固定チューブ１２．１及び第２固定チューブ１２．２とを有している。
前記ガイドワイヤー用チューブ（４Ａ、１４）、前記金属マーカー１１、前記第１固定チューブ１２．１及び前記第２固定チューブ１２．２は、それぞれ管状で、長さ方向と、当該長さ方向に略垂直に交差する側部方向と、前記長さ方向に第１端部と第２端部とを有している。
前記金属マーカー１１、前記第１固定チューブ１２．１及び前記第２固定チューブ１２．２は、それぞれの側部方向の内径は、前記ガイドワイヤー用チューブ（４Ａ、１４）の側部方向の外周に装着できる大きさを有している。
前記金属マーカー１１、前記第１固定チューブ１２．１及び前記第２固定チューブ１２．２を、前記ガイドワイヤー用チューブ（４Ａ、１４）の外周に装着している。
前記金属マーカー１１の前記第１端部の近傍に第１固定チューブ１２．１を装着し、及び前記金属マーカー１１の前記第２端部の近傍に第２固定チューブ１２．２を装着している。
前記第１固定チューブ１２．１は、第２端部から第１端部、すなわち前記ガイドワイヤー用チューブ（４Ａ、１４）の第１端部に向けて下るテーパー部１２．１Ｔを有し、前記第２固定チューブ１２．２は、第１端部から第２端部、すなわち、前記ガイドワイヤー用チューブ（４Ａ、１４）の第２端部に向けて下るテーパー部１２．２Ｔを有している。
前記金属マーカー１１の前記第１端部と前記ガイドワイヤー用チューブ（４Ａ、１４）の側部方向の外周面、及び前記金属マーカー１１の前記第２端部と前記ガイドワイヤー用チューブ（４Ａ、１４）の側部方向の外周面との間に、段差が生じないように形成している。
図５はいわゆるラピッドエクスチェンジタイプといわれる本発明のバルーンカテーテル１Ａの一例を示す概略図（断面図、なお、コネクタ８付近の断面図は前方部２Ｆ付近の断面図より縮小化して記載されている）である。本発明のバルーンカテーテル１Ａはシャフト２の先端にバルーン５を装着し、シャフト２は少なくとも可とう性の前方部２Ｆ（合成樹脂管ともいう）と少なくとも剛性の基端部２Ｂ（シャフトパイプまたは金属管ともいう）より構成されている。
さらに詳述すれば、シャフト２とバルーン５とを有し、前記シャフト２と前記バルーン５は、それぞれ長手方向と、当該長手方向と略垂直に交わる側部方向とを有する。
前記長手方向の前方から後方に向けて、前記バルーン５、前記シャフト２の順に配置し、前記シャフト２と前記バルーン５は、それぞれ前記長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有する。
前記シャフト２は、可とう性の前方部２Ｆと、剛性の基端部２Ｂとを有し、前記前方部２Ｆと前記基端部２Ｂは、それぞれ長手方向と、当該長手方向と略垂直に交わる側部方向とを有する。
前記前方部２Ｆと前記基端部２Ｂとは、それぞれ前記長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有し、前記前方部２Ｆの近位端に、前記基端部２Ｂの遠位端を装着し、前記前方部２Ｆの遠位端に、前記バルーン５の近位端を装着している。
前記シャフト２の前方部２Ｆの内腔に、ガイドワイヤー用チューブ４Ａを配置し、当該ガイドワイヤー用チューブ４Ａは、内腔にガイドワイヤールーメン６を有し、当該ガイドワイヤールーメン６は、先端開口部９Ｆと、後端開口部９Ｂとを有する。
前記先端開口部９Ｆは、前記バルーン５の内腔を経て前記バルーン５の遠位端に配置され、前記後端開口部９Ｂは、前記前方部２Ｆの内腔を経て当該前方部２Ｆの側部に配置されている。
前記前方部２Ｆの内壁面と前記ガイドワイヤー用チューブ４Ａの外壁面との間に形成される流体ルーメン７内に、補強体３を配置している。
当該補強体３は、長手方向と、当該長手方向と略垂直に交わる側部方向とを有し、前記長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有する。
前記ガイドワイヤー用チューブ４Ａに、前記金属マーカー１１と、前記第１固定チューブ１２．１及び前記第２固定チューブ１２．２とを装着している。
前記金属マーカー１１の前記第１端部と前記ガイドワイヤー用チューブ４Ａの側部方向の外周面、及び前記金属マーカー１１の前記第２端部と前記ガイドワイヤー用チューブ４Ａの側部方向の外周面との間に、段差が生じないように形成している。
さらに前記剛性の基端部２Ｂの先端に細径部２Ｓが形成されている。細径部２Ｓは、さらに詳述すると、例えば図５に示すように、前記剛性の基端部２Ｂの先端にスリット２ＳＬを形成しかつテーパー状の第一の細径部２Ｓ１（基端部２Ｂより細径に形成されている）を介して第二の細径部２Ｓ２（第一の細径部２Ｓ１より細径に形成されている）を一体成形ないし接続することにより形成される。前記剛性の基端部２Ｂは、例えば金属製シャフトパイプを延伸し（シャフトパイプの先端内径を補強体３の基端部３Ｂの外径と実質的に同一となるまで延伸する）、さらにシャフトパイプの径を細くし、さらに造影剤が注入できる程度のスリット２ＳＬを形成することにより製造する。
【０００７】
またシャフト２内に先端と後端にそれぞれ開口部９Ｆ、９Ｂを形成しかつガイドワイヤールーメン６を有するガイドワイヤー用チューブ４Ａを前記前方部２Ｆの側面からバルーン５内を経てバルーン５の先端に至るまで配置している。さらに前記前方部２Ｆ内及びガイドワイヤー用チューブ４Ａ外周の間に形成される流体ルーメン７内に補強体３の前方部３Ｆを配置する（シャフト２への開口部９Ｂの形成位置により前方部３Ｆと中間部３Ｍも配置されることがある）とともに前記補強体３の基端部３Ｂを前記基端部２Ｂの細径部に直接接着することなく固定している。さらに詳述すれば前記剛性の基端部２Ｂの先端にスリット２ＳＬを形成した第一の細径部２Ｓ１に連続して形成される第二の細径部２Ｓ２に、前記補強体３の基端部３Ｂを直接接着することなく固定している。
【０００８】
本発明の図５に記載のバルーンカテーテル１で前記「固定」とは前記補強体３の基端部３Ｂを前記細径部（第二の細径部２Ｓ２）に直接溶接等により接着しないで、単に圧入等により挿着またはこれらと実質的に同等の固定手段を意味する。本発明で、細径部２Ｓとは、前記図５に示した第一の細径部２Ｓ１（基端部２Ｂより細径に形成されている）と第二の細径部２Ｓ２（第一の細径部２Ｓ１より細径に形成されている）の形態に限定されず、要するに前記補強体３の基端部３Ｂを直接溶接等により接着しないで、単に圧入等により挿着またはこれらと実質的に同等の固定手段により固定できる形態であれば何でも良い。
また本発明で補強体３の前方部３Ｆは前記ガイドワイヤー用チューブ４Ａの側部（外壁面）及び前方部２Ｆの側部（内壁面）の間に固定される。本発明の図５に記載のバルーンカテーテル１Ａで、前記「固定」とは、図５のように補強体３の前方部３Ｆの側部をガイドワイヤー用チューブ４Ａの側部（外壁面）及び/又は前方部２Ｆの側部（内壁面）に直接又はこれらの間に、溶着または接着剤等により固定すること、もしくはこれらの間に圧入して固定すること（挟持すること）を意味する。
【０００９】
本発明に使用される補強体３としては、例えば図５に示すように基端部３Ｂから先端部３Ｆ方向へ向けて先細りテーパー状に形成されたコアワイヤーが使用されるが、これらのコアワイヤーと実質的に同様の機能を果たすものであれば、何でも使用することができる。
【００１０】
本発明で前記可とう性の前方部２Ｆの構成材料は、例えばポリアミド、ポリアミドエラストマー、ポリエステル、ポリエチレン、ポリイミド、ＰＥＴ等の合成樹脂を使用することができる。
本発明で前記剛性の基端部２Ｂの構成材料は、例えばステンレス、Ｎｉ−Ｔｉ、Ｃｕ−Ｍｎ−Ａｌ系合金等の金属を使用することができる。前記可とう性の前方部２Ｆと剛性の基端部２Ｂは、例えば接着剤、ヒートシール等の手段により接続することができる。
また剛性の基端部２Ｂの後方部はコネクタ８前方の管状体８ａ内に配置され、管状体８ａの内周と剛性の基端部２Ｂの外周の間に接着剤１０を充填することにより固定されている。あるいは剛性の基端部２Ｂの後方部とコネクタ８はインサート成形により固定することができる。コネクタ８後方の管状体８ｂの後端にはバルーンの拡張用流体を導入するための開口部８Ｂが形成されている。
【００１１】
本発明の図５に記載のバルーンカテーテル１Ａは前記補強体３の基端部３Ｂをシャフト２の前記基端部２Ｂをシャフト２の前記基端部２Ｂの細径部２Ｓに直接接着することなく固定するので、剛性の基端部２Ｂに溶接不可能な補強体３でも容易に固定することができる。
また造影剤をシャフト２の基端部２Ｂのスリット２ＳＬから流入させることができるので、バルーン５を膨張させたり、萎ませるまでの時間を容易に調整することができる。
補強体３を後からシャフト２の基端部２Ｂ（シャフトパイプ）に接続できるため、前記補強体３の前方部３Ｆを、シャフト２の前方部２Ｆ（合成樹脂管）のガイドワイヤー用チューブの開口部９Ｂの前後付近の間に固定することができる。
シャフト２の基端部２Ｂ（シャフトパイプ）からのプッシャビリティとトラッカビリティが、単に基端部２Ｂ（シャフトパイプ）から前方部２Ｆ（合成樹脂管）に伝達されるだけでなく、補強体３からも前方部２Ｆ（合成樹脂管）に伝達されるので、バルーン５の挿入を容易に行うことができる。
【００１２】
また本発明のラピッドエクスチェンジタイプのバルーンカテーテルは図５に記載した形態のバルーンカテーテル１Ａの他に、図６（特願２０００−２１６８７３号の図２に記載）に記載した形態のバルーンカテーテル１Ｂも含む。
バルーンカテーテル１Ｂも図５のバルーンカテーテル１Ａと同様に、ガイドワイヤー用チューブ４Ａを有し、当該ガイドワイヤー用チューブ４Ａに、前記金属マーカー１１と、前記第１固定チューブ１２．１及び前記第２固定チューブ１２．２とを装着している。
前記金属マーカー１１の前記第１端部と前記ガイドワイヤー用チューブ４Ａの側部方向の外周面、及び前記金属マーカー１１の前記第２端部と前記ガイドワイヤー用チューブ４Ａの側部方向の外周面との間に、段差が生じないように形成している。
すなわち、図５のバルーンカテーテル１Ａと異なる点として、バルーンカテーテル１Ｂは前方部２Ｆの基端部から途中に至るまで基端部２Ｂが延設され、前記前方部２Ｆ内に補強体３が配置されている。補強体３の基端部は基端部２Ｂの前方内壁面内にヒートシールまたは接着剤等により接続されている。また補強体３の基端部を前記基端部２Ｂの前方内壁面内に直接接着することなく、該補強体３の前方部と略中腹部の側部を前記ガイドワイヤー用チューブ４Ａの側部（外壁面）及び前方部２Ｆの側部（内壁面）にヒートシールまたは接着剤等により接着しても良い。補強体３は基端部から先端部方向へ向けて先細りテーパー状に形成されたコアワイヤーが使用されるが、これらのコアワイヤーと実質的に同様の機能を果たすものであれば、何でも使用することができる。
本発明で「ガイドワイヤー用チューブ４Ａ」とは、ガイドワイヤーＧＷを通すチューブを全て含み、本発明で前記「ガイドワイヤー用チューブ４Ａ」を有する「バルーンカテーテル」とは、図５、図６に示したいわゆるラピッドエクスチェンジタイプといわれるバルーンカテーテル１Ａ、１Ｂの他に、図７（図８は図７のＢ付近の断面図）に記載のいわゆるオーバーザワイヤータイプといわれるバルーンカテーテル１Ｃ（特願２０００−２１６８７３号の図３ないし図４に記載）も含む。
すなわちバルーンカテーテル１Ｃは、ガイドワイヤー用チューブ１４をバルーン１５の先端からバルーン１５内、可とう性のシャフト１２Ａ内を経てコネクタ１８後端の開口部１８Ｂに至るまで配置し、ガイドワイヤーを開口部１９Ｆから挿入しシャフト１２Ａ内を経て開口部１９Ｂから排出するように形成されている。シャフト１２内にはコネクタ１８側部の開口部１８Ｓとバルーン１５内に連通する流体ルーメン１７が形成されている。
さらに詳述すれば、バルーンカテーテル１Ｃは、シャフト１２Ａとバルーン１５とを有し、前記シャフト１２Ａと前記バルーン１５は、それぞれ長手方向と、当該長手方向と略垂直に交わる側部方向とを有する。
前記長手方向の前方から後方に向けて、前記バルーン１５、前記シャフト１２Ａの順に配置し、前記シャフト１２Ａと前記バルーン１５は、それぞれ前記長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有する。
前記シャフト１２Ａは、長手方向と、当該長手方向と略垂直に交わる側部方向とを有し、前記長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有する。
前記シャフト１２Ａの内腔に、ガイドワイヤー用チューブ１４を配置し、当該ガイドワイヤー用チューブ１４は、内腔にガイドワイヤールーメン１６を有する。
当該ガイドワイヤールーメン１６は、先端開口部１９Ｆと、後端開口部１９Ｂとを有する。
前記先端開口部１９Ｆは、前記バルーン１５の内腔を経て前記バルーン１５の遠位端に配置され、前記後端開口部１９Ｂは、前記シャフト１２Ａの内腔を経て、当該シャフト１２Ａの近位端（後端）に装着されたコネクタ１８の近位端に配置される。
前記ガイドワイヤー用チューブ１４に、前記金属マーカー１１と、前記第１固定チューブ１２．１及び前記第２固定チューブ１２．２とを装着している。
前記金属マーカー１１の前記第１端部と前記ガイドワイヤー用チューブ１４の側部方向の外周面、及び前記金属マーカー１１の前記第２端部と前記ガイドワイヤー用チューブ１４の側部方向の外周面との間に、段差が生じないように形成している。
【００１３】
【発明の作用効果】
本発明のカテーテル（１、１ａ）及びバルーンカテーテル（１Ａ、１Ｂ、１Ｃ）は、
〈１〉カテーテルチューブ４（ガイドワイヤー用チューブ４Ａ、１４）の肉厚を薄くすることなくかつ、管状の金属マーカー１１（コイル状のマーカー１３）とカテーテルチューブ４（ガイドワイヤー用チューブ４Ａ、１４）との間の段差をなくすことができる、さらに詳述すれば管状の金属マーカー１１（コイル状のマーカー１３）の第１端部（第２端部）とカテーテルチューブ４（ガイドワイヤー用チューブ４Ａ、１４）の側部方向の外周面との間の段差をなくすことができるため、カテーテルチューブ４（ガイドワイヤー用チューブ４Ａ、１４）の強度を低下させることがない。
〈２〉血管通過性もスエージング加工のものと同じ効果を維持できる。
〈３〉さらに（管状の金属マーカー１１にかえて）コイル状のマーカー１３を採用することにより、コイル状のマーカー１３自体が柔軟に屈曲することで、ガイドワイヤーＧＷに通しながら血管の屈曲部にカテーテルチューブ４（ガイドワイヤー用チューブ４Ａ、１４）を挿入しても、コイル状のマーカー１３が容易に変形するので、血管の屈曲部に止まることなく、速やかに通過することができる。
【図面の簡単な説明】
【図１】本発明のカテーテルの概略図
【図２】図１のＡ―Ａ断面図
【図３】図１のカテーテルのその他の実施例を示す拡大図
【図４】図３の使用状態図
【図５】本発明のバルーンカテーテルの一例を示す概略図（断面図）
【図６】本発明のバルーンカテーテルの一例を示す概略図（断面図）
【図７】本発明のバルーンカテーテルの一例を示す概略図
【図８】図７のＢ付近の断面図
【図９】従来のガイドワイヤー用チューブの拡大図
【図１０】図９の使用状態図
【図１１】従来のカテーテルチューブの断面図
【図１２】従来のカテーテルチューブの断面図
【符号の説明】
１、１ａカテーテル
１Ａバルーンカテーテル
１Ｂバルーンカテーテル
１Ｃバルーンカテーテル
２、１２Ａシャフト
２Ｆ前方部
２Ｂ基端部
２Ｓ細径部
２Ｓ１第一の細径部
２Ｓ２第二の細径部
２ＳＬスリット
３補強体
３Ｆ前方部
３Ｍ中間部
３Ｂ基端部
４カテーテルチューブ
４Ａ、１４ガイドワイヤー用チューブ
５、１５バルーン
６、１６ガイドワイヤールーメン
７、１７流体ルーメン
８、１８コネクタ
８Ｂ、１８Ｂ、１８Ｓ、１９Ｂ開口部（コネクタ）
８ａ、８ｂ管状体
９Ｆ、９Ｂ、１９Ｆ開口部（ガイドワイヤー用チューブ）
１０接着剤
１１金属マーカー
１２．１第１固定チューブ
１２．２第２固定チューブ
１２．１Ｔテーパー部（第２端部側から第１端部側に向けて下る）
１２．２Ｔテーパー部（第１端部側から第２端部側に向けて下る）
１３コイル状のマーカー[0001]
BACKGROUND OF THE INVENTION
TECHNICAL FIELD The present invention relates to an attachment form of a radiopaque metal marker attached to a catheter tube (or a guide wire tube) and an improvement of the form of the metal marker, for example, a catheter such as a brain catheter or a microcatheter, or a percutaneous coronary shape. The present invention relates to an improvement of a balloon catheter used for arterial angioplasty (PTCA) and the like.
[0002]
[Prior art and problems to be solved by the invention]
In order to confirm the insertion length of the catheter into the living body and the position of the catheter tip, for example, as shown in FIG. 9, a radiopaque metal marker 63 is attached to the catheter tube 64 and used. These metal markers 63 are made of a metal material such as platinum, tungsten, iridium, etc., and have a length of 0.5 to 2.0 mm and are formed into a thin and tubular shape. When inserted into a bent blood vessel while passing through the guide wire GW as shown in FIG. 10, there has been a problem that the guide wire GW cannot be used to quickly pass through the bent portion of the blood vessel.
Further, when the metal marker 63 is fixed to the catheter tube 64, for example, as shown in FIG. 11 (cross-sectional view of the catheter tube 64), the metal marker 63 is adhered by an instantaneous adhesive S or the like, or FIG. As shown in the sectional view, the catheter tube 64A is swaged by a swaging machine to form a recess 65, and the metal marker 63 is fixed to the recess 65.
However, in fixing with an adhesive or the like, there is a step between the metal marker 63 and the catheter tube 64, which may impair the blood vessel passage of the catheter.
In the fixing by swaging, there is no step between the metal marker 63 and the catheter tube 64A, but the thickness of the catheter tube 64A is reduced by the recess 65, so that the strength of the catheter tube 64A is reduced and pinholes during swaging are performed. Etc. were concerned.
Therefore, as a result of intensive studies to solve the above problems, the present inventors have reached the following invention.
[0003]
[Means for Solving the Problems]
[1] The present invention provides:Have flexibilityA catheter tube (4), a metal marker (11), a first fixed tube (12.1) and a second fixed tube (12.2);
  The catheter tube (4), the metal marker (11), the first fixed tube (12.1), and the second fixed tube (12.2) are each tubular and have a length direction and the length direction. A side direction that intersects substantially perpendicularly, and a first end and a second end in the length direction,
  The metal marker (11), the first fixed tube (12.1), and the second fixed tube (12.2) each have an inner diameter in the lateral direction of the side of the catheter tube (4). It has a size that can be attached to the outer periphery,
  The metal marker (11), the first fixed tube (12.1) and the second fixed tube (12.2) are attached to the outer periphery of the catheter tube (4),
  A first fixing tube (12.1) is mounted in the vicinity of the first end of the metal marker (11), and a second fixing tube (12 in the vicinity of the second end of the metal marker (11). .2)
  The first fixed tube (12.1) has a tapered portion (12.1T) that descends from the second end toward the first end, that is, the first end of the catheter tube (4);
  The second fixed tube (12.2) has a tapered portion (12.2T) that descends from a first end toward a second end, that is, a second end of the catheter tube (4);
  The first fixed tube (12.1) and the second fixed tube (12.2) are in the vicinity of the first end of the metal marker (11) and the second end of the metal marker (11). Even before installing in the vicinity of
  A tubular shape, having a shape having a length direction, a side direction substantially perpendicular to the length direction, and a first end and a second end in the length direction;
  The inner diameter in the side portion direction maintains a shape that can be attached to the outer periphery in the side portion direction of the catheter tube (4), and is tapered toward the first end of the catheter tube (4) (12 .1T) and the shape of the tapered portion (12.2T) descending toward the second end of the catheter tube (4),
  Further, in the stage in the middle of mounting near the first end of the metal marker (11) and in the vicinity of the second end of the metal marker (11), and in the stage after mounting, before the mounting. Holding the shape,
  The first end of the metal marker (11) and the outer peripheral surface in the side direction of the catheter tube (4), and the second end of the metal marker (11) and the side of the catheter tube (4) Provided is a catheter (1) formed so as not to cause a step between an outer peripheral surface in a direction.
[2] The present invention includes a coiled marker (13) instead of the tubular metal marker (11) of the catheter (1) according to [1],
  The coiled marker (13) has a length direction, a side direction that intersects the length direction substantially perpendicularly, and a first end and a second end in the length direction,
  The coiled marker (13) is a metal wire processed into a coil shape,
  The coiled marker (13), the first fixed tube (12.1) and the second fixed tube (12.2) are attached to the outer periphery of the catheter tube (4),
  A first fixing tube (12.1) is mounted in the vicinity of the first end of the coiled marker (13), and a second in the vicinity of the second end of the coiled marker (13). Install the fixed tube (12.2)
  The first fixed tube (12.1) has a tapered portion (12.1T) that descends from the second end toward the first end, that is, the first end of the catheter tube (4);
  The second fixed tube (12.2) has a tapered portion (12.2T) that descends from a first end toward a second end, that is, a second end of the catheter tube (4);
  The first end of the coiled marker (13) and the outer peripheral surface in the lateral direction of the catheter tube (4), and the second end of the coiled marker (13) and the catheter tube (4) The catheter (1a) is formed so as not to cause a step between the outer peripheral surface in the side direction.
[3] The present inventionHave flexibilityA guide wire tube (4A, 14), a metal marker (11), a first fixed tube (12.1) and a second fixed tube (12.2);
  The guide wire tube (4A, 14), the metal marker (11), the first fixed tube (12.1) and the second fixed tube (12.2) are each tubular, in the length direction, A side direction that intersects the length direction substantially perpendicularly, and a first end and a second end in the length direction;
  The metal marker (11), the first fixed tube (12.1), and the second fixed tube (12.2) have an inner diameter in the side direction of the guide wire tube (4A, 14). It has a size that can be attached to the outer periphery in the side direction,
  The metal marker (11), the first fixed tube (12.1) and the second fixed tube (12.2) are mounted on the outer periphery of the guide wire tube (4A, 14),
  A first fixing tube (12.1) is mounted in the vicinity of the first end of the metal marker (11), and a second fixing tube (12 in the vicinity of the second end of the metal marker (11). .2)
  The first fixed tube (12.1) has a taper portion (12.1T) that descends from the second end portion toward the first end portion, that is, the first end portion of the guide wire tube (4A, 14). Have
  The second fixed tube (12.2) has a tapered portion (12.2T) that descends from the first end toward the second end, that is, the second end of the guide wire tube (4A, 14). Have
  The first fixed tube (12.1) and the second fixed tube (12.2) are in the vicinity of the first end of the metal marker (11) and the second end of the metal marker (11). Even before installing in the vicinity of
  A tubular shape, having a shape having a length direction, a side direction substantially perpendicular to the length direction, and a first end and a second end in the length direction;
  The inner diameter in the side portion direction maintains a shape that can be attached to the outer periphery in the side portion direction of the catheter tube (4), and is tapered toward the first end of the catheter tube (4) (12 .1T) and the shape of the tapered portion (12.2T) descending toward the second end of the catheter tube (4),
  Further, in the stage in the middle of mounting near the first end of the metal marker (11) and in the vicinity of the second end of the metal marker (11), and in the stage after mounting, before the mounting. Holding the shape,
  The first end of the metal marker (11) and the outer peripheral surface of the guide wire tube (4A, 14) in the lateral direction, and the second end of the metal marker (11) and the guide wire tube. Provided is a balloon catheter (1A, 1B, 1C) formed so as not to cause a step between the outer peripheral surfaces in the lateral direction of (4A, 14).
[4] The present invention includes a shaft (2) and a balloon (5), and the shaft (2) and the balloon (5) each have a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly. And
  From the front in the longitudinal direction toward the rear, the balloon (5) and the shaft (2) are arranged in this order,
  The shaft (2) and the balloon (5) each have a distal end on the front side in the longitudinal direction and a proximal end on the rear side in the longitudinal direction;
  The shaft (2) has a flexible front part (2F) and a rigid base end part (2B),
  The front part (2F) and the base end part (2B) each have a longitudinal direction and a side part direction that intersects the longitudinal direction substantially perpendicularly.
  The front part (2F) and the base end part (2B) each have a distal end on the front side in the longitudinal direction and a proximal end on the rear side in the longitudinal direction,
  At the proximal end of the front part (2F), the distal end of the base end part (2B) is attached,
  Attach the proximal end of the balloon (5) to the distal end of the front part (2F);
  In the lumen of the front part (2F) of the shaft (2),Have flexibilityThe guide wire tube (4A) is arranged, and the guide wire tube (4A) has a guide wire lumen (6) in the lumen,
  The guide wire lumen (6) has a front end opening (9F) and a rear end opening (9B),
  The tip opening (9F) is disposed at the distal end of the balloon (5) through the lumen of the balloon (5);
  The rear end opening (9B) is disposed on the side of the front part (2F) through the lumen of the front part (2F),
  In the fluid lumen (7) formed between the inner wall surface of the front portion (2F) and the outer wall surface of the guide wire tube (4A), a reinforcing body (3) is disposed,
  The reinforcing body (3) has a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly.
  Having a distal end on the longitudinal front side and a proximal end on the longitudinal rear side;
  The said metal marker (1) as described in said [3] to the said tube for guide wires (4A).
1) and the first fixed tube (12.1) and the second fixed tube (12.2),
  The first end of the metal marker (11) and the outer peripheral surface of the guide wire tube (4A) in the lateral direction, and the second end of the metal marker (11) and the guide wire tube (4A). The balloon catheter (1A, 1B) is formed so as not to cause a step between the outer peripheral surface in the side direction.
[5] The present invention includes a shaft (12A) and a balloon (15), and each of the shaft (12A) and the balloon (15) has a longitudinal direction and a side portion direction that intersects the longitudinal direction substantially perpendicularly. And
  From the front in the longitudinal direction toward the rear, the balloon (15) and the shaft (12A) are arranged in this order,
  The shaft (12A) and the balloon (15) each have a distal end on the front side in the longitudinal direction and a proximal end on the rear side in the longitudinal direction,
  The shaft (12A) has a longitudinal direction and a side direction intersecting the longitudinal direction substantially perpendicularly,
  Having a distal end on the longitudinal front side and a proximal end on the longitudinal rear side;
  In the lumen of the shaft (12A),Have flexibilityThe guide wire tube (14) is disposed, and the guide wire tube (14) has a guide wire lumen (16) in the lumen,
  The guide wire lumen (16) has a front end opening (19F) and a rear end opening (19B),
  The tip opening (19F) is disposed at the distal end of the balloon (15) through the lumen of the balloon (15);
  The rear end opening (19B) is disposed at the proximal end of the connector (18) attached to the proximal end of the shaft (12A) through the lumen of the shaft (12A),
  The said metal marker (1) as described in said [3] to the said tube for guide wires (14).
1) and the first fixed tube (12.1) and the second fixed tube (12.2),
  The first end of the metal marker (11) and the outer peripheral surface in the lateral direction of the guide wire tube (14), and the second end of the metal marker (11) and the guide wire tube (14). The balloon catheter (1C) is formed so as not to cause a step between the outer peripheral surface in the lateral direction of ().
[6] The present invention provides the balloon catheter (1A, 1B) according to any one of [3] to [5], in which a coiled marker (13) is attached instead of the tubular metal marker (11). 1C).
[0004]
DETAILED DESCRIPTION OF THE INVENTION
  FIG. 1 is a schematic view of a catheter 1 of the present invention, and FIG. 2 is a cross-sectional view taken along line AA of FIG. The catheter 1 of the present invention has a metal marker 11 attached to the outer periphery of the catheter tube 4 and a pair of first fixed tube 12.1 and second fixed tube 12 whose outer periphery is tapered on both sides of the metal marker 11. .2 is formed so that no step is generated between the metal marker 11, the first fixed tube 12.1, and the second fixed tube 12.2.
  More specifically, the catheter 1 of the present invention includes a catheter tube 4, a metal marker 11, a first fixed tube 12.1, and a second fixed tube 12.2.
  The catheter tube 4, the metal marker 11, the first fixed tube 12.1 and the second fixed tube 12.2 are each tubular and have a length direction and a side portion substantially perpendicular to the length direction. And a first end and a second end in the length direction.
  Each of the metal marker 11, the first fixed tube 12.1, and the second fixed tube 12.2 has a size that can be attached to the outer periphery of the catheter tube 4 in the side direction.
  The metal marker 11, the first fixed tube 12.1, and the second fixed tube 12.2 are attached to the outer periphery of the catheter tube 4.
  A first fixed tube 12.1 is mounted in the vicinity of the first end of the metal marker 11, and a second fixed tube 12.2 is mounted in the vicinity of the second end of the metal marker 11. .
  The first fixed tube 12.1 has a tapered portion 12.1T that descends from the second end toward the first end, that is, the first end of the catheter tube 4, and the second fixed tube 12. 2 has a tapered portion 12.2T that descends from the first end portion toward the second end portion, that is, the second end portion of the catheter tube 4.
  Between the first end portion of the metal marker 11 and the outer peripheral surface in the side direction of the catheter tube 4 and between the second end portion of the metal marker 11 and the outer peripheral surface in the side portion direction of the catheter tube 4. , So as not to cause a step.
  In the present invention, the “metal marker 11” is made of a metal material such as platinum, tungsten, iridium, etc., and includes a thin and tubular form having a length of 0.5 to 3.0 mm and a coil form. In the present invention, the “fixing tube 12” is tubular, and the outer periphery thereof is formed to have a gentle taper from the end on the metal marker 11 side toward the outer periphery of the catheter tube 4 on the opposite side. . For this reason, there is no step between the metal marker 11 and the fixed tube 12 arranged on both sides of the metal marker 11 and between the fixed tube 12 and the catheter tube 4, and the passage to the blood vessel is not impaired.
  Further, if the first fixed tube 12.1 and the second fixed tube 12.2 are mounted in the vicinity of the first end of the metal marker 11 and in the vicinity of the second end of the metal marker 1, It is tubular and has a shape having a length direction, a side portion direction substantially perpendicular to the length direction, and a first end portion and a second end portion in the length direction.
  The inner diameter in the side part direction maintains a shape that can be mounted on the outer periphery in the side part direction of the catheter tube 4, and the shape of the tapered part 12.1T that goes down toward the first end of the catheter tube 4 and the catheter The shape of the taper part 12.2T which goes down toward the 2nd end part of the tube 4 is hold | maintained.
  Furthermore, the shape before the mounting is maintained at the stage of mounting near the first end of the metal marker 11 and the vicinity of the second end of the metal marker 11 and also at the stage after mounting.
[0005]
  FIG. 3 is an enlarged view showing another embodiment of the catheter of FIG. 1, and FIG. 4 is a view showing the state of use of FIG.
  In the catheter 1a of the present invention, a coiled marker 13 is provided on the outer periphery of the catheter tube 4.Wearing.
  That is, the coil-shaped marker 13 has a length direction, a side portion direction that intersects the length direction substantially perpendicularly, and a first end portion and a second end portion in the length direction.
  The coil-shaped marker 13 is obtained by processing a metal wire into a coil shape. The coil-shaped marker 13, the first fixed tube 12.1, and the second fixed tube 12.2 are connected to the outer periphery of the catheter tube 4. It is attached to.
  A first fixed tube 12.1 is mounted in the vicinity of the first end of the coiled marker 13, and a second fixed tube 12.2 is mounted in the vicinity of the second end of the coiled marker 13. is doing.
  The first fixed tube 12.1 has a tapered portion 12.1T that descends from the second end toward the first end, that is, the first end of the catheter tube 4, and the second fixed tube 12. 2 has a tapered portion 12.2T that descends from the first end portion toward the second end portion, that is, the second end portion of the catheter tube 4.
  The first end of the coiled marker 13 and the outer peripheral surface of the catheter tube 4 in the lateral direction, and the second end of the coiled marker 13 and the outer peripheral surface of the catheter tube 4 in the lateral direction. Are formed so as not to cause a step.
  In the present invention, the “coiled marker 13” is a metal wire having a wire diameter of 10 μm to 300 μm and made of a metal material such as platinum, tungsten, iridium or the like and processed into a coil shape. The shape can be processed according to the outer diameter of the catheter tube 4. As shown in FIG. 4, the catheter 1a of the present invention has a coiled marker 13 itself that is flexibly bent. Even if the catheter tube 4 is inserted into the bent portion of the blood vessel while passing through the guide wire GW, the catheter 1a is coiled. Since the marker 13 is easily deformed, it can pass quickly without stopping at the bent portion of the blood vessel.
  The catheter tube 4 equipped with the metal markers 11 (including the coiled marker 13) of the catheters 1 and 1a described above is used by replacing the guide wire tube 4A of the balloon catheters 1A, 1B, and 1C described below. can do. That is, the metal marker 11 (including the coiled marker 13) and the fixed tube 12 are mounted on the outer periphery of the guide wire tube 4A.
  If the mounting position of the metal marker 11 (coiled marker 13) and the fixed tube 12 to the catheter tube 4 and guide wire tube 4A is the outer periphery of the catheter tube 4 and guide wire tube 4A, the tube 4, The position may be any of the middle, front end, and rear end of 4A. When mounted on guide wire tubes 4A and 14 for balloon catheters 1A, 1B, and 1C, which will be described later, any position in balloon 5 (15) or its tip or front portion 2F (front portion of shaft 12A) may be used. .
[0006]
  5 to 6 are schematic views (cross-sectional views) showing an example of the balloon catheter (1A, 1B) of the present invention, FIG. 7 is a schematic view showing an example of the balloon catheter of the present invention, and FIG. FIG.
  The balloon catheter (1A, 1B, 1C) has a guide wire tube (4A, 14), a metal marker 11, a first fixed tube 12.1, and a second fixed tube 12.2.
  The guide wire tube (4A, 14), the metal marker 11, the first fixed tube 12.1, and the second fixed tube 12.2 are each tubular and substantially in the length direction and the length direction. It has a first end portion and a second end portion in a side direction that intersects perpendicularly and in the length direction.
  The metal marker 11, the first fixed tube 12.1, and the second fixed tube 12.2 have an inner diameter in the side direction on an outer periphery in the side direction of the guide wire tube (4 </ b> A, 14). It has a size that can be mounted.
  The metal marker 11, the first fixed tube 12.1, and the second fixed tube 12.2 are attached to the outer periphery of the guide wire tube (4A, 14).
  A first fixed tube 12.1 is mounted in the vicinity of the first end of the metal marker 11, and a second fixed tube 12.2 is mounted in the vicinity of the second end of the metal marker 11. .
  The first fixed tube 12.1 has a tapered portion 12.1T that descends from the second end toward the first end, that is, the first end of the guide wire tube (4A, 14), The second fixed tube 12.2 has a tapered portion 12.2T that descends from the first end portion toward the second end portion, that is, the second end portion of the guide wire tube (4A, 14). .
  The first end of the metal marker 11 and the outer peripheral surface of the guide wire tube (4A, 14) in the lateral direction, and the second end of the metal marker 11 and the guide wire tube (4A, 14). ) Is formed so as not to cause a step.
  FIG. 5 is a schematic view showing an example of a balloon catheter 1A of the present invention called a so-called rapid exchange type (a cross-sectional view, where the cross-sectional view in the vicinity of the connector 8 is reduced from the cross-sectional view in the vicinity of the front portion 2F). It is. A balloon catheter 1A according to the present invention has a balloon 5 attached to the tip of a shaft 2, and the shaft 2 has at least a flexible front portion 2F (also referred to as a synthetic resin tube) and at least a rigid base end portion 2B (a shaft pipe or a metal tube). (Also called).
  More specifically, the shaft 2 and the balloon 5 are included, and the shaft 2 and the balloon 5 each have a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly.
  The balloon 5 and the shaft 2 are arranged in this order from the front to the rear in the longitudinal direction, and the shaft 2 and the balloon 5 each have a distal end on the front side in the longitudinal direction, and the longitudinal It has a proximal end on the rear side in the direction.
  The shaft 2 has a flexible front portion 2F and a rigid base end portion 2B, and the front portion 2F and the base end portion 2B intersect with each other in the longitudinal direction and substantially perpendicular to the longitudinal direction. Side direction.
  Each of the front part 2F and the base end part 2B has a distal end on the front side in the longitudinal direction and a proximal end on the rear side in the longitudinal direction, and is proximal to the front part 2F. The distal end of the base end portion 2B is attached to the end, and the proximal end of the balloon 5 is attached to the distal end of the front portion 2F.
  A guide wire tube 4A is disposed in the lumen of the front portion 2F of the shaft 2, and the guide wire tube 4A has a guide wire lumen 6 in the lumen. The guide wire lumen 6 has a tip opening portion. 9F and a rear end opening 9B.
  The front end opening 9F is disposed at the distal end of the balloon 5 via the lumen of the balloon 5, and the rear end opening 9B is disposed on the side of the front portion 2F via the lumen of the front portion 2F. Is arranged.
  The reinforcing body 3 is disposed in a fluid lumen 7 formed between the inner wall surface of the front portion 2F and the outer wall surface of the guide wire tube 4A.
  The reinforcing body 3 has a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly, has a distal end on the front side in the longitudinal direction, and is proximal on the rear side in the longitudinal direction. Has an edge.
  The metal marker 11, the first fixed tube 12.1, and the second fixed tube 12.2 are attached to the guide wire tube 4A.
  The outer peripheral surface of the metal marker 11 in the side direction of the first end portion and the guide wire tube 4A, and the outer peripheral surface of the metal marker 11 in the side portion direction of the second end portion and the guide wire tube 4A. Are formed so as not to cause a step.
  Further, a small diameter portion 2S is formed at the distal end of the rigid base end portion 2B. More specifically, as shown in FIG. 5, for example, the narrow-diameter portion 2S is formed with a slit 2SL at the distal end of the rigid base end portion 2B and a tapered first small-diameter portion 2S1 (base end portion 2B). It is formed by integrally forming or connecting the second small diameter portion 2S2 (which is formed with a diameter smaller than that of the first small diameter portion 2S1) via a smaller diameter. The rigid base end portion 2B extends, for example, a metal shaft pipe (extends the inner diameter of the tip end of the shaft pipe until it is substantially the same as the outer diameter of the base end portion 3B of the reinforcing member 3), and further the shaft pipe. Is manufactured by forming a slit 2SL that can be injected with a contrast medium.
[0007]
Further, a guide wire tube 4A having openings 9F and 9B at the front end and rear end in the shaft 2 and having a guide wire lumen 6 extends from the side surface of the front portion 2F through the balloon 5 to the front end of the balloon 5. Is arranged. Further, the front portion 3F of the reinforcing body 3 is disposed in the fluid lumen 7 formed in the front portion 2F and between the guide wire tube 4A outer periphery (the front portion 3F and the front portion 3F are formed depending on the formation position of the opening 9B in the shaft 2). The intermediate portion 3M may also be disposed), and the base end portion 3B of the reinforcing body 3 is fixed to the narrow diameter portion of the base end portion 2B without being directly bonded. More specifically, the base end of the reinforcing body 3 is formed on the second small diameter portion 2S2 formed continuously with the first small diameter portion 2S1 having the slit 2SL formed at the tip of the rigid base end portion 2B. The part 3B is fixed without directly bonding.
[0008]
In the balloon catheter 1 shown in FIG. 5 of the present invention, the “fixing” means that the base end portion 3B of the reinforcing body 3 is not directly bonded to the small diameter portion (second small diameter portion 2S2) by welding or the like. It means a fixing means that is simply inserted by press-fitting or the like or substantially equivalent thereto. In the present invention, the small-diameter portion 2S includes the first thin-diameter portion 2S1 (formed with a diameter smaller than the base end portion 2B) and the second small-diameter portion 2S2 (first In other words, the base end portion 3B of the reinforcing body 3 is not directly bonded by welding or the like, but is simply inserted by press-fitting or the like. Any configuration can be used as long as it can be fixed by an equivalent fixing means.
In the present invention, the front portion 3F of the reinforcing body 3 is fixed between the side portion (outer wall surface) of the guide wire tube 4A and the side portion (inner wall surface) of the front portion 2F. In the balloon catheter 1A shown in FIG. 5 of the present invention, the “fixed” means that the side part of the front part 3F of the reinforcing body 3 is connected to the side part (outer wall surface) of the guide wire tube 4A and / or as shown in FIG. Alternatively, it means fixing to the side portion (inner wall surface) of the front portion 2F directly or between them by welding or an adhesive, or press-fitting between them (fixing).
[0009]
As the reinforcing body 3 used in the present invention, for example, as shown in FIG. 5, core wires formed in a tapered shape from the base end portion 3B toward the tip end portion 3F are used. Anything can be used as long as it performs substantially the same function.
[0010]
As the constituent material of the flexible front portion 2F in the present invention, for example, a synthetic resin such as polyamide, polyamide elastomer, polyester, polyethylene, polyimide, or PET can be used.
In the present invention, as the constituent material of the rigid base end portion 2B, for example, a metal such as stainless steel, Ni—Ti, or Cu—Mn—Al alloy can be used. The flexible front portion 2F and the rigid base end portion 2B can be connected by means such as an adhesive or heat seal.
The rear portion of the rigid base end portion 2B is disposed in the tubular body 8a in front of the connector 8, and is fixed by filling the adhesive 10 between the inner periphery of the tubular body 8a and the outer periphery of the rigid base end portion 2B. Has been. Alternatively, the rear portion of the rigid base end 2B and the connector 8 can be fixed by insert molding. At the rear end of the tubular body 8b behind the connector 8, an opening 8B for introducing a balloon expansion fluid is formed.
[0011]
In the balloon catheter 1A shown in FIG. 5 of the present invention, the base end portion 3B of the reinforcing body 3 and the base end portion 2B of the shaft 2 are not directly bonded to the small diameter portion 2S of the base end portion 2B of the shaft 2. Since it is fixed, even the reinforcing body 3 that cannot be welded to the rigid base end 2B can be easily fixed.
Further, since the contrast agent can be introduced from the slit 2SL of the base end portion 2B of the shaft 2, the time until the balloon 5 is inflated or deflated can be easily adjusted.
Since the reinforcing body 3 can be connected to the base end portion 2B (shaft pipe) of the shaft 2 later, the front portion 3F of the reinforcing body 3 is opened to the guide wire tube of the front portion 2F (synthetic resin tube) of the shaft 2. It can be fixed between the vicinity of the front and back of the part 9B.
Pushability and trackability from the base end portion 2B (shaft pipe) of the shaft 2 are not only transmitted from the base end portion 2B (shaft pipe) to the front portion 2F (synthetic resin pipe) but also from the reinforcing body 3. Is also transmitted to the front portion 2F (synthetic resin tube), the balloon 5 can be easily inserted.
[0012]
  The rapid exchange type balloon catheter of the present invention also includes a balloon catheter 1B having the form described in FIG. 6 (described in FIG. 2 of Japanese Patent Application No. 2000-216873) in addition to the balloon catheter 1A having the form described in FIG. .
  Similarly to the balloon catheter 1A of FIG. 5, the balloon catheter 1B also has a guide wire tube 4A, and the metal marker 11, the first fixed tube 12.1, and the second fixed wire are attached to the guide wire tube 4A. Tube 12.2 is attached.
  The outer peripheral surface of the metal marker 11 in the side direction of the first end portion and the guide wire tube 4A, and the outer peripheral surface of the metal marker 11 in the side portion direction of the second end portion and the guide wire tube 4A. Are formed so as not to cause a step.
  That is,As a difference from the balloon catheter 1A of FIG.The balloon catheter 1B has a base end portion 2B extending from the base end portion of the front portion 2F to the middle, and a reinforcing body 3 is disposed in the front portion 2F. The base end portion of the reinforcing body 3 is connected to the front inner wall surface of the base end portion 2B by heat sealing or an adhesive. Further, without directly adhering the base end portion of the reinforcing body 3 into the front inner wall surface of the base end portion 2B, the front portion of the reinforcing body 3 and the side portion of the substantially middle portion thereof are the side portions of the guide wire tube 4A. (Outer wall surface) and a side portion (inner wall surface) of the front portion 2F may be bonded by heat seal or adhesive. As the reinforcing body 3, a core wire formed in a tapered shape from the base end portion toward the tip end portion is used. However, any material can be used as long as it functions substantially the same as these core wires. be able to.
  In the present invention, the “guide wire tube 4A” includes all tubes through which the guide wire GW passes. In the present invention, the “balloon catheter” having the “guide wire tube 4A” is shown in FIGS. In addition to the balloon catheters 1A and 1B called the so-called rapid exchange type, the so-called over-the-wire type balloon catheter 1C (Japanese Patent Application No. 2000-216873) shown in FIG. 3 to 4).
  That is, in the balloon catheter 1C, the guide wire tube 14 is disposed from the distal end of the balloon 15 through the balloon 15 and through the flexible shaft 12A to the opening 18B at the rear end of the connector 18, and the guide wire is disposed in the opening 19F. Insert from the shaft 12AIt is formed so as to be discharged from the opening 19B through the inside. In the shaft 12, a fluid lumen 17 communicating with the opening 18 </ b> S on the side of the connector 18 and the balloon 15 is formed.
  More specifically, the balloon catheter 1C includes a shaft 12A and a balloon 15, and the shaft 12A and the balloon 15 each have a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly.
  The balloon 15 and the shaft 12A are arranged in this order from the front to the rear in the longitudinal direction, and the shaft 12A and the balloon 15 each have a distal end on the front side in the longitudinal direction, and the longitudinal It has a proximal end on the rear side in the direction.
  The shaft 12A has a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly, has a distal end on the front side in the longitudinal direction, and a proximal end on the rear side in the longitudinal direction. Have
  A guide wire tube 14 is disposed in the lumen of the shaft 12A, and the guide wire tube 14 has a guide wire lumen 16 in the lumen.
  The guide wire lumen 16 has a front end opening 19F and a rear end opening 19B.
  The front end opening 19F is disposed at the distal end of the balloon 15 through the lumen of the balloon 15, and the rear end opening 19B is disposed at the proximal end of the shaft 12A through the lumen of the shaft 12A. It is disposed at the proximal end of the connector 18 attached to the (rear end).
  The metal marker 11, the first fixed tube 12.1, and the second fixed tube 12.2 are attached to the guide wire tube.
  The outer peripheral surface of the metal marker 11 in the side direction of the first end portion and the guide wire tube 14, and the outer peripheral surface of the second end portion of the metal marker 11 and the guide wire tube 14 in the side direction. Are formed so as not to cause a step.
[0013]
[Effects of the invention]
  The catheter of the present invention(1, 1a)And balloon catheter(1A, 1B, 1C)Is
<1>Catheter tube 4(Guide wire tubes 4A, 14)Without reducing the wall thickness ofTubularMetal marker 11(Coiled marker 13)And catheter tube 4(Guide wire tubes 4A, 14Between)Can eliminate the stepMore specifically, the first end portion (second end portion) of the tubular metal marker 11 (coiled marker 13) and the outer peripheral surface in the side direction of the catheter tube 4 (tubes for guide wire 4A, 14) Can eliminate the step betweenCatheter tube 4(Guide wire tubes 4A, 14)There is no reduction in strength.
<2>The blood vessel permeability can maintain the same effect as that of the swaging process.
<3>further(Instead of the tubular metal marker 11)By adopting the coiled marker 13, the coiled marker 13 itself bends flexibly, so that the catheter tube 4 is inserted into the bent portion of the blood vessel while passing through the guide wire GW.(Guide wire tubes 4A, 14)Since the coiled marker 13 is easily deformed even if it is inserted, it can pass quickly without stopping at the bent part of the blood vessel.
[Brief description of the drawings]
FIG. 1 is a schematic view of a catheter of the present invention.
FIG. 2 is a cross-sectional view taken along line AA in FIG.
3 is an enlarged view showing another embodiment of the catheter of FIG. 1. FIG.
FIG. 4 is a diagram showing the use state of FIG.
FIG. 5 is a schematic view (cross-sectional view) showing an example of a balloon catheter of the present invention.
FIG. 6 is a schematic diagram (cross-sectional view) showing an example of a balloon catheter of the present invention.
FIG. 7 is a schematic view showing an example of a balloon catheter of the present invention.
8 is a cross-sectional view near B in FIG. 7;
FIG. 9 is an enlarged view of a conventional guide wire tube.
FIG. 10 is a view showing the use state of FIG.
FIG. 11 is a cross-sectional view of a conventional catheter tube
FIG. 12 is a cross-sectional view of a conventional catheter tube
[Explanation of symbols]
1, 1a catheter
1A balloon catheter
1B balloon catheter
1C balloon catheter
2, 12A shaft
2F front
2B Base end
2S small diameter part
2S1 1st small diameter part
2S2 2nd small diameter part
2SL slit
3 Reinforcing body
3F front part
3M middle section
3B Base end
4 Catheter tube
4A, 14 Guide wire tube
5, 15 Balloon
6, 16 Guide wire lumen
7, 17 Fluid lumen
8, 18 connectors
8B, 18B, 18S, 19B Opening (connector)
8a, 8b Tubular body
9F, 9B, 19F Opening (guide wire tube)
10 Adhesive
11 Metal marker
12.1 First fixed tube
12.2 Second fixed tube
12.1T  Tapered part (down from the second end side toward the first end side)
12.2T  Tapered part (down from the first end side toward the second end side)
13 Coiled marker

Claims

A flexible catheter tube (4), a metal marker (11), a first fixed tube (12.1) and a second fixed tube (12.2);
The catheter tube (4), the metal marker (11), the first fixed tube (12.1), and the second fixed tube (12.2) are each tubular and have a length direction and the length direction. A side direction that intersects substantially perpendicularly, and a first end and a second end in the length direction,
The metal marker (11), the first fixed tube (12.1), and the second fixed tube (12.2) each have an inner diameter in the lateral direction of the side of the catheter tube (4). It has a size that can be attached to the outer periphery,
The metal marker (11), the first fixed tube (12.1) and the second fixed tube (12.2) are attached to the outer periphery of the catheter tube (4),
A first fixing tube (12.1) is mounted in the vicinity of the first end of the metal marker (11), and a second fixing tube (12 in the vicinity of the second end of the metal marker (11). .2)
The first fixed tube (12.1) has a tapered portion (12.1T) that descends from the second end toward the first end, that is, the first end of the catheter tube (4);
The second fixed tube (12.2) has a tapered portion (12.2T) that descends from a first end toward a second end, that is, a second end of the catheter tube (4);
The first fixed tube (12.1) and the second fixed tube (12.2) are in the vicinity of the first end of the metal marker (11) and the second end of the metal marker (11). Even before installing in the vicinity of
A tubular shape, having a shape having a length direction, a side direction substantially perpendicular to the length direction, and a first end and a second end in the length direction;
The inner diameter in the side portion direction maintains a shape that can be attached to the outer periphery in the side portion direction of the catheter tube (4), and is tapered toward the first end of the catheter tube (4) (12 .1T) and the shape of the tapered portion (12.2T) descending toward the second end of the catheter tube (4),
Further, in the stage in the middle of mounting near the first end of the metal marker (11) and in the vicinity of the second end of the metal marker (11), and in the stage after mounting, before the mounting. Holding the shape,
The first end of the metal marker (11) and the outer peripheral surface in the side direction of the catheter tube (4), and the second end of the metal marker (11) and the side of the catheter tube (4) A catheter (1) characterized in that it is formed so as not to cause a step between the outer peripheral surface in the direction.

Instead of the tubular metal marker (11) of the catheter (1) according to claim 1, it has a coiled marker (13),
The coiled marker (13) has a length direction, a side direction that intersects the length direction substantially perpendicularly, and a first end and a second end in the length direction,
The coiled marker (13) is a metal wire processed into a coil shape,
The coiled marker (13), the first fixed tube (12.1) and the second fixed tube (12.2) are attached to the outer periphery of the catheter tube (4),
A first fixing tube (12.1) is mounted in the vicinity of the first end of the coiled marker (13), and a second in the vicinity of the second end of the coiled marker (13). Install the fixed tube (12.2)
The first fixed tube (12.1) has a tapered portion (12.1T) that descends from the second end toward the first end, that is, the first end of the catheter tube (4);
The second fixed tube (12.2) has a tapered portion (12.2T) that descends from a first end toward a second end, that is, a second end of the catheter tube (4);
The first end of the coiled marker (13) and the outer peripheral surface in the lateral direction of the catheter tube (4), and the second end of the coiled marker (13) and the catheter tube (4) The catheter (1a) is characterized in that it is formed so as not to cause a step between the outer peripheral surface in the lateral direction of ().

A flexible guide wire tube (4A, 14), a metal marker (11), a first fixed tube (12.1) and a second fixed tube (12.2);
The guide wire tube (4A, 14), the metal marker (11), the first fixed tube (12.1) and the second fixed tube (12.2) are each tubular, in the length direction, A side direction that intersects the length direction substantially perpendicularly, and a first end and a second end in the length direction;
The metal marker (11), the first fixed tube (12.1), and the second fixed tube (12.2) have an inner diameter in the side direction of the guide wire tube (4A, 14). It has a size that can be attached to the outer periphery in the side direction,
The metal marker (11), the first fixed tube (12.1) and the second fixed tube (12.2) are mounted on the outer periphery of the guide wire tube (4A, 14),
A first fixing tube (12.1) is mounted in the vicinity of the first end of the metal marker (11), and a second fixing tube (12 in the vicinity of the second end of the metal marker (11). .2)
The first fixed tube (12.1) has a taper portion (12.1T) that descends from the second end portion toward the first end portion, that is, the first end portion of the guide wire tube (4A, 14). Have
The second fixed tube (12.2) has a tapered portion (12.2T) that descends from the first end toward the second end, that is, the second end of the guide wire tube (4A, 14). Have
The first fixed tube (12.1) and the second fixed tube (12.2) are in the vicinity of the first end of the metal marker (11) and the second end of the metal marker (11). Even before installing in the vicinity of
A tubular shape, having a shape having a length direction, a side direction substantially perpendicular to the length direction, and a first end and a second end in the length direction;
The inner diameter in the side portion direction maintains a shape that can be attached to the outer periphery in the side portion direction of the catheter tube (4), and is tapered toward the first end of the catheter tube (4) (12 .1T) and the shape of the tapered portion (12.2T) descending toward the second end of the catheter tube (4),
Further, in the stage in the middle of mounting near the first end of the metal marker (11) and in the vicinity of the second end of the metal marker (11), and in the stage after mounting, before the mounting. Holding the shape,
The first end of the metal marker (11) and the outer peripheral surface of the guide wire tube (4A, 14) in the lateral direction, and the second end of the metal marker (11) and the guide wire tube. A balloon catheter (1A, 1B, 1C) formed so as not to cause a step between the outer circumferential surface in the lateral direction of (4A, 14).

A shaft (2) and a balloon (5), each of the shaft (2) and the balloon (5) has a longitudinal direction and a side direction intersecting the longitudinal direction substantially perpendicularly;
From the front in the longitudinal direction toward the rear, the balloon (5) and the shaft (2) are arranged in this order,
The shaft (2) and the balloon (5) each have a distal end on the front side in the longitudinal direction and a proximal end on the rear side in the longitudinal direction;
The shaft (2) has a flexible front part (2F) and a rigid base end part (2B),
The front part (2F) and the base end part (2B) each have a longitudinal direction and a side part direction that intersects the longitudinal direction substantially perpendicularly.
The front part (2F) and the base end part (2B) each have a distal end on the front side in the longitudinal direction and a proximal end on the rear side in the longitudinal direction,
At the proximal end of the front part (2F), the distal end of the base end part (2B) is attached,
Attach the proximal end of the balloon (5) to the distal end of the front part (2F);
A flexible guide wire tube (4A) is disposed in the lumen of the front portion (2F) of the shaft (2), and the guide wire tube (4A) is provided in the lumen with a guide wire lumen (6). )
The guide wire lumen (6) has a front end opening (9F) and a rear end opening (9B),
The tip opening (9F) is disposed at the distal end of the balloon (5) through the lumen of the balloon (5);
The rear end opening (9B) is disposed on the side of the front part (2F) through the lumen of the front part (2F),
In the fluid lumen (7) formed between the inner wall surface of the front portion (2F) and the outer wall surface of the guide wire tube (4A), a reinforcing body (3) is disposed,
The reinforcing body (3) has a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly, has a distal end on the front side in the longitudinal direction, and on the rear side in the longitudinal direction. Has a proximal end,
The metal marker (11) according to claim 3 and the first fixed tube (12.1) and the second fixed tube (12.2) are attached to the guide wire tube (4A). ,
The first end of the metal marker (11) and the outer peripheral surface of the guide wire tube (4A) in the lateral direction, and the second end of the metal marker (11) and the guide wire tube (4A). The balloon catheter (1A, 1B) is formed so as not to cause a step between the outer peripheral surface in the lateral direction of).

A shaft (12A) and a balloon (15), each of the shaft (12A) and the balloon (15) has a longitudinal direction and a side direction intersecting the longitudinal direction substantially perpendicularly;
From the front in the longitudinal direction toward the rear, the balloon (15) and the shaft (12A) are arranged in this order,
The shaft (12A) and the balloon (15) each have a distal end on the front side in the longitudinal direction and a proximal end on the rear side in the longitudinal direction,
The shaft (12A) has a longitudinal direction and a side direction intersecting the longitudinal direction substantially perpendicularly,
Having a distal end on the longitudinal front side and a proximal end on the longitudinal rear side;
A flexible guide wire tube (14) is arranged in the lumen of the shaft (12A), and the guide wire tube (14) has a guide wire lumen (16) in the lumen;
The guide wire lumen (16) has a front end opening (19F) and a rear end opening (19B),
The tip opening (19F) is disposed at the distal end of the balloon (15) through the lumen of the balloon (15);
The rear end opening (19B) is disposed at the proximal end of the connector (18) attached to the proximal end of the shaft (12A) through the lumen of the shaft (12A),
The metal marker (11) according to claim 3 and the first fixed tube (12.1) and the second fixed tube (12.2) are attached to the guide wire tube (14). ,
The first end of the metal marker (11) and the outer peripheral surface in the lateral direction of the guide wire tube (14), and the second end of the metal marker (11) and the guide wire tube (14). The balloon catheter (1C) is characterized in that no step is formed between the outer peripheral surface in the lateral direction of

The balloon catheter (1A, 1B, 1C) according to any one of claims 3 to 5, wherein a coiled marker (13) is mounted instead of the tubular metal marker (11). ).