JPH0351430B2 - - Google Patents

Info

Publication number
JPH0351430B2
JPH0351430B2 JP62070781A JP7078187A JPH0351430B2 JP H0351430 B2 JPH0351430 B2 JP H0351430B2 JP 62070781 A JP62070781 A JP 62070781A JP 7078187 A JP7078187 A JP 7078187A JP H0351430 B2 JPH0351430 B2 JP H0351430B2
Authority
JP
Japan
Prior art keywords
stent
catheter
tubular organ
temperature
shape memory
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
JP62070781A
Other languages
English (en)
Other versions
JPS63238872A (ja
Inventor
Fumiaki Harada
Hisahiro Sakae
Masakyo Nobeyoshi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Terumo Corp filed Critical Terumo Corp
Priority to JP62070781A priority Critical patent/JPS63238872A/ja
Priority to KR1019880701459A priority patent/KR910002422B1/ko
Priority to DE3852892T priority patent/DE3852892T2/de
Priority to PCT/JP1988/000306 priority patent/WO1988007390A1/ja
Priority to EP88902924A priority patent/EP0411118B1/en
Priority to AU14904/88A priority patent/AU613027B2/en
Publication of JPS63238872A publication Critical patent/JPS63238872A/ja
Priority to US07/607,767 priority patent/US5037427A/en
Publication of JPH0351430B2 publication Critical patent/JPH0351430B2/ja
Granted legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A61F2210/0023—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
    • A61F2210/0042—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply using a fluid, e.g. circulating

Landscapes

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

Description

【発明の詳細な説明】 （産業上の利用分野） 本発明は管状器官の内腔の内径を確保するため
およびこの拡張保持具を導入又は回収するための
カテーテルに関する。
（従来の技術） 例えば冠動脈の狭窄部を血管拡張カテーテルで
拡張した後、その部分の再狭窄を防止する場合な
ど、一般に管状器官の内腔の内径を確保すること
を目的として拡張保持具（以下、ステントとも呼
ぶ）が用いられている。
従来、このような目的に用いられるステントと
してステンレスワイヤを網状に織つたもの
（Surgery、1986年、99巻２号、第199−205頁）、
あるいは一方向性形状記憶合金製のもの（特公昭
61−6655）、が考案されている。このステンレス
製ステントを用いて例えば血管拡張の確保を行う
場合、血管の所定位置にステントを血管拡張カテ
ーテルを介して導入し、ついでカテーテルを先端
部に設けられたバルーンを拡張してステントを血
管径に拡げることができる。また、一方向性形状
記憶合金製ステントの場合は同じく血管の所定個
所に導入後温水等で加熱してステントの拡張がお
こなわれる。
（発明が解決しようとする問題点） このようにして、いつたん拡張されたステント
は外力を与えない限り、その形状を変化させるこ
とができず、留置後、術部が回復しても再び取り
出すことができない。そのため生体への適合性が
非常に問題となつている。そのほか、このような
従来のステントは留置位置が誤つていることが拡
張後発見されたとしても、いつたん拡張された後
は、その留置位置の変更は極めて困難であつた。
本発明は上記事情に鑑み、管状器官内でいつた
ん拡張させた場合でも再び自由に元の形状に縮小
させることができ、したがつて留置位置からの回
収が可能であるとともに、拡張後における留置位
置の変更も自由にできる管状器官用ステントおよ
びこのステントを操作するためのカテーテルを提
供することを目的とする。
（問題点を解決するための手段） 本発明は上記問題点を解決するため、ステント
として二方向性形状記憶合金を用いるという手段
を講じるとともに、このステントを、側孔を設け
たカテーテル先端に取着させ、この側孔を介して
冷却水をステントに適宜接触させステントの縮
小、拡張を自由におこなうことを可能としたもの
である。
すなわち、この発明は上記問題を解決する手段
として、二方向性形状記憶合金からつくられ、温
度変化にともなつて径方向に拡張または収縮し得
る網目状の筒状体からなることを特徴とする管状
器官内腔の内径確保用器具を提供するものであ
る。
なお、この二方向性形状記憶合金筒状体は体温
又は体温近傍で拡張状態を保ち、これにより実質
的に低い温度では縮少状態を保つようなものであ
ることが好ましい。
なお、本発明において形状記憶合金とは熱弾性
型マルテンサイト変態するもので、ある温度以上
になると逆変態を生じあらかじめ記憶させた形状
に変化するものをいい、一方向性形状記憶合金と
はマルテンサイト変態開始温度以下のときは自由
に変形でき、逆変態開始温度以上となり形状変化
するとその後マルテンサイト変態開始温度以下に
なつても外力を与えない限り記憶した形状を維持
するものをいい、二方向性形状記憶合金とはマル
テンサイト変態開始温度以下での形状も記憶して
おり、変態温度を境に２つの形状を可逆的に発現
するものを言う。
（実施例） 以下、この発明を図示の実施例を参照して説明
する。
第１図ａ，ｂは本発明の一実施例に係わる管状
器官用ステント１０を示すものであつて、偏平な
二方向性形状記憶合金線条体（例えばNi−Ti系、
Cu−Al−Ni系、Cu−Zn−Al系合金からなる）
をらせん状に形成したものからなる。このステン
ト１０は体温又は体温に近傍する温度（例えば35
〜37℃）では第１図ｂの如く径方向に拡張した形
状を保ち、それより実質的に低い温度（例えば15
〜20℃）では第１図ａに示す如く径方向に収縮し
た形状を保つ。例えば、肉厚0.04mm、幅１mmのNi
−Ti系二方向性形状記憶合金（Niを約51原子量
％を含む）をらせん状に形成したステントにおい
ては体温で約２mmの内径のものが温度15℃以下で
内径約1.4mmに収縮させることができた。
このステント１０の内径、長さ等は目的とする
留置部位の器官に内部の大きさに応じて適宜選択
される。要は拡張時に留置されるべき血管等の管
状器官の個所の内径と一致させることができ、収
縮時にはその個所まで挿入するものに十分な細さ
とすることができればよい。
ここで管状器官内腔の内径確保用器具の形状と
して上記のらせん状の他に実質的に筒状のものが
あるが、実質的に筒状とは外面を連続させたとき
に筒状となるものをいい、次に示す実施例に限ら
ず、任意の形態を採用し得る。例えば第２図ａに
示すように収縮時においては渦巻き状をなし、拡
張時には第２図ｂの如く円筒をなすようにしたも
の、さらに二方向性形状記憶合金線条件を編組し
た筒状体からなり、収縮時には第３図ａの如く網
目が縮んだ構造の細長形状となり、拡張時には第
３図ｂに示すように網目が拡がつて内径が拡大す
るようなものであつてもよい。さらに、第４図ａ
の如き収縮時に細いパイプ状をなし、拡張時に第
４図ｂに示す如く太いパイプ状となるようなもの
であつてもよい。
上述のステント１０を体内管状器官の目的とす
る留置位置に導入する場合は例えば第５図に示す
如きカテーテル１２が用いられる。
このカテーテル１２は両端が開口したカテーテ
ルチユーブ１４（例えばエチレン−酢酸ビニルコ
ポリマーからなる）と、このカテーテルチユーブ
１４の後端に、カテーテルチユーブのルーメンと
連通するように設けられたハブ部１６（例えばポ
リカーボネートとからなる）とからなつている。
カテーテルチユーブ１４の先端近傍の周面には多
数の側孔１８が穿設されていて、カテーテルチユ
ーブ１４内に導入されたステント冷却液がこの側
孔１８を介して放射状に排出されるようになつて
いる。ハブ部１６は第６図に拡大して示すよう
に、直線状筒状部１６ａと、この直線状筒状部１
６ａの中間から分岐部１６ｂとからなつている。
直線状筒状部１６ａはガイドワイヤの導入口とな
るものであつて、そのため血液等の漏れを防止す
るための逆止弁２０（例えばシリコーンゴム等の
柔軟素材からなる）がその基端開口部近傍に調節
されている。なお、分岐部１６ｂは冷却液等の導
入に用いられるものでポート１６ｃを有する。
ステント１０を管状器官の留置位置へ導入する
に際し、まず、ステント１０をカテーテルチユー
ブ１４の先端の側孔１８部分に挿入する。ついで
例えば氷冷生理食塩水をポート１６ｃから導入
し、側孔１８から排出させることによりステント
１０を15〜20℃に冷却すると第７図に示すように
ステント１０がそのまま収縮してカテーテルチユ
ーブ１４の側孔穿設部分１８に密着する。
次に側孔１８より氷冷生理食塩水を流出させた
まま第８図に示すように、管状器官２２内に予め
導入されているガイドカテーテル２４中をガイド
ワイヤ２６を利用して目的とする留置部位まで導
入する。この留置部位に到達したとき、氷冷生理
食塩水の導入を停止する。これにより、ステント
１０が体温により次第に温められ、体温近傍に温
められると第９図に示す如く、ステント１０が拡
張し、管状器官２２内壁面に圧接し、保持され
る。したがつて、カテーテルチユーブ１４の先端
部をステント１０から容易に引き抜くことがで
き、これによつてステント１０を管状器官２２の
所定位置にそのまま留置させることができる。
このステント１０を回収する場合は、カテーテ
ルチユーブ１４の先端の側孔１８部分をステント
１０内に挿入し、氷冷生理食塩水をポート１６ｃ
から導入し、側孔１８から排出させることによ
り、ステント１０を収縮させ第７図に示す如く側
孔１８部分に密着させることができるから、その
まま引き出すことにより回収することができる。
ステント１０の留置位置を変更させたい場合も同
様の操作でおこなうことができる。
なお、カテーテルチユーブ１４先端に穿設され
る側孔１８の数、範囲についてはステントの大き
さ等を考慮して任意に選択し得る。
（発明の効果） 以上詳述したように、本発明によれば、管状器
官用ステントとして体温を基準とする温度変化に
より拡張、収縮自在な二方向性形状記憶合金の筒
状体を用いたから、留置位置からの回収が可能と
なるとともに、拡張後における留置位置の変更も
容易となるなど顕著な効果を奏する。さらに本発
明に係わるステント操作用カテーテルによれば先
端周面に穿設した側孔を介してステントの収縮を
自由におこなうことができステントの導入、回収
を極めて簡単かつ容易におこなうことが可能とな
る。
【図面の簡単な説明】
第１図ａ，ｂは本発明に係わる管状器官用ステ
ントの側面図であつて、ａは収縮時、ｂは拡張時
の状態を示し、第２図ａ，ｂないし第４図ａ，ｂ
は本発明の管状器官用ステントの斜視図であつて
ａは収縮時、ｂは拡張時の状態を示し、第５図は
上記ステントの操作に用いられるカテーテルの側
面図、第６図は第５図のカテーテルのハブ部を拡
大して示す断面図、第７図は第４図のカテーテル
に第１図のステントを装着した状態を示す側面
図、第８図はおよび第９図は第７図に示すカテー
テルを用いて管状器官にステントを留置させる場
合の操作を説明する部分断面図である。 図中、１０……ステント、１２……カテーテ
ル、１４……カテーテルチユーブ、１６……ハブ
部、１６ａ……直線状筒状部、１６ｂ……分岐
部、１８……側孔、２０……逆止弁、２２……管
状器官、２４……ガイドカテーテル、２６……ガ
イドワイヤ。

Claims (1)

  1. 【特許請求の範囲】 １ 二方向性形状記憶合金からつくられ、温度変
    化にともなつて径方向に拡張または収縮し得る網
    目状の筒状体からなることを特徴とする管状器官
    内腔の内径確保用器具。 ２ 該筒状体が、体温または体温近傍で径方向に
    拡張し、体温または体温近傍より実質的に低い温
    度で、径方向に収縮するものである特許請求の範
    囲第１項記載の管状器官内腔の内径確保用器具。 ３ 二方向性形状記憶合金がNi−Ti系、Cu−Al
    −Ni系およびCu−Zn−Al系合金から選ばれるも
    のである特許請求の範囲第１項記載の管状器官内
    腔の内径確保用器具。
JP62070781A 1987-03-25 1987-03-25 管状器官内腔の内径確保用器具 Granted JPS63238872A (ja)

Priority Applications (7)

Application Number Priority Date Filing Date Title
JP62070781A JPS63238872A (ja) 1987-03-25 1987-03-25 管状器官内腔の内径確保用器具
KR1019880701459A KR910002422B1 (ko) 1987-03-25 1988-03-25 관상기관 내강의 내경확보용 기구 및 이것을 구비한 카테테르
DE3852892T DE3852892T2 (de) 1987-03-25 1988-03-25 Instrument zum aufrechterhalten des innendurchmessers eines tubusförmigen organs sowie katheter mit diesem instrument.
PCT/JP1988/000306 WO1988007390A1 (fr) 1987-03-25 1988-03-25 Instrument permettant de reguler le diametre interne d'une cavite d'un organe tubulaire et catheter comportant cet instrument
EP88902924A EP0411118B1 (en) 1987-03-25 1988-03-25 Instrument for securing inner diameter of inner cavity of tubular organ and catheter equipped with the instrument
AU14904/88A AU613027B2 (en) 1987-03-25 1988-03-25 Instrument for maintaining inner diameter of tubular organs and catheter provided with said instrument
US07/607,767 US5037427A (en) 1987-03-25 1990-10-30 Method of implanting a stent within a tubular organ of a living body and of removing same

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP62070781A JPS63238872A (ja) 1987-03-25 1987-03-25 管状器官内腔の内径確保用器具

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP5022091A Division JP2539955B2 (ja) 1991-02-25 1991-02-25 管状器官内腔の内径確保用器具を備えたカテ−テル

Publications (2)

Publication Number Publication Date
JPS63238872A JPS63238872A (ja) 1988-10-04
JPH0351430B2 true JPH0351430B2 (ja) 1991-08-06

Family

ID=13441408

Family Applications (1)

Application Number Title Priority Date Filing Date
JP62070781A Granted JPS63238872A (ja) 1987-03-25 1987-03-25 管状器官内腔の内径確保用器具

Country Status (7)

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WO1988007390A1 (fr) 1988-10-06
EP0411118B1 (en) 1995-01-25
EP0411118A4 (en) 1991-05-29
AU613027B2 (en) 1991-07-25
AU1490488A (en) 1988-11-02
DE3852892T2 (de) 1995-05-18
JPS63238872A (ja) 1988-10-04
KR910002422B1 (ko) 1991-04-22
KR890700373A (ko) 1989-04-24
US5037427A (en) 1991-08-06
DE3852892D1 (de) 1995-03-09
EP0411118A1 (en) 1991-02-06

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