JPS63238872A - 管状器官内腔の内径確保用器具 - Google Patents

管状器官内腔の内径確保用器具

Info

Publication number
JPS63238872A
JPS63238872A JP62070781A JP7078187A JPS63238872A JP S63238872 A JPS63238872 A JP S63238872A JP 62070781 A JP62070781 A JP 62070781A JP 7078187 A JP7078187 A JP 7078187A JP S63238872 A JPS63238872 A JP S63238872A
Authority
JP
Japan
Prior art keywords
inner diameter
tubular organ
securing
instrument
stent
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.)
Granted
Application number
JP62070781A
Other languages
English (en)
Other versions
JPH0351430B2 (ja
Inventor
原田　文明
寒河江　久太
延吉　正清
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 PCT/JP1988/000306 priority patent/WO1988007390A1/ja
Priority to EP88902924A priority patent/EP0411118B1/en
Priority to AU14904/88A priority patent/AU613027B2/en
Priority to KR1019880701459A priority patent/KR910002422B1/ko
Priority to DE3852892T priority patent/DE3852892T2/de
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

Abstract

(57)【要約】本公報は電子出願前の出願データであるた
め要約のデータは記録されません。

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の拡張保
持具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） 例えば冠動脈の狭搾部を血管拡張カテーテルで′拡張し
た後、その部分の再狭搾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ったもの（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６ｌ−６
６５５）、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軒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、いっ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っている。そ
のほか、このような従来のステントは留置位置が誤って
いることが拡張後発見されたとしても、いったん拡張さ
れた後は、その留置位置の変更は極めて困難であった。
本発明は上記事情に鑑み、管状器官内でいったん拡張さ
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、したがっ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点を解決する手段として
、温度変化にともなって径方向に拡張又は収縮し得る二
方向性形状記憶合金のらせん状または実質的に筒状の成
形体からなることを特徴とする管状器官用ステントを提
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。
さらに、この発明は基端又は両側が開口し、その先端近
傍の周面にこの開口部と連通ずる少なくとも１個の側孔
を穿設してなるカテーテルチューブと、このカテーテル
チューブ後端に連通ずるようにして設けられたハブ部と
、温度変化にともなって径方向に拡張又は収縮し得る二
方向性形状記憶合金筒状体からなり、上記カテーテルチ
ューブの先端の側孔穿設部の少なくとも一部を覆うよう
にして装着された管状器官内腔の内径確保用器具とを具
備してなることを特徴とする管状器官用ステントを備え
たカテーテルを提供するものである。
なお、上記カテーテルのハブ部は２つのポートを具備し
た分岐ハブであって、その一方のポートに逆止弁を設け
るようにしてもよい。
なお、本発明において形状記憶合金とは変態温度を有し
、この温度以上になると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変態温度
以下のときは自由に変形でき、変態温度以上となり形状
変化するとその後変態温度以下になっても記憶した形状
を維持するものをいい、二方向性形状記憶合金とは変態
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を示すものであって、偏平な二方向
性形状記憶合金線条体（例えばＮｉ−Ｔｉ系、Ｃｕ−Ａ
ｌーＮｉ系、Ｃｕ−Ｚｎ−Ａ）系合金からなる）をらせ
ん状に成形したものからなる。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°Ｃ）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１　ｍｍのＮｉ−Ｔｉ系二方
向性形状記憶合金（Ｎｉを約５１原子量％含む）をらせ
ん状に成形したステントにおいては体温で約２　ｍｍ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の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体
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って内径が拡大する
ようなものであってもよい。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ってもよ
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ュー
ブ１４（例えばエチレン−酢酸ビニルコポリマーからな
る）と、このカテーテルチューブ１４の後端に、カテー
テルチューブのルーメンと連通ずるようにして設けられ
たハブ部１６（例えばポリカーボネ−１・からなる）と
からなっている。
カテーテルチューブ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、カテーテルチューブ１４内に
導入されたステント冷却液がこの側孔１Ｂを介して放射
状に排出されるようになっている。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１６ａの中間から分岐部１６ｂとからなって
いる。直線状筒状部１６ａはガイドワイヤの導入口とな
るものであって、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をカテーテルチューブ１４の先端の
側孔１８部分に挿入する。ついで例えば水冷生理食塩水
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°Ｃ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
ーテルチューブ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中をカイトワイヤ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、水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４した
がって、カテーテルチューブ１４の先端部をステント１
０から容易に引き抜くことができ、これによってステン
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、カテーテルチュー
ブ１４の先端の側孔１８部分をステント１０内に挿入し
、水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、カテーテルチューブ１４先端に穿設される側孔１
８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−宮司ス
テントとして体温を基準とする温度変化により拡張、収
縮自在な二方向性記憶合金の円筒体を用いたから、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１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
トの側面図であって、（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って
（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、１
４・・・カテーテルチューブ、１６・・・ハブ部、１６
ａ・・・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 (9)

    【特許請求の範囲】
  1. （１）温度変化にともなって径方向に拡張又は収縮し得
    る二方向性形状記憶合金のらせん状または実質的に筒状
    の成形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. （２）該筒状体が体温又は体温近傍で径方向に拡張し、
    体温又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. （３）該筒状体がコイル状の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。
  4. （４）該筒状体が断面渦巻状の筒体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。
  5. （５）該筒状体がパイプ状の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。
  6. （６）該筒状体が網目状の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。
  7. （７）二方向性形状記憶合金がＮｉ−Ｔｉ系、Ｃｕ−Ａ
    ｌ−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。
  8. （８）基端又は両端が開口し、その先端近傍の周面にそ
    の基端開口部と連通する少なくとも１個の側孔を穿設し
    てなるカテーテルチューブと、このカテーテルチューブ
    後端に連通するようにして設けられたハブ部と、温度変
    化にともなって径方向に拡張又は収縮し得る二方向性形
    状記憶合金筒状体からなり、上記カテーテルチューブの
    側孔穿設部の少なくとも一部を覆うようにして装着され
    た管状器官内腔の内径確保用器具と、を具備してなるこ
    とを特徴とする管状ステントを備えたカテーテル。
  9. （９）ハブ部が２つのポートを具備した分岐ハブからな
    り、その一方のポートに逆止弁が設けられている特許請
    求の範囲第８項記載のカテーテル。
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
PCT/JP1988/000306 WO1988007390A1 (en) 1987-03-25 1988-03-25 Instrument for securing inner diameter of inner cavity of tubular organ and catheter equipped with the 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
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.
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 true JPS63238872A (ja) 1988-10-04
JPH0351430B2 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)

Country Link
US (1) US5037427A (ja)
EP (1) EP0411118B1 (ja)
JP (1) JPS63238872A (ja)
KR (1) KR910002422B1 (ja)
AU (1) AU613027B2 (ja)
DE (1) DE3852892T2 (ja)
WO (1) WO1988007390A1 (ja)

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JPH0286561U (ja) * 1988-12-26 1990-07-09
JPH0435447U (ja) * 1990-07-19 1992-03-25
WO2019188345A1 (ja) * 2018-03-30 2019-10-03 学校法人 久留米大学 ステント

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JPH0286561U (ja) * 1988-12-26 1990-07-09
JPH0415230Y2 (ja) * 1988-12-26 1992-04-06
JPH0435447U (ja) * 1990-07-19 1992-03-25
WO2019188345A1 (ja) * 2018-03-30 2019-10-03 学校法人 久留米大学 ステント
JPWO2019188345A1 (ja) * 2018-03-30 2021-06-17 学校法人 久留米大学 ステント

Also Published As

Publication number Publication date
WO1988007390A1 (en) 1988-10-06
EP0411118A4 (en) 1991-05-29
EP0411118B1 (en) 1995-01-25
KR910002422B1 (ko) 1991-04-22
AU613027B2 (en) 1991-07-25
EP0411118A1 (en) 1991-02-06
US5037427A (en) 1991-08-06
JPH0351430B2 (ja) 1991-08-06
KR890700373A (ko) 1989-04-24
DE3852892T2 (de) 1995-05-18
DE3852892D1 (de) 1995-03-09
AU1490488A (en) 1988-11-02

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