JPH06181993A - 膨張可能なステント及びその製造方法 - Google Patents

膨張可能なステント及びその製造方法

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Publication number
JPH06181993A
JPH06181993A JP4286331A JP28633192A JPH06181993A JP H06181993 A JPH06181993 A JP H06181993A JP 4286331 A JP4286331 A JP 4286331A JP 28633192 A JP28633192 A JP 28633192A JP H06181993 A JPH06181993 A JP H06181993A
Authority
JP
Japan
Prior art keywords
stent
cylindrical
catheter
tube
coating
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
JP4286331A
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English (en)
Other versions
JP2645203B2 (ja
Inventor
Lilip Lau
ラウ リリップ
William M Hartigan
エム ハーティガン ウィリアム
John J Frantzen
ジェイ フランツェン ジョン
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.)
Abbott Cardiovascular Systems Inc
Original Assignee
Advanced Cardiovascular Systems Inc
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=25129650&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JPH06181993(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Advanced Cardiovascular Systems Inc filed Critical Advanced Cardiovascular Systems Inc
Publication of JPH06181993A publication Critical patent/JPH06181993A/ja
Application granted granted Critical
Publication of JP2645203B2 publication Critical patent/JP2645203B2/ja
Anticipated expiration legal-status Critical
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    • 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
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    • A—HUMAN NECESSITIES
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    • 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
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    • 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
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    • 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
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    • 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
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    • A—HUMAN NECESSITIES
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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Materials Engineering (AREA)
  • Mechanical Engineering (AREA)
  • Metallurgy (AREA)
  • Organic Chemistry (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)

Abstract

(57)【要約】 【目的】 動脈のような身体ルーメンに移植するための
膨張可能なステント及びそれを単一長さの管から作る方
法を提供することを目的とする。 【構成】 ステントは、共通の軸線に整列され、１つ又
はそれ以上の相互連結要素によって相互に連結された複
数の半径方向に膨張可能な円筒要素からなる。半径方向
に膨張可能な個々の要素は、波状模様に配置されたリボ
ン状の材料からなる。ステントは、所定長さの管に化学
的エッチングに抵抗性のある材料をコーティングして、
次いで管にステントのためにパターンを形成して、除去
すべき管の部分を露出させるために、コーティングの部
分を選択的に除去することによって作られる。これは、
機械制御動作及びコーティングされた管に関連したレー
ザの相対位置決めによって行うことができる。管のパタ
ーン取り後、ステントは、エッチング工程によって管の
露出した部分を除去することによって形成される。

Description

【発明の詳細な説明】
【０００１】
【産業上の利用分野】本発明は、開通性を維持するため
に、血管のような患者の身体ルーメンに移植されるよう
にした一般的にステントと呼ばれる膨張可能なendprost
hesis 装置に関する。これらの装置は、血管のアテロー
ム硬化の狭搾の処置に非常に役に立つ。
【０００２】ステントは、血管或いは他の切開管空の部
分を開いた状態に維持する機能を有する一般的に管形状
の装置である。ステントは、流体流路を塞ぐことができ
る切開された動脈の内層を支持して、保持して使用する
のに特に適している。先行技術のステントのさらなる詳
細は、アルフィディ他の米国特許第３８６８９５６号、
バルコ他の米国特許第４５１２３３８号、マース他の米
国特許第４５５３５４５号、パルマズの米国特許第４７
３３６６５号、ローゼンブルスの米国特許第４７６２１
２８号、ジアンティルコの米国特許第４８００８８２
号、ヒルテッドの米国特許第４８５６５１６号、ウィク
トールの米国特許第４８８６０６２号に開示されてお
り、ここにそっくりそのまま取り込まれている。
【０００３】種々の装置が、ステントを送出して、移植
するために説明された。バルーンのように膨張可能なス
テントを膨張可能部材に取り付けることを含むステント
を所望の内空位置に送出するためにしばしば説明されて
きた１つの方法は、脈管内のカテーテルの遠位端に設け
られ、カテーテルを患者の本体管空内の所望の位置に進
め、カテーテルのバルーンを膨張させて、ステントを膨
張して恒久的な膨張状態にし、次いでバルーンを収縮さ
せてカテーテルを取り出す。先行のステントを使用する
際に出くわす困難の１つは、身体ルーメンを開いた状態
に保持するのに必要とされる半径方向の剛性を維持する
と同時に、ステントの送出を容易にするためにステント
の長手方向の可撓性を維持することである。
【０００４】必要とされ、これまで利用できなかったも
のは、高い程度の可撓性を有するステントであり、くね
った通路を通って進むことができ、容易に膨張させるこ
とができ、それでも身体ルーメンをステントを膨張した
位置に開いたまま保持するための機械的強度を有するこ
とである。
【０００５】
【従来技術及び発明が解決しようとする課題】本発明
は、くねった身体ルーメンを通す送出を容易にするため
に、長手方向軸線に沿って比較的可撓性を有するが、身
体ルーメンの中に移植させられたとき動脈のような身体
ルーメンの開通性を維持するために膨張した状態で半径
方向に十分な硬くて安定した膨張可能なステントに関す
る。
【０００６】本発明のステントは、一般的に互いに膨張
し、撓む能力について比較的独立な半径方向に膨張可能
な複数の円筒要素を有する。ステントの個々の半径方向
膨張可能な円筒要素は、それら自身の直径より長手方向
に短いように寸法決めされる。隣接した円筒要素の間に
延びる相互連結要素又はストルートは、安定性を増大さ
せ、膨張の際にステントのそりを防止するために位置決
めされるのが望ましい。結果として生じるステントの構
造は、身体ルーメンの壁の小さい切開片がルーメンの壁
の対する位置に押し戻されるが、ステントの長手方向の
可撓性と妥協するような近さに、長手方向に近く間隔を
隔てた一連の半径方向に膨張可能な円筒要素である。個
々の円筒要素は、重大な変形なしに隣接した円筒形の要
素に対して僅かに回転でき、その長さに沿って、その長
手軸線のまわりに可撓性を有するが、崩壊に抵抗するた
めに半径方向になお非常に硬いステントを累積的に与え
る。
【０００７】本発明の特徴を具体化したステントは、送
出用カテーテルの膨張可能部材、例えばバルーンに取り
付けて、カテーテル−ステント組立体を身体ルーメンを
通して移植位置に運ぶことによって所望のルーメン位置
に容易に送出することができる。ステントを所望の位置
に送出するためにステントをカテーテルの膨張可能部材
に固定するための種々の装置が有効である。現状では、
ステントをバルーンに押さえ付けるのが望ましい。ステ
ントをバルーンに固定するための他の装置は、横方向の
動きを抑制するために膨張部材にリッジ又はカラーを設
け或いはbioresorbable な一時的接着剤を含む。
【０００８】膨張可能な円筒要素のための現状の好まし
い構造は、たとえば波状のような波状模様を円周方向に
一般的に有する。円筒要素の波状の要素の横断面は、比
較的小さく、約２対１から約０．５対１の縦横比を有す
るのが望ましい。特に、１対１の縦横比が適しているこ
とがわかっている。ステントの開放網状構造によって、
損傷を受けた動脈の壁の治癒及び修復を改善することが
できる動脈壁の大部分に渡って血液の潅流を可能にす
る。
【０００９】膨張可能円筒体の半径方向の膨張は、波形
の振幅及び周波数を減少させることから生じる波形の変
化と同様に波状模様を変形させる。おそらく、個々の円
筒形構造の波状模様は、膨張させたときにその長さに沿
ったステントの収縮を防止するために、互いに同相であ
る。ステントの円筒形構造は、膨張したときに（NiTi合
金を除く) 塑性変形して、ステントは、膨張した状態の
ままであるので、したがって、使用の際に崩壊するのを
防止するために膨張されたときに十分に硬くなければな
らない。超塑性NiTi合金では、オステナイトからマルテ
ンサイトに相変化してその結果ステントの膨張を可能に
するように、圧縮応力が除去されたときに膨張が生じ
る。
【００１０】隣接した円筒要素を相互に結合した細長い
要素は、膨張可能な円筒要素の波状構成部品の横方向の
寸法と同様な横断面を有するべきである。相互連結要素
は、膨張可能な円筒要素と一体構造で管状要素のような
同じ中級品から形成され、或いは溶接したり、相互連結
要素の端を膨張可能な円筒要素の端に機械的に固定した
りするような適当な手段によって独立に結合して形成さ
せることができる。おそらく、ステントの相互連結要素
の全ては、ステントのための円筒要素の波状の構造に山
或いは谷のいずれかに結合される。この仕方で、膨張の
際ステントは短縮は生じない。
【００１１】隣接した円筒要素を結合する要素の数及び
位置は、膨張していない状態並びに膨張した状態のいず
れの場合にもステント構造で所望の長手方向の可撓性を
発揮させるために、変えることができる。これらの特性
は、ステントが移植される身体ルーメンの自然生理機能
の変化を最小にして、ステントによって内的に支持され
る身体ルーメンの伸展性を維持するために重要である。
一般的に、ステントの長手方向の可撓性が大きくなるほ
ど、より容易にしかもより安全に移植位置にステントを
送出することができる。
【００１２】本発明の現状の好ましい実施例では、ステ
ントは化学的エッチングに対して抵抗性のある材料でコ
ーティングしたステンレス鋼ハイポ管で都合よく、容易
に形成される。次いで、所望のステント構造を発達させ
るために取り除かれるべき下層の管の部分を露出させる
ためにコーティングの部分を取り除く。管の露出部分は
化学的エッチングによってステント構造の所望の模様に
管材料の被覆部分を残す管外部から取り除かれる。エッ
チング工程は小型の製品を機械的或いはレーザ機械工程
の特性であるバリ或いは他の加工品なしに、管壁に平滑
な開口を発達させる。さらに、化学的耐コーティングを
取り除くためのコンピュータ制御されたレーザのパター
ン工程は、写真平板技術をこれらの小製品の製造に適応
させる。本発明の小ステントを作るのに必要とされる極
小寸法のマスクの形成は、最も困難な作業である。複数
のステントは、ステントのパターンを繰り返して、ステ
ントを相互に結合するための小さいウェブ又はタブを設
けることによってハイポ管の１つの長さから形成するこ
とができる。エッチング工程の後、ステントを結合する
小さいウェブ又はタブを提供することによって、ステン
トを分離することができる。
【００１３】
【実施例】図１は、送出用カテーテル１１に設けられた
本発明の特徴を有するステント１０を示す。ステント
は、一般的に、略同軸に配置され、複数の半径方向に膨
張可能な円筒要素１２を有し、該要素は、隣接した円筒
要素の間に配置された要素１３によって相互に結合され
ている。送出用カテーテル１１は、動脈１５内でのステ
ント１０の膨張のために膨張可能な部分又はバルーン１
４を有する。図１に示す動脈１５は、動脈管路の部分を
塞いでいる切開したライニング１６を有する。
【００１４】ステント１０を取り付けた送出用カテーテ
ル１１は、血管形成手術用の従来のバルーン膨張カテー
テルと本質的に同じである。バルーン１４は、ポリエチ
レン、ポリエチレンテレフタル酸エステル、ポリ塩化ビ
ニル、ナイロン及びDu PontCompany の重合体生産部に
よって製造されるSurlynのようなイオノマーのような適
当な材料で形成されるのがよい。他の重合体を使用して
もよい。動脈１５内の損傷部位への送出中、ステント１
０をバルーン１４上の所定位置にとどめる為に、ステン
ト１０をバルーンへ圧縮させる。ステントが送出用カテ
ーテル１１の膨張部分上の所定位置にさらに確実に停ま
るように、かつ所望の動脈位置への送出中、ステント１
０の開放面によって、身体ルーメンの摩耗を防ぐために
「ステント送出装置」と称する1990年4 月25日出願の第
07/647464 号に説明されたような引き込み可能な保護送
出スリーブ２０を設けてもよい。バルーンの作動部分、
即ち、円筒部分の端にカラー或いはリッジを設けるよう
な、ステント１０をバルーン１４に固定するための他の
装置を使用してもよい。
【００１５】ステント１０の各半径方向に膨張可能な円
筒要素１２を、独立に膨張させるのが良い。したがっ
て、バルーン１４は、身体ルーメンの種々の形状でのス
テント１０の移植を容易にするために、円筒形以外の膨
張形状、例えばテーパ形状を有することができる。好ま
しい実施例では、ステント１０の送出は、以下の仕方で
達成される。ステント１０をまず送出用カテーテル１１
の遠位端の膨張可能バルーン１４に取り付ける。バルー
ン１４を僅かに膨らませてステント１０をバルーンの外
部に固定する。カテーテル−ステント組立体を従来のセ
ルディンガー技術で案内用カテーテル（図示せず）を通
して患者の血管系に導入する。切り離した又は切開した
ライニング１６を有する損傷した動脈部分に案内ワイヤ
１８を配置し、次いで、ステント１０が切り離したライ
ニング１６の直ぐ下にくるまで動脈１５内で案内ワイヤ
ー１８に従い、カテーテル−ステント組立体を前進させ
る。図２に示すように、カテーテルのバルーン１４を膨
張させて、ステント１０を動脈１５に向かって膨張させ
る。図に示さないが、ステント１０を動かないように着
座させ、さもなければ固定するためにステント１０の膨
張によって動脈１５を僅かに膨張させるのが望ましい。
動脈の狭搾部分の治療中のある状況では、血液或いは他
の流体の通り容易にするために動脈を相当膨張させさけ
ればならない。
【００１６】図３に示すように、ステント１０は、カテ
ーテル１１を引き抜いた後、動脈１５を開いた状態に維
持するのに役立つ。細長い管状部材からステント１０を
形成することにより、ステント１０の円筒要素の波状構
成部品は、横断面が比較的平らであるから、ステントを
膨張させたとき、円筒要素は、動脈１５の壁に押し込ま
れ、その結果、動脈１５を流れる血液の流れを妨害しな
い。動脈１５の壁に押し込まれたステント１０の円筒要
素１２は、ついには血液の流れの妨害をさらに最小にす
る内皮細胞の成長で覆われる。円筒要素１２の波状部分
は、動脈内でのステントの動きを防止する良好な取付け
特性を与える。さらに、一定の間隔で間隔の狭い円筒要
素１２は、動脈１５の壁の一様な支持を行い、その結
果、図２及び図３に示すように動脈１５の壁の小さいフ
ラップ或いは切開部を留めて、所定位置に良好に保持す
るようになっている。
【００１７】図４は、隣接した半径方向に膨張可能な円
筒要素１２の間の相互連結要素１３の配置をより詳細に
示すためステントの一端を分解図で示した、図１に示す
ステント１０の拡大斜視図である。円筒要素１２の一方
の側の各対の相互連結要素１３は、ステントについて最
大の可撓性を達成するように配置されるのが好ましい。
図４に示す実施例では、ステント１０は、１２０°離れ
た隣接した半径方向に膨張可能な円筒要素１２の間に３
つの相互連結要素１３を有する。円筒要素１２の一端の
各対の相互連結要素１３は、円筒要素の他の側の要素１
３の対から半径方向に６０°食い違っている。交互の相
互連結要素によって、ステントは本質的にあらゆる方向
に長手方向に撓むことができる。相互連結要素の種々の
配置形態が可能であり、図７から図１０に数個の例を概
略に示す。しかし、すでに述べたように個々のステント
の全ての相互連結要素は、ステントの膨張中ステントが
短くなるのを防止するために、波状の構造要素の山或い
は谷のいずれかに固定されるべきである。
【００１８】図１０は、３つの相互連結要素１３を、半
径方向に膨張可能な円筒要素１２の間に配置した本発明
のステントを示す。相互連結要素１３は、ステントの周
のまわりに１２０°の間隔で半径方向に分配される。隣
接した円筒要素１２の間に４つ或いはそれ以上の相互連
結要素１３を配置することのは、一般的には２つ及び３
つの相互連結要素について上で論じた同じ考慮を生じ
る。
【００１９】ステント１０の特性は又、円筒要素１２の
波状模様の変化によって変えることができる。図１１
は、円筒要素が波状模様だが隣接した円筒要素と位相を
異にする交互のステント構造を示す。特定の模様及び円
筒要素１２の円周のまわりの単位長さ当たりの波数或い
は波の振幅は、半径方向の剛性のようなステントの特定
の機械的要求性能を満たすように選択される。
【００２０】波の数は又、例えば波の山に、或いは図５
及び図１１に示すように波の側に沿って相互連結要素１
３を配置するように変えることができる。本発明のステ
ント１０は、多くの方法で作ることができる。しかし、
ステントの好ましい製造方法は、ステンレス鋼のハイポ
管のような薄肉管状部材に化学的エッチングに抵抗性の
ある材料をコーティングし、次いで除去すべき下層のハ
イポ管を露出させるがステントの所望模様でハイポ管の
コーティング部分を残すようにコーティング部分を除去
し、続いて行われるエッチングが、金属管の露出した部
分を除去し、ステントを形成すべき金属管の部分を比較
的そのままに残す。金属管のコーティング部分は、ステ
ントの所望の形状である。腐食液工程は、従来の機械加
工或いはレーザ機械加工に固有のバリ又はスラグを除去
することの必要性を回避する。図６に概略的に示すよう
に機械制御レーザによって耐腐食液材料を除去するのが
好ましい。
【００２１】コーティングは、硬化させたとき化学的腐
食液に抵抗する所定長さの管に適用される。San Jose、
CaliforniaのShipley Company によって作られた「ブル
ーホトレジスト」は、入手可能な適当な写真平板用コー
ティングの例である。コーティングは、電気泳動塗装に
よって行われるのが望ましい。表面仕上げが、適度に一
様であることを確保するために、電気化学研磨のために
使用される電極の1 つは、管状部材の中央部分のまわり
に配置されるドーナッツ形状の電極である。
【００２２】管は、ステンレス鋼、チタニウム、タンタ
ル、超塑性NiTi合金及び高い剛性の熱可塑性重合体のよ
うなあらゆる適当な二極性材料で作ることができる。ス
テントの直径は非常に小さく、したがってステントが作
られる管も又必然的に小さい直径を有しなくてはならな
い。ステントは、典型的には、膨張してない状態でステ
ントが作られるハイポ管の外径と同じ約0.06インチ程度
の外径を有し、0.01インチ或いはそれ以上まで膨張する
ことができる。ハイポ管の肉厚は、約0.003 インチであ
る。ステントがプラスチックである場合には、ステント
の膨張を容易にするために、ステントを膨張させる動脈
の部位内でステントを加熱しなければならない。いった
ん膨張したら、膨張状態を維持するために冷やす。ステ
ントは、バルーン内の流体を加熱することによって、或
いはここにそっくりそのまま言及されている「加熱バル
ーンを有する膨張カテーテル組立体」と称する1990年1
月26日出願の同時継続出願第07/521337 号で開示された
ような適当な装置によってバルーンを直接加熱すること
によって都合よく加熱することができる。ステントは
又、ここにそっくりそのまま言及されている「超塑性案
内部材」と称する1990年12月18日出願の同時継続出願第
07/629381 号で開示されたような超塑性NiTi合金のよう
な材料で作ることができる。この場合、ステントは、原
寸で形成されているが所望の管腔内の部位への移送を容
易にするために送出用カテーテルのバルーン上でより小
さい直径に変形（例えば、圧縮）される。変形によって
引き起こされる応力は、ステントをマルテンサイト相か
らオーステナイト相に転位させ、ステントが所望の管腔
内の位置に達するとき、力が解放されて、マルテンサイ
ト相へ転位して戻ることにより、ステントを膨張させ
る。
【００２３】図６を参照すれば、コーティング管２１
が、管２１をレーザ２４に対して位置決めするために機
械制御装置２３の回転可能なコレット取り付け具２２内
に置かれる。機械で符号した指示に従って、管２１を、
回転させ、同じく機械で制御されるレーザ２４に対して
長手方向に移動させる。レーザは、融蝕によって管の耐
腐食液コーティングを選択的に除去し、引き続いて行わ
れる化学的腐食液工程によって除去すべき管の表面を露
出させるように模様が形成される。したがって、管の表
面は、仕上がりステントの離散模様にコーティングされ
たままである。
【００２４】管のコーティングを除去するための現状の
好ましい装置は、Coherent Model 4４のような８０ワッ
トのＣＯ2 レーザで、パルスモードが0.3mS パルス長、
100Hz で主電流が48mA、主電力が48W で平均電力が0.75
W 、Anorad FR=20、12.5Torrで補助ガスなしの使用を含
む。蒸気がレンズに接触しないようにするために低圧空
気を精密焦点ヘッドを通して指し向ける。レーザ装置の
補助ガスジェット組立体を取り外して、精密焦点ヘッド
とコレット取り付け具のより近接を可能にする。最適な
焦点を、管の表面に設定する。硬化したフォトレジスト
コーティングは、ＣＯ2 波長のエネルギーを容易に吸収
するので、レーザによって容易に取り除くことができ
る。被覆した４インチ長さの0.06インチステンレス鋼管
が望ましく、４つのステントを、所定長さの管にパター
ン取りすることができる。ステント間の３つのタブ或い
はウェブは、腐食液工程の後管の良好なる取り扱い特性
を与える。
【００２５】抵抗性コーティングをステントにパターン
取りする工程は、所定長さの管を付けたり外したりする
ことを除いて、自動化されている。図６を再び参照する
と、これは、所定長さの管を例えば、説明したように機
械制御レーザに対して軸方向に移動させるＣＮＣＸ／Ｙ
テーブル２５と関連して、所定長さの管の軸方向回転の
ためにＣＮＣ対向コレット取り付け具２２を用いてなさ
れる。コレット間の全スペースは、前述の例のＣＯ2 レ
ーザセットアップを使用してパターン取りすることがで
きる。装置を制御するためのプログラムは、使用された
特定の形態及びコーティングで除かれるべきパターンに
依存するが、さもなければ従来のものである。
【００２６】この工程は、ステントを製造する際に、現
状の写真平板技術の適用を可能にする。脈管内ステント
を作るのに要求される小さい大きさの管状のホトレジス
トコーティング部分をマスクし、かつ露出させる実用的
な方法は現状はないが、前述の工程は、従来のマスキン
グ技術の必要性を除去する。かくして、コーティングが
選択的に除かれた後、管をコレット取り付け具２２から
取り出す。次に、ThermoCote N-4のようなワックスを、
望ましくはその融点まで加熱して、真空又は圧力下で管
に挿入する。ワックスを冷却して固めた後、融点以下で
再加熱し、柔らかくして、より小さい直径のステンレス
鋼の軸をやわらかくしたワックスに挿入して、支持を行
う。次いで、管を従来の仕方で化学的に腐食液する。ス
テントを結合するタブを切断した後、タブの表面の粗さ
又は異物を取り除く。ステントを、望ましくは、硫酸、
カルボン酸、ホスフェート、腐蝕防止剤及び生分解性表
面の活性薬剤の混合物であるChicago ILのETECTRO-GLOC
O. で販売されるELECTRO-GLO #300液のような酸性の水
溶液で電気化学的に洗浄する。浴の温度を、約110 -135
°F に、及び電流密度を約0.4 から約1.5amps/in 2 に維
持する。陽極領域に対する陰極は、少なくとも1 対2 に
すべきである。ステントは、さらに所望なら例えば2 極
性のコーティングを適用することによって、処理するこ
とができる。
【００２７】脈管内ステントとしての使用の観点から本
発明を説明したが、ステントは、前立腺肥大の場合に尿
道前立腺部を膨張させるような他の例に使用できること
が当業者に明らかであろう。他の変形及び修正は、本発
明の範囲を逸脱することなく成しうる。
【図面の簡単な説明】
本発明の他の特徴及び利点は、添付例示図面とともに以
下の本発明の詳細な説明からより明らかになるであろ
う。
【図１】送出用カテーテルに設けられ、損傷を受けた動
脈内に配置された本発明の特徴を具体化したステントの
部分的に断面を示す立面図である。
【図２】損傷を受けた動脈内で膨張され、動脈壁に対し
て損傷を受けたライニングを押しつける図１に示したも
のと同様の部分的に断面を示す立面図である。
【図３】送出用カテーテルを引き抜いた後、動脈内で膨
張させたステントを示す部分的に断面を示す立面図であ
る。
【図４】本発明の特徴を具体化した膨張してない状態の
ステントの斜視図を、ステントの一端の詳細を示す分解
図とともに示す。
【図５】図４に示すステントの波状模様を示す本発明の
ステントの平らに伸ばした部分の正面図である。
【図６】本発明のステントの製造の際に、管に適用され
たコーティングを選択的に取り除くための装置の概略図
である。
【図７】ステントの半径方向に膨張可能な円筒要素の間
に相互連結要素を配置する種々の形態を概略的に示す斜
視図である。
【図８】ステントの半径方向に膨張可能な円筒要素の間
に相互連結要素を配置する種々の形態を概略的に示す斜
視図である。
【図９】ステントの半径方向に膨張可能な円筒要素の間
に相互連結要素を配置する種々の形態を概略的に示す斜
視図である。
【図１０】ステントの半径方向に膨張可能な円筒要素の
間に相互連結要素を配置する種々の形態を概略的に示す
斜視図である。
【図１１】ステントの半径方向に膨張可能な円筒要素
の、位相が異なる交互波状模様を示すステントの平らに
伸ばした部分の正面図である。
【符号の説明】 １０ ステント １１ 送出用カテーテル １２ 半径方向に膨張可能な円筒要素 １３ 相互連結要素 １４ バルーン １５ 動脈 １８ 案内ワイヤー
フロントページの続き (72)発明者 ウィリアム エム ハーティガン アメリカ合衆国 カリフォルニア州 94555 フリィモント タナガー コモン 4229 (72)発明者 ジョン ジェイ フランツェン アメリカ合衆国 カリフォルニア州 95132 サン ホセ ヘリティジ パーク 2649

Claims (27)

    【特許請求の範囲】
  1. 【請求項１】 半径方向に独立に膨張可能で、共通の軸
    線に略整列するように相互に連結された複数の円筒形状
    の要素を有する長手方向に可撓性を有するステント。
  2. 【請求項２】 円筒形状部材が、膨張の際に膨張した状
    態を維持するようになった請求項１のステント。
  3. 【請求項３】 膨張していない状態の前記半径方向に膨
    張可能な円筒要素は、その直径より小さい長さを有する
    請求項１のステント。
  4. 【請求項４】 各半径方向に膨張可能な円筒要素は、２
    対１より小さい縦横比を有する横方向寸法を有する構造
    部材で形成され、前記構造部材は、波状模様に形成さ
    れ、前期ステントの長手方向軸線のまわりに配置される
    請求項１のステント。
  5. 【請求項５】 前記構造部材は、ステンレス鋼、タング
    ステン、タンタル、超塑性NiTi合金及び熱可塑性重合体
    の群から選択された二極性材料で形成される請求項４の
    ステント。
  6. 【請求項６】 前記円筒形状部材は、一端が相互連結要
    素を有し、円筒要素の他端が、相互連結要素に軸線方向
    に整列した請求項1 のステント。
  7. 【請求項７】 円筒要素の一端の各相互連結要素は、円
    筒要素の他端の相互連結要素から円周方向に配置される
    請求項６のステント。
  8. 【請求項８】 相互連結要素の円周方向の配置は、均等
    の大きさである請求項6 のステント。
  9. 【請求項９】 隣接した膨張可能な円筒要素の間に配置
    された4 つまでの相互連結要素がある請求項12のステン
    ト。
  10. 【請求項１０】 前記半径方向に膨張可能な要素と前記
    相互連結要素は同じ材料で作られている請求項１のステ
    ント。
  11. 【請求項１１】 前記ステントは、管の単一片から形成
    されている請求項９のステント。
  12. 【請求項１２】 前記円筒要素は、構造部材を波状模様
    に形成している請求項１のステント。
  13. 【請求項１３】 前記ステントの前記構造部材の前記波
    状模様は、同相である請求項１２のステント。
  14. 【請求項１４】 前記ステントの前記連結要素は、前記
    波状構造部材の山或いは谷のいずれかにすべて連結され
    ている請求項１３のステント。
  15. 【請求項１５】 （ａ）所定長さの管に化学的エッチン
    グに抵抗性のあるコーティングを行い、（ｂ）前記管の
    部分を露出させるために、前記抵抗性コーティングの部
    分を選択的に除去し、（ｃ）露出した前記管の部分を除
    去する工程からなるステントの製造方法。
  16. 【請求項１６】 複数のステントは、管の単一片から作
    られる請求項１４のステント。
  17. 【請求項１７】 前記ステントは、重合体、ステンレス
    鋼、タングステン、チタニウム、超塑性NiTi合金及びタ
    ンタルの群から選択された二極性材料で作られる請求項
    １４の工程。
  18. 【請求項１８】 前記コーティングは、電気泳動塗装に
    よって行われる請求項１４のステント。
  19. 【請求項１９】 （ａ）前記ステントを、前記ステント
    を加熱し、膨張させるようにしたカテーテルの膨張可能
    な部分に配置し、（ｂ）前記ステントを前記身体ルーメ
    ン内の所望の位置に送出し、（ｃ）前記ステントを加熱
    し、膨張させて、（ｄ）前記ステントを固くして、前記
    身体ルーメンを開状態に保持するのを可能にするよう
    に、前記ステントを膨張した状態で冷却させて、（ｅ）
    前記カテーテルの前記膨張部分を収縮させ、（ｆ）前記
    カテーテルを引き抜く工程からなる二極性の熱可塑性重
    合体材料で作られる、患者の身体ルーメン内に請求項１
    のステントを配置する方法。
  20. 【請求項２０】前記ステントは、二極性のコーティング
    で被覆される請求項１のステント。
  21. 【請求項２１】 （ａ）所定の別々の長さの薄肉管を提
    供し、（ｂ）前記抵抗性コーティングを前記管の外部に
    形成し、（ｃ）抵抗性コーティングで被覆された完全に
    開かれ、網目状に配置された管状構造の所望のパターン
    を残し、除去すべき管の部分を露出させるために、前記
    管の外部の前記抵抗性コーティングの部分を選択的に除
    去し、（ｄ）前記管の前記露出部分を除去する工程から
    なる開放網目構造の管状構造を製造する方法。
  22. 【請求項２２】 前記管の前記露出部分は、エッチング
    によって除去される請求項２０の方法。
  23. 【請求項２３】 前記抵抗性コーティングの選択的な除
    去は、前記管とレーザとの相対運動を機械で制御するこ
    とによって達成される請求項２０の方法。
  24. 【請求項２４】 前記抵抗性コーティングを選択的に除
    去するために使用される前記レーザは、前記コーティン
    グによって容易に吸収される特定の光の波長を放出する
    請求項２０の方法。
  25. 【請求項２５】 前記レーザは、ＣＯ2 ガスレーザであ
    る請求項２０の方法。
  26. 【請求項２６】 使用される前記抵抗性コーティング
    は、写真平板用の化学的抵抗性コーティングである請求
    項２０の方法。
  27. 【請求項２７】 （ａ）近位端と遠位端と前記遠位端に
    膨張可能な部材とを有する細長いステント送出カテーテ
    ルと、（ｂ）前記カテーテルの膨張可能な部材に摺動可
    能に取り付けられるようになり、半径方向に独立に膨張
    可能で、ある共通軸線に略整列するように相互連結され
    た複数の円筒要素を有する長手方向に可撓性のあるステ
    ントとからなるキット。
JP4286331A 1991-10-28 1992-10-23 膨張可能なステント及びその製造方法 Expired - Lifetime JP2645203B2 (ja)

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US07/783558 1991-10-28

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JP2012507375A (ja) * 2008-11-04 2012-03-29 マイクロポート・メディカル（シャンハイ）カンパニー，リミテッド 薬剤担持溝付き冠動脈ステント
JP2016512749A (ja) * 2013-03-15 2016-05-09 アトリウム メディカル コーポレーションＡｔｒｉｕｍ Ｍｅｄｉｃａｌ Ｃｏｒｐｏｒａｔｉｏｎ 減少した短縮および反跳を有するステントデバイスおよびその製造方法
US10271975B2 (en) 2013-03-15 2019-04-30 Atrium Medical Corporation Stent device having reduced foreshortening and recoil and method of making same
US10842656B2 (en) 2013-03-15 2020-11-24 Atrium Medical Corporation Stent device having reduced foreshortening and recoil and method of making same
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