JPH088933B2 - カテ−テル - Google Patents

カテ−テル

Info

Publication number
JPH088933B2
JPH088933B2 JP62173643A JP17364387A JPH088933B2 JP H088933 B2 JPH088933 B2 JP H088933B2 JP 62173643 A JP62173643 A JP 62173643A JP 17364387 A JP17364387 A JP 17364387A JP H088933 B2 JPH088933 B2 JP H088933B2
Authority
JP
Japan
Prior art keywords
catheter
memory alloy
shape
sheath
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 - Fee Related
Application number
JP62173643A
Other languages
English (en)
Other versions
JPS6417658A (en
Inventor
洋一 杉田
隆司 川端
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.)
Zeon Corp
Original Assignee
Zeon 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 Zeon Corp filed Critical Zeon Corp
Priority to JP62173643A priority Critical patent/JPH088933B2/ja
Priority to DE3823060A priority patent/DE3823060A1/de
Priority to US07/217,483 priority patent/US4969890A/en
Priority to FR8809357A priority patent/FR2617721B1/fr
Publication of JPS6417658A publication Critical patent/JPS6417658A/ja
Publication of JPH088933B2 publication Critical patent/JPH088933B2/ja
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88Stents 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/0004Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular 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
    • A61F2210/0023Particular 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
    • A61F2210/0042Particular 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)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Description

【発明の詳細な説明】 イ.産業上の利用分野 本発明はカテーテルに関し、特に血管等の器官の狭窄
(きょうさく)された部分を永続的に拡張するために用
いられるカテーテルに関するものである。
ロ.従来技術 従来、狭心症や心筋梗塞の治療などのため、例えば生
体心臓の冠状動脈の狭窄された部分にPTCA(経皮的冠状
動脈再建術)カテーテルと称されるカテーテルを挿入す
ることがある。即ち、冠状動脈の狭窄に伴う病変の処理
として、血栓溶解剤等による処置の他に、PTCAカテーテ
ルによって機械的に狭窄部を除去する方法がある。
こうしたカテーテルは一般に、先端部にゴム製バルー
ンを有し、狭窄部に挿入後にそのバルーンを膨らませ、
このバルーンの膨張により、狭窄部分を押圧拡張した
後、カテーテルを抜去する外科的手術が行われている。
この方法の手術は比較的容易であるが、効果に永続性が
なく、時間の経過に伴って組織が元に戻って再び狭窄を
生じ易い欠点がある。
この欠点を改善する方法として、血管内に形状記憶合
金製筒状体を埋め込む(但し、この埋込まれた筒状体
は、その後に生体組織で被覆される)装置が提案されて
いる。例えば、米国特許第3,868,956号及び特公昭61-66
55号がある。このうち前者は、予め拡張された状態を記
憶させ、径を細くした形状記憶合金製筒状体をカテーテ
ルを介して挿入し、電気的方法により加熱し、原形状に
復帰させ、血管を拡張するものである。また、後者は、
形状記憶合金板を正常な血管内径に円筒状に成形記憶さ
せたものを細径に加工し、カテーテルを介して血管所望
位置に挿入後、レーザ光線或いは高周波誘導加熱の手法
により加熱し、原形状に復帰させるものである。
しかしながら、前者の装置では、形状記憶合金筒状体
を別の発熱体によって、又は形状記憶合金の電気抵抗を
利用してそれ自体を電気的方法により加熱するため、漏
電の恐れがあり、電気ショックを生ずる危険があり、ま
た装置も複雑となる。更に後者では、前者の電気加熱方
法に代えて用いられるレーザ光線或いは高周波誘導加熱
の装置は開示されてはいないが、複雑で高価なものとな
る。
ハ.発明の背景 そこで、本出願人は、前記方法によらず、操作が容易
であり施術が非常に安全な狭窄部分の拡張方法を実現で
きるカテーテルを特願昭62-97437号として既に提案し
た。このカテーテルは、先端部に、生体外からの操作に
より血液及び/又は体液の流動を任意に阻止する機能を
備えた阻止部(例えばバルーン)と、前記阻止部の後者
でカテーテルに外嵌されて転移温度以上で予め記憶させ
た形状に復元する形状記憶合金製筒状体と、前記形状記
憶合金製筒状体部分でカテーテル外周部に加温液を供給
する供給手段とを有することを特徴とするものである。
即ち、予め所望の原形状を記憶させ、細径に加工した形
状記憶合金筒状体を、加温された液体により加熱し、原
形状に復帰させるものである。
ところが、上記先願に係るカテーテルについて本発明
者が更に検討した結果、上記の優れた効果を奏するもの
の、なお改善すべき点があることを見出した。即ち、上
記先願に係るカテーテルでは、加温液がカテーテル中の
細いルーメンを通して注入することを例示しているが、
そうした細いルーメンからは加温液の急速な注入は困難
となることがある。従って、加温液として比較的高温の
温水を用いて熱エネルギーを大きくしておく必要があ
る。しかも、加温液用のルーメンを設けるために、カテ
ーテル自体の太さ(径)も比較的大きくする必要があ
り、冠状動脈の如き細い血管においては操作性が悪くな
ることがある。
ニ.発明の目的 本発明の目的は、狭窄部等の処理(特に拡張)を十分
に行え、その再狭窄等を防止できる上に、加温液等の液
体の急速な注入が可能であり、かつカテーテル自体を細
くしてその操作性も向上させたカテーテルを提供するこ
とにある。
ホ.発明の構成 即ち、本発明は、カテーテル本体と、このカテーテル
本体に設けられた形状記憶合金部材と、前記カテーテル
本体に被せられたシース部とを有し、前記形状記憶合金
部材を変形させるための液体が前記カテーテル本体と前
記シース部との間を通して供給されるように構成したカ
テーテルに係るものである。
ヘ.実施例 以下、本発明の実施例を説明する。
第1図〜第4図には、本発明のカテーテルの一例を示す
ものである。
この例によるPTCAカテーテル1は、ポリエチレン、塩
化ビニル、シリコーンゴムやポリウレタンエラストマー
等からなるカテーテル本体2を有し、この本体の先端部
には弾性ゴム製のバルーン3が設けられ、このバルーン
に生理食塩水4を送る(或いは排出する)ためのルーメ
ン5が本体の長さ方向に沿って埋設して形成されてい
る。また、本体2の中心部には、ガイドワイヤ6を通す
ためのルーメン7が後端から先端にまで貫通して形成さ
れている。更に、バルーン3の少し後方位置には、例え
ばNi-Ti合金からなる形状記憶合金コイル8が取付けら
れている。そして、このカテーテルは、バルーン3の部
分を除いて、例えばポリウレタンエラストマーからなる
シース9によって本体2のほぼ全体が覆われていて、シ
ース9の後端側には加温液10を注入する導入口11が分岐
して設けられている。
上記において、コイル8はその合金の転移温度(A
変態点)以上の温度で、予め記憶させた形状に復元、即
ち拡張する性質がある。こうした形状記憶合金として
は、生体に挿入されるために、転移温度が体温より3℃
程度若しくはそれ以上高いもの(特に38℃〜48℃のも
の)がよく、このような転移温度は形状記憶合金の合金
組成を適切に選ぶことにより得られる。また、シース9
の導入口11からは、カテーテル本体2とシース9の内面
との間を通して加温液10がコイル8へと供給されるが、
そうした加温液としては、輸液、生理食塩水などを用い
ることができ、また液の温度としては、挿入部で血液や
体液と混合して温度が低下することを考慮し、かつ火傷
を生じない程度の温度が選ばれる。
なお、上記コイル8は、予め加熱後に所望拡張径とな
るように形状記憶したものを細径のコイル状に巻き直
し、カテーテル外周に装着したものであるが、そのコイ
ル体がカテーテル管壁に沿って滑動しないように、カテ
ーテルのその部分2aの外径を小さくしている。勿論、こ
の部分の外形を小さくする代わりに、コイルにシリコン
ゴム等で作られた環状のストッパーを取り付けてもよ
い。
上記のように構成されたカテーテル1は、第6図に示
すように、例えば大腿動脈15から生体心臓12の冠状動脈
13に対し、バルーン3側から差し込まれる(但し、図面
は理解容易のために挿入状態を概略図示したにすぎな
い)。この際、カテーテル本体2はシース9によって所
定部位まで案内されるが、この案内は上記のガイドワイ
ヤ6によって良好になされる。また、この案内のモニタ
は、カテーテル及び合金ワイヤ8をX線撮影装置で観察
して行える。
そして、第5図(A)のように血管13の狭窄部14の位
置までカテーテルを挿入した後、第5図(B)のよう
に、生理食塩水等4の送入によってバルーン3を膨らま
せて血管内壁に密着させ、血液又は体液の流動を一時停
止させる。この際、前以って第5図(A)のように、コ
イル8はシース9から露出するように、カテーテル本体
2をガイドワイヤ6により前方へ移動させる。次いで、
第5図(C)のように、シース9の導入口11から生理食
塩水10を例えば50℃の恒温に調節して送液する。加熱さ
れた生理食塩水10は、第4図に明示するように導入口11
からシース9内(カテーテル本体外周)を通ってコイル
8側へ導出される。導出された生理食塩水は当初血液等
と混合して温度は低下するが、次第に温度上昇し、コイ
ル8を転移点以上に加熱し、原形状の拡張された形状
(第5図(C)の実線、第4図では仮想線で示す。)に
変化させる。次に、バルーン3の生理食塩水を抜き、バ
ルーン3を収縮させ、第5図(D)のようにカテーテル
を抜去する。こうして、狭窄された部分14を拡張した状
態でコイル8を血管内に留置し、治療の目的を達成する
ことができる。
このように、本実施例のカテーテル1によれば、血管
の狭窄部を拡張し、その再狭窄を確実に防止できると共
に、コイルの変形のための加温液をカテーテル本体内部
を通してではなく、その外周囲でシース内を通して供給
しているために、十分大きな通路を確保でき、より低温
の温液の使用が可能となる。従って、操作が安全とな
り、その急速な注入が可能であり、かつカテーテル本体
自体は細くできる(温液用のルーメンが不要である)の
で、冠状動脈の如き細い血管への挿入が容易となる。ま
た、シースの使用によりカテーテルの挿入も容易とな
り、その挿入操作を確実に行える。
なお、形状記憶合金コイル8の加熱も、従来の加熱方
法と異なり、加温された生理食塩水又は輸液などを用
い、温度も十分コントロールされた状態で送液できるの
で、非常に安全な手術を行うことができる。更に、所定
温度の加熱用液を調整することは容易であり、コスト的
にも極めて有利である。
本カテーテルは、大腿動脈その他の部分から経皮的に
挿入でき、閉塞性動脈硬化症の治療等に特に有効であ
る。
以上、本発明を例示したが、上述の例は本発明の技術
的思想に基づいて更に変形可能である。
例えば、上述の形状記憶合金の組成や材質、更には形
状等は種々変更してよい。材質については、上述の例の
如く原形状へ転移後は元へは戻らぬもの(不可逆転移)
がよいが、その転移形状は上述のコイル状以外にも例え
ばらせん状の網状体であってよく、種々選択できる。ま
た、使用目的によっては転移が可逆的なものであっても
よい(冷却すると縮小する)。また、形状記憶合金の取
付け位置やそのパターンも上述のものに限定されること
はない。なお、本発明のカテーテルは、上述した血管の
狭窄部だけでなく、血管が薄くなって破れそうになって
いる部位に挿入してもよく、その他の部位に挿入しても
よい。
ト.発明の作用効果 本発明は上述した如く、カテーテル本体に設けた形状
記憶合金部材を変形させるようにしているので、この変
形した形状記憶合金部材を血管の狭窄部等に留置するこ
とによってその部位の拡張等の処置を十分に行え、かつ
その再狭窄等を確実に防止できる。
しかも、カテーテル本体にシース部を被せているため
にカテーテルの案内が容易になる上に、シースとカテー
テル本体との間を通して形状記憶合金部材の変形のため
の液体を供給していることから、その急速な注入が可能
であり、かつカテーテル本体自体は細くでき、冠状動脈
の如き細い血管への挿入が容易となる。
【図面の簡単な説明】
図面は本発明の実施例を示すものであって、 第1図はカテーテルの斜視図、 第2図はカテーテル本体の断面図、 第3図はシースの斜視図、 第4図は形状記憶合金コイルの転移状況を示すカテーテ
ルの断面図、 第5図(A)、第5図(B)、第5図(C)、第5図
(D)はカテーテルを血管内に挿入して狭窄部を処置す
る操作を順次示す各要部拡大断面図、 第6図はカテーテル挿入時の概略図 である。 なお、図面に示す符号において、 1……カテーテル 2……カテーテル本体 3……バルーン 4……生理食塩水 6……ガイドワイヤ 8……形状記憶合金コイル 9……シース 10……加温液 13……冠状動脈(血管) 14……狭窄部 である。

Claims (1)

    【特許請求の範囲】
  1. 【請求項1】カテーテル本体と、このカテーテル本体に
    設けられた形状記憶合金部材と、前記カテーテル本体に
    被せられたシース部とを有し、前記形状記憶合金部材を
    変形させるための液体が前記カテーテル本体と前記シー
    ス部との間を通して供給されるように構成したカテーテ
    ル。
JP62173643A 1987-07-10 1987-07-10 カテ−テル Expired - Fee Related JPH088933B2 (ja)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP62173643A JPH088933B2 (ja) 1987-07-10 1987-07-10 カテ−テル
DE3823060A DE3823060A1 (de) 1987-07-10 1988-07-07 Katheter
US07/217,483 US4969890A (en) 1987-07-10 1988-07-07 Catheter
FR8809357A FR2617721B1 (fr) 1987-07-10 1988-07-08 Catheter

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP62173643A JPH088933B2 (ja) 1987-07-10 1987-07-10 カテ−テル

Publications (2)

Publication Number Publication Date
JPS6417658A JPS6417658A (en) 1989-01-20
JPH088933B2 true JPH088933B2 (ja) 1996-01-31

Family

ID=15964415

Family Applications (1)

Application Number Title Priority Date Filing Date
JP62173643A Expired - Fee Related JPH088933B2 (ja) 1987-07-10 1987-07-10 カテ−テル

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FR2617721A1 (fr) 1989-01-13
DE3823060A1 (de) 1989-01-19
JPS6417658A (en) 1989-01-20
FR2617721B1 (fr) 1997-06-27
US4969890A (en) 1990-11-13

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