WO1988007390A1 - Instrument for securing inner diameter of inner cavity of tubular organ and catheter equipped with the instrument - Google Patents
Instrument for securing inner diameter of inner cavity of tubular organ and catheter equipped with the instrument Download PDFInfo
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- WO1988007390A1 WO1988007390A1 PCT/JP1988/000306 JP8800306W WO8807390A1 WO 1988007390 A1 WO1988007390 A1 WO 1988007390A1 JP 8800306 W JP8800306 W JP 8800306W WO 8807390 A1 WO8807390 A1 WO 8807390A1
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- instrument
- inner diameter
- securing
- tubular organ
- tubular
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- 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
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- 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
明 細 書
管状器官内腔の内径確保用器具およびこれを 備えた力テーテル
技 術 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'めの力 テーテルに関する 。
背 景 技 術
例えば冠動脈の狭笮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 ヤを網状に織った もの ( S u r g e. r y , 1 9 8 6 年、 9 9 卷 2 号、 第 1 9 9 — 2 0 5 頁) 、 ある いは一方向 性形状記憶合金製の も の ( 特公昭 6 1 — 6 6 5 5 ) 、 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 を血管径に 拡げる こ と ができ る 。 また、 一方向性形状記' (I合金製ステ ン 卜の場合は同 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 。 - こめよ 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 由に元の彤状に縮小させる 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 。
発 明 の 開 示
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 、 厠孔を設けたカテーテル先端に取着 させ、 この厠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 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実質的に.筒犾の成形体からなる 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妆体は体温又は体
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端.が開口 し 、 その先端 近傍の周面にこの開口部と 連通する少な く と も 1 個の厠孔 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 ユ 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 もなつ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 先端の厠孔穿設部の少な 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 - -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 。 また、 本明細書中において 、 "実質的に筒状の成形体 " と は通常の筒状体のほか、 横断
面渦卷き状の筒体、 コイ ル妆の筒体など種々の形態の筒状 体を含むものと して理解されるべき である 。
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 卜の厠面図であって 、 ( a ) は収縮時、 ( b ) は拡張 時の拔態を示し、 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 卜の操作に もちいられるカテーテルの厠面図、 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 5図のカテーテルに第 1 図のステン ト を装 着した状態を示す厠面図、 第 8図および第 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 。
発明を実施するための最良の形態
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 拔器官用ステン ト 1 0 を示すものであって 、 優平な二方向 性形状記憶合金線条体 (例えば N i 一 T i 系, C u — A J1 — N i 系, C u — Z n— A JT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 1 0 は体温又は体 温に近傍する温度 (例えば 3 5〜 3 7 で ) 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 1 5〜 2 0 eC ) 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 , 0 4譲 、 幅 l mmの N i 一 T i 系二方向性形状記憶合金 ( N i を約 5 1 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 mの内径の のが温度' 1 5 以下で内径約 1 . 4 顏 に収縮させる こ と ができ た。 このステン ト 1 0 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 ほぼ一致させる 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横断面渦卷 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 ィ プ状と なる よ う な も のであっ て も よ い。
上述のステン ト 1 0 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 1 2 が用い られる 。
このカテーテル 1 2 は両端が開口 したカテーテルチュ ーブ 1 4 ( 例えばェチレン—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 1 4 の後端に、 力テーテ ルチューブのルーメ ン と連通する よ う に して設けられたノ、 ブ部 1 6 (例えばポ リ カーボネー トからなる ) と からなつ ている。 カテーテルチューブ 1 4 の先端近傍の周面には多 数の側孔 1 8が穿設されて いて 、 カテーテルチューブ 1 4 内に導入されたステン ト冷却液がこの厠孔 1 8 を介 して放 射状に排出される よ う になっている 。 ハブ部 1 6 は第 6 図 に拡大して示すよ う に、 直線状筒状部 1 6 a と 、 この直線 状筒状部 1 6 aの中間から分岐部 1 6 b と からなっている 。 直線状筒状部 1 6 a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 2. 0 (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、 分歧部 1 6 b は冷却液等の導入に用いられる ものでポー ト 1 6 c を有す る 。
ステン ト 1 0 を管状器官の留置位置へ導入するに際 し、 まず、 ステン 卜 1 0 をカテーテルチューブ 1 4 の先端の厠 孔 1 8部分に揷入する 。 ついで例えば氷冷生理食塩水をポ ー ト 1 6 c から導入 し、 厠孔 1 8から排出させる こ と によ り ステン 卜 1 0 を 1 5 〜 2 0 でに冷却する と第 7 図に示す
よ う にステン ト 1 0 がそのま ま収縮 してカテーテルチュー ブ 1 4 の厠孔穿設部分 1 8 に密着する 。
次に厠孔 1 8 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 2 2 内に予め導入されて いる ガイ ドカテーテル 2 4 中をカイ ドワイ ヤ 2 6 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 1 0 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 1 0 が拡張 し、 管状 器官 2 2 内壁面に圧接 し、 保持される 。 したがっ て 、 カテ 一テルチューブ 1 4 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 つてステン ト 1 0 を管状器官 2 2 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 1 0 を回収する場合は、 カテーテルチュ ーブ 1 4 の先端の厠孔 1 8部分をステン ト 1 0 内に揷入 し、 氷冷生理食塩水をポー 卜 1 6 c から導入 し、 厠孔 1 8から 排出させる こ と によ り 、 ステン ト 1 0 を収縮させ第 7 図に 示す如く 厠孔 1 8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 卜 1 0 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 1 4 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 。
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 に穿設した厠孔を介してステン 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 。
産業上の利用可能性
本発明の内径確保用器具およびこれを備えた力テーテ ルはヒ ト又は動物の血管等の管状器官に揷入し、 その器官 の内径を一定の大き さ に維持拡張させ、 少なく と も一定期 間、 その状態に維持させる場合に利用される 。
Claims
( 1 ) 温度変化に と もなつ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) . 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 実質的に坻ぃ温度で径方向に収縮する ものである請求の範囲第 1 項記載の管状器官内腔の内径確 保用器具。
(3) 該筒状休がコイ ル状の ものである請求の範囲第 1 項 記載の管状器官內腔の内腔確保用器具。
(4) 該筒状体が断面渦卷状の筒体であ る請求の範囲第 1 項記載の管状器官内腔の内径確保用器具。
(5) 該筒状体がパイ プ状のものである請求の範囲第 1 項 記載の管状器官内腔の内径確保用器具。
(6) 該筒状体が網目状の ものである請求の範囲第 1 項記 載の管状器官内腔の内径確保用器具。
(7) 二方向性形状記憶合金が N i — T i 系、 C u — A ϋ — N i 系および C u — Z n— A J! 系合金から選ばれる もの である請求の範囲第 1 項記載の管状器官内腔め内径確保用 器具。
(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 個の厠孔を穿設 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 の実質的に筒状の成形体からなり 、 上記カテーテルチュー ブの厠孔穿設部の少な 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 を特徴と する管状ステン ト を備えたカテーテル。
( 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請求の範囲第 8項記載のカテーテル。
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
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 |
DE3852892T DE3852892T2 (de) | 1987-03-25 | 1988-03-25 | Instrument zum aufrechterhalten des innendurchmessers eines tubusförmigen organs sowie katheter mit diesem instrument. |
KR1019880701459A KR910002422B1 (ko) | 1987-03-25 | 1988-03-25 | 관상기관 내강의 내경확보용 기구 및 이것을 구비한 카테테르 |
Applications Claiming Priority (2)
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 |
JP62/70781 | 1987-03-25 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1988007390A1 true WO1988007390A1 (en) | 1988-10-06 |
Family
ID=13441408
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
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 |
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) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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AU618964B2 (en) * | 1987-08-13 | 1992-01-16 | Terumo Kabushiki Kaisha | Catheter |
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1988
- 1988-03-25 WO PCT/JP1988/000306 patent/WO1988007390A1/ja active IP Right Grant
- 1988-03-25 EP EP88902924A patent/EP0411118B1/en not_active Expired - Lifetime
- 1988-03-25 DE DE3852892T patent/DE3852892T2/de not_active Expired - Lifetime
- 1988-03-25 KR KR1019880701459A patent/KR910002422B1/ko not_active IP Right Cessation
- 1988-03-25 AU AU14904/88A patent/AU613027B2/en not_active Ceased
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1990
- 1990-10-30 US US07/607,767 patent/US5037427A/en not_active Expired - Lifetime
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AU618964B2 (en) * | 1987-08-13 | 1992-01-16 | Terumo Kabushiki Kaisha | Catheter |
Also Published As
Publication number | Publication date |
---|---|
EP0411118A4 (en) | 1991-05-29 |
US5037427A (en) | 1991-08-06 |
DE3852892T2 (de) | 1995-05-18 |
KR910002422B1 (ko) | 1991-04-22 |
JPH0351430B2 (ja) | 1991-08-06 |
KR890700373A (ko) | 1989-04-24 |
JPS63238872A (ja) | 1988-10-04 |
AU1490488A (en) | 1988-11-02 |
DE3852892D1 (de) | 1995-03-09 |
EP0411118A1 (en) | 1991-02-06 |
AU613027B2 (en) | 1991-07-25 |
EP0411118B1 (en) | 1995-01-25 |
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