JPH0644910B2 - 血管内ステント - Google Patents
血管内ステントInfo
- Publication number
- JPH0644910B2 JPH0644910B2 JP63037323A JP3732388A JPH0644910B2 JP H0644910 B2 JPH0644910 B2 JP H0644910B2 JP 63037323 A JP63037323 A JP 63037323A JP 3732388 A JP3732388 A JP 3732388A JP H0644910 B2 JPH0644910 B2 JP H0644910B2
- Authority
- JP
- Japan
- Prior art keywords
- stent
- wire
- balloon catheter
- cylindrical shape
- loops
- 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
Links
Classifications
-
- 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
- A61F2/885—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 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
-
- 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
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
- B21F—WORKING OR PROCESSING OF METAL WIRE
- B21F45/00—Wire-working in the manufacture of other particular articles
- B21F45/008—Wire-working in the manufacture of other particular articles of medical instruments, e.g. stents or corneal rings
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Vascular Medicine (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Cardiology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Mechanical Engineering (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Materials For Medical Uses (AREA)
- Surgical Instruments (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Making Paper Articles (AREA)
- Auxiliary Devices For And Details Of Packaging Control (AREA)
- Prostheses (AREA)
Description
【発明の詳細な説明】 (産業上の利用分野) 本発明はステント、およステントの挿入方法に関する。
(従来の技術) 様々な状況において、収縮した血管を拡張するため、ま
たは血管内に開放通路を保つための装置を与えることが
望まれる。このような状況は、例えば冠状動脈の血管形
成術の後などに生ずる。これらの状況において、拡張さ
れた血管の再狭窄を防ぎ、または血管形成術に伴う内膜
裂断により生ずる「フラップ」による閉塞の危険を除く
ために、ワイヤーステント(wire stent)が有用である。
呼吸管および輸胆管のつぶれそうな組織を補強するのに
も使われることができる。
たは血管内に開放通路を保つための装置を与えることが
望まれる。このような状況は、例えば冠状動脈の血管形
成術の後などに生ずる。これらの状況において、拡張さ
れた血管の再狭窄を防ぎ、または血管形成術に伴う内膜
裂断により生ずる「フラップ」による閉塞の危険を除く
ために、ワイヤーステント(wire stent)が有用である。
呼吸管および輸胆管のつぶれそうな組織を補強するのに
も使われることができる。
従来のワイヤーステントの代表例は、米国特許第4,5805
68号明細書(又は特開昭61-87540号公報)のステントで
あり、それでは、ステントが弾性的に圧縮されて、さや
の中に納められる。さやを血管系の中に配置して、さや
を引き戻しながら、扁平端のプシャーによってステント
を所定位置に保持する。この特定のステントのジグザグ
形態は通路の中で弾性的に膨張して通路を開放、拡張し
たままにする。
68号明細書(又は特開昭61-87540号公報)のステントで
あり、それでは、ステントが弾性的に圧縮されて、さや
の中に納められる。さやを血管系の中に配置して、さや
を引き戻しながら、扁平端のプシャーによってステント
を所定位置に保持する。この特定のステントのジグザグ
形態は通路の中で弾性的に膨張して通路を開放、拡張し
たままにする。
様々な形状のウズ巻バネから成るステントが、米国特許
第4,553,545号明細書および放射線医学(Radiology)19
84年9月号、152:659−663「透光的に挿入
される血管内補綴の法射線医学的追跡治療:拡張式螺旋
を用いる実験的研究(Radiology Follow-up of Trans-lu
minally Inserted Vascular Endoprosth-sis:An Experi
mental Study Using Expan-ding Spirals)」に、マース
(Maass)他によって記載されている。このウズ巻バネの
端にトルクをかけると、コイルの数が増し、その間に、
挿入のためにステント直径が減ずる。挿入が終った後
で、ウズ巻バネに反対向きのトルクをかけてステント直
径を増す。この型式のステントの使用には、ステントが
血管内に挿入された後でステントにトルクをかけるため
の複雑な同軸ケーブルが必要である。
第4,553,545号明細書および放射線医学(Radiology)19
84年9月号、152:659−663「透光的に挿入
される血管内補綴の法射線医学的追跡治療:拡張式螺旋
を用いる実験的研究(Radiology Follow-up of Trans-lu
minally Inserted Vascular Endoprosth-sis:An Experi
mental Study Using Expan-ding Spirals)」に、マース
(Maass)他によって記載されている。このウズ巻バネの
端にトルクをかけると、コイルの数が増し、その間に、
挿入のためにステント直径が減ずる。挿入が終った後
で、ウズ巻バネに反対向きのトルクをかけてステント直
径を増す。この型式のステントの使用には、ステントが
血管内に挿入された後でステントにトルクをかけるため
の複雑な同軸ケーブルが必要である。
ドッター(Dotter)他はカテーテルを通して通路に送りこ
まれる熱記憶合金から成る補綴の使用を報告した。放射
線医学1983年4月号147:259−260「透光
性拡張式ニティノール・コイルステント接合:予備報告
(Transluminal Expandable Nitinol Coil Stent Grafti
ng:Preliminary Report)」ドッター他を参照のこと。こ
のコイルステントは冷却により収縮され、挿入され、ス
テントが通路内で膨張するまでそのまま加熱される。こ
のステントは熱コイルを加熱するための電気エネルギー
を供給し得る取外し自在の位置決め装置によって血管内
に配置される。
まれる熱記憶合金から成る補綴の使用を報告した。放射
線医学1983年4月号147:259−260「透光
性拡張式ニティノール・コイルステント接合:予備報告
(Transluminal Expandable Nitinol Coil Stent Grafti
ng:Preliminary Report)」ドッター他を参照のこと。こ
のコイルステントは冷却により収縮され、挿入され、ス
テントが通路内で膨張するまでそのまま加熱される。こ
のステントは熱コイルを加熱するための電気エネルギー
を供給し得る取外し自在の位置決め装置によって血管内
に配置される。
本発明に関係のありそうな他の文献には次の米細特許第
3,278,176号明細書;同第3,868,956号明細書;同第4,42
5,908号明細書;および同第4,214,587号明細書がある。
3,278,176号明細書;同第3,868,956号明細書;同第4,42
5,908号明細書;および同第4,214,587号明細書がある。
(発明が解決しようとする課題) 従来のワイヤーステントおよび拡張式コイルステントの
欠点は、これらのステントが製作困難であるか、身体の
通路内に挿入する複雑過ぎるか、である。これらのステ
ントの各々はステントを血管内に挿入して拡張させるた
めに複雑な装置の使用を要する。他方、より複雑でない
ワイヤーステントは、著しい曲線や屈曲を有するカテー
テルの中に通すための軸方向の順応性を欠いている。
欠点は、これらのステントが製作困難であるか、身体の
通路内に挿入する複雑過ぎるか、である。これらのステ
ントの各々はステントを血管内に挿入して拡張させるた
めに複雑な装置の使用を要する。他方、より複雑でない
ワイヤーステントは、著しい曲線や屈曲を有するカテー
テルの中に通すための軸方向の順応性を欠いている。
(課題を解決するための手段) 本発明は、製作が容易で、装着が簡単で、血管または通
路の曲線およ屈曲をめぐって送り込むことのできるワイ
ヤーステントを与えることにより、これらの問題の各々
に対処する。一連の直線部分と複数の屈曲部を含むヘビ
状形態に形成されたワイヤーをステントが含む。直線部
分は屈曲部によって結合されて一連のたがいちがいのル
ープ(輪)を形成する。ヘビ状形態は縦軸線を有する円
筒形に成形され、直線部分は縦軸線を取囲みそれにほぼ
垂直な円形形態に曲げられる。円形形態、従って円筒形
状を拡張するための、バルーン・カテーテルを含む装置
が与えられる。バルーン・カテーテルはたたまれて円筒
形状の中に受承され、円筒形状の軸線にそって延在す
る。バルーン(風船)をふくらませるにつれて隣接する
ループが相互に対して円周方向に非弾性(塑性)的に変
形して拡がるように、直線部分がバルーン・カテーテル
を巻くように成形される。
路の曲線およ屈曲をめぐって送り込むことのできるワイ
ヤーステントを与えることにより、これらの問題の各々
に対処する。一連の直線部分と複数の屈曲部を含むヘビ
状形態に形成されたワイヤーをステントが含む。直線部
分は屈曲部によって結合されて一連のたがいちがいのル
ープ(輪)を形成する。ヘビ状形態は縦軸線を有する円
筒形に成形され、直線部分は縦軸線を取囲みそれにほぼ
垂直な円形形態に曲げられる。円形形態、従って円筒形
状を拡張するための、バルーン・カテーテルを含む装置
が与えられる。バルーン・カテーテルはたたまれて円筒
形状の中に受承され、円筒形状の軸線にそって延在す
る。バルーン(風船)をふくらませるにつれて隣接する
ループが相互に対して円周方向に非弾性(塑性)的に変
形して拡がるように、直線部分がバルーン・カテーテル
を巻くように成形される。
本発明の原理の理解を進める目的で、以下に添付図面の
実施例を参照し、該実施例を記載するのに特定の言語を
使用する。しかし、そのために本発明の範囲を制限する
ことは意図されず、本発明が関連する当業者が通常思い
つくような変更、図解される装置の他の変形、そして図
解される本発明の原理の他の応用が考えられることが当
然である。
実施例を参照し、該実施例を記載するのに特定の言語を
使用する。しかし、そのために本発明の範囲を制限する
ことは意図されず、本発明が関連する当業者が通常思い
つくような変更、図解される装置の他の変形、そして図
解される本発明の原理の他の応用が考えられることが当
然である。
(実施例) 第1図を参照すると、図示のワイヤーステント10は縦
軸線26を有する。ステントは縦軸線26に対してほぼ
垂直の位置にある複数の曲線部分11を含む。隣合せの
曲線部分11は屈曲部、つまり尖頭13により結合され
る。ワイヤー端を遮蔽するために、ワイヤーステント1
0の各自由端にループ18が形成される。曲線部分11
は第2図の端面図に示すように円形形態に成形されるの
で、ステント10に円筒形開口部12が形成される。
軸線26を有する。ステントは縦軸線26に対してほぼ
垂直の位置にある複数の曲線部分11を含む。隣合せの
曲線部分11は屈曲部、つまり尖頭13により結合され
る。ワイヤー端を遮蔽するために、ワイヤーステント1
0の各自由端にループ18が形成される。曲線部分11
は第2図の端面図に示すように円形形態に成形されるの
で、ステント10に円筒形開口部12が形成される。
曲線部分11および尖頭13は一連のたがいちがいの時
計回り向きのループ15および反時計回り向きのループ
16を形成する。軸線26に対する時計回り方向は恣意
的に選ばれて、第1図に太い矢印で示されている。ステ
ント10の収縮状態では、これらのループ15,16は
第3図に示す重なり領域20によって明らかにされるよ
うに、縦方向に重なっている。よってこの重なり領域2
0は端から見た時にステントが連続の円形リングである
かのような外見を与えるが、第1図および第3図のよう
に見た時には、ステント10の円形形状は不連続である
ことが明らかである。この特性の意義は第3図と第4図
を比較して説明される。
計回り向きのループ15および反時計回り向きのループ
16を形成する。軸線26に対する時計回り方向は恣意
的に選ばれて、第1図に太い矢印で示されている。ステ
ント10の収縮状態では、これらのループ15,16は
第3図に示す重なり領域20によって明らかにされるよ
うに、縦方向に重なっている。よってこの重なり領域2
0は端から見た時にステントが連続の円形リングである
かのような外見を与えるが、第1図および第3図のよう
に見た時には、ステント10の円形形状は不連続である
ことが明らかである。この特性の意義は第3図と第4図
を比較して説明される。
第3図において、図示のステント10はカテーテル22
の回りに取付けられ、カテーテルにはカテーテルの供給
イリフィス22aを取巻いて膨張自在のバルーン23が
固着される。この実施例に用いられるバルーンは、第3
図に示すようにバルーン23のフラップ23aがカテー
テル22の上にたたまれている折りたたもバルーンであ
る。たたまれたフラップ23aはバルーン材を過度に引
き伸ばすことなく、またバルーンを破裂させる恐れもな
しに、バルーン23を特定直径まで膨張させる。
の回りに取付けられ、カテーテルにはカテーテルの供給
イリフィス22aを取巻いて膨張自在のバルーン23が
固着される。この実施例に用いられるバルーンは、第3
図に示すようにバルーン23のフラップ23aがカテー
テル22の上にたたまれている折りたたもバルーンであ
る。たたまれたフラップ23aはバルーン材を過度に引
き伸ばすことなく、またバルーンを破裂させる恐れもな
しに、バルーン23を特定直径まで膨張させる。
ステントはカテーテル22とバルーン23の回りに圧縮
されているので、身体の特定通路に挿入し得るように決
められた収縮時の直径をとる。時計回りループ15およ
び反時計回りループ16は領域20にて重なっており、
ワイヤーのバネこわさが挿入中にステントをこの位置に
保つ。組立体が身体の通路の曲線部および屈曲部をめぐ
って送られている時でも、ステント10はカテーテル2
2に密着したままである。
されているので、身体の特定通路に挿入し得るように決
められた収縮時の直径をとる。時計回りループ15およ
び反時計回りループ16は領域20にて重なっており、
ワイヤーのバネこわさが挿入中にステントをこの位置に
保つ。組立体が身体の通路の曲線部および屈曲部をめぐ
って送られている時でも、ステント10はカテーテル2
2に密着したままである。
カテーテルおよびステントが充分に通路内に挿入された
後、ステント10を押して通路内面に接触させ、また少
くとも場合によっては、通路を拡張するように決められ
た直径25までバルーン23が膨らませられる。バルー
ンが膨らむにつれて、時計回りループ15および反時計
回りループ16は円周方向に非弾性(塑性)的に変形し
て拡がり、最終的に、ループ間の軸方向の重なりは第4
図に示す領域21にまで減ずる。よって、縦軸線に対す
るステント10の有効直径は、従来技術の提案する熱膨
張またはステントにねじり力をかけることなく、増大す
る。
後、ステント10を押して通路内面に接触させ、また少
くとも場合によっては、通路を拡張するように決められ
た直径25までバルーン23が膨らませられる。バルー
ンが膨らむにつれて、時計回りループ15および反時計
回りループ16は円周方向に非弾性(塑性)的に変形し
て拡がり、最終的に、ループ間の軸方向の重なりは第4
図に示す領域21にまで減ずる。よって、縦軸線に対す
るステント10の有効直径は、従来技術の提案する熱膨
張またはステントにねじり力をかけることなく、増大す
る。
本発明の最良の態様において、ステント10を構成する
ワイヤーは、望ましくは焼なましステンレス鋼、タング
ステンおよプラチナを含む属からのマリアブル(可簇)
材で作られる。標準型バルーン・カテーテルを構成する
薄膜の膨張によってかけられる半径方向外方の圧力によ
りループ15,16を拡げさせるのに充分な塑性変形性
をこのマリアブル材が有する。ステント材は弾性ではな
く可塑性を有するから、バルーン23が収縮してカテー
テル22を取外した後でも、ステントは拡張直径を保
つ。しかし、挿入中にステントがバルーン上で移動しな
いように、またループ15,16が押されて重なり合う
位置に入らないように充分な強度とこわさをこの材料が
有する。さらに、カテーテル22が除かれてバルーンが
もうステントを安定させていない後でも、ステントが通
路内の所定位置を保って移動に抵抗するのに充分な強度
およびこわさを有する。適切なワイヤーの一例は0.0
018in(46μm)の外径を有し、ステンレス鋼AI
SI316合金である。
ワイヤーは、望ましくは焼なましステンレス鋼、タング
ステンおよプラチナを含む属からのマリアブル(可簇)
材で作られる。標準型バルーン・カテーテルを構成する
薄膜の膨張によってかけられる半径方向外方の圧力によ
りループ15,16を拡げさせるのに充分な塑性変形性
をこのマリアブル材が有する。ステント材は弾性ではな
く可塑性を有するから、バルーン23が収縮してカテー
テル22を取外した後でも、ステントは拡張直径を保
つ。しかし、挿入中にステントがバルーン上で移動しな
いように、またループ15,16が押されて重なり合う
位置に入らないように充分な強度とこわさをこの材料が
有する。さらに、カテーテル22が除かれてバルーンが
もうステントを安定させていない後でも、ステントが通
路内の所定位置を保って移動に抵抗するのに充分な強度
およびこわさを有する。適切なワイヤーの一例は0.0
018in(46μm)の外径を有し、ステンレス鋼AI
SI316合金である。
収縮状態の重なり領域20は充分大きくて、ステントと
バルーンの接触面積は大きく、組立体を挿入している間
にステントが移動しないように付加的な予防を与える。
膨張状態において、重なり領域21は、ステントを挿入
する通路に連続の円周方向の支持を与えるのに充分な大
きさを有するべきである。本発明の一例において、重な
り領域20はほとんど円周方向に360゜まで延在する。
判り易くするために、図示の実施例では重なり20がか
なり小さく示されている。
バルーンの接触面積は大きく、組立体を挿入している間
にステントが移動しないように付加的な予防を与える。
膨張状態において、重なり領域21は、ステントを挿入
する通路に連続の円周方向の支持を与えるのに充分な大
きさを有するべきである。本発明の一例において、重な
り領域20はほとんど円周方向に360゜まで延在する。
判り易くするために、図示の実施例では重なり20がか
なり小さく示されている。
望ましい実施例は一重コイルの施線部分に分割されるこ
とができると見なされる。第5図は縦軸線50を有する
ワイヤーステント29の分解図である。右手の法則によ
る時計回り方向が軸線50の回りの太い矢印48によっ
て示される。ステント49は一連のたがいちがいの、一
重コイルの時計回り施線部分51と一重コイルの反時計
回り施線部分52を含む。施線部分51,52はそれぞ
れ、前端51a,52aおよ後端51b,52bを有す
る。隣り合せの施線部分は尖頭部分53により結合さ
れ、施線部分の前端は次の施線部分の後端に連結され
る。よって、時計回り施線部分51の端51aは反時計
回り施線部分52の端52bに連結され、他方、後の端
52aは前者の端51bに連結される。
とができると見なされる。第5図は縦軸線50を有する
ワイヤーステント29の分解図である。右手の法則によ
る時計回り方向が軸線50の回りの太い矢印48によっ
て示される。ステント49は一連のたがいちがいの、一
重コイルの時計回り施線部分51と一重コイルの反時計
回り施線部分52を含む。施線部分51,52はそれぞ
れ、前端51a,52aおよ後端51b,52bを有す
る。隣り合せの施線部分は尖頭部分53により結合さ
れ、施線部分の前端は次の施線部分の後端に連結され
る。よって、時計回り施線部分51の端51aは反時計
回り施線部分52の端52bに連結され、他方、後の端
52aは前者の端51bに連結される。
本発明のステントの使用方法において、ステントとバル
ーン・カテーテルの組立体80は第6図に示すように、
患者の身体70の中の動脈のような通路72に挿入され
る。組立体80は通路72の曲線部76をめぐって操作
される時に、収縮形態にある。カテーテル82の可撓性
は組立体80が曲線部76に追従するようにし、他方、
ステント84の強度とこわさは挿入中にカテーテルのバ
ルーン86にステント84をぴったり係合させたままに
する。通路は通路のもう一つの屈曲部に閉塞を有する。
ーン・カテーテルの組立体80は第6図に示すように、
患者の身体70の中の動脈のような通路72に挿入され
る。組立体80は通路72の曲線部76をめぐって操作
される時に、収縮形態にある。カテーテル82の可撓性
は組立体80が曲線部76に追従するようにし、他方、
ステント84の強度とこわさは挿入中にカテーテルのバ
ルーン86にステント84をぴったり係合させたままに
する。通路は通路のもう一つの屈曲部に閉塞を有する。
第7図において、ステントとバルーン・カテーテルの組
立体80は通路72に充分に挿入されて、ステント84
とバルーン86は閉塞74の直ぐ近くに配置されて通路
の曲線に追従している。第8図では、この組立体が拡張
形態80′で示され、ここではバルーン86′がふくらまさ
れて、ワイヤーステント84′が塑性的に拡張されて通路
に接触し、それを拡げている。判り易くするために、第
8図ではその拡張を誇張してある。組立体は閉塞74
(第7図)を除いて通路を開放するのに充分な量だけ拡
張される。つぎにバルーンをしぼませてカテーテルを抜
き、ステントが通路を開いて保持するままに放置する。
立体80は通路72に充分に挿入されて、ステント84
とバルーン86は閉塞74の直ぐ近くに配置されて通路
の曲線に追従している。第8図では、この組立体が拡張
形態80′で示され、ここではバルーン86′がふくらまさ
れて、ワイヤーステント84′が塑性的に拡張されて通路
に接触し、それを拡げている。判り易くするために、第
8図ではその拡張を誇張してある。組立体は閉塞74
(第7図)を除いて通路を開放するのに充分な量だけ拡
張される。つぎにバルーンをしぼませてカテーテルを抜
き、ステントが通路を開いて保持するままに放置する。
ステントを製作する工程を説明する。第9図を参照し
て、ワイヤー30が扁平なヘビ状形状に曲げられる。こ
ろ形状は屈曲部、または尖頭部35により結合された一
連の直線部分33を含む。成形手順が始まると、直線部
分33は曲線部分11になり、尖頭部35は尖頭部13
になる。また、中心線31の両側のワイヤー部分30は
第9図に示すように時計回りループ15と反時計回りル
ープ16になる。自由端60は第1図のループ18のよ
うなループに成形されることができる。
て、ワイヤー30が扁平なヘビ状形状に曲げられる。こ
ろ形状は屈曲部、または尖頭部35により結合された一
連の直線部分33を含む。成形手順が始まると、直線部
分33は曲線部分11になり、尖頭部35は尖頭部13
になる。また、中心線31の両側のワイヤー部分30は
第9図に示すように時計回りループ15と反時計回りル
ープ16になる。自由端60は第1図のループ18のよ
うなループに成形されることができる。
成形ダイ39は中に直線みぞ42を形成された平板40
を含む。第10図の断面図では、このみぞが判円形表面
43を有することが判る。ワイヤー30は、その中心線
31がみぞ42の中心線に一致するように平板40の上
に平らに置かれる。
を含む。第10図の断面図では、このみぞが判円形表面
43を有することが判る。ワイヤー30は、その中心線
31がみぞ42の中心線に一致するように平板40の上
に平らに置かれる。
第11図および第12図に示すように、成形バー45を
用いて、ワイヤー30がみぞ42の中に押しこまれ、半
円形表面43に対して押しつけられる。成形バー45は
プラツ値ックのバンド46により保持される。ループ1
5,16の端はみぞ42から上方、つまり外外方に、平
板40の表面より上に突き出る。次の段階において、第
13図および第14図に示すように、引張り工具47を
用いてループ15,16を露出表面45a(第12図)
にかぶさるように引張る。引張り工具47の端にある鈎
47aはこの引張り段階中、ループ15,16の尖頭部
13に係合する。次に、成形バーを平板から持ち上げ
て、部分成形されたステントを平板40から取出す。バ
ー45を取外し、この時点で第15図に示す形態の部分
成形ステントが残される。
用いて、ワイヤー30がみぞ42の中に押しこまれ、半
円形表面43に対して押しつけられる。成形バー45は
プラツ値ックのバンド46により保持される。ループ1
5,16の端はみぞ42から上方、つまり外外方に、平
板40の表面より上に突き出る。次の段階において、第
13図および第14図に示すように、引張り工具47を
用いてループ15,16を露出表面45a(第12図)
にかぶさるように引張る。引張り工具47の端にある鈎
47aはこの引張り段階中、ループ15,16の尖頭部
13に係合する。次に、成形バーを平板から持ち上げ
て、部分成形されたステントを平板40から取出す。バ
ー45を取外し、この時点で第15図に示す形態の部分
成形ステントが残される。
第15図に示すように、ステント10の縦方向円筒形開
口部12を通してバルーン・カテーテル22が挿入さ
れ、第3図に示すように、ループ15,16の端がカテ
ーテルに接するように押し付けられる。前記のように、
ループ15,16が最終的な重なり位置にある時、その
重なり量はかなり大きいことが望ましい。本発明の一例
では、この重なり20(第3図)は約360゜である。使
用されるバルーン・カテーテルは、米国特許第4,637,39
6号明細書に示される設計、または、米国インディアナ
州ブルーミングトン(Bloomington)のクック(Cook Inc.)
からカタログ番号OMG4.0-4.5および5.3FRカテーテ
ルとして入手し得るような様々な設計のものであること
ができる。
口部12を通してバルーン・カテーテル22が挿入さ
れ、第3図に示すように、ループ15,16の端がカテ
ーテルに接するように押し付けられる。前記のように、
ループ15,16が最終的な重なり位置にある時、その
重なり量はかなり大きいことが望ましい。本発明の一例
では、この重なり20(第3図)は約360゜である。使
用されるバルーン・カテーテルは、米国特許第4,637,39
6号明細書に示される設計、または、米国インディアナ
州ブルーミングトン(Bloomington)のクック(Cook Inc.)
からカタログ番号OMG4.0-4.5および5.3FRカテーテ
ルとして入手し得るような様々な設計のものであること
ができる。
添付図面および前記記載に本発明を図解し、詳細に説明
したけれども、それらは説明的性格のものと考えるべき
であり、望ましい実施例を開示し記載したのみであるの
は明らかである。
したけれども、それらは説明的性格のものと考えるべき
であり、望ましい実施例を開示し記載したのみであるの
は明らかである。
第1図は本発明のワイヤーステントの斜視図、 第2図は第1図のワイヤーステントの端面図、 第3図はたたまれたバルーン・カテーテルの回りに係合
し、収縮状態で示される、第1図のワイヤーステントの
側面図、 第4図は第3図のワイヤーステントおよびバルーン・カ
テーテルの、拡張状態で示される側面図、 第5図は第1図のワイヤーステントの一部分の分割分解
図、 第6図はワイヤーステントおよびバルーン・カテーテル
が身体の通路の屈曲部に配置された、身体の通路の切断
図、 第7図はステントおよびバルーン・カテーテルが通路の
閉塞部に隣接する通路内にある、第6図に似た切断図、 第8図は、閉塞を除くために、バルーン・カテーテルが
ふくらまされてステントが通路に接している、第7図に
似た切断図、 第9図は扁平なヘビ状形態に成形されて成形ダイ上に置
かれたワイヤーを示す、一段階の視図、 第10図は第9図の成形ダイの、10−10線にそって
矢印の向きに見た断面図、 第11図は成形バーにより成形ダイのみぞの中に押しこ
まれたワイヤーの斜視図、 第12図は第11図の成形ダイおよび成形バーの、12
−12線にそって矢印の方向に見た断面図、 第13図は引張り工具により成形バーの露出部分に引き
かぶせられたヘビ状形態のループを示す、第11図に似
た斜視図、 第14図は第13図の成形ダイおよび成形ダイの、14
−14線にそって矢印の方向に見た断面図、 第15図は本発明の方法の一段階で形成されたほぼ円筒
状の開口部に挿入されたバルーン・カテーテルの斜視図
である。 10……ステント、13……尖頭 49……ステント、80……組立体 84……ステント
し、収縮状態で示される、第1図のワイヤーステントの
側面図、 第4図は第3図のワイヤーステントおよびバルーン・カ
テーテルの、拡張状態で示される側面図、 第5図は第1図のワイヤーステントの一部分の分割分解
図、 第6図はワイヤーステントおよびバルーン・カテーテル
が身体の通路の屈曲部に配置された、身体の通路の切断
図、 第7図はステントおよびバルーン・カテーテルが通路の
閉塞部に隣接する通路内にある、第6図に似た切断図、 第8図は、閉塞を除くために、バルーン・カテーテルが
ふくらまされてステントが通路に接している、第7図に
似た切断図、 第9図は扁平なヘビ状形態に成形されて成形ダイ上に置
かれたワイヤーを示す、一段階の視図、 第10図は第9図の成形ダイの、10−10線にそって
矢印の向きに見た断面図、 第11図は成形バーにより成形ダイのみぞの中に押しこ
まれたワイヤーの斜視図、 第12図は第11図の成形ダイおよび成形バーの、12
−12線にそって矢印の方向に見た断面図、 第13図は引張り工具により成形バーの露出部分に引き
かぶせられたヘビ状形態のループを示す、第11図に似
た斜視図、 第14図は第13図の成形ダイおよび成形ダイの、14
−14線にそって矢印の方向に見た断面図、 第15図は本発明の方法の一段階で形成されたほぼ円筒
状の開口部に挿入されたバルーン・カテーテルの斜視図
である。 10……ステント、13……尖頭 49……ステント、80……組立体 84……ステント
Claims (30)
- 【請求項1】一連の直線部分および複数の屈曲部を含む
ヘビ状形態に成形され、前記直線部分は前記屈曲部によ
り結合されて一連のたがいちがいのループを形成し、前
記ヘビ状形態は縦方向軸線を有する円筒形状に成形さ
れ、前記直線部分は前記軸線を取巻いて該軸線にほぼ垂
直なほぼ円形形態に曲げられている塑性変形可能なワイ
ヤーと、身体の通路内において前記円形形態を半径方向
に塑性変形させて拡張するため前記ワイヤーの前記円筒
形状の中に配置された拡張装置と、から成るステント。 - 【請求項2】前記ワイヤーはマリアブル(可鍛)材料か
ら作られている、請求項(1)記載のステント。 - 【請求項3】前記ワイヤーが、焼なましステンレス鋼、
タングステン及びプラチナから成る群から選択されたマ
リアブル材料で作られている、精求項(1)記載のステ
ント。 - 【請求項4】前記の半径方向に拡張するための拡張装置
はバルーン・カテーテルであり、該バルーン・カテーテ
ルは前記円筒形状内に受承されて前記軸線にそって延在
し、前記バルーン・カテーテルは膨張させられると前記
円形形態のワイヤーに接触して該円形形態を半径方向に
拡張する、請求項(1)記載のステント。 - 【請求項5】前記バルーン・カテーテルは折りたたまれ
たバルーン・カテーテルである、請求項(4)記載のス
テント。 - 【請求項6】前記たがいちがいのループが前記屈曲部に
隣接し縦方向に重なる部分を含むような収縮状態を、前
記円形形態有する、請求項(1)記載のステント。 - 【請求項7】隣り合せのループの前記縦方向に重なる部
分が前記収縮状態から円周方向に拡げられるような拡張
状態を、前記円形形態が有する請求項(6)記載のステ
ント。 - 【請求項8】前記の半径方向に拡張するための拡張装置
はバルーン・カテーテルであり、該バルーン・カテーテ
ルはたたまれて前記円筒形状内に受承され、前記軸線に
そって延在し、前記バルーン・カテーテルは膨張させら
れると前記円形形態のワイヤーの接触して該円形形態を
半径方向に拡張する、請求項(7)記載のステント。 - 【請求項9】前記拡張装置の拡張に応じて円周方向に拡
がるように配置された、縦方向に重なる部分を、前記た
がいちがいのループが前記屈曲部に隣接して有する、請
求項(1)記載のステント。 - 【請求項10】前記半径方向に拡張するための拡張装置
がバルーン・カテーテルであり、該バルーン・カテーテ
ルはたたまれて前記円筒形状内に受承され、前記軸線に
そって延在し、前記バルーン・カテーテルは膨張させら
れると前記円形形態のワイヤーに接触して該円形形態を
半径方向に拡張する、請求項(9)記載のステント。 - 【請求項11】前記ワイヤーは2つの反対側の端を有
し、該端がほぼ蔽されるように該端の各々に隣接するル
ープに前記ワイヤー成形された、請求項(1)記載のス
テント。 - 【請求項12】前記ワイヤーの外形は0.0018in
(46μm)である、請求項(1)記載のステント。 - 【請求項13】縦軸線を有し: a)各々が尖頭部を有する複数の縦方向に隔置されたワ
イヤーループであって、隣り合せの前記ループは一つの
ワイヤー部分を共有し該ループの各々は、該ループを円
周方向に移動させることにより円筒形状を拡張または収
縮し得るように、前記縦軸線の回りで不連続な円筒形状
に成形されている、塑性変形可能なワイヤーループ;お
よび、 b)収縮状態から拡張状態に前記円筒形状を塑性変形さ
せて拡張させるため該円筒形状の中に配置された拡張装
置であって、身体内の通路において前記ワイヤーループ
を円周方向に移動させることにより前記円筒形状を拡張
させる拡張装置;を含むステント。 - 【請求項14】隣り合せのループの前記尖頭部が反対向
きになるように前記ループが配置された、請求項(1
3)記載のステント。 - 【請求項15】前記ループは隣り合せのループの前記尖
頭部が反対向きになるように配置され; 前記隣り合せのループが相互に縦方向に重なるような第
1の重なり領域を有する前記円筒形状を、前記収縮状態
が含む; 請求項(13)記載のステント。 - 【請求項16】前記隣り合せのループが相互に縦方向に
重なる第2の重なり領域であって、前記第1の重なり領
域よりも小さい第2の重なり領域を有する前記円筒形状
を前記拡張状態が含む、請求項(15)記載のステン
ト。 - 【請求項17】前記縦軸線にそって延在して前記円筒形
状の中に受承されるバルーン・カテーテルを前記拡張装
置が含み、該バルーン・カテーテルは膨張させられると
前記円筒形状のワイヤーループに接触し、該ループを円
周方向に移動させる請求項(13)記載のステント。 - 【請求項18】前記拡張装置は折りたたみバルーン・カ
テーテルを含む、請求項(17)記載のステント。 - 【請求項19】前記ワイヤーループの各々がマリアブル
材料で作られている、請求項(13)記載のステント。 - 【請求項20】前記ワイヤーループの各々のワイヤー外
径が0.018in(46μm)である、請求項(1
3)記載のステント。 - 【請求項21】縦軸線を有し; a)前記縦軸線の回りに配置され、隣り合せのものが尖
頭部にて結合された、たがいちがいの、時計回りおよび
反時計回りの一重コイルの、塑性変形可能な螺施線部
分;および、 b)隣り合せの尖頭部が相互に対して円周方向に移動す
るように前記螺施線部分を収縮状態から拡張状態に身体
の通路内で塑性変形させて拡張させるために前記螺施線
部分内に配置された拡張装置; を含むワイヤーステント。 - 【請求項22】前記拡張装置は、前記縦軸線にそって延
在して前記螺施線部分の各々の中に受承された折りたた
みバルーン・カテーテルであって、該バルーン・カテー
テルは膨張させられると前記螺施線部分に接触して前記
隣り合う尖頭部を相互に対して円周方向に移動させる請
求項(21)記載のステント。 - 【請求項23】前記螺施線部分がマリアブル材料で作ら
れている、請求項(21)に記載のステント。 - 【請求項24】前記螺施線部分の各々のワイヤー外径が
0.0018in(46μm)である、請求項(21)
記載にステント。 - 【請求項25】前記拡張装置が、ステントを身体の通路
内に導入するための導入装置を含んでいる、請求項
(1)のステント。 - 【請求項26】前記拡張装置が、バルーン・カテーテル
を含み、該カテーテルが前記導入装置と拡張装置とを兼
ね備えている、請求項(25)のステント。 - 【請求項27】前記円筒形状を拡張する前記拡張装置
が、ステントを身体の通路内に導入する導入装置を含ん
でいる請求項(13)のステント。 - 【請求項28】前記拡張装置がバルーン・カテーテルで
あり、該カテーテルが前記導入装置と拡張装置とを兼ね
備えている請求項(27)のステント。 - 【請求項29】前記螺施線部分を拡張する前記拡張装置
が、ステントを身体の通路内に導入する導入装置を含ん
でいる請求項(21)のステント。 - 【請求項30】前記拡張装置がバルーン・カテーテルで
あり、該カテーテルが前記導入装置と拡張装置とを兼ね
備えている請求項(29)のステント。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US25736 | 1987-03-13 | ||
| US07/025,736 US4800882A (en) | 1987-03-13 | 1987-03-13 | Endovascular stent and delivery system |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS63230158A JPS63230158A (ja) | 1988-09-26 |
| JPH0644910B2 true JPH0644910B2 (ja) | 1994-06-15 |
Family
ID=21827789
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP63037323A Expired - Lifetime JPH0644910B2 (ja) | 1987-03-13 | 1988-02-19 | 血管内ステント |
Country Status (10)
| Country | Link |
|---|---|
| US (2) | US4800882A (ja) |
| EP (1) | EP0282175B1 (ja) |
| JP (1) | JPH0644910B2 (ja) |
| AT (1) | ATE69711T1 (ja) |
| AU (2) | AU593721B2 (ja) |
| CA (1) | CA1312519C (ja) |
| DE (1) | DE3866380D1 (ja) |
| DK (1) | DK168654B1 (ja) |
| ES (1) | ES2027003T3 (ja) |
| GR (1) | GR3003241T3 (ja) |
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| JP2008279283A (ja) * | 1998-01-26 | 2008-11-20 | Anson Medical Ltd | 強化移植片 |
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- 1988-02-16 ES ES198888301265T patent/ES2027003T3/es not_active Expired - Lifetime
- 1988-02-16 EP EP88301265A patent/EP0282175B1/en not_active Expired - Lifetime
- 1988-02-16 DE DE8888301265T patent/DE3866380D1/de not_active Expired - Lifetime
- 1988-02-16 AT AT88301265T patent/ATE69711T1/de not_active IP Right Cessation
- 1988-02-19 JP JP63037323A patent/JPH0644910B2/ja not_active Expired - Lifetime
- 1988-03-08 AU AU12782/88A patent/AU593721B2/en not_active Expired
- 1988-03-10 DK DK130888A patent/DK168654B1/da not_active IP Right Cessation
-
1991
- 1991-11-29 GR GR91401846T patent/GR3003241T3/el unknown
-
1992
- 1992-05-27 AU AU17205/92A patent/AU1720592A/en not_active Abandoned
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1993
- 1993-04-02 US US08/041,946 patent/US5314444A/en not_active Expired - Lifetime
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2008279283A (ja) * | 1998-01-26 | 2008-11-20 | Anson Medical Ltd | 強化移植片 |
Also Published As
| Publication number | Publication date |
|---|---|
| EP0282175B1 (en) | 1991-11-27 |
| AU593721B2 (en) | 1990-02-15 |
| AU1720592A (en) | 1992-08-06 |
| US4800882A (en) | 1989-01-31 |
| ES2027003T3 (es) | 1992-05-16 |
| US5314444A (en) | 1994-05-24 |
| DK168654B1 (da) | 1994-05-16 |
| CA1312519C (en) | 1993-01-12 |
| AU1278288A (en) | 1988-09-15 |
| JPS63230158A (ja) | 1988-09-26 |
| DK130888D0 (da) | 1988-03-10 |
| DK130888A (da) | 1988-09-14 |
| ATE69711T1 (de) | 1991-12-15 |
| DE3866380D1 (de) | 1992-01-09 |
| EP0282175A1 (en) | 1988-09-14 |
| GR3003241T3 (en) | 1993-02-17 |
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