JP2552812B2 - 噛み合わせボールおよびキー溝連結部を備えた離脱可能な押出し具−血管閉塞コイルアセンブリ - Google Patents

噛み合わせボールおよびキー溝連結部を備えた離脱可能な押出し具−血管閉塞コイルアセンブリ

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Publication number
JP2552812B2
JP2552812B2 JP5511086A JP51108693A JP2552812B2 JP 2552812 B2 JP2552812 B2 JP 2552812B2 JP 5511086 A JP5511086 A JP 5511086A JP 51108693 A JP51108693 A JP 51108693A JP 2552812 B2 JP2552812 B2 JP 2552812B2
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Prior art keywords
coil
pusher
keyway
catheter
assembly
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JPH06511174A (ja
Inventor
ティー． エンゲルソン，エリック
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TAAGETSUTO SERAPYUUTEIKUSU Inc
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TAAGETSUTO SERAPYUUTEIKUSU Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • 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
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Cardiology (AREA)
  • Reproductive Health (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Surgical Instruments (AREA)
  • Toys (AREA)
  • Replacing, Conveying, And Pick-Finding For Filamentary Materials (AREA)
  • General Induction Heating (AREA)
  • Hand Tools For Fitting Together And Separating, Or Other Hand Tools (AREA)
  • Wire Processing (AREA)
  • Winding, Rewinding, Material Storage Devices (AREA)

Description

【発明の詳細な説明】 技術分野 本発明は、外科用器具の一般的な分野におけるもので
あり、特に、血管閉塞コイルをカテーテルを介して血管
内の選択された部位（例えば、動脈瘤）に送達するため
の装置に関する。
背景技術 動脈瘤のような血管内の部位を閉塞するために、血管
閉塞コイルまたはワイヤが用いられている。コイルは規
則的な（例えばらせん状の）形状であり得るか、また
は、この部位で無秩序な回旋型形状となり得る。血管閉
塞コイルは、米国特許第4,994,069号に記載されてい
る。コイルは、通常は、プラチナ、金、またはタングス
テンのような放射線不透過性および生体適合性を有する
金属から製造される。動脈瘤の治療では、通常は、複数
の、典型的には４個から12個のコイルを動脈瘤内に配置
する。コイルは、血流に対する物理的な障害物となるこ
とにより、そして部位での血栓の形成を促進することに
より、部位を閉塞する。
１個または複数のコイルは、典型的には、カテーテル
および押出し具を用いて所望の部位に配置されている。
この部位には先ずカテーテルが接近する。閉塞を必要と
する末梢または神経部位の症状を治療する場合には、米
国特許第4,739,768号および第4,813,934号に記載された
カテーテルのような、柔軟で直径の小さいカテーテルを
用いて部位に接近する。カテーテルは、ガイドワイヤを
用いることにより（米国特許第4,884,579号を参照のこ
と）、および／またはカテーテルの遠方端部に配置され
たバルーンのような流動方向性手段を用いることによ
り、部位へと誘導される。部位に達すると、カテーテル
管腔を空にし（すなわち、ガイドワイヤを使用した場合
はガイドワイヤを取り除き）、そしてコイルをカテーテ
ルの基端部に配置して、押出し具を用いてカテーテルを
通して前進させる。押出し具は、押出し具がカテーテル
を通って前進するとき、コイルに係合する（engage）よ
うにされ、このコイルを遠方向に押すようにされた、遠
方端部を有するワイヤである。コイルがカテーテルの遠
方端部に到達すると、コイルは押出し具によってカテー
テルから血管内へ投げ出される。コイルをカテーテルの
遠方端部から投げ出すというこの技術には望ましくない
限界がある。第一に、この投げ出し動作により、部位で
のコイルの位置を高い精度で制御することができない。
第二に、一旦カテーテルから投げ出されると、コイルの
再配置はまた回収を望む場合でもこれを行うのは困難で
ある。実際には、回収器とばれる別の装置をカテーテル
内に通し、これによりコイルを補えてコイルの再配置ま
たは回収を行わなければならない。
これらの限界により、最近、血管内へのコイルの配置
をより正確に行い得る技術が開発されている。ある技術
（1990年３月13日出願の米国特許出願第492,717号に記
載されている）では、コイルは金属−金属の接合部を介
して、コイルとは異なる金属から製造される押出し具の
遠方端部に結合される。このコイルを保持する押出し具
は、カテーテルを通って部位まで前進し、そして押出し
具−コイルアセンブリに低電流が流れる。この電流によ
り、押出し具とコイルとの間の接合部が電気分解により
切断される。次に、押出し具を引っ込めることにより、
離脱したコイルを血管内の正確な位置に放置し得る。よ
り正確なコイル配置が可能となることに加えて、電流に
よりコイル部位での血栓の形成が促進され得る。この方
法で認められる唯一の欠点は、コイルの電気分解による
放出には一定の時間がかかるため、コイルが押出し具か
ら迅速に離脱し得ないことである。別の技術では、押出
し具およびコイルの互いに向かい合う各端部は、押出し
具がワイヤを締めつけて、この締めつけが解除されるま
でワイヤを保持するように設計されている。従って、こ
の方法では、電気分解によるメカニズムではなく機械的
な離脱メカニズムが利用される。
本発明の主たる目的は、血管内の所望の部位で押出し
具から血管閉塞コイルを離脱させる他の機械的な手段を
提供することである。
発明の開示 本発明の１つの局面は、血管内の選択された部位を閉
塞するために使用される、離脱可能な押出し具−血管閉
塞コイルアセンブリであって、このアセンブリは、
（ａ）基端部と遠方端部とを有し、この基端部に拡径部
材を保持する血管閉塞コイル；（ｂ）この拡径部材を噛
み合わせて係合した状態で収容する、遠方端部のキー溝
（Keyway）を有する押出し具；および（ｃ）この押出し
具およびこのコイルの周りに同軸方向に保持される手段
であって、この手段がこのキー溝内に噛み合わされたこ
の部材を閉じ込めて、この部材をこのキー溝内に維持す
る第１の位置から、この手段がこの噛み合わされた部材
およびキー溝を閉じ込めず、この部材がこのキー溝から
外れて引き抜かれ、それによりこの押出し具とこのコイ
ルとの連結が解除される第２の位置へと、この押出し具
およびこのコイルに対して軸方向に移動し得る手段、を
組み合せを備えている。
本発明の別の局面は、血管内の選択された部位を閉塞
する方法であって、この方法は、（ａ）カテーテルの遠
方端部をこの部位に接近させる工程；（ｂ）上記のアセ
ンブリを、上記部材を上記キー溝内に噛み合せた状態
で、このカテーテルを通してこのカテーテルの遠方端部
より遠方側の位置に前進させる工程；（ｃ）この部材を
このキー溝から引き抜き、それにより上記コイルを上記
押し出し具から離脱させる工程；および（ｄ）このカテ
ーテルおよびこの押出し具を血管から引き抜く工程を、
包含する。
図面の簡単な説明 以下の図面では、縮尺は一定ではない。
図１は、本発明の押出し具−血管閉塞コイルアセンブ
リの１つの実施態様の拡大された部分縦断面図であっ
て、押出し具およびコイルが連結された状態を示す。
図２は、図１のアセンブリとカテーテルの拡大された
部分縦断面図であって、押出し具とコイルとの連結が解
除された状態を示す。
図３は、図１の押出し具の遠方端部の拡大された透視
図である。
図面において、基部は左側であり、そして遠方部は右
側である。図面では、アセンブリのいくつかの部材遠方
部分のみが示される。
発明を実施する形態 図に示される、一般に参照番号11で示されるアセンブ
リは、３つの主要な構成部品を備えている。すなわち、
（ａ）押出し具12、（ｂ）血管閉塞コイル13、および
（ｃ）スリーブ14である。
コイル13は、図１では、均一の直径を有するらせん状
のコイルワイヤとして示される。しかし、別の規則的な
形状、または不規則な形状であってもよい。いずれの場
合でも、コイルは、所望の部位に接近し得る大きさのカ
テーテルを通って前進し得る大きさでなければならな
い。コイルはプラチナ、金またはタングステンのような
放射線不透過性および生体適合性を有する金属から製造
され、これにより血管内のコイルの位置がＸ線撮影によ
り観察され得る。
末梢または神経部位を閉塞するために用いる場合は、
コイルは、典型的には、最小ピッチで内径0.15〜0.96mm
となるように巻かれた直径0.05〜0.15mmのプラチナワイ
ヤ（すなわち、その巻き線は密であるか、またはきつ
い）から製造される。（巻かれた状態）のワイヤの長さ
は、通常は0.5〜60cmの範囲であり、好ましくは２〜20c
mの範囲である。前述のように、所望であれば、コイル
は、カテーテルを通って前進し得るように本質的に直線
形状を取るように、そしてカテーテルから放出された後
は不規則な方向に緩められた状態となるように形成され
得る（米国特許第4,994,069号を参照のこと）。
コイルの基部分15（またはコイルの基端部に取り付け
られた独立したワイヤ）は、コイルの巻き線より基部方
向に延びるように変形されている。基部分15の先端部
は、球体またはボール16を保持している。ボールは基部
分に対して中央に配置されるか、または基部分の軸から
ずれて配置され得る。基部分15の長さは通常は0.25〜1.
2mmであり、そしてボール16の直径は、通常は0.2〜1mm
である。後に述べるように、ボール16を操作して押出し
具と係合させ得るように、基部分15は変形可能にすべき
である。さらに、基部分15は、通常は半径方向に偏っ
て、締め付けられた状態にないときは図２に示した位置
を取るようにするのが好ましい。
押出し具12は、押出し具を握って操作し得る手段を提
供する基端部分（図示せず）、主要中心コア17、および
拡径円柱状先端部18を備えている。先端部18は、少なく
ともボール16とほぼ等しい直径を有する軸方向の孔19、
および孔19に交差し、ボール16を収容するようにされた
大きさを有する半径方向のスロットまたはキー溝20を有
する。所望であれば、先端部はまた、遠方端部から半径
方向のキー溝まで延び、基部分15を収容するような大き
さの軸方向のスロットを有し得る。先端部18の外径は、
閉じ込め手段の管腔内に滑り込むように収容され、基部
分15およびボール16をキー溝20内に配置させ得る大きさ
である（図１を参照のこと）。
押出し具の全長は、カテーテル21を通って血管部位ま
で完全に前進し得、しかも押出し具の基端部の十分な部
分がカテーテルの基端部から突き出して押出し具の操作
を可能にし得るような長さとされる。典型的には、コア
部分が押出し具の全長の少なくとも約90〜95％を構成す
る。末梢または神経部位の手術で使用するためには、押
出し具は、通常は長さ約100〜200cmであり、より通常に
は長さ160〜180cmである。押出し具のコア17の直径は、
典型的に0.25〜0.90mmの範囲である。
ボール16は、半径方向に閉じ込めることにより、キー
溝内に維持される。このように連結した押出し具とコイ
ルとを同軸方向に閉じ込める手段は、部位に接近するた
めに使用されるカテーテルの内壁であり得る。しかし、
（ａ）カテーテルの半径方向の弾力性が大きすぎるため
係合を維持することができない場合、または（ｂ）カテ
ーテルの遠方端部より遠方側でも係合を維持したい場合
は、コイルおよび押出し具の周りを同軸方向に収容され
る独立したスリーブ14を使用し得る。
スリーブ14の外径は、スリーブがカテーテル21の管腔
を通って前進し得るような大きさである。それに対応し
て、スリーブの内径は、スリーブがコイルおよび押出し
具を連結した関係で収容し、これらに対して軸方向に移
動し得るような大きさである。末梢または神経部位の手
術で使用するためには、スリーブの内径は、典型的には
0.3〜1mmの範囲である。スリーブは、カテーテル21を通
って前進するように操作され得る柔軟なプラスチックか
ら製造され得る。
アセンブリ11は、以下のように、１つまたはそれ以上
の血管閉塞コイルを血管内の選択された部位に配置する
ために使用される。押出し具およびコイルは、図１に示
すように、キー溝20内にボール16を配置した状態で組み
立てられる。スリーブを用いてボールおよびキー溝を閉
じ込める場合は、連結したアセンブリをスリーブ14内に
挿入する。カテーテル21を血管の管腔（図示せず）を通
って、閉塞される部位（例えば、動脈瘤、血管奇形、ま
たは動静脈フィステル）まで挿入し、操作して前進させ
る。カテーテルを用いて部位に接近するためには、前述
のように、ガイドワイヤおよび／または流動方向性手段
を含む従来のカテーテル挿入法および操作方法を使用し
得る。カテーテルの遠方端部が部位に配置されると（こ
の端部の位置は、カテーテルの遠方端部を放射線不透過
性材料によりコートすることによって、さもなければこ
のような材料をカテーテルの遠方端部に取り付けること
によって決定され得る）、カテーテルを空にし（すなわ
ち、カイドワイヤを使用してカテーテルを配置した場合
は、ガイドワイヤをカテーテル内から引き抜く）、そし
て押出し具およびコイルアセンブリ11をカテーテルを通
って前進させる（図２を参照のこと）。アセンブリをカ
テーテルの遠方端部より遠方側に前進させることによ
り、ボールおよびキー溝はカテーテルから開放され、コ
イルは所望の部位に正確に配置される。スリーブを使用
する場合は、次いでスリーブを引き抜く（基部の方向に
軸方向に移動させる）ことにより、キー溝およびボール
の閉じ込めが解かれる。ワイヤ15が半径方向に偏るた
め、ボール16はキー溝から外れて、コイルと押出し具と
の連結が解除される（図２を参照のこと）。ワイヤ15が
半径方向に偏ることは重要ではなく、連結は重力または
部位での血流によって簡単に解除され得る。部位にコイ
ルをさらに配置する必要がある場合は、押出し具および
スリーブを引き抜き、そしてこの手順を繰り返す。所望
の数のコイルを部位に位置した後、カテーテルを血管か
ら引き抜く。
機械的器具および外科用器具の設計技術分野およびそ
の関連分野の当業者にとって自明である、上記の発明を
実施する形態の変形は、以下の特許請求の範囲内に含ま
れるものとする。

Claims (7)

    (57)【特許請求の範囲】
  1. 【請求項１】血管内の選択された部位を閉塞するために
    使用される、離脱可能な押出し具−血管閉塞コイルアセ
    ンブリであって： （ａ）基端部と遠方端部とを有し、該基端部に拡径部材
    を保持する血管閉塞コイル； （ｂ）基端部と遠方端部、および該コイルの拡径部材を
    噛み合わせの状態で収容する、該遠方端部の半径方向の
    キー溝を有する押出し具；および （ｃ）該押出し具および該コイルの周りに同軸方向に保
    持される手段であって、該手段が該キー溝内に噛み合わ
    された該部材を閉じ込めて、該部材を該キー溝内に維持
    する第１の位置から、該手段が該噛み合わされた部材お
    よび半径方向のキー溝を閉じ込めず、該部材から該半径
    方向のキー溝から外れて引き抜かれ、それにより該押出
    し具と該コイルとの連結が解除される第２の位置へと、
    該押出し具および該コイルに対して軸方向に移動し得る
    手段、を組み合せて備えている、アセンブリ。
  2. 【請求項２】前記手段がカテーテルである、請求項１に
    記載のアセンブリ。
  3. 【請求項３】前記手段が、カテーテル内に収容されるよ
    うにされたスリーブである、請求項１に記載のアセンブ
    リ。
  4. 【請求項４】前記拡径部材が、前記コイルから基部方向
    に延びるワイヤの基端部に保持される、請求項１に記載
    のアセンブリ。
  5. 【請求項５】前記拡径部材が一般的に球形状である、請
    求項１に記載のアセンブリ。
  6. 【請求項６】前記押出し具が円柱状の遠方先端部を有す
    る、請求項１に記載のアセンブリ。
  7. 【請求項７】前記キー溝が、前記押出し具の前記遠方端
    部から該半径方向のキー溝まで延びる軸方向のスロット
    を備えている、請求項１に記載のアセンブリ。
JP5511086A 1991-12-12 1992-12-08 噛み合わせボールおよびキー溝連結部を備えた離脱可能な押出し具−血管閉塞コイルアセンブリ Expired - Lifetime JP2552812B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US07/806,912 US5261916A (en) 1991-12-12 1991-12-12 Detachable pusher-vasoocclusive coil assembly with interlocking ball and keyway coupling
US806,912 1991-12-12
PCT/US1992/010715 WO1993011825A1 (en) 1991-12-12 1992-12-08 Detachable pusher-vasoocclusive coil assembly with interlocking ball and keyway coupling

Publications (2)

Publication Number Publication Date
JPH06511174A JPH06511174A (ja) 1994-12-15
JP2552812B2 true JP2552812B2 (ja) 1996-11-13

Family

ID=25195118

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JP5511086A Expired - Lifetime JP2552812B2 (ja) 1991-12-12 1992-12-08 噛み合わせボールおよびキー溝連結部を備えた離脱可能な押出し具−血管閉塞コイルアセンブリ

Country Status (13)

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US (1) US5261916A (ja)
EP (2) EP0616543B1 (ja)
JP (1) JP2552812B2 (ja)
KR (1) KR0133728B1 (ja)
AT (1) ATE170765T1 (ja)
AU (1) AU666698B2 (ja)
CA (1) CA2125653C (ja)
DE (3) DE9218710U1 (ja)
ES (1) ES2074971T1 (ja)
IL (1) IL104021A (ja)
NO (1) NO942114D0 (ja)
TW (1) TW259717B (ja)
WO (1) WO1993011825A1 (ja)

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TW259717B (ja) 1995-10-11
AU666698B2 (en) 1996-02-22
EP0616543A4 (en) 1995-01-11
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KR0133728B1 (en) 1998-04-21
NO942114L (ja) 1994-06-07
IL104021A (en) 1996-06-18
EP0853955A1 (en) 1998-07-22
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CA2125653C (en) 1996-11-26
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CA2125653A1 (en) 1993-06-24
DE69226960D1 (de) 1998-10-15
WO1993011825A1 (en) 1993-06-24
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US5261916A (en) 1993-11-16

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