JP2002515797A

JP2002515797A - Bioabsorbable hemostatic seal assembly

Info

Publication number: JP2002515797A
Application number: JP53469798A
Authority: JP
Inventors: ハス，ブラドリー・ディー
Original assignee: セント・ジュード・メディカル・プエルト・リコ・ベスローテン・フェンノートシャップ
Priority date: 1997-01-21
Filing date: 1998-01-20
Publication date: 2002-05-28
Also published as: AU5927498A; EP0961580A1; CA2278243C; CA2278243A1; WO1998031287A1; EP0961580A4

Abstract

(57)【要約】本発明は患者内の切開部又は穴を閉じる装置（１８）及び方法に関し、閉塞装置が血管又は目標器官を通る流体の流れを大幅に阻害しないように、閉塞装置の係留部材が血管（１０）の壁又は穴に隣接する目標器官に沿うまで、閉塞装置を切開部又は穴内へ挿入し、次いで、穴又は目標器官の外表面に沿ってコラーゲン部材（２８）を位置決めする。切開部又は穴内での閉塞装置の正確な位置決めは、好ましくはロッド部材（４２）と一体になった係留部材（２６）を使用することにより達成され、係留部材は患者の血管又は目標器官の内壁に沿って位置決めされるようになっており、ロッド部材は穴を通って延び、膨張可能なコラーゲン部材をその上で受け取る。 SUMMARY OF THE INVENTION The present invention relates to a device (18) and method for closing an incision or hole in a patient, such that the occlusion device does not significantly impede the flow of fluid through a blood vessel or target organ. The occluding device is inserted into the incision or hole until the member is along the target organ adjacent the wall or hole of the blood vessel (10), and then the collagen member (28) is positioned along the outer surface of the hole or target organ. . Precise positioning of the occluding device within the incision or hole is achieved by using an anchoring member (26), preferably integral with the rod member (42), the anchoring member being the inner wall of a patient's blood vessel or target organ. The rod member extends through the hole and receives the inflatable collagen member thereon.

Description

【発明の詳細な説明】生体吸収性の止血用シール組立体発明の分野本発明は、全体として、閉塞装置、より具体的には、切開箇所又は穿刺箇所を体液が流れないように密封すべく患者の身体の切開箇所又は穿刺箇所内に挿入可能である、改良に係るシール組立体及び閉塞装置に関する。発明の背景カテーテル法及びその他の医療方法を行う間、外科医は、従来の針、カテーテル、導入子、又は拡張器により患者の動脈、血管又は器官内への開口部を形成する。この開口部の寸法は、その医療方法の型式、及び使用されるカテーテルの寸法によって相違する。例えば、標準的な血管形成法にて使用されるカテーテル及びカテーテルシースの直径は、典型的に、５乃至８フレンチ（それぞれ1.67乃至 2.67ｍｍ）の範囲にある。血管形成法及び増大する数のステント配置方法にて使用されるカテーテル及びカテーテルシースの直径は、約８（2.67ｍｍ）又は９（ 3.33ｍｍ）フレンチとすることができる。大動脈内のバルーンポンプ法にて使用されるカテーテル及びカテーテルシースの直径は、典型的に、14乃至16フレンチ（それぞれ4.67ｍｍ乃至5.33ｍｍ）であり、心肺支持装置と共に使用されるカテーテル及びカテーテルシースの直径は、典型的に、18乃至20フレンチ（それぞれ 6.0ｍｍ乃至6.67ｍｍ）である。更に、カテーテルは、治療部位まで進める間に捩れ又はその他の操作が為され、これにより、患者の身体の切開箇所又は穿刺箇所を更に拡張することになることがしばしばである。医療方法が完了し、カテーテルを動脈又はその他の血管から除去するとき、従来の方法は、血栓が生じる迄、入口箇所に外部圧力を付与することである。これらの方法が施される多くの患者は、ヘパリンのような抗凝血剤が投与されているため、看護婦は、長時間に亙ってその切開箇所に外部圧力を付与しなければならない。切開箇所における出血を止めるために必要とされる時間は、看護婦の時間を効率的に利用することにはならず、血栓が動脈の開口部を塞ぐ迄、動脈の内部からの出血が続くため、痛みを伴う血腫及び醜い傷が生ずる。 1985年５月16日付けにて、カース（Kurth）に付与された米国特許第4,829,9 94号において、骨盤エプロンと、単径部ストラップとから成るエプロン状の装置を提供して、患者の大腿部血管に圧縮力を付与することにより、上記の問題点を解決しようとする試みる。この装置は、看護婦が切開箇所に直接的な圧力を加えることを効果的に不要にするが、この装置を使用することにより、大腿部動脈全体に渡る血流が減少し、弱った患者に血栓が生ずる可能性がある。上記の問題点を解決しようとする別のアプローチ法は、1990年５月29日付けでシノフスキィー（Sinofsky）に付与された米国特許第4,929,246号に開示されている。この特許に開示された装置を使用する方法は、その末端に膨張可能なバルーンを有する半剛性な管を上方の組織を通じて穿刺した動脈の外壁に隣接する位置まで進めるステップを含む。次に、このバルーンを膨張させて、動脈の外壁に対して直接、圧力を付与する。次に、半剛性の管内の中心に配置された光ファイバを介してレーザエネルギが動脈の外壁に向けられ、レーザエネルギが光ファイバ及び半剛性な管のバルーンを透過し、動脈を熱により溶着させ且つ切開箇所を密封する。上記の問題点を解決する更に別のアプローチ法は、1988年５月17日付けでケンゼイ（Kensey）に付与された米国特許第4,744,364号、1989年８月１日付けで及び1990年１月２日付けでケンゼイにそれぞれ付与された関連する米国特許第4,85 2,568号及び同第4,890,612号に開示されている。最初の２つのケンゼイの特許には、内部に除去可能に配置された係留部材を有する長い管状本体から成る、血管壁の開口部を密封する装置が開示されている。この管状本体は、係留部材を管状本体から血管内部に付勢するよう管状本体内に配置された突き出し装置も備えている。引っ込め縫糸が係留部材に固着され、係留部材の係合面が穿刺箇所に隣接する血管の内面と止血可能に係合する。ケンゼイの米国特許第4,890,612号には、穿刺した血管に隣接する組織の部分に係合し得るようにされた一部分と、切開箇所を貫通して伸長し、該切開箇所に隣接する組織に係合し、穿刺箇所を密封する密封部分とを有する長い部材を含む装置が開示されている。ケンゼイ及びその他の者に対し付与されたその後の特許は、上述した基本的アプローチ法に対する改良であり、全体として、切開箇所及び血管を密封すべく縫糸及びコラーゲン部材と組み合わせて使用される係留部材を備えている。ナッシュ（Nash）及びその他の者に対し付与された米国特許第5,411,520号は、上述した基本的アプローチ法の改良であり、全体として、縫糸に沿って可動であるスペーサを備えており、係留部材とコラーゲン部材との間にスペーサが配置され、穿刺箇所及び血管を密封する。スペーサは、コラーゲン部材とアンカーとの間に配置されて、コラーゲン部材が患者の血管に入るのを防止する。フォラー（Fowler）及びその他の者に付与され且つ本発明の譲受人に譲渡された米国特許第5,108,421号には、血管プラグ型のアプローチ法が使用することが開示されており、この場合、止血用閉塞装置が患者の切開箇所内に挿入され、長いバルーン型部材又は注射器型装置のような位置決め部材を使用して、切開箇所内に配置することができる。ジャンセン（Janzen）及びその他の者に付与された米国特許第5,391,183号には、１つ以上の過大寸法の血管プラグがプランジャ部材を備える装置を使用して切開箇所内に挿入される、別の血管プラグ型アプローチ法が開示されている。上記の説明から、血管壁、管路又は器官の穿刺箇所又は切開箇所を確実に閉塞し、患者の歩行時間を短くし且つ血腫又は血栓が形成される危険性を軽減し得る簡単で且つ比較的低廉な手段を開発することを目的とする相当な努力が最近為されているが、これら目的を満足させるために更なる努力が必要であることが明らかである。発明の概要従って、本発明の１つの目的は、構造が簡単であること、展開、作動が容易であり且つ／又は血管の閉塞装置の安全性に関して従来技術の不利益な点を解決する装置及びその使用方法を提供することである。本発明の別の目的は、動脈の切開箇所を密封するのに必要な時間を短くし、カテーテルを切開箇所から除去した後、血腫が形成される可能性を少なくすることである。本発明の上記及びその他の目的は、以下に説明するような装置を使用して、血管、管路又は器官の切開箇所を密封する装置及びその方法を提供することにより実現される。本発明の１つの形態は、その末端に係留部材を有する長い生体吸収性のロッド部材を含む血管の閉塞装置から成るシール組立体を備えることが好ましい。該係留部材は、挿入した後、ロッド部材の末端から横方向に伸長し得るよう予応力が加えられる一方、閉塞装置を切開箇所内に挿入する間に、ロッド部材の長さ方向寸法と整合するのに十分に可撓性であることが好ましい。また、該ロッド部材は、その一部分に沿って伸長するコラーゲン管と、係止溝と、ロッド部材に沿って長さ方向に摺動可能な保持リングとを備えることも好ましい。使用時、シール組立体は、導入子又は処置用シースとを含む導入装置と、伸長ロッドと、プッシュロッドと、生体吸収性のロッド部材を含む閉塞装置と、係留部材と、保持リングとを備えている。導入装置は、最初に、穿刺箇所内に配置され、導入装置の末端が患者の血管内に配置され、閉塞装置が穿刺箇所内に且つ該穿刺箇所を通じて配置される。次に、閉塞装置の末端を導入装置の末端を越えて押し込み、係留部材がロッド部材の長さ方向寸法に対して略平行な第一の位置から、ロッド部材の長さ方向寸法に対して略垂直な第二の位置まで動くことを許容する。次に、係留部材が切開箇所に隣接する血管壁に接触し且つ係合する迄、導入子及び閉塞装置を共に引き出す。次に、ロッド部材及び密封装置のコラーゲン部材を切開箇所内の流体に露呈させるため、導入子の引き出しを続ける。次に、導入装置の円筒状の伸長ロッドをロッド部材の密封装置に沿って末端方向に動かし、保持リングがロッド部材の係止点又は係止溝に達する迄、保持リングをロッド部材に沿って末端方向に押す。ロッド部材に沿った保持リングの末端方向への動きにより、コラーゲン管がロッド部材に沿って圧縮され且つ末端方向に動かされ、コラーゲン管が半径方向に拡張し且つ血管壁に略隣接し且つ該血管壁の基端方向の位置まで移動するようにする。閉塞装置のコラーゲン管は、コラーゲン管の末端が血管の外面の基端方向に確実に配置され且つ切開箇所又は穿刺箇所の末端部分に沿って略伸長し、コラーゲン管が血管内に入らないような寸法とし且つ僅かに鈍角な形状とすることが好ましい末端を備えている。更に、血管壁は係留部材とコラーゲン管との間に保持される。係留部材の１つの機能は、ロッド部材及びコラーゲン管を切開箇所又は穿刺箇所内に便宜に且つ確実に位置決めすることを可能にすることであり、このため、係留部材の寸法及び形状は、切開箇所を通る流体の流れの乱れを最小にし、また、その流体が比較的短時間で患者の体内に吸収されるように選択される。本発明の１つの有利な点は、閉塞装置が縫合部材を備えず、閉塞装置は実質的に単一の密封装置として機能することである。本発明の別の有利な点は、患者の血管、管路又は器官を実質的に妨害せずに、閉塞装置を血管壁に略沿って確実に位置決めするために本発明の係留部材及び導入子を使用できることである。本発明の別の有利な点は、患者の穿刺箇所の深さに著しく影響することなく、閉塞装置を略血管壁に沿って確実に位置決めするために本発明の閉塞装置を使用することができることである。本発明の更に別の有利な点は、装置の機能に悪影響を与えずに、血管壁に略沿って閉塞装置を略任意の寸法の穿刺箇所内に確実に位置決めするために本発明の密封装置が容易に改変可能なことである。図面の簡単な説明図１は、本発明の閉塞装置及び伸長ロッドを示す、部分断面図とした側面図である。図２は、本発明の接近シース及びバイパス部材を示す部分側面図である。図３は、接近シース内に配置された閉塞装置の係留部材の正面図を示す部分断面図とした部分側面図である。図４は、接近シース内に折り畳まれた係留部材の拡大部分側面図である。図５は、閉塞装置の係留部材が接近シースから伸長した状態の穿刺経路内における閉塞装置及び接近シースを示す、部分断面図とした側面図である。図６は、係留部材が伸長し且つ患者の血管の内壁に沿って配置された、本発明のシール組立体を示す、部分断面図とした側面図である。図７は、接近シースが患者から除去され、閉塞装置が最初に切開箇所内に配置された後の、図１の閉塞装置及び伸長ロッドを示す、部分断面図とした側面図である。図８は、伸長ロッド及び閉塞装置に取り付けられたプッシュロッドを示す、部分断面図とした側面図である。図９は、プッシュロッド及び保持リングがロッド部材に沿って末端方向に動かされ、コラーゲン管をロッド部材に沿って半径方向に膨張させ且つ末端方向に移動させた後の、切開箇所における図１の閉塞装置及び伸長ロッドを示す、部分断面図とした側面図である。図１０は、ロッド部材の基端部分が除去された後、穿刺経路内に最初に配置された、図１の閉塞装置を示す、部分断面図とした側面図である。図１１は、図１の伸長ロッドを示す、側面図である。図１２は、本発明のプッシュロッドを示す、側面図である。図１３は、本発明の閉塞装置を示す、側面図である。図１４Ａ、図１４Ｂ、図１４Ｃは、図１の保持リングの別の形態を示す、それぞれの正面図、側面図及び底面図である。図１５は、穿刺経路内に最終的に配置された閉塞装置を示す、図１４の保持リングの別の形態を示す、部分断面図とした側面図である。本発明の詳細な説明本発明は、特に、患者の大腿部動脈１０のような血管の切開箇所又は穿刺箇所を密封すべく、本発明を使用することに関して以下に説明する。閉塞装置１６は、患者の組織及び血管を直ちに止血させ得る設計とされているから、シール組立体１６は、血管造影剤の注入、ステント法、心臓カテーテル法、バルーン血管形成法及びアテローム性動脈の他の型式の再開通法と共に関連して使用されたとき特に有用である。本発明のシール組立体１６は、腹腔鏡法又は同様の手術を含む、患者の体液の損失を防止すべく切開箇所又は穿刺箇所を密封することが望ましい、略任意のカテーテル法又はその他の医療方法と共に使用することが考えられる。更に、本発明の閉塞装置１８は、腹腔鏡法、心臓内視鏡法、胃内視鏡法、心臓内処置法又は同様の方法を含む、患者の体液が損失するのを防止すべく、患者の身体の血管の管腔、管路又は目標器官を確実に配置することが望ましい、穿刺箇所における略任意のカテーテル法又はその他の医療方法或いは導入装置と共に使用することができる。次に、同様の部品を同様の参照番号で表示する幾つかの図面について詳細に参照すると、シール組立体を形成する構成要素の組合せ体が参照番号１６で示してあり、該組立体の一部は、生体吸収性の閉塞装置１８を展開させ、経皮的な穿刺経路１４を密封する色々な非生体吸収性装置を含んでいる。穿刺経路１４は、血管壁の開口部のみならず、その処置方法が行われたときに形成された、血管と患者の皮膚表面１２との間に配置される組織の通路をも有している。本明細書にて使用するように、１つの要素の末端は、患者に最も近い要素の端部として説明し、１つの要素の基端は、患者から最も遠い要素として説明する。本発明をより完全に理解し且つ認識するため、患者の大腿部動脈を通じて行われる従来の血管造影カテーテル法について簡単に説明する。かかる方法において、血管造影針（図示せず）を約25°乃至45°の好適な角度にて、患者の皮膚１２の表皮皮膚層を通じて経皮的に挿入する。針が大腿部動脈を穿刺する迄、この針を、経皮的に約６ｍｍ乃至70ｍｍ、患者の皮膚内に挿入する。針による動脈１０の穿刺は外科医により確認され、小径のガイドワイヤー（図示せず）を約15乃至 20ｃｍの距離だけ針を通じて挿入する。次に、動脈１０に圧力を付与して出血を制限し、また、穿刺箇所における血腫の形成を防止しつつ、この針をガイドワイヤーの外側に沿って引き出す。拡張器（図示せず）及び外側導入子若しくはカテーテル処置用シースがガイドワイヤーの外側に沿って挿入され、次に、そのガイドワイヤーを拡張器の内部から除去する。次に、カテーテルを処置用シースを通じて前進させ、最終的な所望の位置にして処置を行う。この処置が完了したならば、カテーテルを除去して、処置用シースのみが穿刺箇所に止まり、ユーザがシースを交換するか、又は本発明の処置用シースをガイドワイヤーの外側に沿って穿刺箇所内に挿入し、成いは従来の別の方法を使用してシール組立体１６内に挿入する。このため、最初の処置を行うために使用される処置用シースは、以下に説明するように、シール組立体１６の一部を形成する接近シース２０と同一とし又は異なるものとすることができる。図１乃至図１１に図示するように、本発明の１つの好適な形態は、全体として接近シース２０又は処置シース２０を含むシール組立体１６と、閉塞装置１８と、以下に説明するようなプッシュロッド３６、伸長ロッド３４、バイパス部材４２のような関連する構成要素とから成っている。図面に図示するように、本発明の閉塞装置１８は、重合化したポリアセタール酸のような多孔質の生体吸収性材料から成る全体として長く且つ好ましくは円筒状のロッド部材２２を備えており、又は、ポリグリコール酸マトリックス又は同様の生体吸収性材料を使用することもできる。ロッド部材の末端２４は、以下に更に詳細に示すような係留部材２６を備えている。また、本発明は、係留部材２６の基端方向にてロッド部材２２の一部分を取り巻く管状のコラーゲン部材２８と、同様に以下に説明するように、その基端方向に配置された保持リング３０とを備えることが好ましい。更に、生体吸収性ロッド部材２２、コラーゲン部材２８及び閉塞装置の保持リング３０は、組織血栓形成剤のような従来の血栓剤を含むようなフォーミレーションとすることができ、この血栓剤は、局部的な止血を加速し得るように所望の材料の少なくとも一部分に組み込まれる。また、この血栓剤は、外科医の処置が終了した後、ヘパリンのような抗血栓剤を患者に保つことを可能にする。閉塞装置１８の少なくとも一部分は、その内部に放射性不透過性材料を含み、従来の視認化手段を使用して、閉塞装置１８の配置状態を観察することを可能なようなフォーミレーションとすることができる。放射線不透過性材料を使用することは、また、外科医の更なる処置が必要であるならば、その後の時点にて閉塞装置の位置を確認することをも可能にする。閉塞装置は、３つの基本的な生体吸収性構成要素、すなわち、好ましくは一体又は実質的に一体の動脈内の係留部材２６を有するロッド部材２２と、管状のコラーゲン部材２８と、保持リング３０とを有することが好ましい。ロッド部材２２の基端は、ねじにより又はその他の方法にて、細い伸長ロッド３４に接続されることが好ましい。伸長ロッド３４は、接近シース２０を通じて挿入される最初のシール組立体の一部を形成する。これと代替的に、プッシュロッド３６は、以下に説明するように、穿刺経路１４から接近シース２０を一度び除去したならば使用されることが好ましいが、プッシュロッド３６は、最初のシール組立体の一部として含めてもよい。伸長ロッド３４は、接近シース２０内にある間に、ユーザが閉塞装置１８を操作することを可能にすべく接近シース２０を貫通して伸長する、比較的小径の部材である。プッシュロッド３６は、伸長ロッド３４を取り囲み且つ以下に詳細に説明するように、保持リング３０をロッド部材２２に沿って末端方向に押すために使用される、より大径の部材である。伸長ロッド３４及びプッシュロッド３６の双方は、閉塞装置を穿刺経路１４内に配置した後に、除去され、このため、ＰＶＣ又は同様の重合系材料のような従来のカテーテル型の材料にて製造することができる。ロッド部材２２は、好ましくは成形し且つ全体として長い円筒状の部材の形態をしている。例えば、このロッド部材は、ラクチド及びグリコロイドポリマー又は止血促進性及び/又は放射線不透過性材を少なくとも一部分に更に含むことのできる同様の材料のような止血性及び再吸収性材料であることが好ましい。ロッド部材２２の１つの形態において、リップ部材を係留部材２６の基端方向に配置し、その上をコラーゲン部材２８が通ることに対する抵抗力を提供するようにすることができる。ロッド部材２２の長さ及び直径は、閉塞装置１８を穿刺経路内に且つ該穿刺経路１４を通じて容易に挿入して、穿刺経路１４及び血管壁を迅速に密封し得るように選択される。係留部材２６は、長く、比較的剛性で低プロファイルの再吸収性部材であることが好ましい。この再吸収性部材は、穿刺箇所１１を略隣接し又は隣り合った動脈壁に対して動脈内にて着座するように配置されている。係留部材２６は、ロッド部材２２の末端２４の一部として成形されることが好ましく、また、再吸収性ロッド部材２２と同様、又は適合可能な非止血性の再吸収性ポリマーで出来ていることが好ましい。コラーゲン部材２８は、コラーゲンスポンジ又は発泡材料のような非アレルギー性で止血性の再吸収性材料で出来た長い管状部材の形状とされることが好ましい。保持リング３０は、コラーゲン部材２８の基端方向にてロッド部材２２に沿って摺動可能に配置された比較的小さい部材であることが好ましく、また、ラクタイド／グルコタイド共重合体のよな成形した再吸収性の重合系材料で出来ていることが好ましい。保持リング３０の外径は、伸長ロッド３４の外径よりも大きく、以下に説明するように、プッシュロッド２６が保持リング３０をロッド部材２２に沿って末端方向に動かすことを可能にし得るようにすることが好ましい。補強縫い糸３２又はその他の材料をロッド部材２２の末端部分２４内に成形し、係留部材２６を補強し且つ該係留部材２６をロッド部材２２に接続することができる。係留部材２６とロッド部材２２との間の相互接続部は、係留部材２６が相対的に動くための枢支点を提供する働きをする。この相互接続部は、係留部材２６が挿入位置及び横方向に方向決めされた位置から移動するのを許容し得るように形成されることが好ましい。この挿入位置において、係留部材２６はロッド部材２２の長さ方向寸法と整合され、また、この横方向に方向決めされた位置において、係留部材２６は、ロッド部材２２の末端２４から横方向に伸長して患者の血管壁に係合する。コラーゲン部材２８はロッド部材２２に沿って摺動可能に配置され、プッシュロッド３６及び保持リング３０がロッド部材２２に沿って末端方向に動くことにより、コラーゲン部材２８が圧縮され且つコラーゲン部材２８がロッド部材２２に沿って半径方向に膨張し且つ末端方向に動くようにする。更に、以下の説明から理解し得るように、閉塞装置の全体は、術後の穿刺箇所の合併症を軽減し、穿刺箇所を確実に密封し、患者のより速い歩行を可能にし、炎症性の反応を最小にし且つ例えば、60乃至90日といった、比較的短時間に完全に再吸収させ得るような設計とされている。本発明の閉塞装置１８の使用方法に関する以下の一般的な説明に従って、血管内処置法が完了した後、閉塞装置１８が使用される。本発明の方法に従って、接近シース２０を従来のカテーテルの交換方法を使用して処置用シースと交換し又は動脈内に残し、この処置用シースが接近シース２０として使用されるようにする。次に、接近シース２０の末端の位置が血管内にあり且つ穿刺経路１４を僅かに越えて伸長することを確認する。閉塞装置１８は接近シース２０内に予め挿入し、又は次に、接近シース２０内に挿入し、伸長ロッド３４が接近シース２０の基端から伸長するようにする。次に、閉塞装置１８を接近シース内にて末端方向に動かし且つ接近シース２０が患者の皮膚表面１２に対し固定された状態に保持しつつ、伸長ロッド３４を接近シース２０に対して末端方向に動かすことにより、閉塞装置を接近シース２０の末端から部分的に展開させる(突き出す)。伸長ロッド３４が接近シース２０に対して更に末端方向に動くと、係留部材２６及びロッド部材２２の一部分が接近シース２０の末端外に押出され且つ動脈の管腔内に展開される。係留部材２６が接近シース２０の末端から進むと、係留部材２６の方向が、係留部材２６の基端が接近シースの末端を越えて進むため、ロッド部材２２の長さ方向寸法に対して変化する。係留部材の好適な偏倚力が横方向に向けられる結果として、係留部材２６は回動してロッド部材２２の末端２４から横方向に伸長する。次に、抵抗力が感じられる迄、伸長ロッド３４を引き出すことにより、閉塞装置１８が接近シース２０に対して引き出される。係留部材２６が接近シース２０の末端に接触したときに抵抗力が生じる。一度びこの状態が生じたならば(また、係留部材２６が接近シース２０の末端に接触したときに、係留部材がその正確な方向に向いていると仮定して)、接近シース２０及び伸長ロッド３４を共に、患者の皮膚１２に対して短い距離だけ引き出す。穿刺箇所に対するこの引き出し又は基端方向への動きにより、係留部材２６は穿刺経路１４に隣接する動脈壁に係合接触する。次に、接近シース２０を患者の皮膚及び伸長ロッド３４に対して引き出す。接近シースが患者の皮膚１２及び閉塞装置に対して基端方向に動くことにより、ロッド部材２２、コラーゲン部材２８及び保持リング３０は穿刺経路１４内にて組織に露呈される。次いで、プッシュロッド３６をシール組立体上で位置決めし、伸長ロッド３４の一部及びロッド部材２２を取り囲むようにする。次いで、プッシュロッド３６を伸長ロッド３４及びロッド部材２２に関して末端方向へ移動させ、ロッド部材２２に沿って保持リング３０を末端方向へ押し、コラーゲン部材２０を穴の場所に隣接する動脈の壁に係合させる。ロッド部材２２に沿った保持リング３０の末端方向への運動はまた、コラーゲン部材２８をコラーゲン状の塊に変形させる効果を有し、好ましくは、コラーゲン状の塊は血管の壁の穴の直径より大きな直径を有する。コラーゲン部材の直径のこの膨張は、穿刺経路１４を拡張させる別の手続き即ち工程を必要とせずに、血管及び穴における適所での閉塞装置１８の保持を補助する。図に示すように、設置された閉塞装置は血管の壁を係留部材２６とコラーゲン部材２８との間に挟み込む。更に、コラーゲン部材２８が好ましくは圧縮されたコラーゲンにより形成されているので、好ましくは、コラーゲン部材は、配置されたときに、穿刺経路１４内で流体又は血液の存在により膨張され、コラーゲン部材２８の半径方向の拡大に対して更に寄与する。伸長ロッド３４及びロッド部材２２に関してロッド３６を末端方向へ押すことにより、保持リング３０が係止部材３８に遭遇するまで、保持リング３０はロッド部材２２に沿って移動され、係止部材は溝又はロッド部材２２の末端部分の直径即ち円周における他の変化とすることができる。プッシュロッド３６、保持リング３０及び係止部材３８は穿刺経路１４における迅速なシール及び止血を提供するようにコラーゲン部材２８の即座のタンパ(tamper)として役立つ。保持リング３０が係止部材３８に到達した後、伸長ロッド３４をロッド部材２２の基端から接続解除することができ、伸長ロッド３４及びプッシュロッド３６を穿刺経路１４から取り除くことができる。ここで、閉塞装置１８が所望の位置に維持され、閉塞装置のまわりの患者の組織の自然の収縮、患者の初期の凝血作用及び止血コラーゲン部材２８の膨張により、血管の壁がコラーゲン部材２８と係留部材２６との間でクランプされる。従って、動脈の壁がコラーゲン部材２８と係留部材２６との間に挟まれ、穴領域及び穴を通る流体の流れは身体的及び生理学的な作用により停止する。配置後数時間以内に、係留部材２６はフィブリンにより覆われ、従って動脈の壁に強固に取り付けられ、末端塞栓の可能性を最小化する。更に、ロッド部材２２及び係留部材２６内での補強縫合糸又は類似の部材の好ましい使用が、係留部材２６がロッド部材２２の末端２４から幾分離れるかもしれない好ましくない可能性を更に減少させる。同様の係留部材の臨床前試験中、係留材料にほんの小さな付着物がほぼ３０日後に血管の壁に沿って残る。事実、閉塞装置１８のすべての要素の再吸収(resor ption)はほぼ６０日後に生じるものと思われる。従って、再吸収可能な係留子は血液の流れに対して無意味な血流効果を有し、比較的短い時間期間で完全に吸収されながら、上述の閉塞装置の残りの要素の信頼ある位置決めを補助する機能を果たす。以後の本発明の要素の一層詳細な説明により認識できるように、接近シース２０を使用する好ましい形の閉塞装置１８の配置は容易であり、迅速であり、信頼性がある。コラーゲン部材２８の係留及び配置は、患者の一層迅速な動き回りを可能にするような外部の圧力の必要性無しに、繰り返し可能であり、安全で有効である。閉塞装置１８を適正に配置した場合、止血は殆ど瞬間的、例えば１５秒以内に生じるものと思われる。コラーゲン部材２８は、ニュージャージー州プレインズボロ(Plainsboro)のコラテック社(Colla-Tec Inc.)により販売されているものの如き、好ましくは圧縮可能で再吸収可能なコラーゲンフォームで作られた円筒状で管状の部材を有する。コラーゲン部材２８は大径形状から小径で細長い形状に圧縮されるように配列され、小径形状は係留部材２６の基端側でロッド部材２２に沿って位置決めされ、接近シース２０内へ挿入される。コラーゲン部材２８が圧縮され接近シース２０内に挿入される形状においては、ロッド部材２２に沿ったコラーゲン部材２８の付加的な直径は極めて小さく、それ故、接近シース２０内での配置に適している。コラーゲン部材２８の長さは好ましくは血管の壁の基端側での穴の長手方向寸法の実質的な部分をシールするのに十分なものであり、また、穴領域での毛細管出血に由来する穴領域の出血を阻止するのに十分なものである。係留部材２６は基本的にはメディソーブ・テクノロジーズ・インターナショナル・エル・ピー社(Medisorb Technologies International L.P.)により「ＭＥＤＩＳＯＲＢ」なる商品名で売られている再吸収可能なラクチド／グリコライド重合体の如き再吸収可能な材料の薄くて狭いストリップ又はバーからなる。ストリップは十分に剛直であり、動脈に対して適所に位置したとき、変形に対して抵抗し、最初に導入された穿刺経路１４を通って戻るような曲げを排除する。係留部材２６は好ましくはほぼ平坦な頂表面と、ほぼ平坦な底表面と、ロッド部材２２の末端２４に枢着された中央に位置する表面とを有する。係留部材２６の各端部は好ましくは丸みを帯びている。係留部材２６の中央に位置する表面は好ましくは頂表面の中心に位置する半球状の突起を含む。半球状の突起は好ましくは貫通して延びる補強縫合糸３２と、その中にモールド成形された縫合糸を有し、係留部材２６の頂表面に対して垂直に位置する長手方向に延びた溝穴とを含む。係留部材２６の全体の形状は、血管を通しての引き戻しを阻止しながら及び血管を通る血液の流れを大幅に阻害することなく、係留部材２６が血管の壁を最初に貫通して血管内に侵入できるように選定される。これに関し、好ましくは、係留部材２６とロッド部材２２との間の偏倚されて横断方向に延びる連結がロッド部材２２及び係留部材２６のモールド成形中に達成され、好ましくは、比較的剛直な縫合糸３２を使用して更に補強される。ここで、好ましい形の接近シース２０の詳細を説明する。図示のように、接近シース２０は基本的には普通のカテーテル導入器を有し、この導入器はポリエチレン又は塩化ポリビニルの如き幾分可撓性の材料で作られた細長いチューブ４０を含み、細長いチューブ４０のある程度の湾曲が存在すると否とに拘わらず、閉塞装置１８が接近シース２０を自由に通って患者の動脈内の作動位置へ侵入できるようにする。本発明の好ましい実施の形態によれば、接近シース２０の外径はほぼ８フレンチ(french)である。その理由は、大半の関連する手続きが８フレンチの手続きシースを利用するからである。８フレンチの接近シースの選択は本発明の好ましい形態を説明する際の図示の目的のためのものであることを理解すべきであり、本発明の要旨内で他の寸法も容易に選択できる。接近シース２０の基端は、接近シース２０の末端に形成された普通の止血弁（図示せず）を通して閉塞装置１８及び伸長ロッド３４を挿入できるように挿入又は装着された剛直な漏斗状のバイパス部材４２を有することができる。細長いチューブ１０の末端は好ましくは普通の先細り形状となってくびれており、係留部材２６の枢動を容易にし、後述するように接近シース２０の末端に関する係留部材２６の所望の整合を表示するために長手方向に延びた溝穴４４を含むことができる。図面に示すように、本発明の伸長ロッド３４、バイパス部材４２及びプッシュロッド３６は、閉塞装置１８の挿入におけるある工程が完了したことを示す視覚的及び触感的な表示を使用者に提供するため種々の標識及び突起を含む。上述のように、伸長ロッド３４はロッド部材２２の基端に着脱自在に取り付けられた細長い部材である。伸長ロッド３４の長さは、閉塞装置１８の係留部材２６が接近シース２０の末端を越えて延びたときに、伸長ロッド３４の基端上の指把持領域４６が接近シース２０の基端の近傍へ延びるように、選定される。更に、一対の円周方向のバンド４８が指把持領域４６の末端側で伸長ロッド３４上に位置する。基端側の円周方向のバンドは、基端側の円周方向のバンド４８が接近シース２０の基端内で位置決めされたバイパス部材４０に到達したときに、閉塞装置１８の係留部材２６が接近シース２０の末端を越えて延びたことを使用者に知らせるために使用される。伸長ロッド３４はまた対をなす円周方向のバンド４８の末端側で伸長ロッド３４の基端上に位置する別の円周方向に細長いバンド５０を有し、保持リング３０がロッド部材２２上の係止部材３８に到達してしまったことを使用者に知らせる。最後に、バイパス部材４２は好ましくは溝穴又は整合標識４４を有し、これらは接近シースの末端上の溝穴５２と整合することができ、使用者は、閉塞装置が接近シース２０の基端内に挿入されるときに、係留部材２６をバイパス部材４２上の溝穴又は標識４４に整合させることにより、係留部材２６を接近シース２０の末端上の溝穴５２に容易に整合させることができる。バイパス部材４２は係留部材２６の所望の位置と直径方向で対向して位置するその周辺部に別の基準デテント（図示せず）を有することができ、このデテントは、使用者が後述するような接近シース２０内への挿入のために閉塞装置１８の中央長手軸線に関して適正なヨー角度に閉塞装置１８を方位決めする際の補助をなす可視ガイドとして作用する。本発明の好ましい使用方法においては、閉塞装置１８を配置前に接近シース２０の末端を通して挿入する。特に、係留部材２６は、ロッド部材２２の長手方向寸法に関して横断方向から長手方向に係留部材２６の方位を一時的に変更するために、使用前にバイパス部材４２に挿通される。それ故、穴領域及び穴内への閉塞装置１８の初期の挿入中、係留部材２６は接近シース２０の細長いチューブ部分４０内で長手方向に位置する。コラーゲン部材２８は長手方向に指向した係留部材２６の基端側で接近シース２０の細長いチューブ部分４０内に位置する。更に、ロッド部材２２の末端２４は好ましくは係留部材２６の基端の上に位置し、ロッド部材２２の末端２４及び長手方向に位置した係留部材２６の全体の直径がロッド部材２２の基端側の直径にほぼ等しくなり、その回りに位置するコラーゲン部材を有するロッド部材２２の部分の直径より小さくなるようにする。第２図から分かるように、接近シース２０は好ましくはその基端に普通のルーア(luer)取り付け側ポートを有する。バイパス部材４２は好ましくはルーア取り付け部の開口内へ延びるような寸法を有し、手続き中に接近シース２０の基端上の止血弁を開いた状態に維持するために摩擦接触等の任意の適当な手段により適所に固定された漏斗状の部材である。動脈内での接近シース２０の位置決めは、血液の流れにより又は血管の壁との物理的な接触により動脈壁の位置を特定する動脈位置決め装置又はオブチュレータ(obturator)を利用することによって、達成できる。代わりに、あまり好ましくはないが、穴の深さを物理的に測定し、次いで、接近シース上の種々の標識を使用することにより及び（又は）特定の長さを有する選択された接近シースを使用することにより、接近シース２０を穴の適当に測定した深さまで移動させることができる。接近シース２０を動脈内で位置決めした後、コック栓を開き、そこからの血液の流れを観察することができる(入口ポート又は窓が動脈内に位置することを確認する)。次いで、コック栓を通る血液の流れがちょうど停止するまで接近シース２０を引き戻し(基端方向へ移動させる)、接近シースの末端が動脈のルーメン(lumen)からちょうど去ったことを表示する。次いで、接近シース２０を穴内へ約１０ｍｍ再挿入し、接近シース２０の末端が動脈内の所望の位置に来ることを保証する。細長いチューブ４０がよじれず又は遮断されないことを保証するために、この時点で、コック栓を通る血液の流れを再確立すべきである。次いで、コック栓を閉じる。この時点から、接近シース２０が穿刺経路１４内で末端方向又は基端方向に移動しないことを保証するように、接近シース２０を患者の皮膚１２に関して固定しなければならない。次いで、止血弁を開くためにバイパスチューブ４２を接近シース２０の基端内へ挿入する。次いで、閉塞装置をバイパス部材４２内へ挿入してこれと整合させ、係留部材２６を横断方向に延びる位置から長手方向の位置へ逸らせる。次いで、閉塞装置をバイパス部材４２を越えて接近シース２０内へ末端方向に移動させる。バイパスチューブ４２上の溝穴又は標識４４が使用者により特定され、使用者はバイパスチューブ４２を掴んで、溝穴又は標識が上を向き患者から離れるように方位決めする。この整合は、係留部材２６が患者に向かって位置することを保証する。バイパスチューブ４２の剛直な性質が止血弁を通しての閉塞装置の通過を容易にし、また、係留部材２６をロッド部材２２に関して長手方向に方位決めし、閉塞装置１８を損傷から保護する。次いで、閉塞装置１８及び伸長ロッド３４が接近シース２０の下方へ十分に押され、伸長ロッド３４上の基端側の円周方向のバンド４８が接近シース２０の基端上のバイパス部材４２と整合するようにし、閉塞装置１８の末端が接近シースの端部と整合し、係留部材２６が動脈内に位置して接近シース２０の末端を越えて延びたことを使用者に知らせる。次いで、シール組立体１６を作動させ、係留部材２６が適正に配置されたかどうかを決定する。その目的のため、接近シース２０は軸方向運動及び回転運動を阻止するように使用者により保持され続け、閉塞装置１８は接近シース２０及び患者の皮膚１２に関して注意深く引き戻される。この作用により、係留部材２６が接近シース２０の末端に係合しこれを捕縛する。係留部材２６が接近シース２０の末端を捕縛すると、使用者は抵抗感を感じる。この抵抗は、伸長ロッド３４上の末端側の円周方向のバンド４８がバイパス部材４２に沿って見えるようになる時間までに認められねばならない。抵抗を感じたら、係留部材２６が係留部材２６上の半球状の突起の位置において接近シース２０の末端を捕縛したことになる。抵抗を感じない場合は、係留部材２６は配置されておらず、再度引き戻される前に閉塞装置１８をその軸線のまわりでいずれかの側へ１／４回転だけ旋回させることにより、上述の挿入シーケンスを繰り返さねばならない。末端側の円周方向のバンド４８がバイパス部材４２の上方で見えるようになる前に、抵抗を感じたら、これは、係留部材２６の一方の端部のみが接近シース２０の端部上で捕縛され、望ましくない結果が生じたことを示す。従って、閉塞装置１８を接近シース２０内へ再挿入し、今度は、接近シース２０に関して再度引き戻される前に、閉塞装置１８をその軸線のまわりでいずれかの側へ１／４回転だけ旋回させることにより、上述の手続きを再度行わねばならない。係留部材２６が横断方向に延びた方位（第５図）へ適正に配置された後、接近シース２０及び閉塞装置１８が一緒に保持され、ユニットとして穴から引き出され、その間ユニットは垂直の方へ揺動される。この作用により、係留部材２６が穿刺経路１４に隣接する動脈１０の内表面に係合し又はこれを捕縛する。次いで、接近シース２０を取り外す。係留部材２６が動脈壁の内部に留まる限り、接近シース２０の取り外しにより、ロッド部材２２及びコラーゲン部材２８が穿刺経路１４内に存在する流体及び血液に晒される。接近シース２０が穴領域から出ると、係留部材２６が適正に配置されることを保証するために、連続的な安定した抵抗がロッド部材上で感じられねばならない。この時点で、係留部材２６は血管１０の壁に沿って配置されてしまっており、コラーゲン部材２８は動脈の壁の基端側で穿刺経路１４内に位置する。この時点で、プッシュロッド３６が伸長ロッド上に設置され、コラーゲン部材２８がプッシュロッド３６の末端方向の運動により穿刺経路１４内で末端方向に移動される。特に、使用者は、保持リング３０をロッド部材２２に沿って末端方向に移動させるようにプッシュロッド３６を末端方向に静かに移動させることにより、コラーゲン部材２８を圧縮する。プッシュロッド３６及び保持リング３０は使用者によりロッド部材２２の下方へ手動で滑動されて、保持リング３０がプッシュロッド３６の基端に達した着色バンド５０により使用者に知らされたような係止部材３８に係合するまで、保持リング３０は穿刺経路１４内で末端方向に移動される。保持リング３０のこの運動により、コラーゲン部材２８は穿刺経路１４の所望の位置へ末端方向に移動する。静かな末端方向への運動は所望の結果を達成するのに；即ち、コラーゲン部材２８の末端部分が穴に隣接する血管の外側に適合するのを補助し、及び、止血（これは極めて迅速に発生し、閉塞装置を適所に更に係止する）が生じるまでコラーゲン部材２８及び係留部材２６を適所に係止するのを補助するのに十分なものである。保持リング３０及びコラーゲン部材２８の末端方向への運動中、作用がコラーゲン部材２８を血管の内部へ押し込まないことを保証するために、プッシュロッド３６上で使用される荷重より大きな荷重でロッド部材２２上に張力を維持するように注意を払わねばならない。保持リング３０が係止リング３８に到達しこれと係合したとき、伸長ロッド３４をロッド部材２２に関して回転させ或いは操作し、伸長ロッド３４をロッド部材２２から分離させることができる。代わりに、ロッド部材２２の長さは、ロッド部材２２の基端部分が患者の皮膚レベルを越えて延びるように、選定することができ、次いで、ロッド部材２２を切断して、ロッド部材２２を伸長ロッド３４から分離させることができる。次いで、伸長ロッド３４及びプッシュロッド３６を取り除き、保持リング３０の上方へ延びるロッド部材２２の任意の部分を切除することができる。次いで、好ましくは、閉塞装置１８は、完全な止血を可能にするように、数分間だけ遮断されずに、この状態に維持される。この時間後に、患者の状態を評価でき、患者は医者により決定されたように動き回ったり排泄したりすることができる。閉塞装置１８が最終のシール位置にある場合、係留部材２６（閉塞装置の一部のみが血管内に位置する）は血管の内部の実質的な部分を塞がず、従って、血管を通る血液の流れを遮断又は阻害しない。閉塞装置１８の要素がすべて再吸収可能な材料で形成されているため、閉塞装置１８はこれが吸収されるまで人体内の適所に残ることができる。第１４、１５図に示すように、本発明の保持リングは種々の形状に形成することができる。この実施の形態においては、別の形の保持リング６０は好ましくはロッド部材２２を貫通させる開口６４を備えた円形のベース区分６２と、保持リングがロッド部材に沿って末端方向に運動するときにロッド部材２２に押し付けられるように偏倚された一対の脚部材６６とを有する。第１５図に示すように、脚部材６６は好ましくは、シール装置を穴領域内に固定的に保持するための更に別の機構を提供するようにコラーゲン部材２８の基端部分を拡張させる補助を行う。また、前述のことから認識できるように、本発明の閉塞装置、これを配置するための器具、及び、使用方法は、血管内の皮下穴の容易で有効で効率的なシールを可能にする。閉塞装置１８は抗凝血後手続きの継続、血栓剤の積極的な使用、及び大穴のカテーテルの一層安全な使用を許容することができる。また、患者のための不快で複雑なレート(rates)を減少させ、多くの患者内部(in-patient)での手続きを患者外部(out-patient)で安全に遂行できるようにし、介在する手続きの時間及びコストを減少させ、人間の血液に対する病院の人間の接触を減少させるべきである。ここでは本発明の好ましい形態を説明し、図示したが、当業者にとっては、以下の請求の範囲で定義するように、本発明の要旨を逸脱することなく種々の変更及び修正が可能であることは明らかである。例えば、穴の所望の位置での閉塞装置の配置及び保持を容易にするように係留部材及び接近シースを構成する種々の修正が可能である。DETAILED DESCRIPTION OF THE INVENTION Bioabsorbable hemostatic seal assembly Field of the invention The present invention relates generally to an occlusion device, more specifically, an incision or puncture. Can be inserted into an incision or puncture in the patient's body to seal against fluid flow The present invention relates to an improved seal assembly and closure device. Background of the Invention While performing catheterization and other medical procedures, the surgeon can use conventional needles, catheters, Form an opening into a patient's artery, blood vessel, or organ with a tool, introducer, or dilator You. The dimensions of this opening will depend on the type of medical procedure and the dimensions of the catheter used. It depends on the law. For example, catheters and catheters used in standard angioplasty procedures The diameter of the catheter sheath is typically 5-8 French (1. 67 to 2. 67 mm). Used in angioplasty and an increasing number of stent deployment methods The diameter of the catheter and catheter sheath used is about 8 (2. 67mm) or 9 ( 3. 33 mm) French. Used in balloon pump method in aorta The diameter of the catheter and catheter sheath used is typically 14-16 French (4. 67mm to 5. 33 mm), a category used with cardiopulmonary support devices. The diameter of the catheter and catheter sheath is typically 18-20 French (each 6. 0mm to 6. 67 mm). Furthermore, The catheter is While proceeding to the treatment site Twisting or other operations are performed, This allows Incisions or punctures in the patient's body Often this will lead to further expansion. Medical methods are completed, When removing a catheter from an artery or other blood vessel, Obedience The coming method is Until a clot forms The application of external pressure to the entry point. this Many patients treated with these methods Has been given an anticoagulant such as heparin For, The nurse External pressure must be applied to the incision for a long time Absent. The time required to stop bleeding at the incision is Nurse time Will not be used efficiently, Until the thrombus blocks the opening of the artery, Inside the artery Bleeding from Painful hematomas and ugly wounds result. On May 16, 1985, U.S. Patent No. 4, issued to Kurth, 829, 9 In issue 94, A pelvic apron, Apron-like device consisting of a single diameter strap To provide By applying a compressive force to the patient's thigh blood vessels, The above problems Try to solve. This device is The nurse applies direct pressure to the incision Effectively eliminates the need for By using this device, Total femoral artery Reduced blood flow to the body, Thrombosis can occur in weakened patients. Another approach to trying to solve the above problem is As of May 29, 1990 U.S. Pat. No. 4,437,064 to Sinofsky 929, No. 246 disclosed I have. A method using the device disclosed in this patent is: Inflatable bal at its end Adjacent to the outer wall of an artery punctured with a semi-rigid tube having Step. next, Inflate this balloon, On the outer wall of the artery Directly against Apply pressure. next, Optical fiber centered in a semi-rigid tube Laser energy is directed through the basin to the outer wall of the artery, Laser energy is Penetrates the balloon of the butt and semi-rigid tube, The artery is welded by heat and the incision Seal. Yet another approach to solving the above problems is Ken on May 17, 1988 U.S. Patent No. 4, 744, No. 364, Dated August 1, 1989 And related U.S. Patents No. 4, issued to Kensey on January 2, 1990, respectively. 85 2, No. 568 and No. 4, 890, No. 612. First two Kensey patents Is Comprising an elongated tubular body having a mooring member removably disposed therein, Blood vessels An apparatus for sealing a wall opening is disclosed. This tubular body Tubular mooring member Also provided is a protruding device disposed within the tubular body to bias the body into the blood vessel. I have. The retracted suture is fixed to the mooring member, The engagement surface of the mooring member is adjacent to the puncture point Hemostatically engages the inner surface of the blood vessel. Kensey U.S. Pat. 890, On issue 612 , A portion adapted to engage a portion of tissue adjacent to the punctured vessel; Incision Extend through the point, Engages tissue adjacent to the incision, Seal the puncture point An apparatus is disclosed that includes an elongate member having a sealed portion. Kensey and its Subsequent patents granted to others may To the basic approach described above Improvement, as a whole, Suture and collagen to seal the incision and blood vessels It is provided with a mooring member used in combination with the material. U.S. Pat. No. 5,539, issued to Nash and others 411, No. 520 is , An improvement on the basic approach described above, as a whole, Movable along the sewing thread With a certain spacer, A spacer is placed between the mooring member and the collagen member And Seal the puncture site and blood vessel. The spacer is Collagen members and anchors Located between Prevent the collagen member from entering the patient's blood vessels. Granted to Fowler and others and assigned to the assignee of the present invention U.S. Patent No. 5, 108, On issue 421, The vascular plug approach can be used Is disclosed, in this case, A hemostatic closure device is inserted into the patient's incision, Long Using a positioning member such as a balloon-type member or a syringe-type device, Incision point Can be placed within. Granted to Janzen and others US Patent 5, 391, On issue 183, One or more oversized vascular plugs in plunger section Inserted into the incision using a device with a material, Another vascular plug-type approach A method is disclosed. From the above explanation, Blood vessel wall, Securely block puncture or incision in ducts or organs And May shorten the patient's walking time and reduce the risk of hematoma or thrombus formation Considerable effort has recently been made to develop simple and relatively inexpensive means. Has been It is clear that further efforts are needed to satisfy these objectives. Is. Summary of the Invention Therefore, One object of the present invention is to provide Simple structure, Deployment, Easy to operate Solve the disadvantages of the prior art with regard to the safety of existing and / or vascular occlusion devices And a method of using the same. Another object of the invention is Reduce the time needed to seal the incision in the artery, Mosquito After removing the catheter from the incision, Reducing the chance of hematoma formation It is. The above and other objects of the present invention are: Using a device as described below, blood tube, By providing an apparatus and method for sealing an incision in a duct or organ Is achieved. One form of the invention is: Long bioabsorbable rod with anchoring member at its end Preferably, a seal assembly comprising a vascular occlusion device including the member is provided. The clerk The fastening member is After inserting, Prestress is applied to extend laterally from the end of the rod member. While being added, While inserting the occluding device into the incision, Length direction of rod member Preferably, it is flexible enough to match the dimensions. Also, The rod member , A collagen tube extending along a portion thereof, A locking groove, Along the rod member It is also preferred to have a retaining ring slidable in the longitudinal direction. while using it, The seal assembly is An introducer including an introducer or a treatment sheath, Growth Rod and A push rod, An occluding device including a bioabsorbable rod member, Mooring Components, A retaining ring. The introduction device is At first, Placed inside the puncture site And The distal end of the introducer is positioned within the patient's blood vessel, An occluding device is inserted into the puncture site and It is placed through the puncture site. next, Beyond the end of the occlusion device beyond the end of the introducer Push, Whether the mooring member is in the first position substantially parallel to the length dimension of the rod member Et al., Allows movement to a second position approximately perpendicular to the longitudinal dimension of the rod member I do. next, Until the anchoring member contacts and engages the vessel wall adjacent to the incision, Guidance Pull out the nesting and closing device together. next, Collagen for rod members and sealing devices To expose the member to the fluid in the incision, Continue pulling the introductory child. next, Move the cylindrical extension rod of the introducer distally along the rod member seal And Until the retaining ring reaches the locking point or locking groove of the rod member, Lock the retaining ring Push distally along the door member. Of the retaining ring along the rod By movement, A collagen tube is compressed along the rod member and moved distally. And A collagen tube radially expands and is generally adjacent and proximal to the vessel wall Move to the position in the direction. The collagen tube of the occlusion device Ensure that the end of the collagen tube is proximal to the outer surface of the vessel Indeed positioned and substantially extends along the distal portion of the incision or puncture; Collage It is preferred that the tube be dimensioned so that it does not enter the blood vessel and be slightly obtuse. It has a new end. Furthermore, The vessel wall is held between the anchoring member and the collagen tubing It is. One function of the mooring member is Cut the rod member and collagen tube Is to enable convenient and reliable positioning within the puncture point, others , The dimensions and shape of the mooring members Minimize turbulence in fluid flow through the incision, Also, The fluid is selected to be absorbed into the patient in a relatively short time. One advantage of the present invention is that The closure device does not include a suturing member, Occlusion device is substantial Functioning as a single sealing device. Another advantage of the present invention is that The patient's blood vessels, Without substantially obstructing any duct or organ, The anchoring member and guide of the present invention provide for secure positioning of the occluding device substantially along the vessel wall. The ability to use nesting. Another advantage of the present invention is that Without significantly affecting the depth of the puncture site of the patient, Use of the occluding device of the present invention to reliably position the occluding device substantially along the vessel wall That is what you can do. Yet another advantage of the present invention is that Without affecting the function of the device, Almost along the blood vessel wall Of the present invention to reliably position the occlusion device within a puncture site of almost any size. The sealing device can be easily modified. BRIEF DESCRIPTION OF THE FIGURES FIG. Fig. 3 shows the closure device and the extension rod of the present invention, In side view with partial cross section is there. FIG. FIG. 3 is a partial side view showing an access sheath and a bypass member of the present invention. FIG. Partial cut-away view showing a front view of a mooring member of an occlusion device disposed within an access sheath. It is the partial side view made into the front view. FIG. FIG. 9 is an enlarged partial side view of the anchoring member folded within the access sheath. FIG. The anchoring member of the occluding device extends into the puncture path in a state extended from the access sheath. Showing the closing device and the access sheath to open, It is the side view which was made into a partial sectional view. FIG. An anchoring member extending and positioned along an inner wall of a patient's blood vessel; The present invention Showing the seal assembly of It is the side view which was made into a partial sectional view. FIG. The access sheath is removed from the patient, Occlusion device first placed in the incision After being done, 2 shows the closure device and the extension rod of FIG. 1, In side view with partial cross section is there. FIG. FIG. 4 shows an extension rod and a push rod attached to the closure device; Department It is the side view which was made into the sectional view. FIG. Push rod and retaining ring move distally along rod member And The collagen tube is radially expanded along the rod member and displaced distally. After moving 2 shows the closure device and the extension rod of FIG. 1 at the incision point, Partial cut It is the side view made into the front view. FIG. After the rod end has been removed, First placed in the puncture path Was 1 shows the closure device of FIG. It is the side view which was made into a partial sectional view. FIG. 2 shows the extension rod of FIG. It is a side view. FIG. Shows the push rod of the present invention, It is a side view. FIG. FIG. 3 shows the closure device of the invention, It is a side view. FIG. 14A, FIG. 14B, FIG. FIG. 4 shows another form of the retaining ring of FIG. It Front view of each, It is a side view and a bottom view. FIG. Showing the occluding device finally positioned in the puncture path, 14 Showing another form of ringing, It is the side view which was made into a partial sectional view. Detailed description of the invention The present invention In particular, An incision or puncture in a blood vessel such as the patient's femoral artery 10 To seal The use of the present invention is described below. The closing device 16 , Because it is designed to immediately stop the bleeding of the patient's tissues and blood vessels, Seal assembly Body 16 is Injection of angiographic agents, Stent method, Cardiac catheterization, Balloon vessel shape When used in connection with the reconstructive method and other types of recanalization of the atherosclerotic artery Particularly useful. The seal assembly 16 of the present invention includes: Including laparoscopic or similar surgery , It is desirable to seal the incision or puncture to prevent loss of patient fluid. I For use with nearly any catheterization or other medical method You. Furthermore, The closure device 18 of the present invention Laparoscopy, Cardiac endoscopy, Gastroscopy, heart Including visceral treatment methods or similar methods, To prevent patient fluid loss, patient The lumen of the body's blood vessels, It is desirable to place the conduit or target organ securely puncture With almost any catheterization or other medical method or introduction device at the point Can be used. next, Reference is made in detail to some of the drawings, in which like parts are designated by like reference numerals. In light of The combination of components forming the seal assembly is designated by reference numeral 16. Yes, Part of the assembly is Deploying the bioabsorbable occlusion device 18, Percutaneous puncture It includes a variety of non-bioabsorbable devices that seal channel 14. The puncture path 14 is blood Not only the opening in the tube wall, Formed when the method of treatment was performed, Blood vessels and disease It also has a tissue passage disposed between the subject and the skin surface 12. As used herein, The end of one element is Edge of element closest to patient Described as a part, The base of one element is Describe as the element farthest from the patient. To more fully understand and appreciate the present invention, Done through the patient's femoral artery A conventional angiographic catheterization method will be briefly described. In such a way , Angiographic needle (not shown) at a preferred angle of about 25 ° to 45 °, Patient's skin 12 Percutaneously through the epidermal skin layer. Until the needle punctures the femoral artery, This needle To About 6mm to 70mm percutaneously, Insert into the patient's skin. Artery 10 by needle Puncture confirmed by surgeon, About 15 ~ small guide wire (not shown) Insert through the needle a distance of 20 cm. next, Bleeding by applying pressure to artery 10 Restrict, Also, While preventing the formation of hematomas at the puncture site, Use this needle as a guide Pull out along the outside of the sleeve. Dilator (not shown) and outer introducer or catheter A catheter sheath is inserted along the outside of the guidewire, next, That guy Remove dwire from inside dilator. next, Pass the catheter through the treatment sheath Move forward, The treatment is performed in the final desired position. If this action is completed If Remove the catheter, Only the treatment sheath stops at the puncture site, If the user Exchange the source or Or the sheath for treatment of the present invention along the outside of the guide wire Insert into the puncture point, It is inserted into the seal assembly 16 using another conventional method. Enter. For this reason, The treatment sheath used to perform the first treatment less than As explained, The same as the access sheath 20 forming part of the seal assembly 16 Or it can be different. As shown in FIGS. 1 to 11, One preferred form of the invention is as a whole A seal assembly 16 including the access sheath 20 or the treatment sheath 20; With the closing device 18 , A push rod 36 as described below, Extension rod 34, Bypass member 4 And related components such as 2. As illustrated in the drawing, The present invention The closing device 18 of Porous bioabsorbable materials such as polymerized polyacetal acid A generally long and preferably cylindrical rod member 22 comprising , Or Using a polyglycolic acid matrix or similar bioabsorbable material Can also. The distal end 24 of the rod member Mooring member 26 as described in further detail below. It has. Also, The present invention Of the rod member 22 in the proximal direction of the mooring member 26. A tubular collagen member 28 surrounding a portion thereof; Similarly, as described below, It is preferable to include a retaining ring 30 arranged in the proximal direction. Furthermore, Raw Body-absorbent rod member 22, The collagen member 28 and the retaining ring 30 of the occluding device , Formulate to include conventional thrombotics such as tissue thrombogenic agents It is possible, This thrombotic agent Reduce the amount of desired material so that local hemostasis can be accelerated. At least part of it. Also, This thrombotic agent After the surgeon's procedure has ended , Allows patients to keep antithrombotic agents such as heparin. The amount of the closing device 18 is small. At least in part, Contains radiopaque material inside, Conventional visualization means Use, For millet that enables observation of the arrangement of the closing device 18 It can be an option. The use of radiopaque materials Also, Surgery If further medical treatment is needed, Check the position of the occlusion device at a later time Also make it possible. The closure device Three basic bioabsorbable components, That is, Preferably one Or a rod member 22 having a substantially integral intra-arterial anchoring member 26; Tubular core A lagen member 28, It is preferable to have the retaining ring 30. Rod member 2 The base end of 2 By screw or otherwise Connected to a thin elongate rod 34 Preferably. The extension rod 34 First inserted through the access sheath 20 Form part of the seal assembly. Alternatively, The push rod 36 Less than As explained below, Once the access sheath 20 has been removed from the puncture route 14 Although preferably used, The push rod 36 One of the first seal assemblies It may be included as a part. The extension rod 34 While in the access sheath 20, You Extends through the access sheath 20 to allow the user to operate the occlusion device 18. Do The member has a relatively small diameter. The push rod 36 Take the extension rod 34 As enclosed and described in detail below, Hold ring 30 along rod member 22 Used to push distally, It is a member with a larger diameter. Extension rod 34 and And the push rod 36 After placing the occluding device in the puncture path 14, Remove Left For this reason, Conventional catheter-type materials such as PVC or similar polymeric materials It can be manufactured from materials. The rod member 22 is In the form of a preferably cylindrical and generally long cylindrical member You are. For example, This rod member Lactide and glycoloid polymers or May further comprise at least a portion of a hemostatic promoting and / or radiopaque material. Preferably, it is a hemostatic and resorbable material, such as a similar material that can be used. Lot In one form of the arm member 22, Dispose the lip member in the proximal direction of the mooring member 26 And To provide resistance to the passage of collagen member 28 thereover. Can be The length and diameter of the rod member 22 are Occlusion device 18 in puncture path And easily inserted through the puncture path 14, Quick puncture path 14 and vessel wall It is selected so that it can be sealed. The mooring member 26 is long, Be a relatively rigid, low-profile resorbable material Is preferred. This resorbable member Movement of the puncture site 11 approximately adjacent or adjacent It is positioned to sit in the artery against the vein wall. The mooring member 26 is Lot Preferably, it is molded as part of the distal end 24 of the Also, Resorbable Like the rod member 22, Or made of a compatible non-hemostatic resorbable polymer Preferably. The collagen member 28 Non-allergic like collagen sponge or foam material Preferably in the form of a long tubular member made of a resorbable, hemostatic, hemostatic material. No. The retaining ring 30 Along the rod member 22 in the proximal direction of the collagen member 28, Preferably, it is a relatively small member slidably arranged, Also, Easy Made of molded resorbable polymeric material such as tide / glucotide copolymer Preferably. The outer diameter of the retaining ring 30 is Larger than the outer diameter of the extension rod 34 And As explained below, Push rod 26 attaches retaining ring 30 to rod member Preferably, it may be possible to allow it to move distally along 22. Forming a reinforcing suture 32 or other material into the distal portion 24 of the rod member 22; It is possible to reinforce the mooring member 26 and connect the mooring member 26 to the rod member 22. Wear. The interconnection between the mooring member 26 and the rod member 22 Mooring member 26 Serves to provide a pivot point for opposing movement. This interconnect is Mooring member 2 6 to be able to move from the insertion position and the laterally oriented position. Is preferably formed. At this insertion position, The mooring member 26 is a rod portion Aligned with the longitudinal dimension of the material 22, Also, In this laterally oriented position And The mooring member 26 is Extending laterally from the distal end 24 of the rod member 22, Engage with vessel wall. The collagen member 28 is slidably disposed along the rod member 22. Placed, Push rod 36 and retaining ring 30 extend distally along rod member 22 By moving in the direction, Collagen member 28 is compressed and collagen member 28 Expand radially along rod member 22 and move distally. Change To As can be understood from the following description, The entire closure device Postoperative puncture location Reduce complications, Seal the puncture point securely, Allowing the patient to walk faster, inflammation Minimize sexual response and, for example, 60 to 90 days, Completely relaunch in a relatively short time The design is such that it can be absorbed. According to the following general description of how to use the occluding device 18 of the present invention, Blood vessels After the internal procedure is completed, An occlusion device 18 is used. According to the method of the present invention, Contact The proximal sheath 20 can be replaced with a treatment sheath using conventional catheter replacement methods, or Is left in the artery, This treatment sheath is used as the access sheath 20. You. next, The position of the distal end of the access sheath 20 is inside the blood vessel and the puncture path 14 is slightly Confirm that it extends beyond Closure device 18 is pre-inserted into access sheath 20 And Or then: Inserted into the access sheath 20, The extension rod 34 is Extend from the proximal end. next, Closure device 18 distally within access sheath And the access sheath 20 remains fixed relative to the patient's skin surface 12. While doing By moving extension rod 34 distally relative to access sheath 20 , The occluding device is partially deployed (projected) from the distal end of the access sheath 20. Extension b When the pad 34 moves further distally relative to the access sheath 20, Mooring member 26 and b A portion of the pad member 22 is pushed out of the distal end of the access sheath 20 and into the lumen of the artery. Be expanded. As the mooring member 26 advances from the distal end of the access sheath 20, Of the mooring member 26 Direction Since the proximal end of the mooring member 26 advances beyond the distal end of the access sheath, Rod member 22 with respect to the longitudinal dimension. The preferred biasing force of the mooring members is As a result, The mooring member 26 pivots to move laterally from the distal end 24 of the rod member 22. Elongate in the opposite direction. next, Until you feel resistance By pulling out the extension rod 34, Closure The device 18 is withdrawn relative to the access sheath 20. The mooring member 26 is moved to the approach sheath 20. Resistance occurs when contacting the ends of the Once this condition occurs (also , When the mooring member 26 contacts the distal end of the access sheath 20, Mooring members are accurate Direction), The access sheath 20 and the extension rod 34 together, Withdraw a short distance from the patient's skin 12. This drawer for the puncture point Or by the movement in the proximal direction, The anchoring member 26 is located on the arterial wall adjacent to the puncture path Engage contact. next, The access sheath 20 is placed against the patient's skin and the extension rod 34 Pull out. The access sheath can be moved proximally relative to the patient's skin 12 and occlusion device. And by Rod member 22, The collagen member 28 and the retaining ring 30 are used for the puncture path. It is exposed to the tissue within 14. Then Position the push rod 36 on the seal assembly; Extension rod 34 And a part surrounding the rod member 22. Then Push rod 36 Is moved distally with respect to the extension rod 34 and the rod member 22, Rod member Push retaining ring 30 distally along 22; Place the collagen member 20 in the hole To the wall of the artery adjacent to. End of retaining ring 30 along rod member 22 Movement toward the end also Effect of deforming the collagen member 28 into a collagenous mass Have fruit, Preferably, Collagenous mass is larger than the diameter of the hole in the vessel wall Having. This expansion of the diameter of the collagen member Another to extend the puncture path 14 Without the need for procedures or steps, Hold occlusion device 18 in place in blood vessels and holes Assist in holding. As shown in the figure, The installed occluding device is used to connect the vessel wall to the anchoring member 26. And the collagen member 28. Furthermore, Collagen member 28 is preferred Is formed by compressed collagen, Preferably, Collagen part The materials are When placed, Inflated by the presence of fluid or blood in the puncture path 14 , It further contributes to the radial expansion of the collagen member 28. Extension rod 34 And pushing rod 36 distally with respect to rod member 22, Holding phosphorus Until the lock 30 encounters the locking member 38. The retaining ring 30 extends along the rod member 22 Moved The locking member is located at the diameter or circumference of the end of the groove or rod member 22. To Other changes can be made. Push rod 36, Retaining ring 30 and locking part The material 38 is collaged to provide a quick seal and hemostasis in the puncture path 14. Serving as an immediate tamper for the component 28. The retaining ring 30 is the locking member 3 After reaching 8, Disconnecting the extension rod 34 from the proximal end of the rod member 22 Can be Remove the extension rod 34 and the push rod 36 from the puncture path 14. Can be. here, The closure device 18 is maintained in the desired position; Pair of patients around occlusion device Natural shrinkage of the weave, Due to the initial clotting action of the patient and the expansion of the hemostatic collagen member 28 And The wall of the blood vessel is clamped between the collagen member 28 and the anchoring member 26. Obedience What The wall of the artery is sandwiched between the collagen member 28 and the anchoring member 26, Hole area and Fluid flow through the pit is stopped by physical and physiological effects. A few hours after placement Within a minute, The mooring member 26 is covered with fibrin, Therefore, it is firmly attached to the wall of the artery. Attached Minimize the potential for end emboli. Furthermore, Rod member 22 and mooring part The preferred use of reinforcing sutures or similar members within the material 26 The mooring member 26 is locked Further reduces the undesired potential that may be separated from the distal end 24 of the Reduce. During preclinical testing of similar mooring members, Tiny deposits on mooring material almost 30 days It remains later along the walls of the blood vessels. fact, Resorption of all elements of the closure device 18 (resor ption) appears to occur after approximately 60 days. Therefore, Resorbable mooring Has meaningless blood flow effects on blood flow, Complete absorption in a relatively short period of time While being A function that assists in the reliable positioning of the remaining elements of the closure device described above Fulfill. As will be appreciated from the following more detailed description of the elements of the invention, Approaching sheath 2 The arrangement of the preferred form of occlusion device 18 using 0 is easy, Quick and Trust There is. The anchoring and arrangement of the collagen member 28 For faster patient movement Without the need for external pressure to allow Repeatable, Safe and effective It is. If the closing device 18 is properly arranged, Hemostasis is almost instantaneous, For example, 15 seconds Likely to occur within. The collagen member 28 Plainsboro, New Jersey Colla-Tec Inc. ), Preferably such as those sold by Has a cylindrical, tubular member made of shrinkable, resorbable collagen foam You. The collagen member 28 is arranged so as to be compressed from a large diameter shape to a small diameter and elongated shape. The small diameter shape is positioned along the rod member 22 on the proximal side of the mooring member 26. And inserted into the access sheath 20. The collagen member 28 is compressed and the access sheath is In the shape inserted in the collagen member 20, the collagen member 2 along the rod member 22 is used. The additional diameter of 8 is very small and therefore suitable for placement in the access sheath 20 I have. The length of the collagen member 28 is preferably the length of the hole proximal to the vessel wall. That is sufficient to seal a substantial portion of the It is sufficient to prevent bleeding in the hole area resulting from tubular bleeding. The mooring member 26 is basically a Medisorb Technologies International Le L.P. (Medisorb Technologies International L. P. ) Resorbable lactide / glycolide weight sold under the trade name “ISORB” Consists of a thin, narrow strip or bar of resorbable material, such as coalescing. Story The tip is rigid enough to resist deformation when in place with respect to the artery. And eliminates bending back through the puncture path 14 that was initially introduced. Mooring department The material 26 preferably has a substantially flat top surface, a substantially flat bottom surface, and a rod member 22. And a centrally located surface pivotally attached to the distal end 24 of the slab. Each end of the mooring member 26 Is preferably rounded. The centrally located surface of the mooring member 26 is preferably Includes a hemispherical protrusion located at the center of the top surface. Hemispherical protrusions preferably penetrate And having a reinforcing suture 32 extending therethrough and a molded suture therein. A longitudinally extending slot located perpendicular to the top surface of member 26. Mooring The overall shape of member 26 is such that it does not pull back through the vessel and The anchoring member 26 first penetrates the vessel wall without significantly impeding blood flow To be able to enter the blood vessel. In this connection, preferably the mooring member A biased and transversely extending connection between the rod member 2 and the rod member 22 is shown in FIG. 2 and during the molding of the anchoring member 26, preferably a relatively rigid sewing It is further reinforced by using the combination yarn 32. The preferred form of the access sheath 20 will now be described in detail. Approach as shown The sheath 20 basically comprises a conventional catheter introducer, which is a polyethylene introducer. Elongated tube 40 made of a somewhat flexible material such as ren or polyvinyl chloride And whether or not there is some curvature of the elongated tube 40 The occluding device 18 is free to pass through the access sheath 20 and into the working position in the patient's artery. So that According to a preferred embodiment of the present invention, the outer diameter of the access sheath 20 is approximately 8 French. It is a french. The reason is that most related procedures are 8 French This is because the source is used. The choice of an 8 French access sheath is preferred for the present invention. It is to be understood that this is for the purpose of illustration when describing the form. Other dimensions can be easily selected within the scope of the invention. The proximal end of the access sheath 20 is Occlusion device 18 and a conventional hemostasis valve (not shown) formed at the end of base 20 And a rigid funnel-shaped viper inserted or mounted so that the extension rod 34 can be inserted. S member 42. The end of the elongated tube 10 is preferably normal Of the anchoring member 26 to facilitate the pivotal movement of the mooring member 26, which will be described later. To indicate the desired alignment of the anchoring member 26 with respect to the distal end of the access sheath 20 A longitudinally extending slot 44 may be included. As shown in the drawings, the extension rod 34, the bypass member 42 and the push Rod 36 provides a visual indication that a step in the insertion of occlusion device 18 has been completed. Includes various signs and protrusions to provide a user with a tactile and tactile display. The above As described above, the elongated rod 34 is detachably attached to the proximal end of the rod member 22. It is a long member. The length of the extension rod 34 is such that the mooring member 26 of A finger gripping area on the proximal end of the extension rod 34 when extended beyond the distal end of the sheath 20 46 is selected to extend near the proximal end of the access sheath 20. Furthermore, a pair of A circumferential band 48 is located on the extension rod 34 at the distal end of the finger gripping area 46 . The proximal circumferential band 48 is formed by the proximal circumferential band 48 approaching the sheath 2. When the bypass member 40 positioned within the proximal end of the Informs the user that the anchoring member 26 has extended beyond the distal end of the access sheath 20. Used for The extension rod 34 also terminates in a pair of circumferential bands 48. With another circumferentially elongated band 50 located on the proximal end of the elongate rod 34 on the side That the retaining ring 30 has reached the locking member 38 on the rod member 22. Notify user. Finally, the bypass member 42 is preferably a slot or alignment mark 4 4, which can be aligned with slots 52 on the distal end of the access sheath, Person Covers the anchoring member 26 when the occluding device is inserted into the proximal end of the access sheath 20. By aligning the mooring member 26 with the slot or marker 44 on the It can be easily aligned with the slot 52 on the distal end of the access sheath 20. bypass The member 42 has a peripheral portion located diametrically opposite a desired position of the mooring member 26. Can have another reference detent (not shown), which is The central longitudinal axis of the closure device 18 for insertion into the access sheath 20 as described below. A visual aid to assist in orienting the closure device 18 at an appropriate yaw angle with respect to the line. Acts as an id. In a preferred use of the present invention, the access sheath 2 is placed before the occluding device 18 is deployed. Insert through the 0 end. In particular, the mooring member 26 extends in the longitudinal direction of the rod member 22. For temporarily changing the orientation of the mooring member 26 from transverse to longitudinal in terms of dimensions Before use, it is inserted into the bypass member 42. Therefore, closing into the hole area and hole During the initial insertion of the occluding device 18, the anchoring member 26 is connected to the elongated tube portion of the access sheath 20. Located longitudinally within minute 40. Collagen member 28 is moored longitudinally Proximal to member 26 is located within elongated tube portion 40 of access sheath 20. Change In addition, the distal end 24 of the rod member 22 is preferably located above the proximal end of the anchoring member 26, The overall diameter of the distal end 24 of the rod member 22 and the longitudinally located mooring member 26 is The diameter of the rod member 22 is substantially equal to the diameter of the proximal end side thereof, and The diameter is smaller than the diameter of the portion of the rod member 22 having the connecting member. As can be seen from FIG. 2, the access sheath 20 is preferably at its proximal end a conventional It has a luer attachment side port. The bypass member 42 is preferably a luer Sized to extend into the opening of the fitting and over the proximal end of the access sheath 20 during the procedure. To maintain the hemostasis valve open by any suitable means, such as frictional contact. It is a funnel-shaped member fixed in place. Positioning of the access sheath 20 within the artery may be accomplished by blood flow or with the vessel wall. Arterial positioning device or obturator that locates the arterial wall by physical contact This can be achieved by using an obturator. Instead, less preferred Although not necessary, the depth of the hole is physically measured, and then various markers on the access sheath are And / or using a selected access sheath having a specific length. To move the access sheath 20 to an appropriately measured depth of the hole. be able to. After positioning the access sheath 20 in the artery, the cock stopper is opened and The flow of blood from here can be observed (the entrance port or window is located in the artery Make sure you do). Then the blood flow through the stopcock just stops The access sheath 20 is pulled back (moved in the proximal direction) until the distal end of the access sheath moves. Indicates that you have just left the pulse lumen. Then the approach sheath 20 is re-inserted about 10 mm into the hole and the distal end of the access sheath 20 is Guarantee to come to. Make sure that the elongated tube 40 is not kinked or blocked At this point, blood flow through the stopcock should be reestablished to assure . Then, the cock stopper is closed. From this point, the access sheath 20 is in the puncture path 14 The access sheath 20 to ensure that it does not move distally or proximally at It must be fixed with respect to the patient's skin 12. Then to open the hemostasis valve Insert bypass tube 42 into the proximal end of access sheath 20. Then the closing device Is inserted into and aligned with the bypass member 42, and the mooring member 26 extends transversely. Diverted from the vertical position to the longitudinal position. Next, the closing device is connected to the bypass member 42. Over the distal end into the access sheath 20. The slot or marker 44 on the bypass tube 42 is identified by the user and the user Grasps the bypass tube 42 so that the slot or marker faces up and away from the patient Orientation. This alignment ensures that the mooring member 26 is positioned toward the patient. Testify. The rigid nature of the bypass tube 42 allows passage of the occlusion device through the hemostasis valve And the mooring member 26 is oriented longitudinally with respect to the rod member 22. And protects the closure device 18 from damage. Then, the closing device 18 and the extension rod 3 4 is pushed sufficiently below the access sheath 20 and extends proximally on the extension rod 34 in a circumferential direction. Directional band 48 aligns with bypass member 42 on the proximal end of access sheath 20. The distal end of the occluding device 18 is aligned with the end of the access sheath, and the anchoring member 26 is inserted into the artery. Inform the user that it is positioned and extends beyond the distal end of the access sheath 20. Next, the seal assembly 16 is operated to check whether the mooring member 26 is properly arranged. To decide. For that purpose, the approximation sheath 20 provides axial and rotational movement. The closure device 18 continues to be held by the user in a blocking manner and the access sheath 20 and Carefully pulled back with respect to the patient's skin 12. By this action, the mooring member 26 Engages and captures the distal end of the access sheath 20. Mooring member 26 is approach sheath 2 The user feels resistance when the zero end is caught. This resistance is due to the extension rod 34 An upper distal circumferential band 48 is visible along the bypass member 42. Must be acknowledged by a certain time. When the resistance is felt, the mooring member 26 At the position of the hemispherical projection on 26, the distal end of the access sheath 20 has been captured. You. If no resistance is felt, the mooring member 26 is not located and is pulled back again. Before closing, the closure device 18 is turned by a quarter turn around its axis to either side. The insertion sequence described above must be repeated. The distal circumferential band 48 becomes visible above the bypass member 42 If you feel resistance before, this means that only one end of the anchoring member 26 is Trapped on the end of 0, indicating that an undesirable result has occurred. Therefore, The device 18 is reinserted into the access sheath 20, this time with respect to the access sheath 20. Rotate the closure device 18 a quarter turn around its axis to either side before being returned By turning only, the above procedure must be performed again. After the mooring member 26 is properly positioned in the transversely extending orientation (FIG. 5), The sheath 20 and the closure device 18 are held together and pulled out of the hole as a unit. During which the unit is swung vertically. By this action, the mooring member 26 Engage or capture the inner surface of artery 10 adjacent puncture path 14. Then The access sheath 20 is removed. As long as the anchoring member 26 stays inside the artery wall, By removing the sheath 20, the rod member 22 and the collagen member 28 are punctured. It is exposed to fluid and blood present in the tract 14. Access sheath 20 exits hole area And a continuous, stable to ensure that the mooring members 26 are properly positioned. Resistance must be felt on the rod member. At this point, the anchoring member 26 has been positioned along the wall of the blood vessel 10 and The collagen member 28 is located within the puncture path 14 proximal to the wall of the artery. at the time Then, the push rod 36 is set on the extension rod, and the collagen member 28 is pushed. The distal movement of the shroud 36 moves distally within the puncture path 14. . In particular, the user moves the retaining ring 30 distally along the rod member 22. The push rod 36 is gently moved in the distal direction so that The compression member 28 is compressed. Push rod 36 and retaining ring 30 The holding ring 30 is manually slid below the rod member 22 so that the push ring is Do The locking member 3 as informed to the user by the colored band 50 reaching the base end of 36 The retaining ring 30 is moved distally within the puncture path 14 until it engages 8. This movement of the retaining ring 30 causes the collagen member 28 to move to the desired position of the puncture path 14. Move distally to position. Quiet distal movement will achieve the desired result I.e., the distal portion of the collagen member 28 fits outside the blood vessel adjacent the hole. And hemostasis (which occurs very quickly and requires additional closure of the occlusion device in place). Lock the collagen member 28 and the anchoring member 26 in place until Is enough to assist. End of retaining ring 30 and collagen member 28 The action does not push the collagen member 28 into the interior of the blood vessel during end-to-end movement To ensure that the load is greater than the load used on the push rod 36. Care must be taken to maintain tension on the padding member 22. When the retaining ring 30 reaches and engages the locking ring 38, the extension rod 3 4 is rotated or operated with respect to the rod member 22 to extend the extension rod 34 into the rod portion. It can be separated from the material 22. Instead, the length of the rod member 22 is The proximal portion of the arm member 22 extends beyond the skin level of the patient. Then, the rod member 22 is cut, and the rod member 22 is Can be separated from Next, the extension rod 34 and the push rod 36 And cut off any part of the rod member 22 extending above the retaining ring 30. can do. Then, preferably, the occlusion device 18 allows for complete hemostasis. This state is maintained without interruption for a few minutes. After this time, The patient's condition can be assessed and the patient moves around and excretes as determined by the doctor. Or you can. When the closing device 18 is in the final sealing position, the mooring member 26 (part of the closing device) Only located within the blood vessel) does not block a substantial portion of the interior of the blood vessel, Does not block or obstruct the flow of blood through. All elements of the closure device 18 can be resorbed Is made of a functional material, the occlusion device 18 will remain in the human body until it is absorbed. Can stay in place. As shown in FIGS. 14 and 15, the retaining ring of the present invention can be formed in various shapes. Can be. In this embodiment, another form of retaining ring 60 is preferably A circular base section 62 having an opening 64 through which the rod member 22 extends; Pushes against the rod member 22 as it moves distally along the rod member. And a pair of leg members 66 biased so as to be shifted. As shown in FIG. The leg members 66 are preferably further provided for securely holding the sealing device in the bore area. Assists in expanding the proximal portion of collagen member 28 to provide another mechanism. U. Also, as can be appreciated from the foregoing, the occlusion device of the present invention, and placement thereof Device for use and method of use for easy, effective and efficient sealing of subcutaneous holes in blood vessels Enable. The occluding device 18 can be used for continuation of anticoagulant procedures, active use of thrombotics, And safer use of large-bore catheters. Also, the patient Reduces unpleasant and complex rates for many patients in-patient Procedures that can be safely performed outside the patient (out-patient) Time and costs, and reduce hospital human contact with human blood. Should be done. Although the preferred embodiments of the present invention have been described and illustrated herein, those skilled in the art will recognize the following. Various modifications may be made without departing from the spirit of the invention, as defined in the following claims. Obviously, and modifications are possible. For example, a closure device at a desired position of a hole Various anchoring members and access sheaths are configured to facilitate placement and retention of the device. Modifications are possible.

───────────────────────────────────────────────────── フロントページの続き (81)指定国ＥＰ(ＡＴ，ＢＥ，ＣＨ，ＤＥ，ＤＫ，ＥＳ，ＦＩ，ＦＲ，ＧＢ，ＧＲ，ＩＥ，ＩＴ，ＬＵ，ＭＣ，ＮＬ，ＰＴ，ＳＥ)，ＯＡ(ＢＦ，ＢＪ，ＣＦ，ＣＧ，ＣＩ，ＣＭ，ＧＡ，ＧＮ，ＭＬ，ＭＲ，ＮＥ，ＳＮ，ＴＤ，ＴＧ)，ＡＰ(ＧＨ，ＧＭ，ＫＥ，ＬＳ，ＭＷ，ＳＤ，ＳＺ，ＵＧ，ＺＷ)，ＥＡ(ＡＭ，ＡＺ，ＢＹ，ＫＧ，ＫＺ，ＭＤ，ＲＵ，ＴＪ，ＴＭ)，ＡＬ，ＡＭ，ＡＴ，ＡＵ，ＡＺ，ＢＡ，ＢＢ，ＢＧ，ＢＲ，ＢＹ，ＣＡ，ＣＨ，ＣＮ，ＣＵ，ＣＺ，ＤＥ，ＤＫ，ＥＥ，ＥＳ，ＦＩ，ＧＢ，ＧＥ，ＧＨ，ＨＵ，ＩＬ，ＩＳ，ＪＰ，ＫＥ，ＫＧ，ＫＰ，ＫＲ，ＫＺ，ＬＣ，ＬＫ，ＬＲ，ＬＳ，ＬＴ，ＬＵ，ＬＶ，ＭＤ，ＭＧ，ＭＫ，ＭＮ，ＭＷ，ＭＸ，ＮＯ，ＮＺ，ＰＬ，ＰＴ，ＲＯ，ＲＵ，ＳＤ，ＳＥ，ＳＧ，ＳＩ，ＳＫ，ＳＬ，ＴＪ，ＴＭ，ＴＲ，ＴＴ，ＵＡ，ＵＧ，ＵＳ，ＵＺ，ＶＮ，ＹＵ，ＺＷ────────────────────────────────────────────────── ─── Continuation of front page (81) Designated countries EP (AT, BE, CH, DE, DK, ES, FI, FR, GB, GR, IE, IT, L U, MC, NL, PT, SE), OA (BF, BJ, CF) , CG, CI, CM, GA, GN, ML, MR, NE, SN, TD, TG), AP (GH, GM, KE, LS, M W, SD, SZ, UG, ZW), EA (AM, AZ, BY) , KG, KZ, MD, RU, TJ, TM), AL, AM , AT, AU, AZ, BA, BB, BG, BR, BY, CA, CH, CN, CU, CZ, DE, DK, EE, E S, FI, GB, GE, GH, HU, IL, IS, JP , KE, KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MD, MG, MK, MN, M W, MX, NO, NZ, PL, PT, RO, RU, SD , SE, SG, SI, SK, SL, TJ, TM, TR, TT, UA, UG, US, UZ, VN, YU, ZW

Claims

[Claims] 1. An incision or hole in the patient's body is made through the patient's tissue through the patient's blood vessels, conduits. Or in an assembly for sealing an incision or hole extending into the lumen. , A first physiologically absorbable material formed of a patient's blood vessel, conduit or lumen; An anchoring member having dimensions such that it is positioned within; An elongated member formed of the first physiologically absorbable material; A compressible member formed of a physiologically absorbable material, wherein said compressible member is Positioned slidably along the member, and combined with the first member, the incision A compressible member that cooperatively seals the pit from the fluid flow; An assembly comprising: 2. 2. The assembly according to claim 1, wherein said elongated member is rod-shaped. A member, wherein the first physiologically absorbable material of the elongate member is a patient. An assembly further comprising a hemostatic propulsion material that can be absorbed into the body. 3. 2. The assembly of claim 1, wherein said assembly slides along said elongated member. An assembly further comprising a freely positioned ring member. 4. 4. The assembly according to claim 3, wherein said elongate member is disposed thereon. An end and a proximal end portion, wherein the ring member contacts the compressible member and is elongated. Elongate member for sliding the compressible member distally along the member. The ring member frictionally engages at least a portion of the elongated member. An assembly for engaging. 5. 4. The assembly according to claim 3, wherein said ring member is said first member. An assembly formed of a physiologically absorbable material. 6. 4. The assembly according to claim 3, wherein said ring member is made of a rigid material. An assembly formed by: 7. 4. The assembly according to claim 3, wherein said ring member is elongated. An assembly, at least partially surrounding a portion of the member. 8. 4. The assembly according to claim 3, wherein said ring member is said compressible. An assembly located at the proximal end of the functional member. 9. 2. The assembly of claim 1, wherein said compressible member comprises said thin member. A tubular collagen member inserted into an incision or hole along a long member An assembly characterized by the above. 10. 2. The assembly according to claim 1, wherein said anchoring member is a patient's blood vessel. The elongate member is dimensioned to be operatively positioned within the incision or hole. The compressible member sized to be operatively positioned therein, and wherein the compressible member is The retainer, the elongate member and the compressible member allow the blood from the blood vessel to be incised or The elongate portion so as to operatively seal the incision or hole without passing through the hole. An assembly extending along the material. 11. 11. The assembly according to claim 10, wherein said anchoring member is a patient's blood. A compressible member sized to be positioned along an inner surface of a tube wall; The elongate member having a dimension such that the elongate member is positioned along an outer surface of a vessel wall. Have dimensions such that they are positioned between the anchoring member and the compressible member. An assembly, characterized in that: 12. The patient's body extending from the patient's skin, through the walls of the blood vessels, and into the patient's blood vessels An assembly for sealing the holes of Comprising a closing device, wherein the closing device is Formed in a physiologically absorbable material and located within the patient's blood vessels substantially adjacent to the hole A first member having dimensions as set; The first member is formed of a physiologically absorbable material and has a small number of holes in a proximal direction from the first member. A second member sized to extend at least through a portion; Formed of a physiologically absorbable material, slidable along the second member, First, the patient to operatively seal the hole so that blood flow does not flow through the hole Consisted of a tubular member dimensioned to extend along the outer surface of the vessel wall A third member; An assembly comprising: 13. 13. The occlusion device according to claim 12, wherein the first member and the upper member are connected to each other. The second member is formed of a substantially rigid, physiologically absorbable material. And closing device. 14． 13. The occlusion device according to claim 12, wherein the third member is a blood vessel. Compressible slidable distally along the elongate member to a position adjacent to the outer wall of the An occlusion device characterized by being a collagen member. 15. 13. The assembly according to claim 12, wherein said closure device is penetrated. An access sheath having a proximal portion having a bypass member therein capable of passing therethrough. An assembly characterized by the following. 16. 13. The assembly according to claim 12, further comprising an access sheath, A second member has a longitudinal axis, and the first member is provided by the closure device when the access member is closed. When positioned in a space, oriented substantially parallel to the longitudinal axis, It is characterized in that it is substantially perpendicular to the access sheath upon removal from the access sheath. Assembled assembly. 17． 17. The assembly according to claim 16, wherein said first member is connected to said first member. Biased in a direction such that the two members are oriented substantially perpendicular to the longitudinal axis. An assembly characterized in that it is formed as follows. 18. 13. The assembly according to claim 12, wherein said closure device is penetrated. Having a proximal portion having a substantially funnel-shaped bypass member therein. An assembly comprising an access sheath. 19. A patient extending substantially from the patient's skin through the wall of the blood vessel and into the patient's blood vessel In a method for sealing a hole formed in a human body, A seal assembly having an access sheath and a physiologically absorbable seal device is Inserting into the hole formed in the blood vessel and the blood vessel of the patient; Place the occluding device in the access seal so that the distal portion of the occluding device is located within the vessel. Pushing through the holes and into the holes and blood vessels; The distal portion of the occluding device may extend transversely from the rest of the occluding device. And the step of allowing Traverse the occlusion device until the positioning member contacts a predetermined portion of the inner wall of the blood vessel Withdrawing the directional extension from the blood vessel; Push the push rod along the proximal end of the closing device to close the retaining ring. Move it into the locking ring on the occluding device and seal the hole to prevent blood flow through the hole. The process of A method comprising: 20. 20. The method according to claim 19, wherein the retaining ring is moved into the hole. Moving the distal end of the physiologically absorbable member to a position substantially adjacent to the vessel wall The method further comprising causing a directional movement. 21. 20. The method according to claim 19, wherein a table on the push rod is provided. The indicator reaches a predetermined position associated with the access sheath and the retaining ring closes. Push rod until it indicates that it has reached the desired position along the occlusive device. Pushing along a proximal portion of the occluding device. . 22. 20. The method according to claim 19, wherein the device along the occlusion device. Move the tubular collagen member along the occluding device in response to movement of the retaining ring The patient's vessel wall between the collagen member and the distal end of the occluding device. A method comprising the further step of squeezing. 23. 20. The method according to claim 19, wherein the marker associated with the occluding device is included. Knowledge reaches a predetermined location on the access sheath and the distal portion of the occlusion device is Until the user is informed that it has extended beyond the distal portion of the proximal sheath, Moving the access sheath into the access sheath.