JP5296757B2 - 液体塞栓組成物の注入制御装置 - Google Patents

液体塞栓組成物の注入制御装置 Download PDF

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JP5296757B2
JP5296757B2 JP2010214921A JP2010214921A JP5296757B2 JP 5296757 B2 JP5296757 B2 JP 5296757B2 JP 2010214921 A JP2010214921 A JP 2010214921A JP 2010214921 A JP2010214921 A JP 2010214921A JP 5296757 B2 JP5296757 B2 JP 5296757B2
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aneurysm
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アンドリュー・エイチ・クラッグ
ブレア・ディ・ウォーカー
ジョン・パール・Ｉｉ
マイケル・ジョーンズ
ジョージ・ロバート・グリーン
ジョージ・ウォレス
リチャード・ジェイ・グレフ
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コヴィディエン リミテッド パートナーシップ
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Description

本発明は、液体塞栓組成物の患者への注入を制御する装置に関するものであり、特に、凝固中及び凝固後の液体塞栓組成物の閉じ込め及び束縛のための装置に関するものである。制御注入装置は、制御された方法で塞栓組成物の送り込みに使用されるカテーテルシステムに組み込まれてもよい。
多くの臨床的状況において、出血の制御若しくは防止、組織への血液の供給の防止、動静脈奇形（ＡＶＭｓ）の処置、及び、動脈瘤内の血液流の遮断等の種々の目的で、血管を選択的に閉塞されるのは望ましい。所定のポリマー組成物、微粒子、及び／又は、シリコーンバルーン、金属コイル、ＰＶＡ粒子、ゼラチン等を含む硬化材料を使用することによって、血管の塞栓を実施し、血管中の血液の流れを選択的に遮断してきた。しかしながら、これらの塞栓法は欠点を有する。
頭蓋内動脈瘤は血液が異常に詰め込まれた血管壁の膨張であり、このために、多量の出血して血管が破裂したり、周囲の脳組織へ損傷若しくはその死へとつながる。従来、頭蓋内動脈瘤は、切り取られる動脈瘤のネックの回りに金属クリップを取り付けて動脈瘤へ血液が流れ込むのを防止することによって、破裂の危険を低減するように手術で切り取られてきた。しかしながら、動脈瘤の位置及び形状に起因して、又は、患者の状態が頭蓋の手術を許さないため、多くの動脈瘤は外科的に取り扱うことはできない。
動脈瘤が外科的に扱うことができないか、又は、手術が危険すぎるか若しくは侵襲的過ぎるときには、動脈瘤はコイルを用いて血管内で処置してもよい。内部聴診法によって動脈瘤のサイトにカテーテルを延ばし、かつ、白金、ステンレス鋼若しくはタングステンのコイルのような単一の若しくは他の多重の金属コイルをカテーテルを介して動脈瘤に通すことによって、コイルを動脈瘤に設置する。動脈瘤内に設置されたコイルは、動脈瘤を塞ぐ血栓を形成し、血液が動脈瘤に流れ込むのを防止する。コイルを用いて頭蓋内動脈瘤を処置することによって、動脈瘤を動脈循環から孤立させ、破裂及び動脈瘤のの防止に役立つ。しかしながら、頭蓋内動脈瘤を処置するために金属コイルを使用することは永久的な解決にはならない。というのは、血液凝固機能の動的な性質のためにコイルの回りの血液凝塊（クロット）は溶解若しくは分解するからである。一旦、血液凝塊が動脈瘤溶解に置いてコイルの回りに形成されると、コイルはもはや動脈瘤を塞ぐ機能を発揮し得ない。また、コイルは動脈瘤から除去され、移動し、又、患者の血液の流れに入って、血管系内の他の位置で閉塞を生じさせてもよい。コイルは、望まない塞栓の下流への流れを生ずる血液の流れへ延びるループも形成できる。
動脈瘤を塞ぐためのコイルの使用に関連する他の欠点は、コイルが長時間にわたり圧縮することが公知であり、その後の動脈瘤の成長のためのキャビティを残る。また、その後の外科的なクリッピング処置が保証されると、コイルの塊の上にクリップを配置することが難しくなり得る。
動脈瘤を処置する他の方法には、シリコーンバルーンで動脈瘤を閉塞すること、あるいは、特別の材料で動脈瘤を充填することが含まれる。
大きなネックを有する動脈瘤は、外科的なクリッピングによって、又は、コイルによって容易に処置されない。というのは、動脈瘤ネックは外科的に完全にクリップすることができない形状を有するか、又は、ネックが特に大きいときにはコイルが動脈瘤から押しのけられる傾向があるからである。
外科的クリッピング及びコイル技術を用いて問題を扱う頭蓋内動脈瘤を処置する一の最小の侵襲性の方法には、動脈瘤を閉塞するために動脈瘤において凝固する液体塞栓組成物の血管内注入を含む。通常、液体塞栓組成物は生体適合性溶剤で溶解する、水不溶性、生体適合性、非生物分解性のポリマーを含む。一旦、液体塞栓組成物を動脈瘤に注入すると、生体適合性溶剤は血液に放散していき、ポリマーは凝固して動脈瘤を通る血流を押しのける。これらの液体塞栓組成物は、内科医が蛍光透視法によって塞栓処置を見ることができる放射線不透過性材料を含むことが好ましい。
液体塞栓組成物を動脈瘤に送り込む前に、動脈瘤及び送込み装置は、液体塞栓組成物が重力によって動脈瘤へ送り込まれ、凝固し、動脈瘤に残るように配置されるのが好ましい。これは、動脈瘤ネックを用いて動脈瘤を位置付けるために患者の位置をしばしば操作することを意味する。液体塞栓組成物を動脈瘤に送り込むと、溶剤はポリマー材料から放散し、血液の流れにおいて除去されて、それによって動脈瘤内においてポリマー材料が凝固することになる。
液体塞栓組成物が血管に注入される割合及び現在の血流の量に依存して、ポリマーは、溶剤が血液の流れの中に放散していく間のしばらくの間には液体のままであってもよい。また、注入点での溶剤の濃度は、凝固していないポリマー材料の小糸（小ストリング）をポリマー塊から分離し、ポリマーが望まない血管位置を閉塞し得る血液の流れに運び去られてもよい。
さらに、重力に依存しない位置にある動脈瘤が液体塞栓組成物を動脈瘤から血液の流れの中に流すことなく充填することができるように、注入の間、ポリマー材料の凝固を制御する装置又は方法を提供することは望ましい。ポリマーストリングを血液の流れに運ばれることを防止することも望ましい。
本発明は、液体塞栓を塞栓領域以外で凝固することが防止されるように、注入される液体塞栓組成物を捕捉するための閉じ込め部材に関する。
本発明の一態様では、液体塞栓送込みシステムは、液体塞栓組成物をキャビティへ送り込むための管腔を有するカテーテルと、カテーテルの遠位端に位置する閉じ込め部材と、凝固した塞栓組成物の塊からカテーテルを分離するために、液体塞栓組成物の凝固の後に、カテーテルから閉じ込め部材を完全に引き離す引き離し部材と、を含む。閉じ込め部材は、カテーテルの管腔を介して送り込まれる液体塞栓組成物を捕捉するように形作られている。
本発明の他の態様では、体内の塞栓サイトに液体塞栓組成物を閉じ込める方法であって、カテーテルを用いて体内の塞栓サイトに液体塞栓組成物を送り込む段階と、閉じ込め部材を用いて凝固の間に液体塞栓組成物を閉じ込める段階と、凝固した塞栓組成物の塊からカテーテルを離すために、液体塞栓組成物の凝固の後にカテーテルから閉じ込め部材を引き離す段階と、を備えている。
引っ込んだ位置にあるマルチフィラメントブラシを有する液体塞栓送込みシステムの第１の実施形態の側断面図である。 延びた位置にあるマルチフィラメントブラシを有する図１の送込みシステムの側断面図である。 巣の形成前の第２の実施形態による送込みシステムの側断面図である。 形成された巣を有する図３の送込みシステムの側断面図である。 引っ込んだ位置にあるスポンジを有する第３の実施形態による送込みシステムの側断面図である。 延びた位置にあるスポンジを有する図５の送込みシステムの側断面図である。 引っ込んだ位置にある綿棒状部材を有する第４の実施形態による送込みシステムの側断面図である。 延びた位置にある綿棒状部材を有する図７の送込みシステムの側断面図である。 引っ込んだ位置にある磁性部材を有する第５の実施形態による送込みシステムの側断面図である。 延びた位置にある磁性部材を有する図９の送込みシステムの側断面図である。 図３及び図４の送込みシステムによって処置された動脈瘤の側断面図である。 動脈瘤を充填する液体塞栓材料の塊を有する動脈瘤の側断面図である。 送込みシステムが液体塞栓材料の塊から引き離された後、動脈瘤の側断面図である。 引っ込んだ位置にあるフレキシブル袋を含む第６の実施形態による送込みシステムの側断面図である。 延びた位置にあるフレキシブル袋を有する図１４の送込みシステムの側断面図である。 液体塞栓組成物がフレキシブル袋内で凝固した図１４の送込みシステムの側断面図である。 動脈瘤ネック流れ分断システムと共に示す動脈瘤の側断面図である。 動脈瘤ネック流れ分断システムの他の実施形態を示す動脈瘤の側断面図である。 図１８のＡ−Ａ線に沿った断面図である。 図１８のＢ−Ｂ線に沿った断面図である。
本発明を、添付図面で図示した好適な実施形態を参照して説明する。
液体塞栓送込みシステムは管腔を有するカテーテルを含み、その管腔を通して液体塞栓組成物を体内の塞栓サイトに送り込むものである。フレキシブル袋のような閉じ込め部材をカテーテルの遠位端（distal end）に配置させ、液体塞栓組成物を閉じ込め部材に注入する。液体塞栓組成物は凝固（固化）中は閉じ込め部材に捕捉されあるいは調和して、液体塞栓を含み、液体塞栓組成物が血液の流れに入るのが防止される。液体塞栓組成物を閉じ込め部材の好適な実施形態を、図面を用いて以下に説明する。
本発明を説明する前に、以下の用語を詳細に定義する。
“液体塞栓組成物”は、塞栓サイトで注入されかつ固化して塞栓サイトを部分的に若しくは全部を塞栓する流体組成物を称するものである。
“塞栓する”又は“塞栓”は、例えば動脈瘤の場合に動脈瘤への血流及び動脈瘤における圧力がやむように動脈瘤サックを充填するか若しくは埋め込むか及び／又は凝塊形成を促進し、かつ、動静脈奇形（ＡＶＭｓ）及び動静脈異常導管（ＡＶＦｓ）の場合に血流を制御／新ルート変更して適当な組織灌流を可能とするように栓若しくは凝塊を形成する血管又は組織へ流体組成物を注入する工程を称するものである。塞栓は、障害（例えば、器官出血、胃腸出血、血管出血、動脈瘤に関わる出血）に起因する出血を防止し又は制御するのに用いてもよい。また、塞栓は、血液供給を遮断することによって、病気の組織（例えば、腫瘍等）を切除するの用いることが可能である。
本発明で使用する液体塞栓組成物は、体内で固化するいかなる生体適合性組成物、例えば、エタノール、ジメチルスルホキシド（ＤＭＳＯ）、乳酸エチル、アセトン等の適当な生体適合性溶媒と組み合わせた生体適合性ポリマーであってもよい。塞栓組成物の例としては、１９９７年９月１６日に特許された米国特許第５，６６７，７６７号明細書、１９９６年１２月３日に特許された米国特許第５，５８０，５６８号明細書、および、米国特許出願第０８／６８８，０５０号明細書に記載され、それら明細書の内容の全てはここに組み込まれるものとする。他の液体塞栓組成物には、ポリーマ（polyhma）ようなヒドロゲル、他のポリアクリル酸塩、セルロシックス（cellulosics）、他の天然ポリマー及びプレポリマー、シアノアクリル酸塩、ウレタン、及び、シリコーンを含む。
使用される溶媒がＤＭＳＯである本発明の好適な実施形態では、溶媒に接触する送込みシステム要素はＤＭＳＯ互換である。ＤＭＳＯ互換カテーテル材料の例は、ポリエチレン若しくはポリプロピレンのようなポリオレフィン、ＰＴＦＥ及びＥＴＦＥのようなフルオロポリマー、及び、シリコーンを含む。
図１及び図２に示した液体塞栓送込みシステムは、細長フレキシブルカテーテル１０とカテーテル内に配備された閉じ込めブラシ１２とを含んでいる。カテーテル１０は、オーバー・ザ・ワイヤー・カテーテル（over the wire catheter）、流れ指向カテーテル、又は液体塞栓組成物を塞栓サイトに送り込むことが可能な他のタイプのカテーテルであってもよい。ブラシ１２は、患者の体内の外に延びるカテーテルの近位端（proximal end）からブラシを操作するためのカテーテル１０の管腔を通って延びる細長フレキシブルシャフト１４を含む。ブラシ１２は、シャフト１４の遠位端から実質的に径方向に延びる複数のフィラメント１６を含む。
使用の際には、ブラシが完全に若しくは実質的に管腔内に位置する図１で示したような引っ込み位置においてブラシ１２を用いて塞栓サイトにカテーテル１０を送り込む。次いで、シャフト１４はカテーテル１０内で遠位端に移動し、カテーテルの遠位端からブラシ１２を延ばす。ブラシ１２は、カテーテル１０の管腔から出る液体塞栓組成物がブラシに捕捉されるように配置する。好ましくは、ブラシは、カテーテルの遠位端から約0mmないし5mm、さらに好ましくは、約1mmから4mmの位置に、特別の塞栓サイトに依存する正確な位置で配置する。
一旦、ブラシ１２が配置されると、ブラシ１２のシャフト１４が延びる同じ管腔を介して、又は、カテーテルの第２の平行管腔を介して、液体塞栓組成物がカテーテル１０を介して注入される。液体塞栓組成物がカテーテルの下方へ送り込まれると、カテーテルの遠位端を出る液体がブラシ１２の単繊維（filament）１６に注入される。溶剤が液体塞栓組成物から散り始め、ポリマー材料はブラシの毛に沈着し、調和する。その後の液体塞栓材料の注入は、塞栓サイトでブラシを囲繞する固化された塞栓材料の質量を増加する。液体塞栓組成物の注入は、塞栓サイトが完全に塞がれるまで続けられる。ブラシ１２は、沈着材料を含み捕捉するように作用し、重力及び血流の効果によって、ポリマー材料が塞栓サイトから運び去られることになるのを防止する。
液体塞栓組成物がカテーテル１０を通って送り込まれ、ブラシ１２の回りに固形物を形成した後、固形物が以下に記載するような機械的、電気的若しくは化学的切り離しシステムのような切り離し機構によってカテーテル及びブラシシャフト１４から切り離される。
ブラシ１２は、カテーテル１０の管腔を介して延びる細長フレキシブルシャフト１４に取り付けられるように記載したが、ブラシは短いシャフトのような取付部材によって直接カテーテルの遠位端に連結されてもよい。ブラシ１２がカテーテル１０の端部に直接連結するとき、カテーテルとブラシとが一緒に単一のユニットとしてカテーテル１０より大きな直径の独立導入カテーテルを介して導入されてもよい。液体塞栓組成物の送り込みの後、ブラシ１２はカテーテル１０から分離し又はカテーテルの全遠位端が分離可能でもよい。
ブラシ１２の単繊維１６は、ナイロン、ポリエチレン、ポリプロピレン、ポリエステル、ＰＴＦＥ、ダクロン（登録商標）等のような材料から形成されたフレキシブル部材であるのが好ましい。単繊維はソフトで、フレキシブルで、生体適合性があり、ＤＭＳＯ互換であるのが好ましい。単繊維のサイズは応用に依存して変化してもよいが、適当な単繊維の一例としては、約75μｍから約500μｍ、好適には約150μｍから約250μｍの直径、かつ、約1mmから約30mm、好適には約2mmから約10mmの導管サイトの内径に依存した長さを有するものが挙げられる。
図３及び図４は、ワイヤ２０がカテーテル２２の遠位端を出るときにワイヤが塞栓サイトで巣状構造を形成するものであって、ワイヤ２０がカテーテル２２の管腔を介して送り込まれる液体塞栓送込みシステムの他の実施形態を示している。ワイヤ２０は、ワイヤがカテーテル２２の遠位端から外へ送り込まれるときに巣状部材２４を形成する曲率を有するように予備成形（プレフォーム）される。巣状部材２４の形状は通常、塞栓サイトの形状に合致する。例えば、動脈瘤を処置するときに巣状部材２４が動脈瘤の形状に合致する。液体塞栓組成物はその後、カテーテル管腔を介して送り込まれ、ワイヤ巣状部材２４に捕捉され、その上に沈殿（沈着）する。上述のような実施形態においては、塞栓の完了後、塞栓材料の固形物及びワイヤ巣状部材２４がカテーテルから分離される。
ワイヤ２０は、巣状部材２４が特別に予め決められた形状をとるようになるように予備成形されてもよい。巣状部材形状の例としては、図４で示したランダムに曲がったワイヤ形状、及び、コイル若しくはらせん形状を含む。ワイヤ２０は、ステンレス鋼、白金、ニチノール（Nitinol：登録商標）、金、タングステン等のような生体適合性材料から成ってもよい。また、ニチノールのような形状記憶材料からワイヤ２０を形成するのに望ましい。
スポンジ用部材３０及びカテーテル３２を含む本発明の他の実施形態を図５及び図６に示す。図５に示すように、スポンジ３０は、カテーテルを塞栓サイトに送込む間、カテーテル３２の管腔内に圧縮されている。一旦、カテーテル３２の遠位端を塞栓サイトに若しくは塞栓サイト近傍に配置すると、スポンジ３０はカテーテル管腔３２を介して延び、スポンジ３０に連結されたプランジャ若しくはロッド３４によってカテーテルから出てくる。一旦、スポンジ３０がカテーテル３２から出ると、スポンジ３０は図６に示したような外形へと膨張する。膨張スポンジ３０は、液体塞栓組成物が注入される複数の大きな穴３６及び小さめの孔を含む。
図１及び図２の実施形態に示すように、図５及び図６のスポンジ３０は、プランジャ３４への代わりに、カテーテル３２の端部へ固定してもよく、カテーテル及びスポンジ全システムは、導入カテーテルを介して塞栓サイトへ送り込んでもよい。次いで、液体塞栓組成物をカテーテル３２によってスポンジの外部若しくは内部へ送り込んでもよい。一旦、塞栓物がカテーテル管腔を介して液体塞栓組成物を注入することによって、スポンジ３０の回りに形成されると、塞栓物はカテーテル３２から分離され、カテーテル除去後に塞栓サイト内に残る。カテーテル３２及びロッド３４から固形化した塞栓物の分離は、以下に記載するように、機械的、電気的若しくは化学的分離によって実施する。
図５及び図６の実施形態によるスポンジ部材３０は、高い多孔性を有する生体適合性でかつ連続気泡性の圧縮材料、例えば、ポリエチレンスポンジ、ポリプロピレンスポンジ、ポリウレタンスポンジ３０、ＰＶＡ、フルオロポリマー等から成る。スポンジ３０の寸法及び形状は、特別な塞栓サイト内に適当に合うように変更する。スポンジ材料は、動脈瘤を十分に充填する生体適合性でＤＭＳＯ互換の無毒なソフト材料であるのが好ましい。スポンジの膨張率は、約５：１から２０：１であるのが好ましく、約１０：１であればさらに好ましい。
図７及び図８は、液体塞栓組成物を捕捉する閉じ込め部材が繊維材料の綿棒形状部材４０である本発明の他の実施形態に関するものである。綿棒形状部材４０は、押し込み具若しくはロッド４４によってカテーテル４２の管腔内で圧縮され該管腔から出てもよいし、又は、カテーテルの遠位端に永久的に固定し、導入カテーテルを介して挿入してもよい。カテーテル４２を介して送られる液体塞栓組成物は、綿棒形状部材４０及びその回りに捕捉される。さらなる塞栓組成物は、綿棒形状部材４０の傍に備えたコアの回りのシェルで凝固する。綿棒形状部材４０に対する適切な材料は、ポリエステル、ＰＴＦＥ、絹、ダクロン（登録商標）、ポリエチレン、ナイロン、フルオロポリマー、綿のような生体適合性材料を含む。綿棒４０の形状及び寸法は、塞栓サイトの特別な形状と寸法に対応するように変更してもよい。
図９及び図１０で示したように、液体塞栓送込みシステムの他の実施形態は、カテーテル５２の管腔を介して送り込まれる液体塞栓組成物にアタックする帯電部材又は磁石のようなノード５０を含む。ノード５０は、カテーテル管腔を介して延びるロッド５４によって、図９で示した引っ込み位置から図１０で示した延びた位置まで可動であるのが好ましい。ポリマー組成物は、ノードにアタックする磁性粒子を含むのが好ましい。ノード５０は概して塞栓サイトの中心に位置し、液体塞栓剤はノードの回りのシェルで凝固する。
図１１から図１３は、図３及び図４について上述したきたように、ワイヤネスト５４を有する液体塞栓送込みシステムを有する動脈瘤処置法を図示している。図１１で示したように、カテーテル２２は動脈瘤６２のネック６０に若しくはネックの近傍に位置し、動脈瘤内にワイヤネスト（ワイヤの巣）２４を形成するためにワイヤ２０はカテーテル２２の管腔を通っていく。次いで、液体塞栓材料はカテーテル２２の管腔から注入され、凝固中ワイヤネスト２４によって捕捉される。動脈瘤６２が図１２に図示したような液体塊６４で完全に若しくは実質的に充填されるまで、液体塞栓材料の注入は続く。次いで、化学的、機械的、若しくは電気的引き離し手段によって動脈瘤内に液体塞栓材料の固化した塊６４からカテーテルを引き離す。例えば、ワイヤが液体塞栓塊に入る位置でワイヤを壊すためにカテーテル管腔内でワイヤ２０を近位に引く間、カテーテル２２を静止しておくことによって、塞栓組成物の塊６４を引き離してもよい。次いで、液体塞栓塊６４とワイヤネスト２４とを動脈瘤における塊内に埋め込まれたままにして、カテーテル２２及びワイヤ２０を塞栓サイトから除去する。上述のように、壊れたワイヤ２０は、塞栓塊６４をカテーテル２２から分離するために、ワイヤ２０を押し具として用いてもよい。動脈瘤を処置するこの方法は、他の塞栓処置に対して用いてもよい。
液体塞栓組成物の注入によって、塞栓塊の寸法が増大するにつれて開始核から連続的なシェルが形成されるように、本発明による液体塞栓組成物を構成してもよい。また、外皮を最初に形成し、塞栓が塊内にさらに追加して外皮が膨張するように、液体塞栓は閉じ込め部材の中心から注入されてもよい。
図１４から図１６は、カテーテル７２の遠位端に固定されるフレキシブル袋７０を含む液体塞栓送込みシステムを図示する。フレキシブル袋７０のエッジ７８は、公知の方法でカテーテル遠位先端の外側に固定され、それによってフレキシブル袋７０はカテーテルの出口を囲繞する。遠位端に固定されたフレキシブル袋７０を有するカテーテル７２は、カテーテル７２より大きめの直径を有する導入カテーテル７６を介して塞栓サイトに送られる。一旦フレキシブル袋７０を動脈瘤内のような塞栓サイト内に配置すると、液体塞栓組成物をカテーテル管腔を介して注入される。
フレキシブル袋７０は、液体塞栓組成物の沈殿物に対して実質的に不透過性の膜若しくは織物材料から成り、一方、溶剤は透過可能であって溶剤はフレキシブル袋に注入される液体塞栓組成物から散逸することができる。フレキシブル袋７０を形成するのに用いてもよい生体適合性材料の例は、ポリエステル、ＰＴＦＥ、ウレタン、ダクロン（登録商標）、ナイロン、ポリエチレン、フルオロポリマー、シリコーン等を含む。実施形態では、フレキシブル袋は、塞栓組成物を注入するほどバッグの径を増加することができる構造を有する網のバッグである。網の材料は非弾性的であってもよく、また、弾性的でバルーンのように作用するものでもよい。網は溶剤をバッグの外へ放出させることができる一方、バッグの構造は塞栓材料のフィンガ（指状のもの）若しくはストランドが塞栓サイトから出ていくのを防止する。一旦、カテーテルが塞栓サイトから引き抜くことができるように塞栓が完了すると、フレキシブル袋７０はカテーテル７２の遠位端から取り外し可能である。
本発明のカテーテルから上述のような一の閉じ込め部材を引き離す方法は、機械的、電気的、又は化学的のいずれかであってもよい。機械的に引き離す方法の一例には、カテーテルの管腔を介して延びるプランジャ部材を用いる等して、カテーテルの遠位先端から塞栓材料と閉じ込め部材を力学的に引き離すことが含まれる。また、外側カテーテルスリーブはカテーテルの遠位先端から塊を引き剥がすように用いてもよい。機械的引き離しは、種々のインターロック、押し込み、捻り、及び、施錠等の動きによって実施することもできる。
電気的引き離しは、閉じ込め部材とカテーテルとの間に連結部に形成するものであって、弱い部分電流の印加によって容易に蒸発可能な弱い部分を設けることによって実施してもよい。例えば、９Ｖの電源によって引き離しのために約0.3ｍＡの電流を流すものでもよい。電気的引き離し機構の一例は、参考文献として本明細書に組み込まれている米国特許第５，９２８，２２６号明細書に記載されている。
化学的引き離し機構では、カテーテルと閉じ込め部材との間の送り込みシステムに、又は、カテーテルの遠位端に可溶性引き離し部分を含む。可溶性引き離し部分は、カテーテルを介して生体適合性薬品の注入によって、溶解（分解）し、軟化し、膨張し、劣化し、若しくは他に変化する。化学的引き離しシステムの例としては、ＤＭＳＯによって溶解するポリマー部分、フッ素化炭化水素によって溶解するナイロン部分、食塩水若しくは上述の他の生体適合性溶剤によって溶解される部分のような可溶性引き離し部分を含む。
図１７から図２０は、液体塞栓組成物の注入の制御を改善するために、動脈瘤への若しくは動脈瘤からの血流を妨害する液体塞栓送込みシステムを図示している。動脈瘤ネックを介して動脈瘤への若しくは動脈瘤からの血流の妨害によって、動脈瘤内において弱い乱れ若しくは“平穏な”流れ環境が形成され、塞栓材料による動脈瘤への充填を改良することが可能となる。
図１７で示したように、送込みシステム１００は、動脈瘤ネック９２を有する動脈瘤９０のような塞栓サイトに設置する。送込みシステムは２つの管腔、すなわち、液体塞栓組成物の送込み用の内側管腔１０２と動脈瘤ネック９２で血流を分断させるために用いられる塩水等の流体の注入用の外側管腔１０４とを有する。送込みシステム１００は、内側カテーテル１０６と、該内側カテーテル１０６の周囲に同心で配置されかつ動脈瘤ネック９２に配置することができる複数の側部ポート１１０を有する外側カテーテル１０８とから成る。外側カテーテル１０８の遠位端は内側カテーテル１０６の外側部を用いて液密シールを形成する。外側カテーテル１０８のこの遠位端は内側カテーテルに永久接続されてもよいし、又は、バルブ部材を用いて若しくは用いないで内側カテーテルに対して滑動可能であってもよい。内側カテーテル１０６及び外側カテーテル１０８は、それらカテーテルの位置を視覚化するために放射線不透過性マーカー１１２を備えてもよい。また、放射線不透過性マーカーは、外側カテーテル１０８の遠位端でのフューズ接合点の２つの管の間で挟んでもよい。
側部孔１１０は、外側カテーテル１０８の回りに離間して配置し、比較的短い軸方向長の領域内に位置するのが好ましい。使用の際には、送込みシステム１００は、内側カテーテル管腔１０２をガイドワイヤ管腔として用いて、ガイドワイヤにわたって動脈瘤にガイドされる。内側管腔の先端は動脈瘤のドーム内に配置し、側部孔１１０は動脈瘤ネック９２近傍に位置する。次いで、ガイドワイヤを除去し、分断流体（disruption fluid）が外側カテーテル１０８を介して注入され送込み装置の側部孔１１０から出てくる。分断流体は、塩水、造影剤、若しくはそれらの混合物等のいずれかの生体適合性流体であってもよい。動脈瘤ネックで血流の最適分断が生ずるように、分断流体の流れを視覚化し、調整する。次いで、動脈瘤９０が充填され、塞栓組成物が凝固するまで、カテーテル１０６の中心の管腔１０２を介して液体塞栓材料を注入する。
本発明の一実施形態では、内側カテーテル１０６は、液体塞栓組成物が注入される遠位端と混乱側部孔１１０との間の距離の調整ができるように、外側カテーテル１０８に対して滑動可能である。このような送込みシステム１００を調整する能力は、動脈瘤の寸法が変化するので役に立つ。外側カテーテル１０８の遠位端のバルブによって、流体の漏れなしで、外側カテーテルが内側カテーテルに対して軸方向に容易に滑動することができる。
図１８から図２０は、分断流れのパターンをを制御できる送込みシステム１２０の他の実施形態を図示している。多くの動脈瘤９０のネック９は非円形若しくは楕円形断面を有するので、送込みシステムの周縁の回りの異なる側部孔からの動脈瘤ネック分断流体の流量を変化させることが望ましい。言い替えると、楕円ネックの長軸の方向に向いた側部孔での分断流体流を増加する一方、楕円ネックの短軸のの方向に向いた側部孔での流れを減少するのが望ましい。
図１８は、楕円動脈瘤ネック９２を有する動脈瘤９０と液体塞栓組成物及び分断流体を動脈瘤へ送り込むための送込みシステム１２０とを図示している。送込みシステム１２０は、中央管腔１２４と複数の周囲管腔１２６とを有する細長カテーテル１２２を含む。周囲管腔１２６は中央管腔１２４の回りに配置し、それぞれは分断流体の送込み用側部ポート１２８を含んでいる。図１９はＡ−Ａ線に沿ったカテーテル１２２の断面であって、中央管腔１２４と複数の周囲管腔１２６とを図示する。
カテーテル１２２の近位端では、中央管腔を液体塞栓組成物の源に連結するためにために流体連結１３０を備えている。複数の周囲管腔１２６を分断流体の源に連結するために、流体連結１３２も備える。比較的変動し易い速度で異なる周囲の管腔１２６への混乱の送り込みを制御するためにマニホルド１３４と複数のバルブとを備える。マニホルド１３４とバルブとは、動脈瘤ネック９２での異なる側部孔１２８から送られる流体が図２０で示したように注意深く制御することができるように、流体の送り込みのための流れ規制手段を備える。
動脈瘤ネック混乱側部流を有する液体送込みの他の実施形態では、側部孔の一又は二以上の列を備えてもよい。これらの側部孔の列は、動脈瘤のちょうど内側若しくは外側に配置し、ネックを介した血流をさらに混乱させてもよい。
本発明を好適な実施形態を参照して詳細に説明してきたが、本発明を逸脱することなく、種々の変更及び変形も可能であることは当業者には明らかである。
１０ カテーテル
１２ 閉じ込めブラシ
２０ ワイヤ
２２ カテーテル
２４ ワイヤ巣状部材
３０ スポンジ
３２ カテーテル
４０ 綿棒形状部材
４２ カテーテル
６２ 動脈瘤
６４ 塞栓組成物の塊
７０ フレキシブル袋
７２ カテーテル
７６ 導入カテーテル
９０ 動脈瘤
１００ 送込みシステム
１０２ 内側管腔
１０４ 外側管腔
１０６ 内側カテーテル
１０８ 外側カテーテル
１１０ 側部孔
１１２ 放射線不透過性マーカー

Claims (6)

  1. 液体塞栓組成物を塞栓サイトへ接触させる送り込みのための管腔を有するカテーテルであって、閉じ込め部材に直接結合された遠位端を有し、該管腔がカテーテルの遠位端を通して全体に延びる、カテーテルを備え、
    カテーテルの遠位端は、該閉じ込め部材に直接結合された該カテーテルの遠位端からカテーテルを分離することを可能にするために、塞栓サイトでの液体塞栓組成物の凝固の後に分離可能であり、該閉じ込め部材は、凝固した塞栓組成物の塊内に埋め込まれている、
    液体塞栓送込みシステム。
  2. カテーテルの遠位端が機械的に該カテーテルまたは前記閉じ込め部材から分離可能である、請求項１記載の液体塞栓送込みシステム。
  3. カテーテルの管腔を通して塞栓サイトへ接触させる送り込みのための液体塞栓組成物をさらに含む、請求項１記載の液体塞栓送込みシステム。
  4. カテーテルは、液体塞栓組成物が管腔を通って送り込まれ塞栓サイト内の血液と接触するように構成されている、請求項３記載の液体塞栓送込みシステム。
  5. 液体塞栓組成物は、生体適合性溶媒と結合した生体適合性ポリマーを含む、請求項３記載の液体塞栓送込みシステム。
  6. 前記溶媒がジメチルスルホキシド（ＤＭＳＯ）である、請求項５記載の液体塞栓送込みシステム。
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US20110264073A1 (en) 2011-10-27
CA2379442A1 (en) 2001-03-08
WO2001015608A9 (en) 2002-08-08
JP2012232166A (ja) 2012-11-29
EP1207791B1 (en) 2004-10-06
JP2003508107A (ja) 2003-03-04
DE60014672D1 (de) 2004-11-11
ATE278359T1 (de) 2004-10-15
JP2011019930A (ja) 2011-02-03
US7976527B2 (en) 2011-07-12
US20080045922A1 (en) 2008-02-21
US8454649B2 (en) 2013-06-04
DE60014672T2 (de) 2005-11-17
US9358014B2 (en) 2016-06-07
EP1207791A1 (en) 2002-05-29
US20130211443A1 (en) 2013-08-15
US6511468B1 (en) 2003-01-28
WO2001015608A1 (en) 2001-03-08
US20030040733A1 (en) 2003-02-27

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