JP4723584B2 - 生物学的、生物分解性若しくは合成重合体又は繊維が巻き付けられた体腔を閉塞するための金属製コイル - Google Patents
生物学的、生物分解性若しくは合成重合体又は繊維が巻き付けられた体腔を閉塞するための金属製コイル Download PDFInfo
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Description
金属コイルと装置構成、非伸縮性部材、繊維材料、生物活性材料、適用
[金属コイルと装置構成]
本発明の閉栓装置は、望ましくは繊維が巻き付けられている金属コイル等のコイルで作られている。ある形態では、装置は螺旋の形をし、単純に一つの螺旋で形成されている。しかし他の形態では、図1に示されるように、コイルは、2次螺旋、又は、繊維が一次コイルを通して巻き付けられた他の2次形態に巻き付けられた螺旋に付着している1次螺旋コイルを有するコイルオンコイルである。図1で、装置10は直径Dsの大きい又は二次の螺旋と、直径Dpの小さい又は一次の螺旋とを持つ金属コイル12を示している。複数の繊維14、16、18は2-2’、3-3’、4-4’に示された構成で一次螺旋のコイルを通して巻きつけられており、図2、3、3A、4にそれぞれ拡大して示されている。これら4つの巻き付け構成は代表的な例に過ぎず、繊維とコイルとが適切に結合された均等な構成もまた本発明の範囲に含まれる。
本発明の装置は非伸縮性部材を含み得る。非伸縮性部材は装置の除去、再設置等の過程での移動、変形を防ぎ得る。非伸縮性部材は少なくとも装置の一端に固定的に付着され得る。ある形態では、非伸縮性部材は装置の両端に固定的に付着され、コイルの内部を通り得る。
ある形態では、繊維は重合体材料で構成し得る。重合体材料は体内移植に許可された、あるいは許可を取得し得る材料を含み得る。これらの素材はポリエチレン、ポリアクリル酸(polyacrylics)、ポリプロピレン、ポリ塩化ビニル、ナイロン6.6等のナイロンのようなポリアミド、ポリウレタン、ポリビニルピロリドン、ポリビニルアルコール、ポリ酢酸ビニル、酢酸セルロース、ポリスチレン、ポリテトラフルオロエチレン、ポリエチレンテレフタレート(Dacron)等のポリエステル、絹、綿、などの非生物的分解性材料を含み得る。ある特定の形態では重合体要素用の非分解性材料としてポリエステル、ポリエ−テル、ポリアミド、又はポリフルオロカーボンで構成し得る。
ある形態では、繊維はその中に生物活性材料を含み得る。別の形態では、生物活性材料はコイル、非伸縮性部材、繊維、又はこれらのさまざまな組み合わせを包むコーティングの中に含まれ得る。本発明のある形態では、生物活性材料のコーティングはコイルに一つの層として付けられ得て、生物活性材料を伴う又は伴わない繊維は除外することもできる。しかし、他の形態では生物活性材料は繊維の中に分散されているか、繊維の表面にコーティングされている。図6に示されるように、この構成は金属コイル又は繊維の芯30と生物活性材料からなる一層の外側コーティング32を含んでいる。
本発明の装置は特定の場所に設置し得る。したがって、本発明の装置は様々な疾患に適応し得る。例えば、動脈瘤の治療には、複数の装置で動脈瘤を埋め尽くし得る。もしくは、ただ1個の装置も投入し得る。動脈瘤に装置が設置されてからまもなく、生物活性材料の影響で塞栓が任意的に形成し得る。
AT−10のプラチナコイルが得られ、その端で平坦表面に固定された。コイルは直径0.028mmの一次螺旋を有する。直径0.099〜0.029mmの複数のVicryl90/100PGLAの縫合(suture)が得られた。これらの縫合は直径約12μmの小さなマイクロ繊維6−7本の束から構成されている。同様のサイズの単一フィラメントも使用し得る。繊維は2cm長さに切断され、図2〜5に示される構造のT-10コイルの巻きの間で物理的に巻き付けられる。この巻き付けは、1cm当り全体で約10〜20本の繊維がコイルから外方に延びるまでなされる。繊維はコイルから延びる長さが2〜4cmの長さになるよう刈り込まれる。
1.氷コンテナに冷水を満たし、温度が4〜6℃に到達するのに必要なだけ氷を追加する。
2.コンテナ/バケットに15mlの遠心管ラックを浸漬する。
3.(pH7.4±2のコラーゲン溶液で満たされた)15mlの遠心管を遠心ラックに配置する。
4.プラチナコイルを孔の開いた遠心カップを通して溶液中に挿入する。
5.コイルを溶液中に20分間放置する。
6.コイル及び(コイルをコラーゲン溶液中に確保する)管をコンテナ/バケットから除去する。
7.コイルを37℃で4時間置く。
8.コイルをコラーゲン溶液から取り出し、コイルをPBS中で3回、蒸留水中で3回リンスする。
9.コートされたコイルを1晩中乾燥させる。
Claims (36)
- a)腔(lumen)並びに第1及び第2の端部を備え、患者の血管ネットワーク中の使用部位に挿入される大きさのコイルと、
b)前記コイルの前記第1の端部に固定して取り付けられる第1の端部と前記コイルの前記第2の端部に固定して取り付けられる第2の端部とを有する非伸縮性部材と、
c)その各々が前記非伸縮性部材の回りに少なくとも2回巻かれた(wrapped)複数の繊維と、
を備える、患者の血流を閉塞するための血管閉塞装置。 - 前記非伸縮性部材は、前記コイルの前記腔(lumen)を軸方向に横切ることを特徴とする請求項1記載の装置。
- 前記非伸縮性部材は、金属ワイヤで構成されることを特徴とする請求項1記載の装置。
- 前記金属ワイヤは、白金、パラジウム、ロジウム、レニウム、イリジウム、金、銀、タングステン、タンタル、又は、これら金属のうちの2つ以上の合金、又は、超弾性金属から選択される金属から構成されることを特徴とする請求項3記載の装置。
- 前記非伸縮性部材は重合体から構成されることを特徴とする請求項1記載の装置。
- 前記重合体は、非生物分解性重合体及び生物分解性重合体のうちの一つであることを特徴とする請求項5記載の装置。
- 前記非伸縮性部材は、生物活性コーティングをさらに備えることを特徴とする請求項1記載の装置。
- 前記生物活性コーティングは、成長因子、遺伝子、オリゴヌクレオチド、ペプチド、海洋生物由来高分子(marine biopolymer)、モノ−サッカライド、ジ−サッカライド、ポリ−サッカライド、コラーゲン及びこれらの組み合わせから選択されることを特徴とする請求項7記載の装置。
- 前記生物活性コーティングは重合体を備えることを特徴とする請求項7記載の装置。
- 前記コイルは金属ワイヤで構成されることを特徴とする請求項1記載の装置。
- 前記金属ワイヤは、白金、パラジウム、ロジウム、レニウム、イリジウム、金、銀、タングステン、タンタル、又は、これら金属のうちの2つ以上の合金、又は、超弾性金属から選択される金属から構成されることを特徴とする請求項10記載の装置。
- 前記コイルは、それ自体巻かれて(wound)二次的な形状となっている一次螺旋から構成されることを特徴とする請求項1記載の装置。
- 前記二次的な形状は螺旋であることを特徴とする請求項12記載の装置。
- 前記繊維は、生物活性材料及び生物不活性材料のうちの一つであることを特徴とする請求項1記載の装置。
- 前記繊維は、グリコール酸と乳酸との共重合体から構成されることを特徴とする請求項1記載の装置。
- 前記繊維は、生物活性コーティングをさらに備えることを特徴とする請求項1記載の装置。
- 前記生物活性コーティングは、潤滑性の親水性コーティング及び疎水性コーティングのうちの一つであることを特徴とする請求項16記載の装置。
- 前記生物活性コーティングは共重合体を備えることを特徴とする請求項16記載の装置。
- 前記共重合体は乳酸とグリコール酸とから構成されることを特徴とする請求項18記載の装置。
- 前記繊維は、非生物分解性重合体から構成されることを特徴とする請求項1記載の装置。
- 前記非生物分解性重合体は、ポリエチレン、ポリアクリル酸(polyacrylic)、ポリプロピレン、ポリ塩化ビニル、ポリアミド、ポリウレタン、ポリビニルピロリドン、ポリビニルアルコール、ポリ酢酸ビニル、酢酸セルロース、ポリスチレン、ポリテトラフルオロエチレン、ポリエステル、絹、ナイロン、ポリエチレンテレフタレート又は綿から選択されることを特徴とする請求項20記載の装置。
- 前記繊維は、生物分解性重合体から構成されることを特徴とする請求項1記載の装置。
- 前記生物分解性重合体は、ポリグリコール酸、ポリカプロラクトン、ポリヒドロキシブチレートバレレート(Polyhydroxybutyrate valerate)、ポリオルトエステル(Polyorthoester)、ポリ乳酸、ポリ−p−ジオキサノン(poly(p-dioxanone))、ポリバレトラクトン(Poly(valetolactone))、ポリタルトロン酸、ポリ−β−マロン酸、ポリプロピレンフマレート、チロシンを基にしたポリカーボネート(tyrosine based polycarbonate)、及び、ポリエチレンオキサイドとポリブチレンテレフタレートとの共重合体から選択されることを特徴とする請求項22記載の装置。
- グリコール酸の乳酸に対する比は、99:1、1:99、95:5、5:95、50:50、90:10及び10:90のうちの一つに選択されることを特徴とする請求項19記載の装置。
- 前記コーティング材料は、成長因子、遺伝子、オリゴヌクレオチド、ペプチド、海洋生物由来高分子(marine biopolymer)、モノ−サッカライド、ジ−サッカライド、ポリ−サッカライド、コラーゲン及びこれらの組み合わせから選択されることを特徴とする請求項16記載の装置。
- 前記生物活性コーティングは、前記コイル及び前記非伸縮性部材に適用されることを特徴とする請求項16記載の装置。
- 前記生物活性コーティングは前記繊維に単一層として適用されることを特徴とする請求項16記載の装置。
- 前記生物活性コーティングは、前記コイル及び前記非伸縮性部材に単一層として適用されることを特徴とする請求項26記載の装置。
- 前記生物活性コーティングは、前記繊維全体にわたって分散されていることを特徴とする請求項16記載の装置。
- 前記生物活性コーティングは、細胞接着を促進し、血栓形成を促進するものであることを特徴とする請求項16記載の装置。
- 前記生物活性コーティング材料は、コラーゲン、フィブリノーゲン、ビトロネクチン、血管内皮増殖因子、及び、アルギニン−グリシン−アスパラギン酸(RGD)配列を備えるペプチドから選択されることを特徴とする請求項16記載の装置。
- 前記繊維のそれぞれは第1及び第2の端部を備え、前記第1及び第2の繊維端部のそれぞれは前記コイルから自由に延びていることを特徴とする請求項1記載の装置。
- a)腔(lumen)、第1及び第2の端部、並びに、張力がかかっていないもとで隣接するワインディング(winding)間で繊維を掴む間隔を備える螺旋状に巻かれたワイヤ芯を得る工程と、
b)前記ワイヤ芯を延伸された状態まで延伸する工程と、
c)前記螺旋状に巻かれたワイヤの前記腔(lumen)の中へ非伸縮性部材を挿入し、前記非伸縮性部材の第1の端部を前記螺旋状に巻かれたワイヤの少なくとも一つの端部に固定して取り付ける工程と、
d)前記非伸縮性部材の回りに複数の繊維を少なくとも2回巻く(wrap)工程と、
e)前記コイルを緩和し、それにより前記コイルの前記隣接するワインディング(winding)に前記繊維を掴まえさせる工程と、
を備える、血管閉塞装置を製造する方法。 - 前記非伸縮性部材の第2の端部を前記螺旋状に巻かれたワイヤの第2の端部に固定して取り付ける工程をさらに備えることを特徴とする請求項33記載の方法。
- 前記巻く工程は前記コイルの複数のワインディング(winding)を通して行われることを特徴とする請求項33記載の方法。
- 前記繊維のそれぞれは第1及び第2の端部を備え、
前記方法は、前記繊維のそれぞれの前記第1及び第2の端部を前記コイルから自由に延ばすよう構成する工程をさらに備えることを特徴とする請求項33記載の方法。
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ATE490736T1 (de) | 2010-12-15 |
JP2008500148A (ja) | 2008-01-10 |
EP1761178A2 (en) | 2007-03-14 |
CA2567331A1 (en) | 2005-12-01 |
JP2011136189A (ja) | 2011-07-14 |
US8267955B2 (en) | 2012-09-18 |
EP2316355A1 (en) | 2011-05-04 |
WO2005113035A3 (en) | 2006-02-23 |
DE602005025215D1 (de) | 2011-01-20 |
JP5052682B2 (ja) | 2012-10-17 |
US20060036281A1 (en) | 2006-02-16 |
EP1761178B1 (en) | 2010-12-08 |
WO2005113035A2 (en) | 2005-12-01 |
US7896899B2 (en) | 2011-03-01 |
ES2357243T3 (es) | 2011-04-20 |
CA2567331C (en) | 2012-08-14 |
EP2316355B1 (en) | 2013-09-18 |
ES2440650T3 (es) | 2014-01-29 |
US20110118777A1 (en) | 2011-05-19 |
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