JP4383746B2 - 膨張性の糸状塞栓装置の製造方法 - Google Patents
膨張性の糸状塞栓装置の製造方法 Download PDFInfo
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Description
図1は、本発明の第1の好ましい具体例に従う脈管塞栓形成装置の立面図である。
図2は、図1の線2−2を切断した断面図である。
図3は、図2の線3−3を切断した断面図である。
図4〜図7は、本発明の塞栓形成方法の一具体例に従って脈管部位(具体的には動脈瘤)を閉鎖させる方法の段階を示す概略図である。
図8は、本発明の塞栓形成装置が好ましくは配置器具の遠位末端部に装着される機構の詳細な透視図である。
図9は、図8と同様に、配置器具から分離された後の本発明の塞栓形成装置を示す詳細な透視図である。
図10、11及び12は、図4〜7に例示されるものに加えて、本発明の塞栓形成方法の好ましい具体例に従って脈管部位を閉鎖させる方法を継続する段階を示す概略図である。
図13は、本発明の塞栓形成方法の別の具体例に従って脈管部位を閉鎖させる方法の段階を示す概略図である。
図14は、通常の又は膨張していない状態の装置を示す本発明の第2の好ましい具体例に従う塞栓性装置の部分断面正面図である。
図15は、図14の線15−15を切断した断面図である。
図16は、図14に示される装置の一部分の詳細な横断面図である。
図17は、脈管部位に配置された後の膨張した状態の図14の装置を示す図16と同様の図である。
図18は、脈管部位に配置された後の膨張した状態の図14の装置を示す図15と同様の図である。
図19は、通常の又は膨張していない状態の装置を示す本発明の第2の好ましい具体例に従う塞栓性装置の第1の改変型の部分横断面図である。
図20は、脈管部位内に置かれた後の膨張した状態の図19の装置を示す図19と同様の図である。
図21は、通常の又は膨張していない状態の装置を示す本発明の第2の好ましい具体例に従う塞栓性装置の第2の改変型の部分横断面図である。
図22は、脈管部位に配置された後の膨張した状態の図21の装置を示す図21と同様の図である。
図23は、本発明の第2の好ましい具体例に従う塞栓性装置の第3の改変型の詳細な横断面図である。
図24は、本発明に従う塞栓形成装置の第3の典型具体例を製造するための第1の典型方法に従う膨張した軟質親水性重合体塞栓形成要素の断面正面図である。
図25は、管状ホルダーに挿入された図24の塞栓形成要素の断面正面図である。
図26は、内腔心棒によって内部で支持された螺旋状キャリヤーによって同軸方向に串刺しにされつつある図25の塞栓形成要素の断面正面図である。
図27は、螺旋状キャリヤー及び内腔心棒によって完全に串刺しにされた後の図26の塞栓形成要素の断面正面図である。
図28は、本発明の塞栓形成装置の第3の典型具体例に従う未完成の塞栓形成装置を画定するために管状ホルダーから押し出されつつある図27の串刺しにされた塞栓形成要素の断面正面図である。
図29は、塞栓形成要素を収縮させるために乾燥浴中で脱水されつつある図28の塞栓形成装置の断面正面図である。
図30は、塞栓形成要素の水和速度を水性環境の物理的パラメーターのレベルに応じて調整するために酸浴中に浸漬された図29の塞栓形成装置の断面正面図である。
図31は、塞栓形成要素を乾燥させるためにオーブン中で加熱乾燥されつつある図30の塞栓形成装置の断面正面図である。
図32は、塞栓形成装置の第3の典型具体例に従う、図26の内腔心棒が所定位置に残った状態の完成塞栓形成装置の正面図である。
図33は、図32の塞栓形成装置の断面正面図である。
図34は、図33の線34−34を切断した断面によって明らかにされるような図33の塞栓形成装置の部分拡大断面図である。
図35は、塞栓形成装置から心棒を除去することによって該装置中に画定された軸方向溜めを示す図34と同様の図である。
図36は、本発明に従う塞栓形成装置の製造方法の第2の典型具体例に従って成形されつつある本発明に従う塞栓形成装置の第4の典型具体例の断面正面図である。
図37は、図36の塞栓形成装置のキャリヤーを示す線37−37を切断した断面図によって明らかにされるような図36の初期の塞栓形成装置の部分拡大断面図である。
図38は、重合体中に包封されたキャリヤーを示す図37と同様の部分拡大断面図である。
図39は、塞栓形成装置の第4の典型具体例の一つの変形例の正面図である。
図40Aは、螺旋状に巻き付けられたキャリヤーのコイルが互いに隙間なく配置された塞栓形成装置の一つの見込まれる変形例を示す図39の線40−40を切断した断面によって明らかにされるような図39の塞栓形成装置の部分拡大断面図である。
図40Bは、キャリヤーのコイルが互いに間隔をあけて配置された別の変形例を示す図40Aと同様の図である。
図41は、塞栓形成装置のキャリヤー内の内腔心棒を示す塞栓装置の第4の典型具体例の別の変形例の正面図である。
図42Aは、螺旋状に巻き付けられたキャリヤーのコイルが互いに隙間なく配置され、しかも内腔心棒が取り除かれてキャリヤー内に軸上溜めが画定された塞栓形成装置の一つの見込まれる変形例を示す図41の線42−42を切断した断面によって明らかにされるような図41の塞栓形成装置の部分拡大断面図である。
図42Bは、キャリヤーのコイルが互いに間隔をあけて配置された別の変形例を示す図42Aと同様の図である。
図43は、塞栓形成装置の可撓性を測定するための方法及び装置の略正面図である。
図44は、図43中の丸で囲まれた細部44によって明らかにされるような図43で測定されている塞栓形成装置の部分拡大断面図である。
塞栓形成装置:第1の好ましい具体例
本発明の第1の好ましい具体例に従う脈管塞栓形成装置10を図1、2及び3に示す。この好ましい具体例では、塞栓形成装置10は複数の塞栓形成体を含み、それぞれは実質的に円筒形の「マイクロペレット」12として構成され、このマイクロペレット12は糸状キャリヤー14に沿って間隔をあけて設置されている。マイクロペレット12の数は、キャリヤー14の長さに依存して変化し、これは、同様に、閉鎖されるべき脈管部位の寸法に依存するであろう。大きな脈管部位については、例えば、8〜12個のマイクロペレットが使用できるが、必要ならばさらに多数を使用してもよい。いくらかの用途では(例えば非常に小さい動脈瘤)、1又は2個程度のマイクロペレットが使用できる。
図14〜23は、本発明の第2の好ましい具体例に従う塞栓形成装置を例示している。最初に図14〜17を参照すると、この第2の具体例に従う装置100は、細長く可撓性のある糸状キャリヤー102を含み、このものには膨張性塞栓形成要素104が取り外せないように保持されている。キャリヤー102は、好ましくは、白金、金、タングステン若しくはタンタルのような好適な金属又はステンレス鋼若しくはニチノールのような合金から作られた連続長の中空マイクロコイル106から形成される。これらの材料のうち、白金及びニチノールが好ましい。このマイクロコイルは、ぴったりと巻き付けられたコイルで形成されているため、隣接するコイルの間には間隔が殆ど又は全くない。また、キャリヤー102は、マイクロコイル106に沿って軸方向に延びる糸状心線108も含み得る。心線108は、好ましくはニチノールのような形状記憶金属から作られた薄い金属製ワイヤーである。装置100は、マイクロコイル106を同軸に包囲し且つ丸みのある遠位先端部112で終端する外側コイルからなる遠位部分を含む。上に記載され且つ図8及び9に例示されたタイプのヒドロゲル結合要素(示さない)は、有利には、キャリヤーの近位端部に備えられる。
体腔を閉塞させるための装置300の第3の典型具体例を図32〜35に例示し、装置300の第3の具体例を製造するための方法の第1の典型具体例を図24〜31に例示する。
体腔を閉塞させるための塞栓形成装置400の第4の典型具体例を図39〜42に例示し、装置400の第4の具体例を製造するための方法の第2の典型具体例を図36〜38に例示する。
塞栓形成装置10(第1の好ましい具体例)又は塞栓形成装置100(第2の好ましい具体例)のいずれかを使用して血管部位を閉鎖させる一方法を図4〜7に例示する。この方法を第1の好ましい具体例の塞栓装置10に関して記載するが、この方法は、第2の好ましい具体例の装置100にも同様に適用できることが分かるであろう。
12 マイクロペレット
14 キャリヤー
20 遠位保持部材
24 ヒドロゲル結合要素
30 配置器具
32 外側部分
34 ワイヤー心線
36 遠位部分
40 マイクロカテーテル
42 動脈瘤
50 血管塞栓性装置
60 血管内装置
100 塞栓形成装置
104 糸状キャリヤー
104 膨張性塞栓形成要素
106 中空マイクロコイル
108 糸状心線
101’ 塞栓装置
106' 中空マイクロコイル
108' 中央軸心線
100" 塞栓装置
300 塞栓形成装置
302 糸状キャリヤー
304 同軸重合体部材
306 軸方向溜め
308 管状ホルダー
316 支持心棒
320 オーブン
400 塞栓形成装置
402 糸状キャリヤー
404 同軸部材
408 型
410 空洞
422 第1水平表面
424 張り出し部分
426 第2水平表面
428 高さ
430 非支持末端部
432 水平距離
434 支持末端部
Claims (45)
- 次の工程:
拘束されていないときに三次元形状を形成する、細長く可撓性のある糸状キャリヤーを準備し、及び
該キャリヤーの全長の少なくとも一部分を膨張性の親水性重合体であってその膨張が周囲の生理学的pHにより誘発されるもの中に同軸に包封すること
を含む体腔閉塞装置の製造方法。 - キャリヤーの包封が、重合体の細長い部材を軟化された状態で準備し、及び該部材をキャリヤーで同軸方向に串刺しにすることからなる、請求項1に記載の方法。
- 細長い部材の準備が、該部材を管状ホルダーに該部材が径方向に閉じ込められ且つその中に同軸方向に拘束されるように挿入することからなる、請求項2に記載の方法。
- キャリヤーの包封が、中に細長い空洞を有する型を準備し、該型の空洞内にキャリヤーを同軸方向に配置し、及び該空洞に重合体を該重合体が該キャリヤーの全長の少なくとも一部分を同軸に包封する部材に成形されるように移すことからなる、請求項1に記載の方法。
- キャリヤーが軸方向内腔を含み、しかもキャリヤーの包封が該キャリヤーの包封部分の内腔を重合体で実質的に満たすことからなる、請求項1に記載の方法。
- キャリヤーが軸方向内腔を含み、しかも該内腔に軸方向溜めを形成させることをさらに含む、請求項1に記載の方法。
- 軸方向溜めの形成が、キャリヤーの内腔に細長い心棒を挿入してからこれを包封し、及びその包封後に該心棒をキャリヤーの内腔から取り出すことからなる、請求項6に記載の方法。
- 体腔を閉塞させるための装置であって、
拘束されていないときに三次元形状を形成する、細長く可撓性のある糸状キャリヤーと、
該キャリヤーの全長の少なくとも一部分を同軸に包封した膨張性の親水性重合体の部材
と
を含み、ここで、該親水性重合体は、周囲の生理学的pHレベルによりその膨張速度が変化するものである、体腔を閉塞させるための装置。 - キャリヤーが軸方向内腔を含み、しかも部材の重合体が該キャリヤーの包封部分の内腔
を実質的に満たす、請求項8に記載の装置。 - キャリヤーが中に軸方向溜めを有する軸方向内腔を含む請求項8に記載の装置。
- キャリヤーが可撓性ワイヤー、螺旋状コイル及びチューブよりなる群から選択される糸状要素を含む請求項8に記載の装置。
- 同軸部材が円筒形である請求項8に記載の装置。
- 同軸部材がヒドロゲルからなる請求項8に記載の装置。
- 同軸部材が生分解性及び生体吸収性のうちの少なくとも一つである請求項8に記載の装置。
- 同軸部材が乾燥したときよりも水和したときに実質的により大きい潤滑性を有する請求項8に記載の装置。
- 空洞を閉塞させるための装置であって、
生体適合性材料から形成された細長い糸状キャリヤーであって、該キャリヤーに三次元形状のバイアスをかける弾性記憶及び外部表面を有するものと、
該キャリヤーの外部表面のかなりの部分を覆うように該キャリヤー上に形成された膨張性ヒドロゲルの同軸部材と
を含み、
該装置が、該ヒドロゲルが脱水されたときよりも該ヒドロゲルが水和したときにより大きい可撓性及びより大きい潤滑性のうち少なくとも一つを有すること、及び
該ヒドロゲルが血液のpHレベルにより誘発される容積膨張を受けること
を特徴とする、空洞を閉塞させるための装置。 - 装置の一部分の非支持末端部が該部分の重量を受けて該部分の反対側の支持末端部に対して、
ヒドロゲルが乾燥状態にあって該部分の双方の末端部間の水平距離が2.25インチ(5 7.2mm)以上であるとき、
ヒドロゲルが中程度に水和した状態にあって該水平距離が1.5インチ(38.2mm)〜2.25インチ(57.2mm)の間にあるとき、及び
ヒドロゲルが完全に水和した状態にあって該水平距離が1.5インチ(38.2mm)未満であるときに
0.75インチ(19.1mm)下方に撓むことを特徴とする、請求項16に記載の装置。 - 体腔を閉塞させるための装置であって、
拘束されていないときに三次元形状をとる、外部表面を有する細長い糸状キャリヤーと、
該キャリヤーの外部表面のかなりの部分を覆う親水性重合体の同軸部材と
を含み、
該同軸部材の水性環境中での物理的性質が該環境中での時間及び該環境のpHレベルの関数である
ことを特徴とする、体腔を閉塞させるための装置。 - 物理的性質が部材の可撓性及び潤滑性のうちの少なくとも一つであり、しかも環境の物理的パラメーターが該環境の温度及びpHのうちの少なくとも一つである、請求項18に記載の装置。
- 遠位先端部及び外部表面を有する可撓性のある糸状キャリヤーであって拘束されていないときに三次元形状を形成するものと、該遠位先端部の近位に該キャリヤーの全長のかなりの部分に沿って該キャリヤーの該外部表面に取り外せないように固定された細長く連続した同軸塞栓形成要素であって血液にさらされたときに容積膨張を生じるプロトン化を受けるものとを含む脈管塞栓形成装置。
- 塞栓形成要素が耐伸長性の生体適合性重合体から形成された請求項20に記載の塞栓形成装置。
- 塞栓形成要素が膨張性の親水性重合体から形成された請求項20に記載の塞栓形成装置。
- キャリヤーがX線下で視覚化できる材料を含む請求項20に記載の塞栓形成装置。
- 重合体が環境に感受性のある重合体であって温度及びpHよりなる群から選択される環境パラメーターの変化に応答してその物理的特性を変化させるものである請求項22に記載の塞栓形成装置。
- 塞栓形成要素が2倍〜100倍の間の容積膨張係数によって膨張できる請求項22に記載の塞栓形成装置。
- 塞栓形成要素が放射線不透過性である請求項20に記載の塞栓形成装置。
- キャリヤーが拘束されていないときに三次元形状をとり得るマルチループ構造の形で配置された請求項20に記載の塞栓形成装置。
- 三次元形状が円形、螺旋形及び卵形よりなる群から選択される請求項27に記載の塞栓形成装置。
- 細長く可撓性のある糸状キャリヤーであって拘束されていないときに三次元形状を形成するものと、該キャリヤーに取り外せないように固定され、生理学的pHレベルに応答して増加する速度で膨張する膨張性重合体から形成された塞栓形成要素とを含む、脈管塞栓形成装置。
- 重合体が多孔性ヒドロゲルである請求項29に記載の塞栓形成装置。
- 塞栓形成要素がキャリヤーの外部表面に該キャリヤーの全長のかなりの部分に沿って取り外せないように固定された細長く連続した同軸塞栓形成要素からなる請求項29に記載の塞栓形成装置。
- 塞栓形成要素がキャリヤーに取り付けられた複数の膨張性重合体繊維からなる請求項29に記載の塞栓形成装置。
- 塞栓形成要素が放射線不透過性である請求項29に記載の塞栓形成装置。
- キャリヤーが拘束されていないときに三次元形状をとり得るマルチループ構造の形で配置された請求項29に記載の塞栓形成装置。
- 三次元形状が円形、螺旋形及び卵形よりなる群から選択される請求項34に記載の塞栓形成装置。
- 次の構成:
弾性記憶を有する所定の長さのワイヤーから形成され且つ最初に一部分がループ構造を形成する状態で配置され、それによって三次元形状をとる可撓性の糸状キャリヤーと、
該キャリヤーの周囲に同軸に配置され且つそれに取り外せないように取り付けられた塞栓形成要素であって、その少なくとも一部分が、周囲の生理学的pHレベルによって誘発される膨張を受ける親水性重合体から形成されているものと
を含む、糸状塞栓性装置。 - キャリヤーが連続長のマイクロコイルからなる請求項36に記載の装置。
- 塞栓形成要素がキャリヤーに塗布された被覆剤を含む請求項36に記載の装置。
- 被覆剤がキャリヤー全長の少なくとも一部分を包封する請求項38に記載の装置。
- 次の構成:
拘束されていないときに三次元形状をとる可撓性の糸状キャリヤーであって外部表面と遠位先端部とを有するものと、
該キャリヤーの外部表面にその近位先端部から近接した位置で取り外せないように固定された耐伸長性の塞栓形成要素であって、少なくとも一部分が、血液のpHを有する環境により誘発される膨張速度の変化を受ける親水性重合体から形成されたものと
を含む脈管塞栓形成装置。 - 次の構成:
可撓性のある重合体フィラメントと該フィラメントを同軸に取り囲むマイクロコイルとからなる所定の長さのキャリヤーであって拘束されていないときに三次元形状を形成するものと、
該キャリヤー上に同軸に配置され且つそれに取り外せないように取り付けられた重合体塞栓形成要素であって、該キャリヤーの全長の少なくとも一部分を事実上連続的に覆い、かつ、血液によりプロトン化されたときに膨張するものと
を含む、脈管部位を閉鎖させるための装置。 - 塞栓形成要素が親水性重合体からなる請求項41に記載の装置。
- マイクロコイルが少なくとも部分的に白金から作られた請求項41に記載の装置。
- キャリヤーが拘束されていないときに螺旋形、円形及び卵形よりなる群から選択される形状をとるループ構造に形成されている請求項41に記載の装置。
- 塞栓形成要素が耐伸長性である請求項41に記載の装置。
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US09/867,340 US6602261B2 (en) | 1999-10-04 | 2001-05-29 | Filamentous embolic device with expansile elements |
US10/157,621 US7014645B2 (en) | 1999-10-04 | 2002-05-29 | Method of manufacturing expansile filamentous embolization devices |
PCT/US2002/016873 WO2002096302A1 (en) | 2001-05-29 | 2002-05-29 | Method of manufacturing expansile filamentous embolization devices |
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JP2004527342A5 JP2004527342A5 (ja) | 2006-01-05 |
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JP (1) | JP4383746B2 (ja) |
AT (1) | ATE516759T1 (ja) |
AU (3) | AU2002344223B2 (ja) |
CA (2) | CA2449055C (ja) |
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2002
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- 2002-05-29 AU AU2002344223A patent/AU2002344223B2/en not_active Ceased
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- 2002-05-29 CA CA2689598A patent/CA2689598A1/en not_active Abandoned
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JP2004527342A (ja) | 2004-09-09 |
US7491214B2 (en) | 2009-02-17 |
EP1401338B1 (en) | 2011-07-20 |
US20020177855A1 (en) | 2002-11-28 |
CA2689598A1 (en) | 2002-12-05 |
CA2449055C (en) | 2010-03-02 |
EP1401338A1 (en) | 2004-03-31 |
AU2010200166A1 (en) | 2010-02-04 |
ATE516759T1 (de) | 2011-08-15 |
US7014645B2 (en) | 2006-03-21 |
US20060149299A1 (en) | 2006-07-06 |
AU2002344223C1 (en) | 2002-12-09 |
AU2006225285B2 (en) | 2009-10-29 |
AU2002344223B2 (en) | 2006-07-06 |
CA2449055A1 (en) | 2002-12-05 |
US20040059370A1 (en) | 2004-03-25 |
AU2006225285A1 (en) | 2006-10-26 |
EP2319430A2 (en) | 2011-05-11 |
US20090232869A1 (en) | 2009-09-17 |
ES2441341T3 (es) | 2014-02-04 |
US8603128B2 (en) | 2013-12-10 |
EP2319430A3 (en) | 2011-09-28 |
WO2002096302A1 (en) | 2002-12-05 |
US7842054B2 (en) | 2010-11-30 |
EP2319430B1 (en) | 2013-11-13 |
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