JP2007514497A - ePTFE/テキスタイル及びePTFE/ステント/テキスタイルの複合補綴材を形成するための加圧積層法 - Google Patents
ePTFE/テキスタイル及びePTFE/ステント/テキスタイルの複合補綴材を形成するための加圧積層法 Download PDFInfo
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- JP2007514497A JP2007514497A JP2006545354A JP2006545354A JP2007514497A JP 2007514497 A JP2007514497 A JP 2007514497A JP 2006545354 A JP2006545354 A JP 2006545354A JP 2006545354 A JP2006545354 A JP 2006545354A JP 2007514497 A JP2007514497 A JP 2007514497A
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Abstract
Description
本発明は、エラストマー結合剤によって互いに固着されたePTFE層とテキスタイル材料層とを含む移植可能な複合補綴材、望ましくは血管補綴材を提供する。本発明の血管補綴材は、ePTFEでライニングされたテキスタイル血管移植片、テキスタイル被覆材を含むePTFE血管移植片、及びePTFE/テキスタイル複合血管パッチを含む。
(f)更に、複合材アセンブリーを備えた中空部材を圧力チャンバ内に配置する工程と、
(g)圧力チャンバ内の圧力が中空部材の流路内の圧力よりも大きくなるように差圧を付与する工程と、
(h)結合剤に熱を加える工程と、を有し、それにより、テキスタイル層及びePTFE層を接着剤で結合させ、積層複合材アセンブリーを形成する。
テキスタイル及びePTFEを本発明に従って加圧下で積層させ、加圧下で積層された補綴材を得た。加圧下で積層された装置を、同様の装置、即ち、加圧しないで積層された調製済みのコントロール品と比較した。
直径約13mmの金属ステント(Wallstent:登録商標)を準備し、上述した13mmのマンドレル上に配置する。コレタン(登録商標)をステントワイヤにも塗布し、ステント及びePTFEを結合させたことを除き、実施例1で得たテキスタイル/ePTFE複合補綴材構成要素(即ち、テキスタイル、コレタン、及びePTFE)を上記のように使用した。テキスタイル、ePTFE及びステントの補綴材構成要素を本発明に従って加圧下で積層させ、実施例1に記載した条件下で加圧下で積層された補綴材を形成し、また実施例1に記載した条件下でコントロール品を調製した。
(2)線形、即ち、真直ぐな管状テキスタイル/ePTFEステント移植片サンプル
(3)分岐形テキスタイル/ePTFEステント移植片
Claims (29)
- テキスタイルとePTFEの移植可能な複合材装置を形成する方法であって、
(a)微小繊維により相互接続されたノードの微細多孔構造を備え、且つ、両面を有するePTFE層を準備する工程と、
(b)両面を有するテキスタイル層を準備する工程と、
(c)ePTFE層又はテキスタイル層の両面の一方に、エラストマー結合剤のコーティングを塗布する工程と、
(d)中空部材を準備する工程と、を有し、この中空部材は、開放端及びこれと反対側の閉鎖端を有し、前記開放端と前記閉鎖端の間に流路を有し、少なくとも1つの孔が貫通した壁部分を有し、前記孔と前記流路とが流体連通し、
(e)更に、前記ePTFE層及び前記テキスタイル層を、前記中空部材上に同心的に且つ前記中空部材の少なくとも1つの孔の上に配置する工程を有し、それにより、複合材アセンブリーを形成し、この複合材アセンブリーは、内側複合材層及び外側複合材層を有し、前記内側複合材層が前記ePTFE層及び前記テキスタイル層の一方であり、外側複合材層が前記ePTFE層及び前記テキスタイル層の他方であり、
(f)更に、前記複合材アセンブリーを備えた前記中空部材を圧力チャンバ内に配置する工程と、
(g)前記圧力チャンバ内の圧力が前記中空部材の流路内の圧力よりも大きくなるように差圧を付与する工程と、
(h)前記結合剤に熱を加える工程と、を有し、それにより、前記テキスタイル層及び前記ePTFE層を接着により結合させ、積層複合材アセンブリーを形成する方法。 - 前記コーティングを塗布する工程は、更に、前記結合剤の溶液を塗布する工程を有する、請求項1に記載の方法。
- 前記コーティングを塗布する工程は、更に、前記ePTFE層の表面に前記溶液を噴霧コーティングする工程を有する、請求項2に記載の方法。
- 前記テキスタイル層は、内側テキスタイル表面及び外側テキスタイル表面を有する中空の管状テキスタイル層であり、前記ePTFE層は、前記内側テキスタイル表面に付けられる、請求項1に記載の方法。
- 前記ePTFE層は中空の管状構造体である、請求項4に記載の方法。
- 前記テキスタイル層は、内側テキスタイル表面及び外側テキスタイル表面を有する中空の管状テキスタイル層であり、前記ePTFE層は、前記外側テキスタイル表面に付けられる、請求項1に記載の方法。
- 更に、前記外側複合材層の外側表面の上に弾性バリア部材を付ける工程を有する、請求項1に記載の方法。
- 前記弾性バリア部材を、前記外側複合材層の外側表面の上にそれと隣接して配置する、請求項7に記載の方法。
- 前記弾性バリア部材を、前記外側複合材層の外側表面の上に、それらの間に流動性質量粒子を適用することなしに、それと隣接して配置する、請求項7に記載の方法。
- 付与される前記差圧は、約1psiから約50psiである、請求項1に記載の方法。
- 前記結合剤に熱を加える工程は、前記結合剤を約325°F〜約450°Fで加熱する工程を有する、請求項1に記載の方法。
- 前記エラストマー結合剤のコーティングを塗布する工程は、前記微細多孔構造内に前記結合剤が配置された状態で、前記ePTFE層の両面の一方に前記コーティングを塗布する工程を有する、請求項1に記載の方法。
- 更に、拡張ステントを準備する工程と、
前記テキスタイル層と前記ePTFE層の間に前記拡張ステントを配置する工程と、を有する、請求項4に記載の方法。 - 更に、前記拡張ステントと前記テキスタイル層の間に、ePTFEの第2の層を形成する工程を有する、請求項13に記載の方法。
- 更に、拡張ステントを準備する工程と、
前記ePTFE層及び前記テキスタイル層を前記中空部材上に配置する工程の前に、前記拡張ステントを前記中空部材の上に配置する工程と、を有する、請求項4に記載の方法。 - 前記結合剤は、ウレタン、スチレン/イソブチレン/スチレンブロック共重合体、シリコーン、及びそれらの組合せから選択される、請求項1に記載の方法。
- 前記結合剤がポリカーボネートウレタンである、請求項1に記載の方法。
- 前記テキスタイル層が、編みテキスタイル層、織りテキスタイル層、高伸長縦編みテキスタイル層、編上げテキスタイル層、及びこれらの組合せである、請求項1に記載の方法。
- 前記移植装置が血管補綴材である、請求項1〜18の何れか1項に記載の方法。
- 請求項1〜18の何れか1項に記載の方法によって形成された血管補綴材。
- 前記テキスタイル層及び前記ePTFE層が実質的に平坦である、請求項1に記載の方法。
- 前記複合材装置が血管パッチである、請求項21に記載の方法。
- 請求項21に記載の方法により形成された血管パッチ。
- 複合血管補綴材であって、
微小繊維によって相互連結されたノードの微細多孔構造を有する管状ePTFE構造体、
管状テキスタイル構造体と、
前記ePTFE構造体及び前記テキスタイル構造体を接着により固着させる硬化エラストマー結合剤と、を有し、
前記テキスタイル構造体及び前記ePTFE構造体は、結合剥離強度が少なくとも32g/mmであり且つ結合剥離強度変動が約4未満である複合血管補綴材を形成するように、加圧下で互いに積層される複合血管補綴材。 - 前記テキスタイル構造体及び前記ePTFE構造体は、加圧しないで積層されたePTFE/テキスタイルアセンブリーの結合剥離強度と比較して少なくとも15パーセント大きい結合剥離強度を有する複合血管補綴材を形成するように、加圧下で互いに積層される、請求項24に記載の複合血管補綴材。
- 更に、拡張可能なステントと、
前記ePTFE構造体及び前記テキスタイル構造体体を前記ステントに接着により固着させる硬化エラストマー結合剤と、を有し、
前記テキスタイル構造体及び前記ePTFE構造体は、結合剥離強度が少なくとも5.5g/mm2であり且つ結合剥離強度変動が約2未満である複合血管補綴材を形成するように、加圧下で互いに積層される、請求項24又は25に記載の複合血管補綴材。 - 前記テキスタイル構造体及び前記ePTFE構造体は、加圧しないで積層されたePTFE/テキスタイルアセンブリーの結合剥離強度と比較して少なくとも20パーセント大きい結合剥離強度を有する複合血管補綴材を形成するように、前記ステントに加圧下で互いに積層される、請求項26に記載の複合血管補綴材。
- 請求項1〜18の何れか1項に記載の方法によって形成された複合血管補綴材であって、
結合剥離強度が少なくとも32g/mmであり、且つ、結合剥離強度変動が約4未満である複合血管補綴材。 - 請求項13〜15の何れか1項に記載の方法によって形成された複合血管補綴材であって、
結合剥離強度が少なくとも4.5g/mm2であり、且つ、結合剥離強度変動が約2未満である複合血管補綴材。
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US10/741,209 US7560006B2 (en) | 2001-06-11 | 2003-12-19 | Pressure lamination method for forming composite ePTFE/textile and ePTFE/stent/textile prostheses |
US10/741,209 | 2003-12-19 | ||
PCT/US2004/042008 WO2005060875A1 (en) | 2003-12-19 | 2004-12-15 | PRESSURE LAMINATION METHOD FOR FORMING COMPOSITE ePTFE/TEXTILE AND ePTFE/STENT/TEXTILE PROSTHESES |
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JP2015509785A (ja) * | 2012-03-02 | 2015-04-02 | ダブリュ.エル.ゴア アンド アソシエイツ,インコーポレイティドW.L. Gore & Associates, Incorporated | 改良型生体適合性表面及び当該表面を組み込むデバイス |
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JP2018051322A (ja) * | 2012-03-02 | 2018-04-05 | ダブリュ.エル.ゴア アンド アソシエイツ,インコーポレイティドW.L. Gore & Associates, Incorporated | 改良型生体適合性表面及び当該表面を組み込むデバイス |
US11504454B2 (en) | 2012-03-02 | 2022-11-22 | W. L. Gore & Associates, Inc. | Biocompatible surfaces and devices incorporating such surfaces |
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CA2554631C (en) | 2011-12-06 |
JP4871734B2 (ja) | 2012-02-08 |
US20040182511A1 (en) | 2004-09-23 |
WO2005060875A1 (en) | 2005-07-07 |
US7560006B2 (en) | 2009-07-14 |
EP1706064A1 (en) | 2006-10-04 |
CA2554631A1 (en) | 2005-07-07 |
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