JP2010521226A - 形状記憶要素糸を備えた織布 - Google Patents
形状記憶要素糸を備えた織布 Download PDFInfo
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Abstract
Description
動脈瘤が血管中で起こる部位は、加齢、疾病、または遺伝的素因により、血管強度または弾性が不十分なため、血管壁が弱くなるおよび/または血液がそこを流れる際に血管壁の形が崩れることがあり、その結果、強度/弾性が限られた部位で血管が膨化または伸張し、よって、動脈瘤嚢を形成する部位である。処置せずにおくと、血管壁は、血管壁の残存強度が耐えられない程度まで拡張し続けることがあり、動脈瘤部位で血管不全になるおそれがあり、多くは致死的結果を伴う。
この発明の第1の局面に従って、植込み型医療用具に適した織布が提供され、この織布は、第1の方向に整列された形状記憶要素糸および織り糸(textile strand)を含み、形状記憶要素糸および織り糸は、第2の方向に整列された織り糸と織り合わされており、第1の方向に整列された形状記憶要素糸のうち少なくとも1本は、第2の方向に整列された
少なくとも5本の織り糸の少なくとも1つの浮きを有する。
この開示は、形状記憶要素糸が複数の織り糸の浮きを有するよう、第2の方向に整列された織り糸と織られた、第1の方向に整列された形状記憶要素糸および織り糸を含む布に関する。
用語「植込み型」は、医療用具が、体内管腔内などの体内の部位に位置決めされることができることを指す。
ランダム第G95−1号に規定される生体適合性試験に、材料が合格できることによって評価することができる。典型的に、こういった試験は、材料の毒性、感染性、発熱性、刺激性ポテンシャル、反応性、溶血作用、発癌性、および/または免疫原性を測定する。生体適合性構造または材料は、大部分の患者に導入されても、典型的に外科手術または異物の生体中への植込みに伴う穏やかで一過性の炎症とは区別される、著しく悪い、永続する、または段階的に増大する生物学的反作用または反応は引起さない。
織布は、基本的な織り方として任意の種類の織り方を含んでもよい。たとえば、織布の基本的な織り方には、限定するものではないが、平織り、斜子織り、レップまたは畝織り(rep or rib weave)、綾織り(twill weave)(たとえばストレートツイル、リバースツイル、ヘリンボーンツイル)、朱子織り、および二重織り(たとえばダブル幅の管状二重織り、逆二重織り)などの織り方が含まれてもよい。1つの例において、基本的織り方は、管状二重層織りを含む。
100は、形状記憶要素糸100の織り糸115との織り合わせを最少化することによって布の多孔度を低下させることができる。形状記憶要素糸100は、図1Bに示される、上10/下6の織り合わせ構成を有する。つまり、形状記憶要素糸100は、10本の織り糸115の「上」を浮き、次に、6本の織り糸の「下」を横切る。用語「上」および「下」は、相対的であることを意図されている。たとえば、逆も真であり、形状記憶要素糸100は、10本の織り糸115の「下」を浮き、次に、6本の織り糸115の「上」を横切る。この織り糸115との最小限の織り合わせは、接結点の数を減少させることによって織布が低多孔度を維持することを可能にし、同時に形状記憶特性を布に与える。加えて、形状記憶要素糸100を第1の方向に6本の糸ずつ間隔をあけて配置すると、形状記憶要素糸の接結点がさらに減少されることによって、布の低多孔度が改良され、その一方で、布が所望される形状記憶特性を維持することが可能となる。
−図5Dには、斜子織り500、レップ織り510、綾織り520、およびヘリンボーン織り530を含む基本的な織り方を有する織り糸が示されている。
織り糸は、任意の生体適合性材料を含んでもよい。織り糸は、天然の、合成の、または加工されたものであってもよい。たとえば、織り糸を形成することができる生体適合性材料には、限定するものではないが、ポリ(エチテンテレフタレート)などのポリエステル、ポリテトラフロオロエチレン(PTFE)および延伸PTFEの繊維などのフッ化重合体、ならびにポリウレタンなどが含まれる。加えて、本来的には生体適合性でない材料は、この材料を生体適合性にするために、表面改質されてもよい。表面改質の例には、材料表面からの生体適合性重合体のグラフト重合、架橋生体適合性重合体での表面の被覆、生体適合性機能グループでの化学修飾、およびヘパリンまたは他の物質などの相溶化剤の固定化が含まれる。よって、最終の布が生体適合性であるという条件で、任意の繊維材料を用いて織り糸材料を形成してもよい。
形状記憶要素糸に用いられる材料は、生体適合性であるかまたは生体適合性にすることができさえすればよい。形状記憶要素糸に適した材料には、形状記憶金属および形状記憶重合体が含まれる。
5,145,935号、およびビトラー(Bitler)他に対する米国特許第5,665,822号を参照のこと。
この発明の布は、織布を含む任意の形状または構成からなるさまざまな、たとえば外科的にまたは管腔内に、植込み型または挿入可能な医療用具において用いるのに適している。典型的な被術者(この明細書中で「患者」とも呼ばれる)は、脊椎動物被術者(すなわち脊索動物門の亜門(subphylum cordata)の構成員)であり、ウシ、ヒツジ、ブタ、ヤギ、ウマ、イヌ、ネコ、およびヒトなどの哺乳類が含まれる。
この発明は、形状記憶要素糸と織り糸とを含む織布の製造方法にも適用可能である。1つの実施例において、この方法は、織り糸および形状記憶要素糸を提供するステップと、織布を製造するために形状記憶要素糸および織り糸を織るステップとを含む。
Claims (20)
- 植込み型医療用具に適した織布であって、第1の方向に整列された形状記憶要素糸および織り糸を備え、前記形状記憶要素糸および前記織り糸は、第2の方向に整列された織り糸と織り合わされており、前記第1の方向に整列された前記形状記憶要素糸のうち少なくとも1本は、前記第2の方向に整列された少なくとも5本の織り糸の少なくとも1つの浮きを有する、織布。
- 前記織り糸は、ポリエステル、ポリプロピレン、ポリエチレン、ポリウレタン、およびポリテトラフルオロエチレン、ならびにそれらの組合せからなる群から選択される重合体を含む、請求項1に記載の織布。
- 前記織り糸は、約0.1デニールから約200デニールの間のデニールを有する、請求項1または2に記載の織布。
- 前記形状記憶要素糸は、形状記憶重合体、形状記憶金属、およびそれらの組合せからなる群から選択される、請求項1から3のいずれかに記載の織布。
- 前記形状記憶要素糸は、超弾性ニチノールワイヤを含む、請求項1から3のいずれかに記載の織布。
- 前記超弾性ニチノールワイヤの直径は、約70μmから約125μmの間である、請求項5に記載の織布。
- 前記第1の方向の前記形状記憶要素糸は、前記第2の方向の6から12本の間の織り糸の少なくとも1つの浮きを有する、請求項1から6のいずれかに記載の織布。
- 前記布は、平織り、斜子織り、レップ織り、畝織り、綾織り、絡み織り、模紗織り(mock leno weave)、朱子織り、二重織り、またはそれらの変形からなる群から選択される基本的な織り方を含む、請求項1から7のいずれかに記載の織布。
- 前記布は、管状二重織りを含む、請求項1から7のいずれかに記載の織布。
- ポリエステル、ポリプロピレン、ポリエチレン、ポリウレタン、およびポリテトラフルオロエチレン、ならびにそれらの組合せからなる群から選択された重合体を含む織り糸と、
約0.1デニールから約200デニールの間のデニールを有する織り糸と、
形状記憶重合体、形状記憶金属、およびそれらの組合せからなる群から選択される形状記憶要素糸と、
直径が約70μmから約125μmの間である超弾性ニチノールワイヤを含む形状記憶要素糸と、
前記第2の方向の6から12本の間の織り糸の少なくとも1つの浮きを有する前記第1の方向の形状記憶要素糸と、
平織り、斜子織り、レップ織り、畝織り、綾織り、絡み織り、模紗織り、朱子織り、二重織り、またはそれらの変形からなる群から選択される基本的な織り方と、のうち任意の2つ以上をさらに備える、請求項1に記載の織布。 - 植込み型医療用具のための織布の製造方法であって、
第1の方向に整列される織り糸および形状記憶要素糸を提供するステップと、
第2の方向に整列される織り糸を提供するステップと、
織布を製造するために、前記形状記憶要素糸および織り糸を織るステップとを備え、
前記形状記憶要素糸のうち少なくとも1本は、織られて、前記第2の方向の少なくとも5本の織り糸の少なくとも1つの浮きを有する、方法。 - 前記第1の方向に整列された前記形状記憶要素糸および織り糸は、横糸を含み、前記第2の方向に整列された前記織り糸は、縦糸を含む、請求項11に記載の方法。
- 前記形状記憶要素糸を、前記織るステップの前にマンドレル上で加熱するステップをさらに備える、請求項11または12に記載の方法。
- 前記形状記憶要素糸は、形状記憶金属を含み、前記形状記憶金属は、前記形状記憶金属のオーステナイト変態終了温度を超えた温度まで加熱される、請求項11から13のいずれかに記載の方法。
- 前記加熱された形状記憶要素糸を、前記織るステップの前に冷却するステップをさらに備える、請求項13または14に記載の方法。
- 前記形状記憶要素糸は、形状記憶金属を含み、前記形状記憶金属は、前記形状記憶金属のマルテンサイト変態開始温度未満の温度まで冷却される、請求項13から15のいずれかに記載の方法。
- 前記織布を、オーステナイト変態開始温度を超えた温度まで加熱するステップをさらに備え、前記形状記憶要素糸は、形状記憶金属を含む、請求項15または16に記載の方法。
- 織り方は、管状二重織りを含む、請求項11から17のいずれかに記載の方法。
- 織られた管状ステントグラフトであって、
第1の方向に整列された形状記憶要素糸と、前記第1の方向に整列されたポリエステル糸とを備え、前記形状記憶要素糸および前記ポリエステル糸は、第2の方向に整列された織り糸と織り合わされており、さらに
管状二重織りを含む基本的な織り方を備え、
前記形状記憶要素糸のうち少なくとも1本は、前記第2の方向に整列された6から12本の間の織り糸の少なくとも1つの浮きを有する、ステントグラフト。 - 前記形状記憶要素糸は、直径が約70μmから約125μmの間である超弾性ニチノールワイヤを含み、前記織り糸は、約マイクロデニールから約200デニールの間のデニールを有するポリエステルを含む、請求項19に記載のステントグラフト。
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JP2012139498A (ja) * | 2010-12-30 | 2012-07-26 | Cook Medical Technologies Llc | 腔内装置のための複合織物 |
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WO2019093387A1 (ja) * | 2017-11-10 | 2019-05-16 | 旭化成株式会社 | 医療用織物 |
JPWO2019093387A1 (ja) * | 2017-11-10 | 2020-10-22 | 旭化成株式会社 | 医療用織物 |
JP2021511139A (ja) * | 2018-01-19 | 2021-05-06 | エドワーズ ライフサイエンシーズ コーポレイションEdwards Lifesciences Corporation | カバー付き人工心臓弁 |
JP7335251B2 (ja) | 2018-01-19 | 2023-08-29 | エドワーズ ライフサイエンシーズ コーポレイション | カバー付き人工心臓弁 |
JPWO2020066915A1 (ja) * | 2018-09-28 | 2021-08-30 | テルモ株式会社 | フィルターデバイス |
JP7437312B2 (ja) | 2018-09-28 | 2024-02-22 | テルモ株式会社 | フィルターデバイス |
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DE602008003323D1 (de) | 2010-12-16 |
WO2008112242A3 (en) | 2009-06-25 |
AU2008226869A1 (en) | 2008-09-18 |
US20080228028A1 (en) | 2008-09-18 |
US8177834B2 (en) | 2012-05-15 |
AU2008226869B2 (en) | 2012-10-25 |
US20150127088A1 (en) | 2015-05-07 |
EP2136858B1 (en) | 2010-11-03 |
US20120204387A1 (en) | 2012-08-16 |
US8940041B2 (en) | 2015-01-27 |
EP2136858A2 (en) | 2009-12-30 |
US9427342B2 (en) | 2016-08-30 |
WO2008112242A2 (en) | 2008-09-18 |
JP5292619B2 (ja) | 2013-09-18 |
ATE486622T1 (de) | 2010-11-15 |
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