JP6297666B2 - 吸収性及び非吸収性材料の不規則に均一な三次元組織スカフォールド - Google Patents
吸収性及び非吸収性材料の不規則に均一な三次元組織スカフォールド Download PDFInfo
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Description
ウサギへの埋め込み後の本発明の材料の引き抜き力を試験するため、この実験を実施した。本発明の材料(2.35mmの加熱間隙を用いて処理された、ポリプロピレン、ポリグラクチン910及びポリジオキサノンの繊維を含む)のサンプル及び対照材料(Gynemesh(登録商標)、非吸収性ポリプロピレンソフトメッシュインプラント)を、ウサギに埋め込んだ。本発明の材料及び対照のそれぞれについて、2種類の異なる大きさの埋め込み物を用いた。「小さい」埋め込み物は、1.0cm×1.4cmのポリエチレンシースで覆った1.5cm×1.0cmのシートであり、0.5cm×1.0cmの部分は覆われていなかった。「大きい」埋め込み物の大きさは、1.0cm×1.4cmのポリエチレンシースで覆った2.0cm×1.0cmであり、1.0cm×1.0cmの部分は覆われていなかった。シース及び埋め込み可能な材料を超音波で溶着させた。シースは、組織平面上の組織内部成長を阻害又は制限し、生体内曝露後の試験のための、構造物の握り部を提供した。3回の時間ポイントそれぞれに対し2例のウサギを割り当て、各ウサギについて脊椎の両側の傍脊椎筋系中に6つを埋め込んだ。対照埋め込み物を左側に、本発明の埋め込み物を右側に設置した。
初期織物構造体の調製
それぞれ吸収性及び非吸収性材料の量を変えて、3種類の埋め込み可能な材料を調製した。実験前に決定し、以下に示される横編み用ループサイズを更新した以外は、全てAlveolar Tamponade加工パラメータを用いて編んだ。Alveolar Tamponadeでは、2つの同じ円形に編まれた管(靴下)を最初に作製した。次に、両方の管を同時にほどき、得られたねじれたフィラメント糸を初期の緩い織物構造体として横編みした。材料を作るのに使用したフィラメントには、紫色を呈すように染色したVicryl(登録商標)、PDS、及びポリプロピレンを含んだ。靴下Aは第1吸収性材料及び第2吸収性材料で作製した。靴下Bは第1吸収性材料、第2吸収性材料、及び第1非吸収性材料で作製した。靴下Cは第1吸収性材料及び第2非吸収性材料で作製した。各チューブは、以下の表2に示す3種類の割合の材料のうち1つを用いて作製した。
上記で調製された初期織物構造体を、3枚の130mm×130mmのシートにして103℃の第1加熱工程と105〜120℃の第2加熱工程にかけ、その後、各シート全体の密度の一貫性を試験するため、各シートを6枚のストリップに切断した。続いて各ストリップを実験計画書の通りに評価したが、これは、初期加熱を約103℃で約20秒間実施したときに、各ストリップの3箇所の位置で厚さを測定し、様々な初期加熱距離の間隙において、収縮の一貫性を評価することを含む。プレート間の間隙寸法を予め規定した2枚のプレート間に初期織物構造体のシートを置くことによって、収縮を達成した。2.35mm、1.85mm及び1.35mmの様々な間隙寸法で試験を実施した。得られた材料は「初期加熱構造体」と称する。続いて、収縮後、初期加熱構造体を第2加熱にかけた。第2加熱は、0.9mmの間隙距離において、約120秒間、105℃又は120℃のいずれかの温度で加熱プレートを用いることによって達成した。
最終の得られたストリップを用いて、各シートの平均重量を測定したが、これを以下の表6A、6B及び6Cに再現する。
上記のように加熱したシートを用い、シートを6枚のストリップに切断して各ストリップを3箇所の位置で測定し、平均厚さを測定したが、これを以下の表7A、7B及び7Cに再現する。
上記のように形成された3種類の得られる加熱した構造体のそれぞれについて、構造体の面積重量を得て、ポリプロピレン(PP)含量を得た。各測定値は、異なる加工パラメータ、例えば、間隙寸法の変更及び第2加熱の105℃から120℃への変更において取得した。結果を以下の表8に示す。
上で説明したように3種類の得られる構造体を作製したが、それぞれ間隙寸法2.35mm、1.85mm、又は1.35mm、第2加熱温度を105℃又は120℃のいずれかで作製した。各得られたストリップをZWICKテスターで測定し、引張り強度の違いを評価した。1%ひずみ及び10%ひずみにおける負荷レベル(N)を測定した。
本発明の構造体を作製し、多孔性、及び曲げ強度又は剛性について試験した。この実施例に用いた本発明の構造体は、vicryl、ポリプロピレン及びPDSを、5部(重量で)のvicryl、1部のポリプロピレン(重量で)、及び1部のPDS(重量で)で含んでいた。初期の緩い織物構造体を作製し、1.5mm間隙において103℃の初期加熱にかけた。次に、初期加熱構造体を、0.9mm間隙における105℃の第2加熱にかけ、最終の得られたデバイスを得た。得られたデバイスは、実質的に平坦で、板様形状を有していた。
本発明の構造体を含む、様々な構造体の伸び特性を試験した。伸長を得るために、本発明の構造体の様々なサンプル(埋め込み可能な状態及び加水分解が起こった後の両方)、加水分解されたVYPRO(登録商標)(約1.5cm長さ×2cm幅)、加水分解されたUltrapro(登録商標)(約5cm長さ×1cm幅)、及び非吸収性ポリプロピレンメッシュ製品(Gynemesh(登録商標))(約5cm長さ×2cm幅)を準備した。埋め込み前の埋め込み可能なデバイスの1サンプル(約5cm長さ×2cm幅)、本発明のデバイスの加水分解された単一層2サンプル(約5cm長さ×2cm幅;約1.5cm長さ×2cm幅)、本発明のデバイスの加水分解された2層1サンプル(互いに90°で置かれた層)(約1.5cm長さ×2cm幅)、及び本発明のデバイスの加水分解された4層1サンプル(2つの層が別の2つの層と90°で置かれたもの)(約1.5cm長さ×2cm幅)について、測定値を得た。種々おもりを製品から吊り下げ、得られる長さを測定した。一部のサンプルでは、サンプルの入手の関係から、1つ又は2つのおもりのみを測定した。それぞれの場合において、最も軽いおもり(10グラム)を比較目的で使用した。結果は以下の表9で示される。
(1) 埋め込み可能なデバイスを形成する方法であって、
a.第1糸及び第2糸を形成する工程であって、前記第1糸及び第2糸の少なくとも1つが、第1非吸収性フィラメントを含み、前記第1糸及び第2糸の少なくとも1つが、第1吸収性フィラメントを含み、前記第1吸収性フィラメントが、前記第1非吸収性フィラメントより低い融点を有する、工程と、
b.前記第1糸と、前記第2糸と、を含む、初期織物構造体を形成する工程と、
c.前記初期織物構造体を、前記第1吸収性フィラメントを収縮させるのに十分な第1温度で第1熱処理にかけ、それによって少なくとも前記第2糸を曲げて初期加熱構造体を形成する工程と、
d.前記初期加熱構造体を第2温度まで加熱する工程であって、前記第2温度が前記第1温度より高く、前記第1吸収性フィラメントの少なくとも一部が融解される、工程と、
e.前記加熱構造体を冷却し、結果として得られる埋め込み可能なデバイスを形成する工程と、を含む、方法。
(2) 前記第1糸又は第2糸を形成する前に、前記第1吸収性フィラメント及び前記第1非吸収性フィラメントのうち少なくとも1つをねじる工程を更に含む、実施態様1に記載の方法。
(3) 前記初期加熱構造体を第2温度で加熱する前記工程中に、前記初期織物構造体を圧縮する工程を更に含む、実施態様1に記載の方法。
(4) 前記第1糸が、第1非吸収性フィラメントと、第1吸収性フィラメントと、を含み、前記第2糸が、第2非吸収性フィラメントと、第2吸収性フィラメントと、を含む、実施態様1に記載の方法。
(5) 前記第1吸収性フィラメントがポリジオキサノンであり、前記第1非吸収性フィラメントがポリプロピレンである、実施態様4に記載の方法。
(7) 前記第1吸収性フィラメントがポリグラクチンであり、前記第2吸収性フィラメントがポリジオキサノンであり、前記第1非吸収性フィラメントがポリプロピレンである、実施態様6に記載の方法。
(8) 前記結果として得られる埋め込み可能なデバイスが、前記冷却工程後に約0.1〜2mmの厚さを有する、実施態様1に記載の方法。
(9) 前記初期織物構造体を第1熱処理にかける前記工程が、前記初期織物構造体の前記厚さと少なくとも同じ幅である間隙を有する熱源中に前記初期織物構造体を置くことを含む、実施態様1に記載の方法。
(10) 前記初期織物構造体を第1熱処理にかける前記工程が、前記初期織物構造体中の最低融点を有する吸収性フィラメントの融点よりも約0.1〜約2℃低い第1温度に、前記初期織物構造体を曝すことを含む、実施態様1に記載の方法。
(12) 不規則な方向の非吸収性フィラメントを有する埋め込み可能なデバイスであって、
a.第1糸及び第2糸を形成する工程であって、前記第1糸及び第2糸の少なくとも1つが、第1非吸収性フィラメントを含み、前記第1糸及び第2糸の少なくとも1つが、第1吸収性フィラメントを含み、前記第1吸収性フィラメントが、前記第1非吸収性フィラメントより低い融点を有する、工程と、
b.前記第1糸と、前記第2糸と、を含む、初期織物構造体を形成する工程と、
c.前記初期織物構造体を、前記第1吸収性フィラメントを収縮させるのに十分な第1温度で第1熱処理にかけ、それによって少なくとも前記第2糸を曲げて初期加熱構造体を形成する工程と、
d.前記初期加熱構造体を第2温度まで加熱する工程であって、前記第2温度が前記第1温度より高く、前記第1吸収性フィラメントの少なくとも一部が融解される、工程と、
e.前記加熱構造体を冷却し、結果として得られる埋め込み可能なデバイスを形成する工程と、を含む、方法によって形成される、埋め込み可能なデバイス。
(13) 前記第1糸又は第2糸を形成する前に、前記第1吸収性フィラメント及び前記第1非吸収性フィラメントのうち少なくとも1つをねじる工程を更に含む、実施態様12に記載の埋め込み可能なデバイス。
(14) 前記初期加熱構造体を第2温度で加熱する前記工程中に、前記初期織物構造体を圧縮する工程を更に含む、実施態様12に記載の埋め込み可能なデバイス。
(15) 前記第1糸が、第1非吸収性フィラメントと、第1吸収性フィラメントと、を含み、前記第2糸が、第2非吸収性フィラメントと、第2吸収性フィラメントと、を含む、実施態様12に記載の埋め込み可能なデバイス。
(17) 前記第1糸が、第1非吸収性フィラメントと、第1吸収性フィラメントと、第2吸収性フィラメントと、を含み、前記第2糸が、第2非吸収性フィラメントと、第3吸収性フィラメントと、を含む、実施態様12に記載の埋め込み可能なデバイス。
(18) 前記第1吸収性フィラメントがポリグラクチンであり、前記第2吸収性フィラメントがポリジオキサノンであり、前記第1非吸収性フィラメントがポリプロピレンである、実施態様17に記載の埋め込み可能なデバイス。
(19) 前記結果として得られる埋め込み可能なデバイスが、前記冷却工程後に約0.1〜2mmの厚さを有する、実施態様12に記載の埋め込み可能なデバイス。
(20) 前記初期織物構造体を第1熱処理にかける前記工程が、前記初期織物構造体の前記厚さと少なくとも同じ幅である間隙を有する熱源中に前記初期織物構造体を置くことを含む、実施態様12に記載の埋め込み可能なデバイス。
(22) 前記第2温度が、前記初期織物構造体中の最低融点を有する吸収性フィラメントの融点よりも約0.1℃〜約20℃高い温度である、実施態様12に記載の埋め込み可能なデバイス。
Claims (22)
- 埋め込み可能なデバイスを形成する方法であって、
a.第1糸及び第2糸を形成する工程であって、前記第1糸及び第2糸の少なくとも1つが、第1非吸収性フィラメントを含み、前記第1糸及び第2糸の少なくとも1つが、第1吸収性フィラメントを含み、前記第1吸収性フィラメントが、前記第1非吸収性フィラメントより低い融点を有する、工程と、
b.前記第1糸と、前記第2糸と、を含む、初期織物構造体を形成する工程と、
c.前記初期織物構造体を、前記第1吸収性フィラメントを収縮させるのに十分な第1温度で第1熱処理にかけ、それによって少なくとも前記第2糸を曲げて初期加熱構造体を形成する工程と、
d.前記初期加熱構造体を第2温度まで加熱する工程であって、前記第2温度が前記第1温度より高く、前記第1吸収性フィラメントの少なくとも一部が融解され、第2加熱構造体が形成される、工程と、
e.前記第2加熱構造体を冷却する工程であって、結果として得られる埋め込み可能なデバイスを形成する、工程と、を含む、方法。 - 前記第1糸又は第2糸を形成する前に、前記第1吸収性フィラメント及び前記第1非吸収性フィラメントのうち少なくとも1つをねじる工程を更に含む、請求項1に記載の方法。
- 前記初期加熱構造体を第2温度で加熱する前記工程中に、前記初期織物構造体を圧縮する工程を更に含む、請求項1に記載の方法。
- 前記第1糸が、第1非吸収性フィラメントと、第1吸収性フィラメントと、を含み、前記第2糸が、第2非吸収性フィラメントと、第2吸収性フィラメントと、を含む、請求項1に記載の方法。
- 前記第1吸収性フィラメントがポリジオキサノンであり、前記第1非吸収性フィラメントがポリプロピレンである、請求項4に記載の方法。
- 前記第1糸が、第1非吸収性フィラメントと、第1吸収性フィラメントと、第2吸収性フィラメントと、を含み、前記第2糸が、第2非吸収性フィラメントと、第3吸収性フィラメントと、を含む、請求項1に記載の方法。
- 前記第1吸収性フィラメントがポリグラクチンであり、前記第2吸収性フィラメントがポリジオキサノンであり、前記第1非吸収性フィラメントがポリプロピレンである、請求項6に記載の方法。
- 前記結果として得られる埋め込み可能なデバイスが、前記第2加熱構造体を冷却する工程後に0.1〜2mmの厚さを有する、請求項1に記載の方法。
- 前記初期織物構造体を第1熱処理にかける前記工程が、前記初期織物構造体の厚さと少なくとも同じ幅である間隙を有する熱源中に前記初期織物構造体を置くことを含む、請求項1に記載の方法。
- 前記初期織物構造体を第1熱処理にかける前記工程が、前記初期織物構造体中の最低融点を有する吸収性フィラメントの融点よりも0.1〜2℃低い第1温度に、前記初期織物構造体を曝すことを含む、請求項1に記載の方法。
- 前記第2温度が、前記初期織物構造体中の最低融点を有する吸収性フィラメントの融点よりも0.1℃〜20℃高い温度である、請求項1に記載の方法。
- 不規則な方向の非吸収性フィラメントを有する埋め込み可能なデバイスであって、
a.第1糸及び第2糸を形成する工程であって、前記第1糸及び第2糸の少なくとも1つが、第1非吸収性フィラメントを含み、前記第1糸及び第2糸の少なくとも1つが、第1吸収性フィラメントを含み、前記第1吸収性フィラメントが、前記第1非吸収性フィラメントより低い融点を有する、工程と、
b.前記第1糸と、前記第2糸と、を含む、初期織物構造体を形成する工程と、
c.前記初期織物構造体を、前記第1吸収性フィラメントを収縮させるのに十分な第1温度で第1熱処理にかけ、それによって少なくとも前記第2糸を曲げて初期加熱構造体を形成する工程と、
d.前記初期加熱構造体を第2温度まで加熱する工程であって、前記第2温度が前記第1温度より高く、前記第1吸収性フィラメントの少なくとも一部が融解され、第2加熱構造体が形成される、工程と、
e.前記第2加熱構造体を冷却する工程であって、結果として得られる埋め込み可能なデバイスを形成する、工程と、を含む、方法によって形成される、埋め込み可能なデバイス。 - 前記第1糸又は第2糸を形成する前に、前記第1吸収性フィラメント及び前記第1非吸収性フィラメントのうち少なくとも1つをねじる工程を更に含む、請求項12に記載の埋め込み可能なデバイス。
- 前記初期加熱構造体を第2温度で加熱する前記工程中に、前記初期織物構造体を圧縮する工程を更に含む、請求項12に記載の埋め込み可能なデバイス。
- 前記第1糸が、第1非吸収性フィラメントと、第1吸収性フィラメントと、を含み、前記第2糸が、第2非吸収性フィラメントと、第2吸収性フィラメントと、を含む、請求項12に記載の埋め込み可能なデバイス。
- 前記第1吸収性フィラメントがポリジオキサノンであり、前記第1非吸収性フィラメントがポリプロピレンである、請求項15に記載の埋め込み可能なデバイス。
- 前記第1糸が、第1非吸収性フィラメントと、第1吸収性フィラメントと、第2吸収性フィラメントと、を含み、前記第2糸が、第2非吸収性フィラメントと、第3吸収性フィラメントと、を含む、請求項12に記載の埋め込み可能なデバイス。
- 前記第1吸収性フィラメントがポリグラクチンであり、前記第2吸収性フィラメントがポリジオキサノンであり、前記第1非吸収性フィラメントがポリプロピレンである、請求項17に記載の埋め込み可能なデバイス。
- 前記結果として得られる埋め込み可能なデバイスが、前記第2加熱構造体を冷却する工程後に0.1〜2mmの厚さを有する、請求項12に記載の埋め込み可能なデバイス。
- 前記初期織物構造体を第1熱処理にかける前記工程が、前記初期織物構造体の厚さと少なくとも同じ幅である間隙を有する熱源中に前記初期織物構造体を置くことを含む、請求項12に記載の埋め込み可能なデバイス。
- 前記初期織物構造体を第1熱処理にかける前記工程が、前記初期織物構造体中の最低融点を有する吸収性フィラメントの融点よりも0.1〜2℃低い第1温度に、前記初期織物構造体を曝すことを含む、請求項12に記載の埋め込み可能なデバイス。
- 前記第2温度が、前記初期織物構造体中の最低融点を有する吸収性フィラメントの融点よりも0.1℃〜20℃高い温度である、請求項12に記載の埋め込み可能なデバイス。
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BR112015022772A8 (pt) | 2019-11-26 |
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EP2968665A1 (en) | 2016-01-20 |
MX2015012101A (es) | 2016-05-05 |
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CN105188784B (zh) | 2017-10-10 |
RU2662557C2 (ru) | 2018-07-26 |
ES2656907T3 (es) | 2018-02-28 |
US20160243278A1 (en) | 2016-08-25 |
WO2014143562A1 (en) | 2014-09-18 |
AU2014228575B2 (en) | 2017-07-27 |
HK1218632A1 (zh) | 2017-03-03 |
CA2904842A1 (en) | 2014-09-18 |
RU2015143938A (ru) | 2017-04-19 |
AU2014228575A1 (en) | 2015-10-29 |
CN105188784A (zh) | 2015-12-23 |
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