JP2021533964A - 屈折率のナノ勾配を示すポリマー組成物 - Google Patents
屈折率のナノ勾配を示すポリマー組成物 Download PDFInfo
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- JP2021533964A JP2021533964A JP2021532286A JP2021532286A JP2021533964A JP 2021533964 A JP2021533964 A JP 2021533964A JP 2021532286 A JP2021532286 A JP 2021532286A JP 2021532286 A JP2021532286 A JP 2021532286A JP 2021533964 A JP2021533964 A JP 2021533964A
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Abstract
Description
本出願は、2018年8月17日に出願された米国仮特許出願第62/765,088号の優先権を主張し、あらゆる目的のために参照により本明細書に組み込まれる。
屈折率の多方向変化を示す、電離放射線吸収、線量感受性及び非常に柔軟なポリマー組成物が提供される。また、ポリマー組成物において屈折率の精密な多方向勾配を生成する方法も提供される。
特定の実施形態のコポリマー系は、大部分の非イオン性アクリルモノマーと、小部分の有機酸などのイオン性モノマーから構成される。「有機酸」という用語は、有機ラジカル(炭素(炭化水素)含有部分)を含む分子から構成される酸を包含する。このような酸には、例えば、アクリル酸、ギ酸(H−COOH)、酢酸(CH3COOH)及びクエン酸(C6H8O7)が含まれ、それぞれイオン化可能な−COOH基を含む。モノマーに適用される「アクリル」という用語は、アクリル酸から誘導された合成プラスチック樹脂を包含する。親水性モノマー及び疎水性モノマーは、疎水性モノマーが親水性モノマーに可溶であるように選択されなければならない。親水性モノマーは、疎水性モノマーの溶媒として機能する。適切なモノマーは、本開示が関係する当業者によって容易に選択され得る。適切なアクリルモノマーの例として、4−メタクリロキシ−2−ヒドロキシベンゾフェノン、エチル−3−ベンゾイルアクリレート、N−プロピルメタクリレート)N−プロピルメタクリレート(アクリル)、エチルメタクリレート、メチルメタクリレート、n−ヘプチルメタクリレート、2−ヒドロキシエチルメタクリレート(HEMA)、ヒドロキシプロピルメタクリレート、2−ヒドロキシエチルメタクリレート、ヒドロキシプロピルメタクリレートポリ(エチレングリコール)nモノメタクリレート、4−ヒドロキシブチルメタクリレート、及び当該技術分野で既知の他のモノマーが含まれる。塩化ナトリウム又は他の塩がコポリマー系に存在する場合、水中での膨潤が減少することが一般的に観察されている。したがって、レンズが眼の外側にあるときにコポリマー系内の塩分を操作することによって、目標とする膨潤量は変更され得る。レンズは、移植前に配置された溶液に応じて、房水に曝されたときに眼に移植されると多かれ少なかれ拡張され得る。
コポリマーは、コラーゲン又は類似の生体分子をポリマーに添加することによって修飾され得、その場合、放射線法が使用され得る。この配合方法は、GRINを備えたIOLを製造し得る結果として得られる材料の構造的及び寸法的特性を提供する。任意の供給源からの任意のタイプのコラーゲンが使用され得る。適切なコラーゲン材料には、ブタの眼の強膜又は角膜から得られるコラーゲン、又は(例えば、遺伝子組み換え酵母等から人工的に産生又は培養される)線維芽細胞が含まれるが、これらに限定されない。コラーゲンは、疎水性、ヒドロキシル性及び分極性アミノ酸を含む自然に安定なポリエン、例えば、テロコラーゲン等である。コラーゲン材料を含むコポリマー材料は、米国特許第5,654,349号、第5,910,537号及び第5,661,218号明細書に記載されている。コラマーは、放射線に対するその安定性のために、特定の実施形態において望ましい場合がある。ヒドロゲルは石灰化(ヒドロキシアパタイト沈着)に関連している。変性コラーゲン等の生体分子は、レンズに組み込まれると、フィブロネクチンを引き付けて保護層を形成し得る。この(個々の患者に固有の)フィブロネクチンの保護層は、異物として認識されないため、レンズの石灰化に対する感受性が低下する。したがって、レンズの構成要素として放射線学的に耐性があり、生物学的に活性である材料を提供することによって、特に光劣化に対して優れた安定性、及び生体適合性を有するレンズが得られ得る。
Claims (65)
- 三次元ポリマーマトリックスを有するコポリマーから製造された光学体を含み、
前記コポリマーの前記三次元ポリマーマトリックスは、不均一な架橋密度を有する、眼科用レンズ。 - 前記三次元ポリマーマトリックスは、第2領域よりも架橋が少ない第1領域を含む、請求項1に記載の眼科用レンズ。
- 前記第1領域及び第2領域は、架橋密度の勾配内にある、請求項2に記載の眼科用レンズ。
- 前記三次元ポリマーマトリックスは、勾配内にない第3領域をさらに含み、
前記第3領域は、均一な架橋密度を有する層を含む、請求項2に記載の眼科用レンズ。 - 前記第1領域は、前記第2領域よりも前記光学体の周辺に近い、請求項3に記載の眼科用レンズ。
- 前記第1領域は、第1架橋密度を有する第1層にあり、
前記第2領域は、第2架橋密度を有する第2層にある、請求項2に記載の眼科用レンズ。 - 前記第1領域は、前記光学体の表面層であり、前記第2領域よりも少ない架橋を有する、請求項6に記載の眼科用レンズ。
- 前記第1領域は、前記光学体の周辺に近い、請求項2に記載の眼科用レンズ。
- 前記光学体全体は、架橋密度勾配を有する、請求項2に記載の眼科用レンズ。
- 前記三次元ポリマーマトリックスは、天然水晶体の屈折率分布と実質的に同じ屈折率分布を有する、請求項2に記載の眼科用レンズ。
- 前記光学体の形状は、天然水晶体の形状と実質的に同じである、請求項2又は10に記載の眼科用レンズ。
- 前記光学体の全体は、架橋密度勾配を有さない、請求項2に記載の眼科用レンズ。
- 前記光学体は、トーリックレンズである、請求項2に記載の眼科用レンズ。
- 前記コポリマーは、少なくとも1つの非イオン性アクリルモノマー及び少なくとも1つのイオン性モノマーを含む、請求項2に記載の眼科用レンズ。
- 前記コポリマーは、コラーゲン材料をさらに含む、請求項14に記載の眼科用レンズ。
- 前記イオン性モノマーは、有機酸である、請求項14に記載の眼科用レンズ。
- 非イオン性アクリルモノマーとイオン性モノマーとの重量比は、10:1〜10,000:1、例えば50:1〜200:1、例えば75:1〜175:1、例えば75:1、100:1、125:1、150:1、又は175:1である、請求項14に記載の眼科用レンズ。
- 非イオン性アクリルモノマーは、ヒドロキシエチルメタクリレートである、請求項14に記載の眼科用レンズ。
- 前記マトリックスの不均一な架橋密度は、前記光学体が眼の房水に曝されたときに該光学体に反射防止表面層を作成するように適合されている、請求項1に記載の眼科用レンズ。
- 前記反射防止表面層は、50nm〜400nmの厚さであるマトリックスの領域を含む、請求項19に記載の眼科用レンズ。
- 前記反射防止表面層は、0.1μm〜10μmの厚さであるマトリックスの領域を含む、請求項19に記載の眼科用レンズ。
- 前記反射防止表面層は、1μm〜100μmの厚さであるマトリックスの領域を含む、請求項19に記載の眼科用レンズ。
- 前記反射防止表面層は、前記光学体に形成される中央開口の周りに少なくとも部分的に配置されている、請求項19に記載の眼科用レンズ。
- 前記光学体は、IOLの光学体である、請求項2に記載の眼科用レンズ。
- 前記三次元マトリックスは、湿布の一部として蒸気滅菌に対して寸法的に安定であり、長期間の使用中に加水分解的に安定である、請求項2に記載の眼科用レンズ。
- 前記不均一な架橋密度は、眼に配置されて房水に曝されたときに、前記光学体が移動又は形状を変更することなく、任意で0〜3D、任意で0〜2.5D、任意で0〜2D、任意で0〜1.5D、任意で0〜1.0Dの輻輳で広範囲の距離から光を集束するように適合される、請求項2に記載の眼科用レンズ。
- 前記不均一な架橋密度は、眼に配置されて房水に曝されたときに、前記光学体を適合させて乱視を矯正する、請求項2に記載の眼科用レンズ。
- 前記三次元ポリマーマトリックスは、光学体の表面の近くで、表面に対してさらに内側の領域よりも低い架橋密度を有する、請求項2に記載の眼科用レンズ。
- 前記レンズは、非光学体部(例えば、1つ又は複数の触覚部)をさらに含み、
前記非光学体部は、非光学三次元ポリマーマトリックスを含み、
前記非光学三次元ポリマーマトリックスは、不均一な架橋密度を有する、請求項2に記載の眼科用レンズ。 - 前記光学体が曝される水和溶液をさらに含み、
前記水和溶液で水和されるときに、前記不均一な架橋密度は前記三次元ポリマーマトリックスを不均一に膨潤させて、前記光学体内に不均一な屈折率を生成する、請求項1に記載の眼科用レンズ。 - 前記水和溶液は、平衡塩類溶液である、請求項30に記載の眼科用レンズ。
- 前記水和溶液は、前記レンズが眼の房水に曝されたときに、前記三次元ポリマーマトリックスの膨潤量が実質的に変化しないような構成要素を含む、請求項30に記載の眼科用レンズ。
- 前記水和溶液は、平衡塩類溶液である、請求項32に記載の眼科用レンズ。
- 前記水和溶液は、前記レンズが眼の房水に曝されたときに、前記三次元ポリマーマトリックスの膨潤量が増加するような構成要素を含む、請求項30に記載の眼科用レンズ。
- 前記水和溶液は、塩化ナトリウム溶液である、請求項34に記載の眼科用レンズ。
- 前記水和溶液は、前記レンズが眼の房水に曝されたときに、前記三次元ポリマーマトリックスの膨潤量が減少するような構成要素を含む、請求項30に記載の眼科用レンズ。
- 前記水和溶液は、マグネシウムイオン又はカルシウムイオンのうちの少なくとも1つを含む、請求項30に記載の眼科用レンズ。
- 前記不均一な屈折率は、第1及び第2屈折率をそれぞれ有する第1及び第2離散層を含む、請求項30に記載の眼科用レンズ。
- 前記不均一な架橋密度は、架橋密度勾配を含む、請求項30に記載の眼科用レンズ。
- 請求項1〜39のいずれか1項に記載の眼科用レンズを水和溶液に配置する方法であって、
前記レンズを前記水和溶液に配置することは、前記マトリックスの不均一な膨潤を引き起こすことによって前記光学体に不均一な屈折率を生成する、方法。 - 前記水和溶液は、平衡塩類溶液である、請求項40に記載の方法。
- 請求項1〜39のいずれか1項に記載の眼科用レンズを移植する方法であって、
前記マトリックスの膨潤に変化を引き起こす、移植方法。 - 前記移植は、前記マトリックスの少なくとも一部においてより膨潤を引き起こす、請求項42に記載の移植方法。
- 前記移植は、前記マトリックスの少なくとも一部の膨潤の減少を引き起こす、請求項42に記載の移植方法。
- 前記レンズを移植することは、該レンズの全体積が移植された構成に増加する、請求項42に記載の移植方法。
- 請求項1〜39のいずれか1項に記載の眼科用レンズを移植する方法であって、
前記マトリックスの膨潤に実質的な変化を引き起こさない、移植方法。 - 請求項1〜39のいずれか1項に記載の眼科用レンズを移植する方法であって、
前記レンズを移植することは、前記レンズが完全に水和され、移植された状態の体積よりも小さい体積を有する状態で、送達デバイスを通して該レンズを挿入することを含む、移植方法。 - 三次元ポリマーマトリックスに屈折率勾配を誘導するための方法であって、
少なくとも1つの非イオン性アクリルモノマー及び少なくとも1つのイオン性モノマーから調製されたコポリマー系を含む三次元ポリマーマトリックスを有する形成体を提供することと、
前記三次元ポリマーマトリックスに、該マトリックス内に不均一な架橋密度を生成するように構成されたパターンでイオン化エネルギーを照射することとを含む、方法。 - 前記マトリックスは、請求項1〜39のいずれか1項に記載のマトリックスである、請求項48に記載の方法。
- 前記イオン化エネルギーは、電子ビームである、請求項48に記載の方法。
- 前記形成体を静止位置に維持することをさらに含み、前記照射はイオン化エネルギー源を少なくとも一方向に移動させることを含む、請求項48に記載の方法。
- 前記イオン化エネルギー源を静止位置に維持することと、
前記照射ステップ中に前記形成体を少なくとも一方向に移動させることとをさらに含む、請求項48に記載の方法。 - 前記照射ステップは、前記マトリックスの少なくとも一部に架橋密度勾配を生成する、請求項48に記載の方法。
- 前記照射ステップは、実質的に前記マトリックス全体に架橋密度勾配を生成する、請求項53に記載の方法。
- 前記照射ステップは、前記マトリックスの第2領域の架橋密度よりも小さい第1架橋密度を有する第1層を生成する、請求項48に記載の方法。
- 前記第1層は、前記形成体の表面層である、請求項55に記載の方法。
- 前記コポリマー系は、コラーゲン材料をさらに含む、請求項48に記載の方法。
- 前記イオン性モノマーは、有機酸である、請求項48に記載の方法。
- 前記少なくとも1つの非イオン性アクリルモノマーは、ヒドロキシエチルメタクリレートであり、前記少なくとも1つのイオン性モノマーはアクリルモノマーである、請求項48に記載の方法。
- 前記形成体は、眼内レンズの光学体である、請求項48に記載の方法。
- 照射された前記三次元ポリマーマトリックスは、湿布の一部としての蒸気滅菌に対して寸法的に安定であり、長期間の使用中に加水分解的に安定である、請求項48に記載の方法。
- 前記照射ステップは、任意で50nm〜400nm、任意で0.1μm〜10μm、又は1μm〜100μmの厚さの表面反射防止層を作成する、請求項48に記載の方法。
- 前記照射ステップは、不均一な架橋密度を生成し、前記形成体が眼の房水で水和されたときに、移動又は形状を変更することなく、任意で0〜3D、任意で0〜2.5D、任意で0〜2D、任意で0〜1.5Dの輻輳で広範囲の距離から光を集束するように適合される、請求項48に記載の方法。
- 前記照射ステップは、1つ又は複数の周辺支持体(例えば、触覚部)が前記形成体と一体的に形成された後に開始される、請求項48に記載の方法。
- 前記イオン化エネルギーは、X線である、請求項48に記載の方法。
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KR102560250B1 (ko) | 2023-07-27 |
WO2020037314A1 (en) | 2020-02-20 |
JP7324927B2 (ja) | 2023-08-10 |
JP2023153918A (ja) | 2023-10-18 |
KR20210076901A (ko) | 2021-06-24 |
JP2023036838A (ja) | 2023-03-14 |
US20220363795A1 (en) | 2022-11-17 |
EP4235275A3 (en) | 2023-12-13 |
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