JP2015525102A - 医療分野、特に眼科におけるその使用のための生体適合性ヒドロゲルで作られている物体を調製するための方法 - Google Patents
医療分野、特に眼科におけるその使用のための生体適合性ヒドロゲルで作られている物体を調製するための方法 Download PDFInfo
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- JP2015525102A JP2015525102A JP2015516739A JP2015516739A JP2015525102A JP 2015525102 A JP2015525102 A JP 2015525102A JP 2015516739 A JP2015516739 A JP 2015516739A JP 2015516739 A JP2015516739 A JP 2015516739A JP 2015525102 A JP2015525102 A JP 2015525102A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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Abstract
Description
(i)アクリロニトリルとアニオン性基を有するオレフィン性不飽和コモノマーの共重合体を非プロトン性溶媒に、場合によって非溶剤の存在下で、溶解することによってポリマー溶液を調製するステップと、
(ii)所望の物体の形状を有する型において、ステップ(i)の終了時に得られたポリマー溶液を成形しゲル化を開始するステップであって、前記型は前記非溶剤を含有する材料または前記非溶剤に対して透過性である材料からなり、好ましくは室温で行われるステップと、
(iii)ステップ(ii)によって生じるゲル化を起こしている物体を非溶剤中で十分な時間浸漬し、前記非溶剤と溶媒の完全な交換を可能にし、ヒドロゲルで作られている物体を得るステップと
を含む方法である。
− 優れた光学特性:可視光に対する完全な透明性、UV照射の吸収、角膜のものに近い屈折率、
− 非常に良好な物理化学的な特性:水、生理食塩水、小型および中型の分子に対する高い透過性、溶解ガスに対する透過性、高い親水性、毒性基を持たない化学的性質、
− 優れた寸法安定性
− 特定の生物学的特性:生理環境において非生体吸収性である、滅菌可能および/または再滅菌可能である、この環境における老化に対する良好な耐性、角膜支質における移植部位の良好な組織耐性(角膜上皮および内皮の変化を引き起こさない)、タンパク質に対する低親和性
を示す。
− 1から10質量%、好ましくは2から6質量%のアガロースまたはアルギン酸、
− 90から99質量%、好ましくは94から98質量%の水または無機塩水溶液または有機塩水溶液
からなる。
− 第1に:ゲル化を起こしている物体を非溶剤の冷浴中で、好ましくは0℃から10℃の範囲の温度で、5から15分であり得る間、浸漬するステップと、
− 第2に:ゲル化を起こしている物体を非溶剤の浴中で室温で、15から45分であり得る間、好ましくは約30分間浸漬するステップと
で行うことができる。
アガロースヒドロゲルで作られている型の調製:
アガロースヒドロゲル型を会社Essilorによって提供されるコンタクトレンズのポリプロピレンマトリックス(雄部および雌部)から調製する。
以下に示されている組成物に対応するポリマー溶液を撹拌しながら60℃の温度で水浴上で調製する:
予め調製したポリマー溶液1滴をアガロースヒドロゲル型の予め調製した雌部分に注ぐ。型の雌部分を直ちに雄部分で閉じる。
− レンズの形状(凸状/凹状)が変更されなかった、
− 「保水量」が2%減少した、
− 光パワーが非常にわずかに(±0.25D)変化した。
Claims (17)
- 生体適合性ヒドロゲルで作られている物体を製造するための方法であって、
(i)アクリロニトリルとアニオン性基を有するオレフィン性不飽和コモノマーの共重合体を非プロトン性溶媒に、任意選択で非溶剤の存在下で、溶解することによってポリマー溶液を調製するステップと、
(ii)前記非溶剤を含有する材料または前記非溶剤に対して透過性である材料からなる型において、ステップ(i)の終了時に得られたポリマー溶液を成形しゲル化を開始するステップと、
(iii)ステップ(ii)によって生じるゲル化を起こしている物体を非溶剤中で浸漬するステップと
を含むことを特徴とする方法。 - アクリロニトリル/コモノマー共重合体が、90/10から100/0の範囲、好ましくは95/5から99/1の範囲のモル比を有する、請求項1に記載の方法。
- オレフィン性不飽和コモノマーのアニオン性基が、スルホン酸基、カルボン酸基、リン酸基、ホスホン酸基および硫酸基から選択される、請求項1または請求項2に記載の方法。
- アクリロニトリル/コモノマー共重合体がアクリロニトリル−メタリルスルホン酸ナトリウム共重合体である、請求項1から3の一項に記載の方法。
- 非プロトン性溶媒が有機または無機の極性非プロトン性溶媒から選択される、請求項1から4の一項に記載の方法。
- 非プロトン性溶媒が、ジメチルホルムアミド(DMF)、ジメチルスルホキシド(DMSO)、N,N−ジメチルアセトアミド(DMAC)、Nーメチルピロリドン(NMP)から選択される、請求項5に記載の方法。
- 非溶剤が、水、無機塩水溶液および有機塩水溶液から選択される、請求項1から6の一項に記載の方法。
- 非溶剤が水または塩化ナトリウム水溶液から選択される、請求項7に記載の方法。
- ステップ(ii)の型がヒドロゲルで作られている型である、請求項1から8の一項に記載の方法。
- ステップ(ii)の型が、アガロース、アルギン酸、ポリヒドロキシエチルメタクリレート(PHEMA)、ポリヒドロキシプロピルメタクリレート(PHPMA)またはポリアクリレートをベースとするヒドロゲルで作られている型である、請求項9に記載の方法。
- ステップ(ii)の型がアガロースヒドロゲルで作られている型である、請求項10に記載の方法。
- ステップ(ii)の型が、
− 1から10質量%、好ましくは2から6質量%のアガロースまたはアルギン酸、
− 90から99質量%、好ましくは94から98質量%の水または無機塩水溶液または有機塩水溶液
からなる、請求項10または請求項11に記載の方法。 - 浸漬ステップ(iii)が2つのステップ:
− 第1に:ゲル化を起こしている物体を非溶剤の冷浴中で、好ましくは0℃から10℃の範囲の温度で浸漬するステップと、
− 第2に:ゲル化を起こしている物体を非溶剤の浴中で室温で浸漬するステップと
で行われる、請求項1から12の一項に記載の方法。 - 請求項1から13の一項に記載の方法によって得られることを特徴とする、生体適合性ヒドロゲルで作られている物体。
- 医療、生物学、眼科および/または特別な眼科使用のためのフィルム、糸、ロッドまたはインプラントから選択されることを特徴とする、請求項14に記載の物体。
- 眼用インプラントの形態であることを特徴とする、請求項15に記載の物体。
- 前記眼用インプラントが、近視、遠視、老眼、円錐角膜またはLASIK後の拡張症を補正するための角膜内レンズである、請求項16に記載の物体。
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FR1255631A FR2991988B1 (fr) | 2012-06-15 | 2012-06-15 | Procede de preparation d'objets en hydrogel biocompatible pour leur application dans le domaine medical, et plus particulierement en ophtalmologie |
FR1255631 | 2012-06-15 | ||
PCT/IB2013/054874 WO2013186747A1 (fr) | 2012-06-15 | 2013-06-14 | Procédé de préparation d'objets en hydrogel biocompatible pour leurs applications dans le domaine médical, et plus particulièrement en ophtalmologie |
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CN107233144A (zh) * | 2017-05-31 | 2017-10-10 | 中山大学中山眼科中心 | 去细胞角膜基质透镜在治疗眼科疾病中的应用 |
CN112694556B (zh) * | 2021-01-07 | 2021-11-02 | 西南交通大学 | 一种湿态环境下粘附性可调控水凝胶及其制备和使用方法 |
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CN104520334A (zh) | 2015-04-15 |
RU2015101092A (ru) | 2016-08-10 |
US20150148900A1 (en) | 2015-05-28 |
IN2015DN00314A (ja) | 2015-06-12 |
WO2013186747A1 (fr) | 2013-12-19 |
FR2991988B1 (fr) | 2015-08-07 |
EP2861634A1 (fr) | 2015-04-22 |
BR112014031267A2 (pt) | 2017-06-27 |
RU2638849C2 (ru) | 2017-12-18 |
US9999708B2 (en) | 2018-06-19 |
JP6326046B2 (ja) | 2018-05-16 |
FR2991988A1 (fr) | 2013-12-20 |
ES2834103T3 (es) | 2021-06-16 |
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