JP2013542089A - ビニルアルコールコポリマーで作成された眼科学デバイス成型用の型、その中で成型された眼科学デバイス、および関連する方法 - Google Patents
ビニルアルコールコポリマーで作成された眼科学デバイス成型用の型、その中で成型された眼科学デバイス、および関連する方法 Download PDFInfo
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- JP2013542089A JP2013542089A JP2013522299A JP2013522299A JP2013542089A JP 2013542089 A JP2013542089 A JP 2013542089A JP 2013522299 A JP2013522299 A JP 2013522299A JP 2013522299 A JP2013522299 A JP 2013522299A JP 2013542089 A JP2013542089 A JP 2013542089A
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- mold
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- vinyl alcohol
- device body
- alcohol copolymer
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Abstract
【選択図】 なし
Description
約160℃〜約250℃なる範囲の溶融温度;
約160℃〜約250℃なる範囲のバレル温度;
約30℃〜約70℃なる範囲のスロート温度;
約30℃〜約95℃なる範囲の金型温度;
約1秒〜約5秒なる範囲の滞留時間;
約50mm/秒〜約250mm/秒なる範囲の射出速度;
約100mm/秒〜約300mm/秒なる範囲の可塑化速度;
約5〜約18MPa(約50〜約180bar)なる範囲の射出成形圧力;
約1〜約20MPa(約10〜約200bar)なる範囲の保持圧力;
約0.5〜約2.5MPa(約5〜約25bar)なる範囲の背圧。
次いで、該表面張力の前記算出された分散成分(σL D)を、前記測定された全表面エネルギー(σL T)から差引き、次の式:σL P = σL T - σL Dを用いて、該表面張力の極性成分を得ることができる。該重合性組成物の平均極性は、該極性成分(σL P)を、上記全表面エネルギー(σL T)で割り、100を乗じることにより算出される。
展開係数= σS - σL - σSL
付着エネルギー= 2 [(σS D σL D)1/2 + (σS P σL P)1/2]
実施例1(比較例、理論的な例)
所定量のエチレン-ビニルアルコールコポリマーを、顆粒またはペレットとして準備する。該ポリマーの一部を、従来の射出成形法により、第一および第二のコンタクトレンズ成型用型部材に加工する。シリコーンヒドロゲルコンタクトレンズを製造するための重合性組成物は、本明細書に記載したように製造され、また図2に示したように、複数の流込み成形された、重合シリコーンヒドロゲルレンズ本体を作成するために使用される。該重合性組成物を含む型アセンブリーは、熱またはUV輻射を利用して硬化される。硬化後に、該流込み成形された重合レンズ本体を含む該型アセンブリーは、湿式または乾式成型品取出し処理に付されて、該型アセンブリーの該2つの型部材が分離される。該乾式成型品取出し段階の後、湿式レンズ取出し工程を利用して、該成型品取出し段階後に接触状態に維持されている該型部材の一つから、該重合レンズ本体を解放(release)する。該開放されたレンズ本体を、引続き有機溶媒を含む液体、次いで本質的に有機溶媒を含まない水性溶液を用いて洗浄するか、あるいは本質的に有機溶媒を含まない水性溶液を用いて洗浄する。該洗浄段階は、追加の水和段階を含むことができ、あるいは該レンズ本体を包装し、また滅菌する前に、別途の水和段階を含むことができる。許容し得るレンズ本体の収率は、約65%以下である。
所定量のビニルアルコールコポリマーを、顆粒またはペレットとして準備する。該ポリマーの一部を、従来の射出成形法により、コンタクトレンズ成型用型部材に加工する。シリコーンヒドロゲルコンタクトレンズを製造するための重合性組成物は、本明細書に記載したようにして製造され、また図2に示したように、複数の流込み成形された、重合シリコーンヒドロゲルレンズ本体を作成するために使用される。該重合性組成物を含む型アセンブリーは、熱、マイクロ波輻射またはUV輻射を利用して硬化される。硬化後、該流込み成形された重合レンズ本体を含む該型アセンブリーは、湿式または乾式の成型品取出し処理に付されて、該型アセンブリーの該2つの型部材が分離される。該乾式の成型品取出し段階の後、湿式レンズ取出し工程を利用して、該成型品取出し段階後に接触状態に維持されている該型部材の一つから、該重合レンズ本体を解放する。該開放されたレンズ本体を、引続き有機溶媒を含む液体、次いで本質的に有機溶媒を含まない水性溶液を用いて洗浄するか、あるいは本質的に有機溶媒を含まない水性溶液を用いて洗浄する。該洗浄段階は、追加の水和段階を含むことができ、あるいは該レンズ本体を包装し、また滅菌する前に、別途の水和段階を含むことができる。許容し得るレンズ本体の収率は、約75%を越える。該製造工程が、該レンズ本体の最低限度の取扱いを含む場合、該型アセンブリーが、該ブリスターパッケージ内に収納され、また該レンズ本体が、該ブリスターパッケージ内の該型アセンブリーを溶解することにより、成型品取出し処理およびレンズ取出し処理に付され、次いで該パッケージ内で該レンズ本体を洗浄した際には、許容し得るレンズ本体の収率は、約85%を越える。
所定量のニチゴG-ポリマー(Nichigo G-PolymerTM)ビニルアルコールコポリマーを、顆粒またはペレットとして準備する。該ポリマーの一部を、従来の射出成形法により、雄および雌型のコンタクトレンズ成型用型部材に加工する。シリコーンヒドロゲルコンタクトレンズを製造するための重合性組成物は、本明細書に記載したようにして製造され、また図2に示したように、複数の流込み成形された、重合シリコーンヒドロゲルレンズ本体を作成するために使用される。該重合性組成物を含む型アセンブリーは、熱またはUV輻射を利用して硬化される。硬化後、該流込み成形された重合レンズ本体を含む該型アセンブリーは、該ポリマー製レンズ本体を含む該型アセンブリーを、トレーに入れ、該型アセンブリーに対して液体を適用して、少なくとも部分的に該ビニルアルコールコポリマーを溶解し、結果として該レンズ本体を、該型アセンブリーの両型から解放することにより、同時に湿式成型品取出しおよびレンズ取出し処理に付される。場合によれば、該型アセンブリー、該型部材、または該液体は、該成型品取出しおよびレンズ取出し段階中に攪拌することができる。該開放されたレンズ本体は、引続き包装用溶液を含むブリスターパッケージに移され、また封止および滅菌処理に付される。
Claims (20)
- 眼科学デバイスの製造方法であって、以下の工程:
(a) 少なくとも1種のビニルアルコールコポリマーを準備する工程;
(b) 該少なくとも1種のビニルアルコールコポリマーを使用して、第一の型部材および第二の型部材の少なくとも一方を形成する工程、ここで該少なくとも一方の第一の型部材および第二の型部材は、70度未満の静的な定着液滴の接触角を有し、またプラズマ処理されていない、デバイス-形成用成型面を含み、該第一の型部材は、眼科学デバイスの前面を成型するように形作られた成型面を含み、かつ該第二の型部材は、眼科学デバイスの後部面を成型するように形作られた成型面を含み、また該第一の型部材および該第二の型部材は、結合して型アセンブリーとされた場合に、これらの間に眼科学デバイス-形状を持つキャビティを形成するように形作られており;
(c) 少なくとも1種の親水性モノマーを含む重合性組成物を、該第一の型部材または該第二の型部材内に配置する工程;
(d) 該第一の型部材および該第二の型部材を接触させることにより、該型アセンブリーを組立てて、該2つの型部材間に該眼科学デバイス-形状を持つキャビティを形成する工程、ここで該重合性組成物は、該型アセンブリーの該眼科学デバイス-形状を持つキャビティ内に収容されており;および
(e) 該型アセンブリー内の該重合性組成物を硬化して、該型アセンブリーの該眼科学デバイス-形状を持つキャビティ内で、流込み成形された重合反応生成物を生成する工程、ここで該重合反応生成物は、ポリマー製眼科学デバイス本体を含む、
ことを特徴とする、前記眼科学デバイスの製造方法。 - 前記眼科学デバイスが、コンタクトレンズを含み、前記第一の型部材が、コンタクトレンズの前面を成型するように形作られた凹型の成型面を含み、前記第二の型部材が、コンタクトレンズの後部面を成型するように形作られた凸型の成型面を含み、該第一の型部材および該第二の型部材が、結合して型アセンブリーとされた場合に、これらの間にコンタクトレンズ-形状を持つキャビティを形成するように形作られており、かつ前記重合反応生成物が、ポリマー製コンタクトレンズ本体を含む、請求項1記載の方法。
- 前記少なくとも一つの第一の型部材および第二の型部材の、前記静的な定着液滴の接触角が、43度未満である、請求項1または2記載の方法。
- 前記重合性組成物が、ケイ素-含有重合性組成物を含み、かつ前記ポリマー製デバイス本体が、シリコーンヒドロゲルポリマー製眼科学デバイス本体を含む、請求項1〜3の何れか1項に記載の方法。
- 前記ポリマー製眼科学デバイス本体が、十分に水和された場合に、45度未満の静的な定着液滴の接触角を持つ、請求項1〜4の何れか1項に記載の方法。
- 前記ポリマー製デバイス本体が、ポリマー系湿潤剤の相互貫入型網状構造または擬似-相互貫入型網状構造を含まず、かつ該ポリマー製デバイス本体の表面が、プラズマ処理に付されていない、請求項1〜5の何れか1項に記載の方法。
- 前記少なくとも1種のビニルアルコールコポリマーが、エチレン-ビニルアルコールコポリマーではない、請求項1〜6の何れか1項に記載の方法。
- 前記少なくとも1種のビニルアルコールコポリマーが、水溶性である、請求項1〜7の何れか1項に記載の方法。
- 前記少なくとも1種のビニルアルコールコポリマーが、ニチゴG-ポリマー(NICHIGO G-POLYMERTM)を含む、請求項1〜8の何れか1項に記載の方法。
- 前記少なくとも1種のビニルアルコールコポリマーを使用して、前記少なくとも一つの第一の型部材および第二の型部材を形成する前記工程が、以下に列挙するプロセス設定:約180℃〜約250℃なる範囲の溶融温度、約180℃〜約250℃なる範囲のバレル温度、約30℃〜約70℃なる範囲のスロート温度、約30℃〜約95℃なる範囲の金型温度、約1秒〜約5秒なる範囲の滞留時間、約50mm/秒〜約250mm/秒なる範囲の射出速度、約100mm/秒〜約300mm/秒なる範囲の可塑化速度、約5〜約18MPa(約50〜約180bar)なる範囲の射出成形圧力、約1〜約20MPa(約10〜約200bar)なる範囲の保持圧力、約0.5〜約2.5MPa(約5〜約25bar)なる範囲の背圧、およびこれらの任意の組合せ、からなる群から選択されるプロセス設定を使用して、該ビニルアルコールコポリマーを射出成形する工程を含む、請求項1〜9の何れか1項に記載の方法。
- 前記型アセンブリー内で前記重合性組成物を硬化する前記工程が、マイクロ波輻射を使用して該重合性組成物を硬化する段階を含む、請求項1〜10の何れか1項に記載の方法。
- 前記方法が、更に前記硬化工程後に、前記型アセンブリーを湿式成型品取出し処理に付す工程をも含む、請求項1〜11の何れか1項に記載の方法。
- 前記方法が、更にレンズ取出し処理後に、前記ポリマー製デバイス本体を湿式レンズ取出し処理に付す工程をも含む、請求項1〜11の何れか1項に記載の方法。
- 前記方法が、更に、少なくとも部分的に、少なくとも一つの前記型部材を水性溶液に溶解することにより、該型部材から、前記ポリマー製デバイス本体を解放する段階をも含む、請求項1〜11の何れか1項に記載の方法。
- 眼科学デバイス本体であって、
重合性組成物の反応生成物を含む、流込み成形され重合されたデバイス本体を含み、ここで該重合性組成物は、少なくとも1種の親水性モノマーを含み、
該デバイス本体が、第一の型部材および第二の型部材を含む型アセンブリー内で流込み成形され、該第一の型部材および該第二の型部材の少なくとも一方が、少なくとも1種のビニルアルコールコポリマーで作られており、また70度未満の静的な定着液滴の接触角を有し、プラズマ処理に付されていない、デバイス-形成用成型面を含む、ことを特徴とする、前記眼科学デバイス本体。 - 前記デバイス本体が、少なくとも1種のケイ素-含有モノマーおよび少なくとも1種の親水性モノマーを含有する重合性組成物の反応生成物を含む、流込み成形され重合されたシリコーンヒドロゲルコンタクトレンズ本体を含む、請求項15記載の眼科学デバイス本体。
- 前記ポリマー製眼科学デバイス本体が、十分に水和された場合に、45度未満の静的な定着液滴の接触角を持つ、請求項15または16記載の眼科学デバイス本体。
- 前記ポリマー製眼科学デバイス本体が、ポリマー系湿潤剤の相互貫入型網状構造または擬似-相互貫入型網状構造を含まず、かつ該ポリマー製デバイス本体の表面が、プラズマ処理に付されていない、請求項15〜17の何れか1項に記載の眼科学デバイス本体。
- 前記ポリマー製デバイス本体が、十分に水和された場合に、同一の重合性組成物から作成され、またプラズマ処理されたデバイス-形成用成型面を持たない、ポリプロピレンで作成された型部材のみを用いて流込み成形されたポリマー製デバイス本体よりも、少なくとも5度低い静的な定着液滴の接触角を持つ、請求項15〜18の何れか1項に記載の眼科学デバイス本体。
- 眼科学デバイス本体を流込み成形するための型部材であって、
デバイス-形成用成型面および非-成型領域を含む型部材を含み、該型部材の少なくとも該デバイス-形成用成型面が、少なくともビニルアルコールコポリマーを含み、70度未満の静的な定着液滴の接触角を持ち、かつプラズマ処理に付されていないことを特徴とする、前記型部材。
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