JP5671138B2 - ビニルアルコール製眼科学的レンズ成型用金型、その中で成型された眼科学レンズ、及び関連する方法 - Google Patents
ビニルアルコール製眼科学的レンズ成型用金型、その中で成型された眼科学レンズ、及び関連する方法 Download PDFInfo
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- JP5671138B2 JP5671138B2 JP2013522297A JP2013522297A JP5671138B2 JP 5671138 B2 JP5671138 B2 JP 5671138B2 JP 2013522297 A JP2013522297 A JP 2013522297A JP 2013522297 A JP2013522297 A JP 2013522297A JP 5671138 B2 JP5671138 B2 JP 5671138B2
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- vinyl alcohol
- alcohol copolymer
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Images
Classifications
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Description
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)なる範囲の射出成型圧力;
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。
一例において、これらのプロセス設定の少なくとも2つを使用して、前記ビニルアルコールコポリマーを射出成形する。もう一つの例においては、これらプロセス設定の3つ、4つ、5つ、6つ、7つ、8つ、9つ、10、又は全てを使用して、該ビニルアルコールコポリマーを射出成形する。
シリコーン-含有モノマー、マクロマー又はプレポリマーは、例えば以下の一般的な構造(I)を有するものであり得る:
有用な前記シリコーン-含有モノマー、マクロマー、又はプレポリマーの具体的な例は、例えば3-[トリス(トリメチルシリルオキシ)シリル]プロピルメタクリレート(米国PA州モリスビル(Morrisville, PA, USA)のゲレスト(Gelest)社から入手できる「トリス(Tris)」)及びモノメタクリロキシプロピル末端を有するポリジメチルシロキサン(米国PA州モリスビルのゲレスト社から入手できる「MCS-M11」)であり得る。幾つかのシリコーン-含有モノマーの例は、公開米国特許出願第2008/0269429号に記載されている。これらシリコーン-含有モノマーは、二価の結合基としてアルキレン基(例えば、-(CH2)p-)を有することができ、また「a」は、前記構造(I)に関しては0であり得、また少なくとも2つのシロキサニル基を有することができる。これらのシリコーン含有成分は、ここでは構造(A)群のシリコーン-含有モノマーと命名される。これらのシリコーン-含有モノマーの非-限定的な例は、以下に示すようなものである:
本開示に従って有用な、前記有用なシリコーン含有成分の他の具体例は、以下の式により表される化学物質、又は公開日本国特許出願第2008-202060A号に記載されている化学物質であり得る:
線型方程式としてのオウエンス-ベント-ラベル-ケーベルの式は、以下の通りである:
所定量の低いアモルファス含有率を有するエチレン-ビニルアルコールコポリマーを、顆粒又はペレットとして準備する。該ポリマーの一部を、従来の射出成型法により、コンタクトレンズ成型用金型部材に加工する。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1に示したように、流延成形された、複数の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該金型アセンブリーは、熱又はUV輻射を利用して硬化される。硬化後、該流延成形された重合レンズ本体を含む該金型アセンブリーは、湿式又は乾式成型品取出し処理に付されて、該金型アセンブリーの該2つの金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金型部材の一つから、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65%以下である。
所定量の高いアモルファス含有率を有するビニルアルコールコポリマーを、顆粒又はペレットとして準備する。該ポリマーの一部を、従来の射出成型法により、コンタクトレンズ成型用金型部材に加工する。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1に示したように、流延成形された、複数の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該金型アセンブリーは、熱又はUV輻射を利用して硬化される。硬化後、該流延成形された重合レンズ本体を含む該金型アセンブリーは、湿式又は乾式の成型品取出し処理に付されて、該金型アセンブリーの該2つの金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金型部材の一つから、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、該金型アセンブリーが、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金型アセンブリーを溶解することにより、成型品取出し処理及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)、即ち高いアモルファス含有率を有するビニルアルコールコポリマーを、顆粒又はペレットとして準備する。該ポリマーの一部を、従来の射出成型法により、雄型及び雌型のコンタクトレンズ成型用金型部材に加工する。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1に示したように、流延成形された、複数の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該金型アセンブリーは、熱又はUV輻射を利用して硬化される。硬化後、該流延成形された重合レンズ本体を含む該金型アセンブリーは、該重合されたレンズ本体を含む該金型アセンブリーを、トレーに入れ、該金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、該金型アセンブリーの両金型から解放することにより、同時に湿式の成型品取出し及びレンズ取出し処理に付される。場合によれば、該金型アセンブリー、該金型部材、又は該液体は、該成型品取出し及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、また封止及び滅菌処理に付される。
104・・該コポリマーを金型部材製造において使用する段階
106・・重合性組成物を金型部材に配置する段階
108・・金型アセンブリー製造段階
110・・重合性組成物の硬化段階
112・・重合レンズ本体の金型部材からの分離段階
114・・レンズ本体の洗浄段階
116・・デバイス本体の包装段階
118・・検査段階
120・・封止、滅菌段階
202・・要素、例えば高いアモルファス含有率を有するビニルアルコールコポリマー
204・・要素、例えば金型部材又は成型面
206・・要素、例えば重合性組成物
208・・要素、例えば重合レンズ本体
210・・水和レンズ本体
212・・包装レンズ製品
214・・包装され、検査された本体
Claims (20)
- 眼科学レンズの製造方法であって、以下の工程、
(a) 高いアモルファス含有率を有する少なくとも1種のビニルアルコールコポリマーを準備する工程であって、該高いアモルファス含有率を有する少なくとも1種のビニルアルコールコポリマーが、10%〜30%の平均結晶化度のレベルを有するビニルアルコールコポリマーである工程、
(b) 該高いアモルファス含有率を有する少なくとも1種のビニルアルコールコポリマーを使用して、第一の金型部材及び第二の金型部材の少なくとも一方を製造する工程であって、該第一の金型部材は、レンズの前面を成形するように形作られた凹型成型面を含み、かつ該第二の金型部材は、レンズの後部面を成形するように形作られた凸型成型面を含み、該第一の金型部材及び該第二の金型部材は、金型アセンブリーとして結合された際に、これらの間にレンズ形状を有するキャビティを形成するように形作られる工程、
(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、該第一の金型部材又は該第二の金型部材内に配置する工程、
(d) 該第一の金型部材及び該第二の金型部材を、これらの間に該レンズ形状を有するキャビティを形成するように接触させることにより、該金型アセンブリーを組立てる工程であって、該重合性組成物が、該金型アセンブリーの該レンズ形状を有するキャビティ内に収容される工程、及び
(e) 該金型アセンブリー内の該重合性組成物を硬化して、該金型アセンブリーの該レンズ形状を有するキャビティ内に、流延成形された重合反応生成物を形成する工程であって、該重合反応生成物は、眼科学レンズ本体を含む工程、
を含むことを特徴とする、前記眼科学レンズの製造方法。 - 前記高いアモルファス含有率を有する少なくとも1種のビニルアルコールコポリマーが、15%〜25%の平均結晶化度のレベルを有するビニルアルコールコポリマーである、請求項1記載の方法。
- 前記高いアモルファス含有率を有する少なくとも1種のビニルアルコールコポリマーが、140℃〜190℃の融点を有する、請求項1又は2記載の方法。
- 前記高いアモルファス含有率を有する少なくとも1種のビニルアルコールコポリマーが、60℃〜85℃のガラス転移点を有する、請求項1〜3の何れか1項に記載の方法。
- 前記高いアモルファス含有率を有する少なくとも1種のビニルアルコールコポリマーが、ニチゴG-ポリマーである、請求項1〜4の何れか1項に記載の方法。
- 前記重合性組成物を、前記第一の金型部材又は前記第二の金型部材内に配置する前記工程が、少なくとも1種のシリコーンモノマー、シリコーンマクロマー、シリコーンプレポリマー、又はこれらの組合せ、及び少なくとも1種の親水性モノマーを含有する重合性組成物を、該第一の金型部材に配置する工程を含み、かつ前記眼科学レンズ本体が、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1〜5の何れか1項に記載の方法。
- 前記高いアモルファス含有率を有する少なくとも1種のビニルアルコールコポリマーを使用して、前記第一の金型部材及び前記第二の金型部材の少なくとも一つを生成する前記工程が、該第一の金型部材及び該第二の金型部材の少なくとも一つを射出成形する工程を含む、請求項1〜6の何れか1項に記載の方法。
- 少なくとも一つの前記第一の金型部材及び前記第二の金型部材の射出成型が、少なくとも一つの該第一の金型部材及び該第二の金型部材の成型面を、完全に射出成型により生成する工程を含む、請求項7記載の方法。
- 前記第一の金型部材及び前記第二の金型部材の少なくとも一つを、射出成型する工程が、該第一の金型部材及び該第二の金型部材の少なくとも一方の本体を、射出成型により形成し、該射出成型された本体を機械加工、旋盤加工又は削摩することにより、該第一の金型部材及び該第二の金型部材の少なくとも一つの成型面を形成する工程を含む、請求項7又は8記載の方法。
- 前記高いアモルファス含有率を有するビニルアルコールコポリマーを射出成形する前記工程が、180℃〜250℃の溶融温度、180℃〜250℃のバレル温度、30℃〜70℃のスロート温度、30℃〜95℃の金型温度、1秒〜5秒の滞留時間、50mm/秒〜250mm/秒の射出速度、100mm/秒〜300mm/秒の可塑化速度、5〜18MPa(50〜180bar)の射出成型圧力、1〜20MPa(10〜200bar)の保持圧力、0.5〜2.5MPa(5〜25bar)の背圧、及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する、請求項7〜9の何れか1項に記載の方法。
- 前記高いアモルファス含有率を有する少なくとも1種のビニルアルコールコポリマーを使用して、前記第一の金型部材及び前記第二の金型部材の少なくとも一つを形成する前記工程が、該少なくとも1種の高いアモルファス含有率を有するビニルアルコールコポリマーを使用して、該第一の金型部材及び該第二の金型部材の少なくとも一つの上に、成型面を生成する工程を含み、ここで該少なくとも一つの第一の金型部材及び第二の金型部材の非-成形領域が、第二の材料で作られており、かつ前記重合性組成物を、該第一の金型部材又は該第二の金型部材内に配置する前記工程が、該重合性組成物を、該高いアモルファス含有率を有するビニルアルコールコポリマーを含む該成型面と直接接触した状態に置く工程を含む、請求項1〜10の何れか1項に記載の方法。
- 前記レンズ本体に表面処理を施すことなしに、あるいは前記重合性組成物の硬化中に、該組成物内に、該レンズ本体中に湿潤剤の相互貫入型網状構造(IPN)を形成する成分を存在させることなしに、該レンズ本体が眼科学的に許容される湿潤性の前面及び後部面を有する、請求項1〜11の何れか1項に記載の方法。
- 前記方法が、更に、前記金型アセンブリーを分離する工程をも含み、該分離は、前記第一の金型部材及び前記第二の金型部材の一つ及び唯一つと接触状態に維持されている前記レンズ本体を与え、ここで該第一の金型部材及び第二の金型部材の一つ及び唯一つは、前記少なくとも1種の高いアモルファス含有率を有するビニルアルコールコポリマーを含む該第一の金型部材及び第二の金型部材の少なくとも一つであり、あるいは該分離は、該レンズ本体を形成するのに使用した該金型部材の全てから解放された該レンズ本体を与える、請求項1〜12の何れか1項に記載の方法。
- 前記金型アセンブリーを分離する前記工程が、前記少なくとも1種の高いアモルファス含有率を有するビニルアルコールコポリマーを含む前記第一の金型部材及び前記第二の金型部材の少なくとも一つに液体を適用し、少なくとも部分的に該液体に溶解した、該少なくとも1種の高いアモルファス含有率を有するビニルアルコールコポリマーを含む、該第一の金型部材及び第二の金型部材の少なくとも一つを与える、請求項13記載の方法。
- 前記液体を適用する前記工程が、更に該液体を攪拌し、あるいは前記少なくとも1種の高いアモルファス含有率を有するビニルアルコールコポリマーを含む前記第一の金型部材及び第二の金型部材の少なくとも一つを攪拌する工程をも含む、請求項14記載の方法。
- 前記少なくとも1種の高いアモルファス含有率を有するビニルアルコールコポリマーを含む、前記第一の金型部材及び前記第二の金型部材の少なくとも一つを溶解する前記工程が、70℃又はそれ以下の温度にて行われ、また該少なくとも1種の高いアモルファス含有率を有するビニルアルコールコポリマーを含む、該第一の金型部材及び該第二の金型部材の少なくとも一つが、240分未満なる期間内に完全に溶解する、請求項14又は15記載の方法。
- 前記方法が、更に、前記レンズ形状を有するキャビティ内に前記硬化されたレンズ本体を含む前記金型アセンブリーを、包装用溶液を含むブリスターパッケージ内に配置し、該パッケージを封止し、かつ滅菌する工程をも含み、該金型アセンブリーが、該滅菌処理の後に、該包装用溶液中に完全に溶解する、請求項1〜12の何れか1項に記載の方法。
- 前記第一の金型部材及び前記第二の金型部材の少なくとも一方の前記成型面が、前記少なくとも1種の高いアモルファス含有率を有するビニルアルコールコポリマーを含み、また該第一の金型部材及び該第二の金型部材の少なくとも一方の前記非-成形領域が、前記包装用溶液に対して不溶性である少なくとも1種のポリマー材料で作られており、かつブリスターパッケージとして使用するように形作られている、請求項17記載の方法。
- 包装されたシリコーンヒドロゲルコンタクトレンズ本体であって、
疎水性ポリマー材料で作成されたブリスターパッケージ、
重合性組成物の反応生成物を含む、流延成形され重合されたレンズ本体であって、該重合性組成物が、少なくとも1種のシリコーンモノマー、シリコーンマクロマー、シリコーンプレポリマー又はこれらの任意の組合せ、及び少なくとも1種の親水性モノマーを含む本体、及び
包装用溶液中に、10%〜30%の平均結晶化度のレベルを有する、高いアモルファス含有率を有する少なくとも1種のビニルアルコールコポリマーの溶解生成物を含む液体、
を含むことを特徴とする、前記包装されたシリコーンヒドロゲルコンタクトレンズ本体。 - シリコーンヒドロゲルコンタクトレンズ本体を、流延成形するための金型部材であって、
成型面及び非-成型面を含む金型部材を含み、該金型部材の少なくとも該成型面が、少なくとも1種の、10%〜30%の平均結晶化度のレベルを有する、高いアモルファス含有率を有するビニルアルコールコポリマーを含むことを特徴とする、前記シリコーンヒドロゲルコンタクトレンズ本体を流延成形するための金型部材。
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