JP2019524364A - デュアルモード調節型−非調節型眼内レンズ - Google Patents
デュアルモード調節型−非調節型眼内レンズ Download PDFInfo
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- JP2019524364A JP2019524364A JP2019510778A JP2019510778A JP2019524364A JP 2019524364 A JP2019524364 A JP 2019524364A JP 2019510778 A JP2019510778 A JP 2019510778A JP 2019510778 A JP2019510778 A JP 2019510778A JP 2019524364 A JP2019524364 A JP 2019524364A
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- Prostheses (AREA)
Abstract
Description
本出願は、2016年8月24日に出願された米国仮特許出願第62/378737号の優先権および恩典を主張しており、その開示は、参照により全体として本明細書に組み込まれる。
本発明の実施形態は概して、眼内レンズ(人工水晶体)に関する。より具体的には、本発明の実施形態は、調節(遠近調節)型および非調節(非遠近調節)型眼内レンズ(Accommodative andDisaccommodative Intraocular lens:AD−IOL)システム、及び毛様小帯キャプチャ・ハプティック・システムと結合するように適合された形状シフトするフレキシブルなオプティックに関する。このフレキシブルなオプティック及び毛様小帯キャプチャ・ハプティック・システムの組み合わされた特徴は、新規なデュアルモードAD−IOLという結果になり、この場合、オプティックは、形状および眼内の位置の双方をシフトして、水晶体の挙動を模倣し、小さいオプティックは、従来の白内障の手術によって生じる、閉じた(closed)線維状水晶体嚢の機能に適合される。
正常状態では、健康なヒトの眼は、毛様筋を収縮および弛緩し、それによって眼内の毛様小帯の張力を縮小および解放することによって、近く及び遠くの対象物に焦点を合わせる。眼の弾性力は非遠近調節をもたらし、水晶体の弾性収縮力が遠近調節をもたらす。2つの対抗する弾性力間のバランスは、毛様体の神経学的に制御された収縮により調整される。毛様筋の収縮は毛様小帯の緊張を解き(遠近調節状態)、水晶体が更に球形又は球状の休止形状に戻ることを可能にする。毛様筋の弛緩は毛様小帯の緊張を高め、眼組織の弾性力が固有の水晶体の弾力性に打ち勝ち、そして水晶体赤道を伸ばして、水晶体の湾曲状態を平坦化するという結果になる(非遠近調節状態)。
本発明の実施形態の基本は、デュアルモードの動作を有するフレキシブルな形状シフトするオプティック及び毛様小帯キャプチャ・ハプティックを備える調節型−非調節型IOL(AD−IOL)であり、オプティックの軸方向シフト及びオプティックの形状シフトは、フレキシブルなオプティックに対する毛様小帯キャプチャ・ハプティックの動作とオプティック及び/又はハプティック・システムの形状記憶との間の動的なバランスにより駆動される。本発明の実施形態は、多くの個々の要素(幾つかは、様々な様式のIOLの構成要素として別個に前述された)を合わせて、新規で包括的なまとまりのある設計にする。この独自の設計は特に、従来の白内障の手術後に生じるような、閉じた及び繊維化した水晶体嚢において機能するように構築され、従来のIOLと同様のサイズを有するAD−IOLという結果になる。オプティックの形状シフトは、軸方向シフト成分だけにより提供されるのに比べて、遠近調節のはるかに大きい範囲を可能にする。双方の構成要素は、得られる遠近調節量を増加するために、相乗的に働く。白内障の手術後の治癒および瘢痕化の避けられない生物学的反応は、回避されないが、むしろ小帯の半径方向の引く力により付勢されるこのデュアルモードAD−IOLの適切な機能に利用される。対照的に、従来技術は、嚢の閉鎖を防止しようとする試み、及び様々なオプティック設計に力を伝達する機械的構造を圧縮するために融合されていない開いた水晶体嚢を使用する又は毛様筋の直接的な圧縮を使用するための試みを説明する。
本明細書で引用される全ての特許出願、特許、及び他の文献は、参照により本開示に全体として組み込まれる。
Claims (43)
- デュアルモード調節型−非調節型眼内レンズ(デュアルモードAD−IOL)であって、
形状記憶を有する複数の閉じたループのハプティックを含むハプティック・システムと、
前方視嚢および後方視嚢を含む形状シフトするフレキシブルなオプティックであって、2つの視嚢のそれぞれは、融合区域を含み、2つの視嚢の前記融合区域は合わさって融合され、それによりそれらの間に眼胞を画定し、前記眼胞は、流体で満たされ、(i)前記ハプティックが前記オプティックに取り付けられ、前記ハプティックの動作が前記オプティックの形状を変更することを可能にし、(ii)前記形状シフトするフレキシブルなオプティックが8mm以下の直径を有し、(iii)休止状態である前記デュアルモードAD−IOLは、前記ハプティック・システムの形状記憶および前記フレキシブルなオプティックの形状シフトする能力の少なくとも1つの結果として完全に遠近調節された構成の状態にある、形状シフトするフレキシブルなオプティックと、
前記遠近調節された構成と比較した場合に、前記AD−IOLの遠近調節されていない構成において、より平らな角度およびより大きな直径の少なくとも1つの状態に前記ハプティックを固定するような大きさで且つそのように固定するように構成された拘束用構成要素とを含む、デュアルモードAD−IOL。 - 前記閉じたループのハプティックが、台形およびT字形状の少なくとも1つである、請求項1に記載のデュアルモードAD−IOL。
- オプティック・リングを更に含み、
前記オプティック・リングが前記ハプティックを互いに且つ前記オプティックに接続する、請求項1に記載のデュアルモードAD−IOL。 - 前記ハプティックは、前記融合区域において前記オプティックに埋め込まれている各ハプティックの部分により、前記オプティックに取り付けられる、請求項1に記載のデュアルモードAD−IOL。
- 各閉じたループのハプティックが、前記AD−IOLの非遠近調節中に毛様小帯の張力により生成された半径方向の引く力を前記オプティックに伝達するために適合されるように構成されている、請求項1に記載のデュアルモードAD−IOL。
- 各閉じたループのハプティックが、前記AD−IOLの遠近調節中に、設定された形状に戻るために適合されるように構成されている、請求項1に記載のデュアルモードAD−IOL。
- 前記拘束用構成要素は、ハプティック又はオプティック・リング上に配置された拘束用タブ、ハプティック部分により画定された拘束用穴、オプティックの融合区域においてオプティックにより画定された拘束用穴、ハプティック・アーム上のクロスバー、拘束用リング、及び縫合糸からなるグループから選択される、請求項1に記載のデュアルモードAD−IOL。
- 前記オプティックの前方視嚢と後方視嚢との間に埋め込まれたリング形状プレートを更に含む、請求項1に記載のデュアルモードAD−IOL。
- 前記リング形状プレートが、穴の少なくとも1つの同心リングを画定する、請求項8に記載のデュアルモードAD−IOL。
- 前記リング形状プレートが、形状記憶を有する材料からなる、請求項8に記載のデュアルモードAD−IOL。
- 前記リング形状プレートが、(i)前記オプティックより剛性であり、(ii)前記オプティックに構造的安定性を提供する、請求項8に記載のデュアルモードAD−IOL。
- 前記リング形状プレートが、無反射の表面を含む、請求項8に記載のデュアルモードAD−IOL。
- 前記閉じたループのハプティックのそれぞれが、正弦曲線形状の赤道部分を含む、請求項1に記載のデュアルモードAD−IOL。
- 前記閉じたループのハプティックのそれぞれが、第1の接続特徴要素を含み、前記オプティックは、前記第1の接続特徴要素と係合するように適合された第2の接続特徴要素を含む、請求項1に記載のデュアルモードAD−IOL。
- 前記第1の接続特徴要素が、前記閉じたループのハプティックのそれぞれにより画定されたリングを含み、前記第2の接続特徴要素が、前記オプティックにより画定された複数のペグを含み、各リングは、ペグを受容する大きさであり且つペグを受容するように構成されている、請求項14に記載のデュアルモードAD−IOL。
- 前記第1の接続特徴要素が、前記閉じたループのハプティックのそれぞれにより画定されたTを含み、前記第2の接続特徴要素が、前記オプティックにより画定され且つ各Tを受容する大きさであり且つ各Tを受容するように構成されたT字形状溝を含む、請求項14に記載のデュアルモードAD−IOL。
- 前記閉じたループのハプティックのそれぞれが、前記オプティックの軸方向シフト及び形状シフトに寄与するように設定された形状である、請求項1に記載のデュアルモードAD−IOL。
- 前記複数の閉じたループのハプティックは、前記デュアルモードAD−IOLが移植される水晶体嚢の直径の変化に応じて直径を変化させるように構成された連続的なループにより画定され、それにより小帯からのオプティックに対する一様でない張力が減少される、請求項1に記載のデュアルモードAD−IOL。
- 前記閉じたループのハプティックのそれぞれが、前記オプティックに近接して間隔を置いた端部を含み、それにより前記閉じたループのハプティックの膨張が可能になる、請求項1に記載のデュアルモードAD−IOL。
- 前記ハプティック・システムが、少なくとも2つのオプティック・リングを含み、各オプティック・リングは、2つの閉じたループのハプティックを含み、前記オプティック・リングは、前記デュアルモードAD−IOLをインジェクタに装填することを容易にするためにそのプロファイルを低減するように、前記オプティックの上に配置されて且つ近接したオプティック・リングの前記ハプティックの上に第1のオプティック・リングの前記ハプティックを重ねて回転するように構成されている、請求項1に記載のデュアルモードAD−IOL。
- 少なくとも1つの閉じたループのハプティックが、半径方向セグメント、及び前記半径方向セグメント上に配置され、前記オプティックの一部を圧縮するように構成されたパドルを含む、請求項1に記載のデュアルモードAD−IOL。
- 前記オプティック及び前記ハプティック・システムの遠近調節の記憶の合計が、休止状態にある遠近調節である、請求項1に記載のデュアルモードAD−IOL。
- 少なくとも前記オプティック及び前記ハプティック・システムの遠近調節の記憶または非遠近調節の記憶の合計が、1グラム重量未満である、請求項1に記載のデュアルモードAD−IOL。
- 少なくとも前記オプティック及び前記ハプティック・システムの遠近調節の記憶または非遠近調節の記憶の合計が、毛様小帯の張力未満である、請求項1に記載のデュアルモードAD−IOL。
- 前記前方視嚢および後方視嚢が、結合材料でもって融合され、前記融合区域は、余分な結合材料を受容するように構成されたチャネルを画定する、請求項1に記載のデュアルモードAD−IOL。
- 前記フレキシブルなオプティックの形状の変化が、眼胞の表面積対前記眼胞の体積の比を変化させ、前記ハプティック・システムが、前記比の変化を調節するためにサイズ及び形状を変化させる、請求項1に記載のデュアルモードAD−IOL。
- 前記視嚢の1つが、乱視矯正を含む一定の屈折力を担う厚い剛性の光学区域を含む、請求項1に記載のデュアルモードAD−IOL。
- 前記剛性の光学区域の軸が、外部からマーキングされる、請求項27に記載のデュアルモードAD−IOL。
- 前記剛性の光学区域が、前記ハプティック・システムに対する中心化および固定区域の役割を果たす、請求項27に記載のデュアルモードAD−IOL。
- 前記視嚢の1つが、中央光学区域に近接して配置されたより薄くてより容易に曲げられる屈曲区域を含む、請求項1に記載のデュアルモードAD−IOL。
- 前記視嚢の1つが、前記屈曲区域・光学区域内に又は前記屈曲区域・光学区域に近接して配置され、且つ流体を前記眼胞の中心の方へ押すように適合された、より厚くてそれほど容易に曲がらないピストン区域を含む、請求項30に記載のデュアルモードAD−IOL。
- 前記より厚いピストン区域が、前記ハプティック・システムの半径方向アームをキャプチャする及び固定するように適合された複数の構造体を含む、請求項29に記載のデュアルモードAD−IOL。
- 各融合区域が、前記ハプティック・システムの個々のハプティックを埋め込むように適合されている、請求項1に記載のデュアルモードAD−IOL。
- 前記眼胞は、形状シフトに対して最小限の抵抗を生じさせるために、ただの最小限に伸ばされた構成に過ぎない状態で一定量の流体で満たされる、請求項1に記載のデュアルモードAD−IOL。
- 前記眼胞は、形状記憶を有する、請求項1に記載のデュアルモードAD−IOL。
- 前記流体が、水の屈折率より大きい屈折率を有する、請求項1に記載のデュアルモードAD−IOL。
- 前記流体の屈折率が、前記眼胞の屈折率と実質的に同じである、請求項36に記載のデュアルモードAD−IOL。
- 前記ハプティック・システムが、IOL投入システム内に収まるように適合されている、請求項1に記載のデュアルモードAD−IOL。
- 前記ハプティック・システムが、円筒体に転がり込むように適合されている、請求項38に記載のデュアルモードAD−IOL。
- 前記AD−IOLが、移植時に及び水晶体嚢の融合および繊維化の間に、平らになって伸ばされた遠近調節されていない構成に拘束されるように適合される、請求項1に記載のデュアルモードAD−IOL。
- 前記AD−IOLが、外部のレーザの印加により、解放されるように適合されている、請求項1に記載のデュアルモードAD−IOL。
- 前記外部のレーザの印加は、ハプティック間の半径方向切断により前記拘束用デバイス及び眼の融合した水晶体嚢の双方を同時に分割し、前記半径方向切断が、眼の繊維化した水晶体嚢の剛性において解放の所望量を生成するために画定された距離にわたって、眼の水晶体前嚢のエッジから眼の水晶体嚢の赤道の方へ延びている、請求項41に記載のデュアルモードAD−IOL。
- デュアルモード調節型−非調節型眼内レンズ(デュアルモードAD−IOL)を移植するための方法であって、
AD−IOLを準備するステップであって、前記AD−IOLが、
形状記憶を有する複数の閉じたループのハプティックを含むハプティック・システムと、
前方視嚢および後方視嚢を含む形状シフトするフレキシブルなオプティックであって、2つの視嚢のそれぞれは、融合区域を含み、2つの視嚢の前記融合区域は合わさって融合され、それによりそれらの間に眼胞を画定し、前記眼胞は、流体で満たされ、(i)前記ハプティックが前記オプティックに取り付けられ、前記ハプティックの動作が前記オプティックの形状を変更することを可能にし、(ii)前記形状シフトするフレキシブルなオプティックが8mm以下の直径を有し、(iii)休止状態である前記デュアルモードAD−IOLは、前記ハプティック・システムの形状記憶および前記フレキシブルなオプティックの形状シフトする能力の少なくとも1つの結果として完全に遠近調節された構成の状態にある、形状シフトするフレキシブルなオプティックと、
前記遠近調節された構成と比較した場合に、前記AD−IOLの遠近調節されていない構成において、より平らな角度およびより大きな直径の少なくとも1つの状態に前記ハプティックを固定するような大きさで且つそのように固定するように構成された拘束用構成要素とを含む、ステップと、
前記AD−IOLを患者の眼へ移植するステップと、
眼の水晶体嚢が前記ハプティックを介して融合することを可能にするステップと、
前記ハプティックをそれらの間で半径方向切断を行なうことにより解放するステップとを含み、前記半径方向切断が、眼の繊維化した水晶体嚢の剛性において解放の所望量を生成するために画定された距離にわたって、眼の水晶体前嚢のエッジから眼の水晶体嚢の赤道の方へ延びている、方法。
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CN109890325A (zh) | 2019-06-14 |
JP7074960B2 (ja) | 2022-05-25 |
WO2018039353A1 (en) | 2018-03-01 |
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US20180055626A1 (en) | 2018-03-01 |
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