JP7074960B2 - 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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- 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
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- 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
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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 (18)
- 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、
前記前方視嚢の前記融合区域と前記後方視嚢の前記融合区域との間に埋め込まれたリング形状プレートとを含み、
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み、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、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又は2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1~3の何れか1項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1~4の何れか1項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1~5の何れか1項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1~6の何れか1項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前記オプティックの融合された前方視嚢と後方視嚢内に包囲される、請求項1~7の何れか1項に記載のデュアルモードAD-IOL。
- 前記リング形状プレートの表面が黒ずんでいる又は無反射である、請求項1~8の何れか1項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1~9の何れか1項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1~10の何れか1項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1~11の何れか1項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・システムの形状記憶により提供される遠近調節弾力または非遠近調節弾力の合計が、1グラム重量未満である、請求項1~12の何れか1項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1~13の何れか1項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1~14の何れか1項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み、前記厚い剛性の光学区域の厚さは、200μm~500μm(ミクロン)の範囲から選択され、当該厚さは、前記厚い剛性の光学区域に近接して配置された屈曲区域の厚さより大きい、請求項1~15の何れか1項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1~16の何れか1項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1~17の何れか1項に記載のデュアルモードAD-IOL。
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US10512535B2 (en) | 2019-12-24 |
WO2018039353A1 (en) | 2018-03-01 |
KR102220676B1 (ko) | 2021-03-02 |
CN109890325A (zh) | 2019-06-14 |
EP3503843B1 (en) | 2023-11-15 |
CN109890325B (zh) | 2021-10-26 |
JP2019524364A (ja) | 2019-09-05 |
US20180055626A1 (en) | 2018-03-01 |
EP3503843A1 (en) | 2019-07-03 |
KR20190045230A (ko) | 2019-05-02 |
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