JP2004535251A - Small incision lens and method of using the same - Google Patents

Abstract

The present invention represents a deformable intraocular lens for implantation in the human eye. The lens (10) is used for transplantation after cataract surgery. The optical component of the lens consists of one smooth optical surface. The second optical surface is a series of annular concentric rings (14). These rings allow the lens to have very thin edges, which reduces glare, halo and distortion. With a thin tactile sensation, an extremely thin lens can be rolled, folded, or crushed to pass through a small incision in the cornea or sclera of the human eye.

Description

【００６２】
Ｔｅ＿２は、中心軸に平行なレンズの縁に沿った距離であり、光学径が４ｍｍのときに中心軸から２ｍｍである。Ｔｅ＿３は、中心軸に平行なレンズの縁に沿った距離であり、光学径が６ｍｍのときに中心軸から３ｍｍである。平行に計られ、中心軸又は本初子午線に対して片寄った、前面の頂点から前面の縁までの距離がＴｒ１で表される。平行に計られ、中心軸又は本初子午線に対して片寄った、前面の頂点から後面の縁までの距離がＴｒ２で表される。Ｔｃは頂点での中心厚さである。最後の欄はレンズの縁の厚さを示す。この縁の厚さは、最良の場合、ＰＭＭＡが巻かれた場合の理論的な最大厚さに近似する。実際の実験からは、この材料は完全には元の形に戻らない。即ち、０．２５ｍｍの厚さで、材料に幾分かの永久的な変形がある。したがって、このレンズは１／８インチの合わせピンの周りに巻くことはできず、変形し得る屈折レンズではない。事実、以前に設計したレンズは、前面と後面が互いに平行な光学面に沿って一定の厚さを持ってはいない。薄いレンズを用いた場合、各表面の半径は互いに接近し、その結果、両方の表面が同じ倍率を有する。一方、前面は正であり、後面は負であって、このレンズの倍率は互いに打ち消しあう。レンズが、ヒドロゲル、親水性のアクリル樹脂、又は疎水性のアクリル樹脂等の材料で作られた場合、これらのレンズはＰＭＭＡよりもはるかに大きい厚さで曲がる。そして、この厚さは、標準レンズのほぼ半分以下まで増すことができる。その結果、本発明を用いると嵩が減少し、より小さな切開で済む。
【００６３】
グラッサー博士（Ｄｏｃｔｏｒ Ｇｌａｓｓｅｒ）の論文で（グラッサー及びカウフマン（Ｇｌａｓｓｅｒ ａｎｄ Ｋａｕｆｍａｎ）「老眼：視力（Ｐｒｅｓｂｙｏｐｉａ：Ａ Ｖｉｅｗ）」、眼科医学ジャーナル（Ｔｈｅ ｅＭｅｄｉｃｉｎｅ Ｊｏｕｒｎａｌ）、２００１年８月２０日、第２巻、第８号、１〜１５頁）、序文中で、著者は、老眼は、進行性で、年齢に関係して振幅の遠近調節性を失うことにより特徴付けられると述べている。遠近調節性の完全な喪失は、通常５０歳で頂点に達する。正視眼の患者は十分な遠方視力を有するが、近方視力を矯正する必要がある。近視の患者の近方視力は問題が少ない。
【００６４】
前述の論文で、グラッサー博士は、１９０９年にヘルムホルツにより提案された遠近調節の理論を論じている。この遠近調節の理論は、遠近調節は、毛様筋が収縮して、レンズの赤道の縁上の休止している小帯の緊張を解放するときに生じると理論化している。他の方法で述べれば、図１５に示すように、毛様体４０は、近くにある物を視覚化している間の毛様体の大きさに較べて、目が遠方を見ているときに小さくなる。一般的な目の解剖学的構造を図１５に示す。小さな毛様体４０は小帯４２を伸ばす。小帯４２は帯の一形態である。伸ばされた小帯４２は、今度は、天然の水晶体を収納している被膜の嚢３４を伸ばす。これにより、水晶体１１が遠方を見るためにより平坦になる。より平坦になった水晶体は、離れたものの上に収束するように目に像を見させる。毛様体４０が膨張するときは、小帯４２、あるいは帯、の緊張を解放し、水晶体１１はより自然な丸まった形となり、近いものに収束することができる。グラッサー博士は、遠近調節が何故年とともに減少するかについての幾つかの理論を述べている。遠近調節は、平均的な人で３５歳までに無くなり始め、６０歳までには完全に無くなってしまう。４５歳から５０歳までの年齢までに、平均的な人は、近方視力のために、読書のための眼鏡あるいはコンタクトレンズが必要となるであろう。
【００６５】
上記序文の第２節の最終段落において、グラッサ−博士の論文は、遠近調節の間、毛様筋が前方の内部に動き、レンズの赤道の縁が強膜から遠ざかる方向に動くことが実験により示されていると述べている（グラッサー及びカウフマン「老眼：視力」、眼科医学ジャーナル、２００１年８月２０日、第２巻、第８号、１〜１５頁）。偶角ビデオグラフを用いたビデオが遠近調節を用いて撮影され、小帯繊維あるいは帯が遠近調節の間弛緩していた。論文は、更に、毛様筋の後部結合と毛様体突起の間に伸びている後部小帯繊維が、遠近調節の間、毛様筋の頂部の前方及び軸方向運動により伸びていることを画像が示していると述べている。
【００６６】
老眼と題された第３節において、グラッサー博士は、何故遠近調節が失われるかについての幾つかの理論を論じている（グラッサー及びカウフマン「老眼：視力」、眼科医学ジャーナル、２００１年８月２０日、第２巻、第８号、１〜１５頁）。これらの理論を支配する２つの内の１つは、天然のレンズの結晶性構造が年とともにもろくなるということである。もう一つの理論は、毛様筋と脈絡膜の弾性の喪失である。同様な理論は、目の天然のレンズは、レンズにより及ぼされる力に筋肉が打ち勝つことができなくなり形状の変化ができなくなるまで、年とともに成長し続けるということである。
【００６７】
外科医が早期に白内障を取り除いた場合には、水晶体を小さな部分に切り刻んで吸い出すのは容易である。白内障の成熟が許された場合には、外科医は水晶体の取り出しに極めて長時間を要するであろう。年を経た白内障は非常に硬くなっているものである。ＭＲＩの測定により、年老いた目では調節性の毛様体輪の直径の収縮が、献呈された若い目に較べて減少していることが示された（ストレンク（Ｓｔｒｅｎｋ）他、「人の毛様筋とレンズの年齢に関係する変化：磁気共鳴画像研究」（Ａｇｅ−ｒｅｌａｔｅｄ ｃｈａｎｇｅｓ ｉｎ ｈｕｍａｎ ｃｉｌｉａｒｙ ｍｕｓｃｌｅ ａｎｄ ｌｅｎｓ： ａ ｍａｇｎｅｔｉｃ ｒｅｓｏｎａｎｃｅ ｉｍａｇｉｎｇ ｓｔｕｄｙ）、授ける眼科学（Ｉｎｖｅｓｔ Ｏｐｈｔｈａｌｍｏｌｏｇｙ）、視覚科学（Ｖｉｓ．Ｓｃｉ．）１９９９年５月、４０（６）：１１６２−１１６９、また、グラッサーとカウフマンの「老眼：視力」、眼科医学ジャーナル、２００１年８月２０日、第２巻、第８号、１〜１５頁でも論じられている）。年老いた毛様筋は多くの遠近調節ができるようにはなっていない。グラッサー博士は、加齢と共に変化する幾つかの局面を認定するタム（Ｔａｍｍ）の仕事（タム・イー（Ｔａｍｍ Ｅ）、クロフト・エム・エー（Ｃｒｏｆｔ ＭＡ）、ジャングクンツ・ダブリュー（Ｊｕｎｇｋｕｎｚ Ｗ）他、「アカゲザルにおける加齢に伴う毛様筋の運動性の喪失。脈絡膜の役割。（Ａｇｅ−ｒｅｌａｔｅｄ ｌｏｓｓ ｏｆ ｃｉｌｉａｒｙ ｍｕｓｃｌｅ ｍｏｂｉｌｉｔｙ ｉｎ ｔｈｅ ｒｈｅｓｕｓ ｍｏｎｋｅｙ． Ｒｏｌｅ ｏｆ ｔｈｅ ｃｈｏｒｏｉｄ．）」、第一の眼科学（Ａｒｃｈ Ｏｐｈｔｈａｌｍｏｌｏｇｙ）１９９２年６月、１１０（６）：８７１−６；タム・イー、ルチェンドレコール・イー（Ｌｕｔｊｅｎ−Ｄｒｅｃｏｌｌ Ｅ）、ジャングクンツ・ダブリュー他：「若い猿、遠近調整のできる老いた猿、老眼の猿における毛様筋の後方取り付け（Ｐｏｓｔｅｒｉｏｒ ａｔｔａｃｈｍｅｎｔ ｏｆ ｃｉｌｉａｒｙ ｍｕｓｃｌｅ ｉｎ ｙｏｕｎｇ， ａｃｃｏｍｍｏｄａｔｉｎｇ ｏｌｄ， ｐｒｅｓｂｙｏｐｉｃ ｍｏｎｋｅｙｓ）」授ける眼科学、視覚科学、１９９１年４月、３２（５）：１６７８−９２；タム・エス、タム・イー、ローエン・ジェイダブリュー（Ｒｏｈｅｎ ＪＷ）「人の毛様筋の加齢による変化。定量的外形計測研究（Ａｇｅ−ｒｅｌａｔｅｄ ｃｈａｎｇｅｓ ｏｆ ｔｈｅ ｈｕｍａｎ ｃｉｌｉｌａｒｙ ｍｕｓｃｌｅ． Ａ ｑｕａｎｔｉｔａｔｉｖｅ ｍｏｒｐｈｏｍｅｔｒｉｃ ｓｔｕｄｙ）」機械的加齢の進展（Ｍｅｃｈ Ａｇｅｉｎｇ Ｄｅｖ）１９９２年２月、６２（２）、２０９−２１）の要約に進んだ。毛様筋の全体の面積は減少する。その長さは、３０〜８５歳の成人のほぼ半分まで減少し、毛様体の長さ方向の網様の部分の面積は減少し、円の部分の面積は増大し、毛様体の長さ方向の部分の結合組織は増大し、毛様体の内部の頂点から強膜棘突起までの距離は減少する。
【００６８】
グラッサーによるヘルムホルツの要約から、毛様体の収縮は、レンズの赤道の縁上の休止している小帯の緊張を解放し、したがって、毛様体の直径は小さく、小帯の緊張は取り除かれることを我々は学んだ。以前、第３節のグラッサーの議論から、遠近調節の機構の下で、遠近調節中に、毛様体が前面に、虹彩の方向に、移動し、レンズの赤道の縁が強膜から遠ざかる方向に移動することを我々は学んだ。小帯繊維は、遠近調節中は弛緩する。グラッサー博士は、毛様体と毛様体突起とは、毛様筋の頂端の前方及び軸方向の動きにより、遠近調節中、伸張することを続いて述べている。
【００６９】
眼内レンズが移植されるときには、公知の眼内レンズは、触覚学上力を生じ、多くのレンズは、目の後方に湾曲されあるいは角度がつけられる。３本のひげに見える触覚ですら水晶体嚢の赤道領域に力を及ぼす。本発明は、固定部によりほとんどあるいは全く力を及ぼされない眼内レンズである。ある実施の形態においては、レンズ１０は、図１３Ａ、図１３Ｂに最もよく示されているように、小帯４２と虹彩２８の後面３２に対して圧力をかけるように置かれる。図１３Ａにおいては、固定部５０は目の前部に巻かれている。図１３Ｂにおいては、固定部５０は目の後部領域に巻かれている。異なった方向に巻かれている固定部５０に加えて、前述したように、レンズ１０は、レンズ１０の第１の表面４６を目の前眼房２６に向けるか、又はレンズ１０の第２の表面４４を目の前眼房２６に向けるか、何れかの方法で挿入できる。
【００７０】
他の実施の形態においては、レンズ１０は、図１０、図１１及び図１２に最もよく示されるように、嚢３４の前面３６及び嚢３４の後面３８に対して圧力を及ぼすように置かれる。この実施の形態においては、眼内レンズ１０は、嚢３４の後面３８及び前面３６からの横の力で、固定部として機能する、レンズ１０を固定位置に保持する触覚の足板２０を挟んだ状態で嚢３４の中に置かれる。上述の図で固定足板２０により代表される固定部５０に加えて、前述のように異なる方向に巻くことにより、レンズ１０は、その第１の表面４６を目の前眼房２６に向けた状態か、あるいはその第２の表面４４を目の前眼房２６に向けた状態かのいずれかで挿入できる。
【００７１】
目が遠い物体に収束した状態で、毛様体４０は弛緩し、小帯はピンと張っている。したがって、レンズは水晶体嚢の赤道に沿って静止している。目が近いものを見たときには、毛様体４０は膨張し、小帯を弛緩させる。膨張する毛様体４０は硝子体を変位させ、それにより小さな力を後方嚢と小帯とに及ぼして、それらを前方に押す。レンズ１０は、水晶体嚢３４の赤道領域を伸ばした状態に保つので、小帯４２は自由に前方に移動する。図１４に示すように、小帯４２の、移動軸３７で示される前方への移動により、レンズを格納した嚢３４が前方に移動し、それにより、眼内レンズが前方に移動して遠近調節がなされる。
【００７２】
ここに開示する本発明は、光のグレア、ハロー及び環の問題を補正することに関する驚くべき結果を提供する。本発明は、また、遠近調節の欠如の補正について驚くべき結果を提供する。
【００７３】
ある実施の形態においては、触覚１８の領域が後方に傾斜することができ、そのことにより、レンズ１０が嚢３４の赤道の背後に、又は網膜の方向に置かれる。固定部５０は、また、触覚１８、固定足板２０、板触覚２２、又は他の類似の構造で呼ばれる。他の実施の形態においては、触覚１８の領域は、また、前方に傾斜することができ、そのことにより、レンズ１０が嚢３４の赤道の前、又は虹彩２８の方に置かれる。触覚１８の領域は、平坦であることもでき、それにより、レンズ１０は嚢３４の赤道に沿って置かれる。触覚１８の領域は、切開口に挿入するために、レンズ１０の光学部４８と触覚１８部の巻き込み、押し潰し、又は他の圧縮の手段を行なうことができるような厚さを有する。ある実施の形態においては、切開は１．５ｍｍより小さい。他の実施の形態においては、切開は２．５ｍｍより小さい。他の実施の形態においては、切開は約１．５ｍｍである。ある実施の形態においては、レンズ１０の光学部４８は、固定部５０、触覚１８、あるいは固定足板２０を構成するのに用いられる材料とは異なった材料で構成される。このような実施の形態においては、これらの材料は、当該技術に於いて普通に知られているように、溶解され、接続され、又は取り付けられることができる。
【００７４】
ある実施の形態においては、レンズ１０の固定部５０は、図５に示すように、板触覚２２である。他の実施の形態においては、レンズ１０の固定部５０は、図７に示すように、レンズ１０の方向又は配向を示す標識２４を備えた板触覚２２である。
【００７５】
触覚足板とも呼ばれる固定足板２０の数は０から８まで変化することができる。固定足板２０を備えていないある実施の形態においては、レンズ１０はドーム構造を形成する。図５に最もよく示される他の実施の形態においては、レンズ１０は板触覚２２を有することができる。
【００７６】
比較の手段として、標準の負の２０度レンズの光学縁は、光学径が４ｍｍのとき０．３６０ｍｍの縁厚を有する。同じ倍率で同じ光学径であるために、本発明は０．０５ｍｍの縁厚を有する。フェドロブ他の発明である米国特許第５２５８０２５号に対しては、０．１ｍｍの中心厚を有する２０ジオプトリの負の倍率のレンズを得るために、レンズの縁は０．３４８ｍｍでなければならないことに注意すべきである。同じ光学径４ｍｍを有する本発明の縁厚は０．０３２３ｍｍである。しかし、本発明は、２０ジオプトリ負倍率のレンズに対して、０．０７７６ｍｍの最大厚さを有する。フェドロブ他のレンズの厚さの結果として、それはＰＭＭＡの弾性限界を超えるため、丸めるには厚すぎる。万一、フェドロブ他のレンズがヒドロゲル、親水性のアクリル樹脂等の材料で作られた場合、このレンズは丸まり、あるいは押し潰せるであろう。しかし必要な切開の大きさは、本発明の切開の大きさよりはるかに大きいであろう。
【００７７】
シンプソン他による米国特許第５０７６６８４号は、最小の厚さを得るために前面及び後面を接近して共に移動させる試みの何もない多焦点レンズを記述している。シンプソン他は、環状輪を記述するが、レンズを薄くする目的のものではない。シンプソン他は、請求項１において、少なくとも上記光学倍率の一部は回折により生じると述べている。１８００年代にフレネルが、灯台で使用するための環状輪を有する回折レンズを開発した。多焦点レンズを開発するための環状輪の使用は、シンプソン他の特許の基本であるように思われる。
【００７８】
本発明は環状輪をきわめて薄いレンズ１０を作るために用いる。ある実施の形態においては、環状輪５４の機能により、小さな切開を通して固定するために、レンズ１０を折り畳みあるいは丸めることができる。他の実施の形態においては、環状輪５４の機能は、環状輪５４が存在することにより光のグレア、ハロー及び環が減少ないしは除去されるような光学的な性質のものである。眼内レンズ１０の目的は、材料を十分に薄くして、材料の弾性限界を超えることなく丸めることができ、かつ切開の大きさを小さくすることを可能とすることである。前述した従来例のどれもが、材料の弾性限界を超えることなく丸めるのに十分な薄いレンズを得るために環状輪を用いることを議論していない。事実、参照したどの仕事も、レンズを十分に薄くして、材料の弾性限界を超えることなく丸めることも、このような薄いレンズを切開の大きさを小さくするために作ることも論じてはいない。
【００７９】
薄いレンズは、光のグレア及びハローと環とが視覚化されることを取り除くために望ましい。最初の眼内レンズを移植した患者は、眼内レンズからのグレア、ハロー及び環をこぼしたので、それは重要な問題であると考えられる。光は縁に引っかかり目に反射される。この光は焦点が合っていないが、厚い縁により患者に環又はハローとして見える光が反射される。街灯やトンネルのような高い頭上照明のあるほの暗く照明された場所に患者がいる夜に、この状態がより目に付く。この状態は、明るい太陽光の下にある日中ですらある程度存在する。ここに記述する本発明のためには、光学部４８の薄い縁１６はほぼ５０μｍないしほぼ２００μｍの厚さである。近視のレンズに対して１０００μｍを超える光学部の縁を有する標準の６ｍｍ光学レンズと較べた場合、本発明のレンズの厚さは非常に薄いものである。
【００８０】
本発明は、遠近調節の欠如を矯正するために用いられるレンズ、及びその使用方法を開示する。レンズを薄くし、厚いレンズに存在する材料を除去することにより、本発明は、固定足板２０あるいは板触覚２２等の固定手段５０がレンズをその場所に保持し、及びレンズ１０が軸方向に動くことができるだけ十分に可撓性を有することを可能にする。この軸方向の動きは、図１４に示すように、患者のための遠近調節を提供する。以前の設計では、カミング（Ｃｕｍｍｉｎｇ）による米国特許第６１９７０５９号のように、ヒンジの概念を用いてレンズを動けるようにしていた。本発明においては、薄いデザインにより、レンズ１０の光学部分４８を十分に軽くして、かつ、固定足板２０又は板触覚２２をレンズ１０に対して十分に撓むようにして、嚢の自然な動きと共に移動できるようにしている。自然な動きは、小帯上の緊張を取り除くことにより生じることができる。そのことにより、光学部分４８や固定手段５０が軸方向に前方に移動でき、自然な前方運動が生じる。
【００８１】
図１６Ａ，図１６Ｂ及び図１６Ｃに示すように、移植の前にレンズ１０は丸められ、切り口から挿入できるようにされる。図１６Ａに示すように、棒４３のようなものの周りに巻くことができる。他の実施の形態においては、レンズ１０は、それ自身の上に単に巻かれることもできる。
【００８２】
レンズ１０は、丸められる、即ち変形される前に、温められ、即ち加熱される。ある実施の形態においては、レンズ１０は華氏１００度近辺まで温められる。他の実施の形態においては、レンズ１０は華氏約９０度から華氏約１５０度まで温められる。レンズが室温まで冷やされるとき、即ち脱水するとき、レンズはもろくなる。ある実施の形態では、レンズ１０の温度はレンズ１０を目の切り口に挿入する前にレンズ１０の温度が減少した。レンズ１０を再加水する、即ち温めるとき、目の中に存在する流体により水を含むとき、レンズ１０はそれ自身では広がらない。
【００８３】
ある実施の形態においては、レンズが目の中に置くことが出来るように目の中に切り口が切られる。このような切り口を切開しその位置を決める道具に関する技術においては、共通のプロトコルが周知されている。ある実施の形態においては、切り口は１．５ｍｍより小さい。他の実施の形態においては、切り口は２．５ｍｍより小さい。図１６Ｂに示すように、レンズを切り口を介して目１５に挿入する。図１６Ｃは、目１５中に挿入され、広がり、即ち変形し、始めたレンズ１０を示す。
【００８４】
図１１に示すように、ある実施の形態においては、レンズ１０は、嚢３４中に置かれて、嚢３４の前面３６と嚢３４の後面３８に対して圧接される。また、図１１に示すように、レンズの固定部は目の前方向に向かって捻じ曲がっていてよい。図１２に示すように、固定部は目の後方に向かって捻じ曲がっていてよい。他の実施の形態においては、レンズ１０は裏返しであってよい。また、第１の光学面と第２の光学面の他の凹状と凸状を有するレンズを上述した図面中に示したように使用してもよい。
【００８５】
他の実施の形態においては、図１３Ａと図１３Ｂに示すように、固定部５０は小帯４２と虹彩２８の後面３２とに対して圧接されている。上述したように、レンズ１０の固定部５０は、図１３Ａに示すように、前方向に捻じ曲がっていてよいし、あるいは、図１３Ｂに示すように、後ろ方向に捻じ曲がっていてよい。他の実施の形態においては、レンズ１０の方向は、図１３Ａ又は図１３Ｂのいずれかに示されたような後ろ側に面している面が前側に面するように反転してもよい。また、第１の光学面と第２の光学面の他の凹状と凸状を有するレンズを上述した図面中に示したように使用してもよい。また、固定部はアコーデオンであってもよい。アコーデオンにした固定部５０、この実施の形態においては固定足板２０、を図１０に示す。
【００８６】
ある実施の形態においては、挿入に続いて、レンズ１０が天然のレンズ嚢３４中で広がり、触覚足板とも言う固定足板２０が組織にぶつかるまで開く。固定足板２０が組織にぶつかると、レンズは広がるのを止める。極端に薄い触覚１８と固定足板２０とは、元々目の天然のレンズを保持していた天然のレンズ嚢３４の内側にほとんど力を及ぼさない。レンズ１０の挿入と展開に続いて、この技術分野でよく知られているように、ほとんどの場合切り口は修復を要さない。
【００８７】
レンズ１０は天然のレンズ嚢３４の中で動くことができる。毛様体４０の前部が膨張すると、前部の小帯上の力が減少する。そして、目の中の圧力がレンズ１０を前方に押し、軸方向の運動ができるようにする。薄い光学部分４８と薄い触覚１８とにより、レンズ１０が軸方向に動き、遠近調節を行なう。他の実施の形態においては、遠近調節の欠落の矯正の方法は、図１１に示すように、天然のレンズ嚢３４の前面３６の方に触覚足板２０を捻じ曲げることが含まれる。他の実施の形態においては、遠近調整の欠落の矯正方法には、図１２に示すように、更に、天然のレンズ嚢３４の後面３８の方に触覚足板２０を捻じ曲げることが含まれる。他の実施の形態においては、レンズ１０は、無水晶体の目の毛様体４０中に挿入される。更に他の実施の形態においては、レンズ１０は、虹彩３２の後面に挿入され取り付けられる。毛様筋が弛緩すると、レンズは嚢を張り詰めず、レンズは前方に移動する。ある実施の形態においては、レンズ１０は目の前眼房２６中で移動できる。この動作により、患者に遠近調節が生じる。
【００８８】
人工のレンズは、代表的にはアクリル樹脂で製造され、このアクリル樹脂はポリメチルメタアクリレート（ＰＭＭＡ）、又は材料が永久に変形することなく丸まり又は曲がることのできる低い弾性率を有する疎水性のアクリル樹脂であることができる。他の使用できるアクリル材料は、メタアクリレート酸のヒドロキシエチルエステルとメチルメタアクリレートとの共重合体やヒドロゲルのような疎水性材料である。このような疎水性材料は、非常に高い弾性率を有し、乾燥したときにもろくガラス質であるが、水を含んで膨張すると柔らかく可塑的になる（「プラスチック技術ハンドブック（Ｐｌａｓｔｉｃｓ Ｔｅｃｈｎｏｌｏｇｙ Ｈａｎｄｂｏｏｋ）」、第３版、マナス・チャンダ（Ｍａｎａｓ Ｃｈａｎｄａ）及びサリル・ケー・ロイ（Ｓａｌｉｌ Ｋ．Ｒｏｙ）、マーセル・デッカー社（Ｍａｒｃｅｌ Ｄｅｋｋｅｒ，Ｉｎｃ．）ニューヨーク、５８４頁）。このような材料は、それが生物学的に目の組織と適合しており、自然に分解しないので、好ましい材料である。
【００８９】
レンズ製品の材料は、１．４と２．０との間の屈折率を有する、生物学的に適合した、光学的に適切な、可撓性を有する、加工ないしは鋳造できる全ての材料が適合する。レンズ製品に使うことのできる材料の例は、制限的なものではないが、アクリル樹脂、親水性アクリル樹脂、疎水性アクリル樹脂、又はポリメチルメタアクリレート（ＰＭＭＡ）である。本発明の製品に使う、７５パーセント以上から１８パーセントまでの水を含んだ、水を有する親水性材料は、コンタマック社（Ｃｏｎｔａｍａｃ Ｌｔｄ）、ベアワルデン・ビジネス・パーク（Ｂｅａｒｗａｌｄｅｎ Ｂｕｓｉｎｅｓｓ Ｐａｒｋ）、サフロン・ワルデン・エセックス（Ｓａｆｆｒｏｎ Ｗａｌｄｅｎ Ｅｓｓｅｘ）、ＣＢ１１、４ＪＸ、英国から購入できる。一つの材料は、３８％の水を含んだポリヒドロキシエチルメタアクリレートである。第２の材料は、Ｎ−ビニルピロリドンと２−ヘドロキシエチルメタアクリレートとの共重合体である。同様な材料は７６％程度の水を含んでいる。アルカリメタアクリレートとシロキシアニルメタアクリレートとの共重合体及びコモノマーを含むフッ素とが同じ供給者から利用できる。眼内レンズに対して、コンタマック社は、紫外線遮断材を添加したヒドロキシエチルメタアクリレートとメチルメタアクリレートとの共重合体を製造している。水含有率は１８．５％から２６％まで変化させることができる。同じ会社は、ＰＭＭＡボタンも製造している。他の供給者もレンズ鋳造のためのシリコン化合物を製造している。
【００９０】
ある実施の形態においては、光学部分４８は、アクリル樹脂、親水性アクリル樹脂、疎水性アクリル樹脂又はヒドロゲルにより構成される。他の実施の形態においては、光学部はアクリル樹脂で構成され、固定部はポリメチルメタアクリレートにより構成される。更に別の実施の形態においては、光学部はヒドロゲルから構成され、固定部はポリメチルメタアクリレートから構成される。他の実施の形態においては、光学部はヒドロゲルから構成され、固定部はアクリル樹脂から構成される。
【００９１】
白内障の手術の経験により、小さな切り口を形成すると非点収差が減少するということが示されている。このことから、レンズを小さな切り口を通して扱うことができれば、日点収差の厳しさを減少することとなる。しかし、瞳孔を適当に覆うためには、眼内レンズの光学部は少なくともほぼ６ｍｍの径を持たなければならない。したがって、より小さな切り口からレンズを通過させるための唯一の方法は、対向する縁が重なり合うように、最初に、レンズをＵ字形に折り畳むか丸めるしかない。しかし、現在設計された疎水性又は親水性のレンズは、丸めるか折り畳むためには硬いかもろすぎる。あるいは、折り畳まれたときに、なおほぼ３ｍｍの切り口を必要とする。この３ｍｍの切り口は、非点収差を生じてしまう。与えられた厚さで硬い材料は薄くすると撓むことができることは知られているが、ＰＭＭＡが撓むことのできる最大の材料厚さは約０．２５ｍｍである。他のアクリル樹脂材料は、より多く撓むことができるが、なお非点収差を生じてしまう大きさの切り口を必要とする。
【００９２】
あるレンズは、入射光が通過する凸の第１の表面を有する。このレンズは、屈折光が出射する、第１の表面に対向する、第２の表面４４も有する。第２の表面４４は、凸、平面、又は凹であってよい。レンズの倍率は、第１の表面４６と第２の表面４４の曲率により決定される。
【００９３】
図２に示すように、患者に見える光のグレア、ハロー及び環を防止するためには、レンズ１０の光学部４８の縁１６が極めて薄くなければならない。望ましい実施の形態においては、レンズの縁１６は２００μｍである。光学部４８の屈曲を防止するためには、触覚１８は縁１６よりも薄くなければならない。ある実施の形態においては、触覚足板２０の厚さは、ほぼ５０μｍである。他の実施の形態においては、触覚足板２０の厚さは５０μｍより小さい。更に他の実施の形態においては、触覚足板２０の厚さは、約５０μｍから約２００μｍである。ここに述べるように、固定部５０は触覚足板２０、板触覚２２又は他の型の触覚であってよい。固定部５０は、約１０μｍから約１００μｍの厚さを有する。他の実施の形態においては、固定部５０は、１００μｍより薄い厚さを有する。触覚１８は、２から８までの多触覚足板２０を有することができる。望ましい実施の形態では、図７に示すように、４つの触覚足板２０を有している。望ましい実施の形態においては、図１１に示すように、触覚足板２０は目の前眼房２６の方に丸まっている。
【００９４】
一旦外科医がレンズ１０を目の中心に置くと、触覚力がレンズを中心に保持する。触角１８が薄い構造であると、目の内部表面上に半径方向内向きの圧力をほとんど与えない。
【００９５】
レンズ１０の正確な直径は、幾つかの要素により決定される。レンズ１０が、被膜の嚢としても知られる、天然のレンズ嚢３４に挿入されたときは、レンズ１０の直径は、天然のレンズが除去された被膜の嚢３４中にそれがぴったり入るようなものである。あるいは、レンズ１０は、目の、虹彩３２の後面と、靭帯としても知られる小帯構造４２との間にある、毛様体腔４５中に載置できる。レンズ１０が被膜の嚢３４中に載置されたときに、レンズ１０の直径は、約１０ｍｍから約１４ｍｍ、望ましい実施の形態においては約１１ｍｍである。図１に示すように、レンズ１０の直径は約１０ｍｍから約１４ｍｍである。図６と図８に示すように、板状のレンズは角度９４を有する。角度９４は、望ましい実施の形態である前眼房レンズの０度から、＋１０度〜０度の範囲で変化できる。
【００９６】
一つの実施の形態においては、レンズ１０は、角膜９６又は強膜９８中の１．５ｍｍの切り口を通して人の目の中に移植される。レンズ１０を丸めて、目１５中に挿入し、レンズ１０が広がり始める過程が図１６に示される。この実施の形態は、図２又は図３に示したような、光学部４８を有する極めて薄い触覚１８を用いている。この特定の実施の形態、又は移植について説明した前述した他の何れかの実施の形態、の移植の間、幾つかの薬剤供給者により製造され、そのようなものとして張り紙した、当業者に周知の、平衡塩類溶液（ＢＳＳ）で洗浄される。ある実施の形態においては、移植は室温近辺で行なわれ、レンズは、眼内流体が、華氏８５度から１００度の範囲で、望ましくは華氏９８．６度の温度に、その温度を上昇させたときに、広がる。図１６は、レンズ１０を丸めて、丸めたレンズを切り口を通して挿入し、目の中でレンズが広がり始める過程を示す。
【００９７】
白内障を取り除くために目に入り込むのに使う多くの技術が存在する。切り口の大きさと位置とは、角膜９６の曲率に影響を及ぼし、非点収差を潜在的に誘発する。より小さな切り口を設けることにより、非点収差の発生を最小化することができる。強膜９８（目の白い部分）の切り口は、典型的には６ｍｍ長であるが、角膜９６の透明な部分の切り口はかなり小さく（ほぼ３ｍｍ）しかできない。これらの角膜の切り口は非常に小さいので、傷口を閉じるのに実に縫合を要しない。さらに、強膜９８における切開と異なり、角膜９６の切開をするのに関係して出血することはない。本発明は、角膜の切り口を１．５ｍｍ以下に減少する。多くの外科医は、１．５ｍｍの２個の切り口を挿入し、水晶体超音波液化吸引機を用いて一つの切り口を通して白内障を除去する双手技術と呼ばれることを行う。水晶体超音波液化吸引機は、１ｍｍのカニューレの内側に適合する極端に小さいジャックハンマに類似している。第２の切り口は、白内障の天然レンズの操作のための器具を挿入するのに用いられる。第２の切り口に挿入される器具も、目に平衡塩類溶液を供給するための開口を有している。白内障の天然のレンズは小片に切り刻まれるので、吸引して運び去る。ＢＳＳは目の中の失われた体液と入れ替わる。今日の最も現代的な白内障の外科医は、２．５ｍｍかそれより小さい切り口を必要とする水晶体超音波液化吸引システムを用いる。標準の白内障レンズを移植するには、切り口の大きさを拡大する必要がある。
【００９８】
一つの実施の形態においては、遠近調節の喪失又は遠近調節の欠落の何れかを補正しあるいは改善する方法が、目の前眼房に到達するために、１．５ｍｍより短い長さの切り口を形成することと、ここに開示したレンズでここに開示した径を有するレンズを提供することと、レンズを固定するための支持触覚を一体的に提供することと、材料の弾性限界を超えることなくレンズと支持触覚とを巻かれたユニットに巻くことと、巻かれたユニットを切り口を介して前眼房中に挿入することと、巻かれたユニットを前眼房の中で広げることと、ここに開示された触覚を固定することと、必要ならば目に設けられた切り口を修復することとを備えている。
【００９９】
他の実施の形態においては、遠近調節の喪失又は遠近調節の欠落の何れかを補正しあるいは改善する方法が、１．５ｍｍより短い長さの切り口を形成することと、０．２５ｍｍ以下の厚さを有し、１１ｍｍの直径を有するある光学等級のアクリル樹脂材料により形成された凸の第１の表面と第２の表面とを有し、第２の表面は、一連の環状輪により半径方向に取り巻かれた中央円盤を備え、一連の環状輪は、一連の環状輪の中の中央円盤上に見出され、一連の環状輪は、この第２の表面に沿って半径方向に一連の階段を形成するようなレンズを提供することと、レンズを固定するためにレンズ支持触覚用固定部材を一体的に提供することと、材料の弾性限界を超えることなくレンズと支持触覚とを巻かれたユニットに巻くことと、巻かれたユニットを切り口を介して眼の中に挿入することと、巻かれたユニットを広げることと、触覚を固定することとを備えている。
【０１００】
上述したように、レンズ１０の光学部４８中の一連の環状輪１４は幾つかの機能を行なう。一連の環状輪１４は、レンズ１０の厚さを減少させ、それによりレンズ１０の重量を軽くする。光学部品の重量が軽くなると、触覚１８、板触覚２２、及び／又は固定足板２０を含む、しかしそれに制限しない、固定手段を薄く、しかもレンズ１０を目の中に正しく配置するための剛性を有することができる。更に、板触覚２２を含む薄い触覚１８により、レンズ１０は、図１４に示すように、遠近調節を生じる毛様体４０の膨張する緊張に基づいて前方に移動できる。
【０１０１】
レンズ１０の一つの表面は連続した曲面でかつ球状である。正確な画像の細部の記述を与えるためのガウスの理論の近軸光線の公式（「光学の基礎」ジェンキンス及びホワイト、１４９頁）からの全ての偏差は、球面収差として知られている。球面レンズは収差を生じるために、多くの商用のコンピュータでプログラムされた旋盤は球状パターンを切削する。ガウスの公式は、球面レンズに基づき、球面レンズに入射する光線は、レンズの中心からの距離が増大するほど、より短い焦点距離に収束する。この効果が球面収差として知られ、収束しない光線からレンズ中にグレアを生じる。一連の環状輪１４は、レンズの本初子午線として同一点に収束する各環５４から焦点距離を調節することにより、連続曲線からの球面収差を補正するように設計されている。レンズの本初子午線は、レンズの中心軸に沿ったレンズの焦点距離である。球面収差の補正に加えて、ここに開示するレンズ１０はコマ収差を補正する。コマ収差は、３次理論の単色収差の第２である。ジェンキンスとホワイトの「光学の基礎」に述べられているように（１６２頁、１６３頁）、「レンズ軸からちょっと離れて位置する物点の画像の彗星状の外観からその名前が生じている」。さらに、著者等は、「レンズの異なる部分では倍率が異なるように見える」と述べている。
【０１０２】
レンズ設計は、レンズ１０が極端に軽く、かつ目に対して過度の力を生じないように、光学部４８、触覚１８及び固定足板２０の全ての過剰な材料を取り除いた極端に薄いレンズを更に要求する。再び、レンズ１０の薄さはレンズ１０の質量を減少させ、かくして、１．５ｍｍより小さい目の切り口を通過するように、レンズ１０が折り畳まれ、丸められ、あるいは押し潰されることができる。
【０１０３】
本発明は、ウォースト（Ｗｏｒｓｔ）による米国特許第５１９２３１９号及び第４２１５４４０号に開示されたレンズを修正することにより実施することができる。例えば、ウォーストのレンズの光学部は本発明の光学表面を用いて修正することができる。
【０１０４】
他の実施の形態においては、レンズ１０の光学部４８は、凸の第１の表面４６を有している。光学部４８の周辺は平行なレンズ状の領域を備えている。この平行なレンズ状の領域は均一な厚さを有し、縁効果として知られている現象を防止するためのものである。非光学的な遷移領域５２が、図５に示すように、平行なレンズ状領域を取り巻いている。他の実施の形態においては、固定部５０は遷移領域５２から延伸している。更に他の実施の形態においては、固定部５０は、レンズ１０の光学部分４８を回転させる一対の触覚１８を備えている。この一対の触覚１８のそれぞれは、目の組織に圧接するための外部が円周形の触覚の縁を有している。
【０１０５】
中央円盤１２と一連の環状輪１４とは、第２の表面４４を横切って一連の半径方向の階段を形成し、第１の表面４６に対する近似を維持している。第１の表面４６の頂点での中央円盤１２の厚さは、レンズ材料の弾性限界を超えることなくレンズ１０が丸められるように、所定の最大厚さ以下である。中央円盤１２の周辺の厚さは、レンズ１０が丸められた後に事前に曲げられた形状を保持するように所定の最小厚さ以上である。
【０１０６】
ある実施の形態においては、中央円盤１２の表面と各環状輪５４の表面とは凸である。第１の表面４６の頂点での中央円盤１２の厚さは所定の最大厚さ以下である。中央円盤１２の周辺の厚さは、所定の最小厚さ以上である。
【０１０７】
他の実施の形態においては、中央円盤１２の表面と各環状輪５４の表面とは凹である。中央円盤の１２の周辺での中央円盤１２の厚さは、所定の最大厚さ以下である。第１の表面４６の頂点と中央円盤１２との間のレンズの厚さは所定の最小厚さ以上である。
【０１０８】
上述した全ての特許と刊行物とは参照によりそれらの全体がここに明白に組み入れられる。
【０１０９】
本発明は以上のように述べられたが、本発明は多くの方法で変更できることは明らかである。このような変更は本発明の精神と範囲から逸脱するものではないとみなされ、当業者に明白な全ての変更は本発明の範囲内に含まれるものと意図されている。
【０１１０】
かくして、新しく有用な小切開レンズとその使用方法に関する本発明の特定の実施の形態を説明したが、特許請求の範囲に述べられたことを除いて、このような参照が本発明の範囲を制限するように解釈されることは意図されていない。
【図面の簡単な説明】
【０１１１】
【図１】極端に薄い光学部品と触覚とを備えたレンズ１０の平面図である。中央円盤１２、一連の環状輪１４、光学部１６の薄い縁、固定部５０、この場合は触覚１８、及び触覚足板とも呼ばれる固定足板２０もまた示される。レンズの固定部は光学部より薄い。本図においては、５個の足板がある。レンズ１０は、生物学的に人の目の組織に適合する材料で作られている。図示するように、触覚１８は、レンズ１０の光学部４８に巻きつく、又は取り囲む。各固定足板２０は、目に対する取り付けのために用いられる支持構造に対して圧接される。
【図２】凸の第１の光学表面４９を有するレンズ１０の断面図である。本図は、固定部５０を含むレンズ１０の極端な薄さを図示している。この図において、触覚１８は０より大きい角度を有している。
【図３】凹の第１の光学表面１４９を有するレンズ１０の断面図である。再び、この図はレンズ１０の極端な薄さを示している。
【図４】各個別の環状輪５４、環状輪の第１の部分５６、及び環状輪の第２の部分５８を含む一連の環状輪１４の詳細を示すレンズ１０の断面図である。
【図５】板触覚２２を有するレンズ１０の平面図である。本図は、薄い光学部品の設計と結び付いて、１．５ｍｍより小さい切り口を通して適合するレンズを形成することのできる極端に薄い触覚の異なった型の一つを示す。幅９２は、約５ｍｍから約８ｍｍの範囲で変化することができる。長さ９０は、約１０ｍｍから約１４ｍｍの範囲で変化することができる。
【図６】板型レンズの断面図である。角度９４が示され、＋１０度の角度を表しているが、角度９４は約＋１０度から約０度まで変化できる。レンズは、滑らかな第１の表面４６を前方又は後方に向けた状態で移植できる。屈折レンズに対して、この連続表面は通常前方を角膜９６の方向に向けて移植される。白内障のレンズとして用いられるときには、このレンズは連続表面を後方に位置決めして移植される。したがって、触覚が角度を付けられるときには、連続表面が前方を向いているときにその角度は正であり、連続表面が後方を向いているときにその角度は負である。本図は、また、凸の第１の光学表面４９と凸の第２の光学表面５１とを有する両凸レンズを示している。
【図７】固定部５０が極端に薄い板触覚として示されている修正された板レンズである。この固定部は、図２及び図３に示す薄い光学設計と共に用いることができる。レンズ触覚中の標識２４は位置決めに用いられ、当該技術分野で周知である。触覚中の、適形開口とも呼ばれる、標識２４は、また、レンズが正しい位置にあるときを示す。本図において、標識２４は時計回りに位置を示す。したがって、標識２４は方位を示す。
【図８】望ましい実施の形態において用いられるレンズ１０の変形された極端に薄い板触覚２２の断面である。
【図９】嚢３４中で丸くなった触覚２０の薄い部分を備えた無水晶体の目中のレンズ１０を示す。レンズ１０は、嚢３４の後方表面に対して配置され、嚢３４の後方表面３８と嚢３４の前方表面３６とに支えられている触覚足板２０によりその位置に保たれている。時と共に、前方と後方の嚢が共に成長し、図５に示すように、位置決め標識２４を介して前方及び後方の区分からの組織が共に成長するため、レンズが目の中に更に固定される。
【図１０】触覚２０の薄い部分が嚢中で蛇腹式に折り畳める無水晶体の目の中のレンズ１０を示す。
【図１１】目の前部の方向に巻かれた固定足板２０の詳細を示す。この実施の形態においては固定部として機能している固定足板２０が、嚢３４の前表面３６と嚢３４の後表面３８に対して圧接されていることに注意すべきである。
【図１２】目の後部の方向に巻かれた固定足板２０の詳細を示す。この実施の形態においては固定部として機能している固定足板２０が、嚢３４の前表面３６と嚢３４の後表面３８に対して圧接されていることに注意すべきである。
【図１３Ａ】小帯４２と虹彩２８の後表面３２に圧接されているレンズ１０の固定部５０の詳細を示す。固定部５０は目の前部方向に曲げられている。
【図１３Ｂ】小帯４２と虹彩２８の後表面３２に圧接されているレンズ１０の固定部５０の詳細を示す。固定部５０は目の後部方向に曲げられている。
【図１４】目に対するレンズ１０の移動軸３７を示す。
【図１５】目の断面図を示す。本図は、目の天然の水晶体１１、目の前眼房２６、目の後眼房２７、虹彩２８、虹彩の前表面３０、虹彩の後表面３２、天然のレンズ嚢３４の前表面３６、天然のレンズ嚢３４の後表面３８、小帯４２及び毛様体４０を示す。
【図１６Ａ】棒４３の周りに丸められた、本発明により説明される、眼内レンズ１０である。レンズ１０は、ほぼ華氏１００度まで熱せられた平衡塩類溶液、ＢＳＳ、を含むバイアルから丁度取り出されたところである。レンズ１０は、その材料が、冷やされたときあるいは脱水されたときに堅くなるので、温かいＢＳＳから取り出した直後に巻かれなければならない。
【図１６Ｂ】目１５の１．５ｍｍより短い長さの、創傷とも呼ばれる切り口に軽く貫通したレンズ１０を示す。
【図１６Ｃ】目１５の中のレンズ１０を示す。目１５の中に一旦入ると、レンズ１０は、人の目１５の温かい水、即ち眼内流体、に接触し、直ちに広がり始める。広がるのにほぼ１５秒掛かる。
【図１７】屈折率１．４７を有する材料を使用したときの所与の２０ジオプトリの度に対する典型的な厚さを有する標準レンズ７６を示す。本図は、レンズの頂点でこのレンズに入射し、屈折することなくレンズを通過する、本初子午線として知られる、レンズの中心軸に沿った光線８０を示す。本初子午線から１ｍｍの、本初子午線に平行な第２の光線８２が示され、そこでは本初子午線より前の焦点をこの光線が通るような屈折がある。表２の計算が、本初子午線から１ｍｍでレンズに入射する第２の光線８２の焦点が本初子午線の焦点の前約１ｍｍに収束することを示している。本初子午線から２ｍｍで標準レンズ７６に入射する第３の光線８４が、本初子午線の前約３ｍｍに収束することが示されている。
【図１８】レンズ１０の頂点でこのレンズに入射し、屈折することなくレンズを通過する、本初子午線として知られる、レンズの中心軸に沿った光線８０を示す。本図は、各輪５４を有する第２の光学表面５１上の倍率を調整することにより、本初子午線の焦点と、本初子午線の焦点から２ｍｍで本発明のレンズ１０に入射する第３の光線８４が同一点に収束することも示す。従って球面収差が減少する。
【図１９】屈折率１．４７を有する材料から作られた２０ジオプトリのレンズに対する球面収差に対する計算中に記述された角度を図式的に示したものを提供する。
【図２０】コマ収差と呼ばれる状態を示す。コマ収差においては、光線１（６８）からの光は標準レンズ７６内を２．２ｍｍ以上の間進行し、光線２（７０）からの光は１．９６ｍｍの距離だけそのレンズを通過する。コマ収差は彗星又はゴースト像として現れる。本発明の極端に薄いレンズ１０は多くのコマ収差を除去するはずである。
【図２１】標準レンズ７６に入射する光７２を示す。光７２は、第１の表面７３で屈折する。屈折光は第２の表面７５の方向に進行する。光７２の大半は、標準レンズ７６の第２の表面により屈折し、屈折光７７はこのレンズから出射する。しかし、ごく一部が反射光７８となり、標準レンズ７６の第１の表面７３の方向に進行する。その光の大半は第１の表面７３で再び屈折する。しかし、反射光７８の一部は再び反射され、反射光７９は第２の表面７５に進行し、第２の表面７５で再び屈折し、光８１がレンズから出射する。幾分かの歪の高調波が生じ得る。第２の表面７５から投射される各追加画像は、もともとの屈折光線７７と位相がずれているので、歪を生じる。
【図２２】第１の表面４６と、中央円盤１２の表面と各環状輪５４の表面とが凸である、本発明の一実施の形態の断面図を示す。
【図２３】第１の表面１４９と、中央円盤１１２の表面と各環状輪１５４の表面とが凹である、本発明の一実施の形態の断面図を示す。
【図２４Ａ】第１の表面４６が凸であり、中央円盤１２の表面と各環状輪５４の表面とが凸である、本発明の一実施の形態の断面図を示す。
【図２４Ｂ】第１の光学表面４９が凸であり、中央円盤１１２の表面と各環状輪１５４の表面とが凹である、本発明の一実施の形態の断面図を示す。
【図２５】光学部４８の第１の光学表面４６と中央円盤１２の表面とが凸である、本発明の一実施の形態の断面図を示す。各環状輪１５４の外部表面１５９は凹である。
【符号の説明】
【０１１２】
１０ 眼内レンズ
１２、１１２ 中心円盤
１８ 触覚
２６ 前眼房
２８、３２ 虹彩
３１ 前方角
４０ 毛様体
４２ 小帯
４４ 第２の表面
４６ 第１の表面
４８ 光学部
４９、１４９ 第１の光学表面
５０ 固定部
５１、１５１ 第２の光学表面
５４、１５４ 環状輪
５６ 第１の部分
５８ 第２の部分
５９、１５９ 外部表面
７６ 標準レンズ
８０、８２、８４ 光線
９６ 角膜【Technical field】
[0001]
The invention relates generally to the field of intraocular lenses and their use for correcting vision problems. In particular, the present invention provides a lens for correcting malalignment and a method of using the same. This lens can be inserted into the human eye by an incision of 1.5 mm or less.
[Background Art]
[0002]
Doctors skilled in ophthalmology routinely remove the cataract-injured natural lens from the patient's eyes and then implant an artificial lens to prevent blinding. .
[0003]
The use of intraocular lenses to correct visual problems is presently problematic. An incision is made through the cornea or sclera to insert the intraocular lens. A new lens is inserted through the incision into the anterior chamber of the eye. The inserted lens is located above the pupil and is anchored anteriorly or posteriorly to the iris or other structure of the eye. Unfortunately, the incision creates astigmatism in the cornea.
[0004]
Other lens materials are currently used to replace the natural lens of cataract patients. One such other lens material is an acrylic resin having a lower molecular weight than polymethyl methacrylate (PMMA). This low molecular weight acrylic resin lens is softer than PMMA and can be folded into a U-shape. However, unless treated very carefully, the low molecular weight acrylic resin will be creased and unusable. In addition, this material is soft enough to be rounded enough to overlap or to stick to itself when folded.
[0005]
Another lens material is silicon, the same material used as an insert for breast augmentation. Silicon, in some patients, collects protein, has a yellow appearance, and reduces light transmission. This protein is very high in concentration and produces secondary cataract appearance, severely impairing the patient's ability to see. This is usually of less interest to cataract patients when compared to blindness that would result from cataracts. Also, as most cataract patients tend to be older, protein accumulation may not progress so quickly during their lifetime. However, some cataract patients have to remove and replace the silicon lens to accumulate protein. Due to the problems associated with protein accumulation, it cannot be used for long term intraocular lens implantation for young patients.
[0006]
[Patent Document 1]
U.S. Pat. No. 4,573,998
[Patent Document 2]
U.S. Pat. No. 5,522,890 An invention of a deformable intraocular lens was issued to U.S. Pat. No. 4,573,998 issued to Mazzocco in March 1986, and to Nakajima et al. In June 1996. No. 5,522,890 issued. These inventions use a molded lens of an elastic material. These inventions do not suggest the use of PMMA, nor do they suggest that extremely thin lenses can be rolled so that the size of the incision can be significantly smaller than is required for a folded lens. Not.
[0007]
Other inventions generally related to optical lens technology include U.S. Pat. No. 4,254,509 (adapted intraocular implant) issued to Tennant in March 1981, and Blackmore in April 1986. U.S. Pat. No. 4,855,456 issued to Blackmore (corrective lens for natural lenses of the eye); U.S. Pat. No. 4,655,775 issued to Clasby in April 1987 (provided with ridges). U.S. Pat. No. 4,769,035 issued to Kelman in September 1988 (artificial lens and method of implanting the same), issued to Glendahl in January 1989. U.S. Pat. No. 4,795,462 (cylindrically divided region of the main affected-artificial lens), March 1989. U.S. Pat. No. 4,816,032 issued to Hetland (arrangement of an intraocular anterior chamber lens) and U.S. Pat. No. 4,950,290 issued to Kammerling in August 1990. Intraocular intraocular lens), U.S. Patent No. 4,994,080 issued to Shepard in February 1991 (optical lens having at least one small diameter aperture in the central region), and Simpson in December 1991. U.S. Pat. No. 5,076,684 issued to Simpson et al. (Multifocal diffractive ophthalmic lens); U.S. Pat. No. 5,098,444 (Epiphakic eye) issued to Fester in March 1992; Inner lens and transplantation process), Portni in November 1992 U.S. Pat. No. 5,166,711 issued to Portney, a multifocal ophthalmic lens, and U.S. Pat. No. 5,229,797 issued to Fuhey et al. In July 1993, a multifocal diffractive ophthalmic lens. U.S. Pat. No. 5,258,025 (corrective intraocular lens) issued to Fedorov et al. In November 1993 and U.S. Pat. No. 5,480,428 (corrective intraocular lens). None of these inventions solves the above described problems associated with currently known deformable intraocular lenses.
DISCLOSURE OF THE INVENTION
[Means for Solving the Problems]
[0008]
Disclosed herein is a deformable intraocular lens for implantation in the human eye. This lens is used for correction of myopia, hyperopia, presbyopia, astigmatism, or implantation after cataract surgery. This lens consists of one smooth optical surface. The second optical surface is a series of annular concentric rings. This annulus allows the lens to have an extremely thin edge, which reduces glare, halo and distortion. In addition, the ring allows the overall thickness of the lens to be much smaller and thinner than a standard lens. This allows the lens to be inserted through an opening of 1.5 mm or less. Current standard lenses pass through an aperture of approximately 3 mm. The ring on the second surface is adjusted to reduce spherical aberration by designing the lens on the first surface to be spherical. Such thin lenses are known from coma and other Third Order Theory Aberrations ("Fundamentals of Optics", Francis A. Jenkins and Harvey E. Jenkins). Harvey E. White, 4th edition, McGraw-Hill, 1950, Revision 1957, 1976, pp. 151-160, which reduces halo and glare.
[0009]
Also disclosed herein is a method of correcting the loss of accommodation comprising removing the natural lens from the eye and inserting an intraocular lens into the eye. In certain embodiments, the method further comprises expanding the intraocular lens and holding the intraocular lens in place by contacting the haptic footplate with the natural lens capsule or ciliary body. , Causing minimal radial force on the eyes.
[0010]
Accordingly, one aspect of the present invention comprises an optical portion having a first optical surface, the optical portion comprising a material that is biologically compatible with eye tissue, wherein the material exceeds its elastic limit. An optical portion having a predetermined maximum thickness such that the material can be rounded without having a predetermined minimum thickness above which the material can maintain the normal shape, and the intraocular lens being the eye. An optical portion such that the intraocular lens is deformed to pass through an incision having a length less than about 1.5 mm to be placed therein, and an optical portion having a second optical surface. A second optical surface comprises a central disk radially surrounded by a series of annular rings, the focal length from one annular ring being adjusted to converge to the same point as the prime meridian of the lens. So that the central disk and the series of annular Form a series of radial steps along the second optical surface, wherein the second optical surface and the first optical surface are separated by a minimum of 0.025 mm and a maximum of 0.45 mm An optical portion and a fixing portion attached to the optical portion, the fixing portion being made of a material that is biologically compatible with the tissue of the eye, and capable of pressing against the supporting structure of the eye. It is an intraocular lens. In one embodiment, the second optical surface and the first optical surface are separated by a minimum of 0.025 mm and a maximum of 0.065 mm.
[0011]
Another aspect of the present invention is that the first optical surface and the second optical surface are convex in order to obtain a specific degree of convergence. In one embodiment, the first optical surface and the second optical surface are concave to obtain a specific degree of convergence. In yet another embodiment, the first optical surface is convex to achieve a particular degree of convergence, and the second optical surface is convex to achieve a particular degree of convergence. , A predetermined concave. In another embodiment, the first optical surface is concave to obtain a particular degree of convergence and the second optical surface is concave to achieve a particular degree of convergence. , A predetermined convex. In still another embodiment of the present invention, the first optical surface is concave to obtain a specific convergence, and the second optical surface has a specific convergence. It is a predetermined concave to get.
[0012]
Another embodiment of the present invention is an extremely thin fixing portion. In one embodiment, the fixing portion has a thickness of about 10 μm to about 100 μm. In another embodiment, the anchor has a maximum thickness of approximately 100 μm. In another embodiment, the fixing portion has a plurality of fixed foot plates or tactile sensations.
[0013]
Yet another aspect of the invention is an acrylic resin material, a hydrophilic acrylic resin material, a hydrophobic acrylic resin material, any semi-rigid material having a thickness less than the elastic limit of the semi-rigid material, a hydrogel, a polymethyl methacrylate. Or a lens composed of a material having a refractive index from about 1.4 to about 2.0.
[0014]
Another aspect of the claimed invention is a method of using an intraocular lens. In one embodiment, a method for correcting a visual defect is provided. The method provides an intraocular lens as described herein, wherein the intraocular lens is warmed to a temperature from about 90 degrees F to about 150 degrees F, forming an incision in the eye that is less than 1.5 mm in length. Removing the natural lens of the eye, deforming the intraocular lens, cooling the intraocular lens to a temperature of about 60 degrees Fahrenheit to about 80 degrees Fahrenheit, and cooling the intraocular lens through the incision. Inserting into the eye, contacting the intraocular lens with the intraocular fluid in the eye so that the intraocular lens warms and spreads, so that the fixing portion is pressed against the support structure of the eye, Place the intraocular lens. In one embodiment, during placement of the intraocular lens, the anchor is pressed against the front surface of the capsule and the posterior surface of the capsule to produce minimal radial force on the eye. In yet another embodiment, when positioning the intraocular lens, the fixation portion is pressed against the zonules and the posterior surface of the iris, producing minimal radial force in the eye. As a result, the fixed part of the intraocular lens is held at the fixed position.
[0015]
Another aspect of the present invention is to deform the intraocular lens. In one embodiment, the intraocular lens is wrapped around a rod. In another embodiment, the intraocular lens is wrapped around itself. In one embodiment, the cut is repaired.
[0016]
Once wrapped and passed through the cornea, the implanted intraocular lens is placed in a position. In one embodiment, the implanted lens is placed in the anterior chamber of the eye, in front of the iris. When this position is selected, the tactile edge of each tactile finger is pressed against the anterior chamber angle 31. This angle is formed by the cornea, the root of the iris, and the back of the trabecular bone. Once deployed and allowed to spread, the implanted lens returns to its original shape.
[0017]
Alternatively, the implanted lens is placed behind the iris and rests in front of the natural lens capsule of the eye. When this position is selected, the haptic edge of each haptic finger is pressed against the zonules and the posterior surface of the iris, or ciliary sulcus. The implanted lens can be placed behind the iris because of its thinness.
[0018]
The lens can also be implanted into the capsule containing the natural lens after removal of the natural lens. One reason for removing the natural lens is clouding of the natural lens, cataract. A second reason for natural lens removal is that the intraocular lens can be placed in cases of low vision caused by extreme cases of myopia or hyperopia.
[0019]
Another aspect of the present invention is the use of the lenses disclosed herein to correct glare, halo visualization, reduce coma, and correct spherical aberration. In some embodiments, the lens moves to compensate for the lack of accommodation. In one embodiment, the intraocular lens moves toward the front of the eye when the hair muscle of the eye relaxes.
[0020]
During placement of the intraocular lens, in one embodiment, the anchor is twisted toward the anterior surface of the capsule structure. In another embodiment, the anchor is twisted toward the posterior surface of the sac structure.
[0021]
Another embodiment of the present invention is a lens having a sign indicating the direction of the lens.
[0022]
The present invention provides a deformable that can be rolled or folded for insertion into the human eye to correct common vision problems or to replace natural lenses after cataract surgery It is an intraocular lens. The lens can be deformed because all parts of the lens are manufactured to have a thickness that is within a predetermined thickness range. More specifically, at the first end of the range, the thickness of the lens is less than the maximum material thickness, the threshold at which the material can deflect. At the second end of the range, the lens thickness is greater than the minimum material thickness, again above which the lens material can maintain the pre-bent shape after being bent. The novel design allows the deformable lens to have all the desired convexities or depressions necessary for correcting vision problems. Of course, the deformable lenses of the present invention are biologically compatible that can be manufactured thinner than a predetermined maximum material thickness that can be rolled or folded to pass through small incisions in the cornea or sclera. It is also possible to use all other materials.
[0023]
To securely place the deformable intraocular contact lens in front of the natural lens of the eye, a fixation is attached to the optic. In one embodiment, the lens also has a non-optical transition region interconnecting the fixation portion to the optics of the lens. This transition region has a thickness of approximately 0.025 mm. The fixing portion includes a pair of antenna fingers that extend from the transition region and rotate the optical lens. The thickness of the haptic finger is pre-selected for an optimal combination of strength and flexibility. The outer periphery of the haptic finger has a haptic rim. The antennal edge of the implanted lens is pressed against the intraocular tissue. The tactile rim thickness is pre-selected to provide minimal resistance to eye tissue.
BEST MODE FOR CARRYING OUT THE INVENTION
[0024]
Many visual problems can be corrected only by removing the natural lens and replacing it with an intraocular lens. While such lens replacement enhances the patient's visual ability, the lenses described in the prior art often have secondary visual problems. For example, many patients have difficulty driving at night due to glare, halos, and torus resulting from oncoming headlamps, taillights, and streetlights. Secondary visual problems are often tertiary aberrations ("The Fundamentals of Optics", by Francis A. Jenkins and Harvey E. White, copyright 1965, updated, Library of Congress, ISBNO-07-0323330-5). , 151-152). This third-order aberration is generally the sum of the deviations of the rays from the path where all the rays crossing the lens surface can converge on the focal point of the prime meridian. As the distance from the prime meridian increases, the error from the Gaussian equation increases. This equation also assumes an infinitesimally thin lens, which removes coma and other aberrations. The error associated with the Gaussian equation is represented by five sum terms called the Seidel sum. The Seidel sum includes spherical aberration, coma, distortion, astigmatism, and field curvature.
[0025]
The intraocular lenses and methods of use described herein solve many of the secondary visual problems caused by commonly occurring third order aberrations. In summary, the intraocular lens 10 has a series of annular rings 14 that round or crush or otherwise compress the lens 10 to provide a corneal incision smaller than 1.5 mm, or a pleural incision. It has the largest thickness that can be inserted through. Each of the annular rings 54 has two side surfaces arranged as shown in FIGS. 2, 3, 4, 6, 8, 8, 18, 22, 23 and 24. In addition, because the lens 10 and the haptics 18 are thin, the lens 10 can move within the insertion position to correct for lack of accommodation.
[0026]
As used herein, "aphakic eye" means an eye from which the natural lens has been removed.
[0027]
As used herein, "phakic eye" means an eye that still has a natural lens in place.
[0028]
As used herein, "support structure of the eye" means an eye structure on which a lens can be placed. The following is an example of a support structure. These examples do not exclude other support structures not mentioned. As shown in FIGS. 9 to 13, the anterior corner 31 of the anterior chamber 26 of the eye is a region where the end of the cornea 96 and the iris 28 are located, and where the two structures meet. As also shown in FIGS. 9-13, in another example of a support structure, the zonules 42 include a ciliary tuft 45 defined as an area that adheres to the posterior surface of the ciliary body 40 and iris 32. The lens can also be placed in the coating 34 remaining after removing the natural lens. When the lens is placed in the coating 34 left after removing the natural lens, the fixation stops against the rear surface 38 of the coating 34 and the front surface 36 of the coating 34.
[0029]
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are now described. All publications, patent applications, patents, and references mentioned herein are incorporated by reference herein in their entirety. Unless otherwise indicated, the materials, methods, and examples described herein are illustrative only and are not intended to limit the invention.
[0030]
Prior to the development of the present invention, the existence of a truly thin lens was theoretically considered ("Dr. H. Walker", Bruce H. Walker, Optical Engineering Fundamentals). C. O'Shea, Ed., George Institute of Technology, SPIE Optical Engineering Press, SPIE Publications, Optical International Society, Bellingham, Washington, USA. On page 57 of the textbook, "A thin lens is a lens whose thickness is zero and is assumed to be negligible. This thin lens is a design tool. It is stated to. "Used to simulate the true lens in preparation for the design and analysis of optical systems. Later in the same paragraph, this textbook greatly simplifies the formulas used to calculate the object-image relationship by assuming a lens shape of zero thickness. The disadvantage of using thin lenses is that it is not possible to determine image quality without including the actual lens thickness (and other lens data) in the calculation. As a result, by applying the thin lens theory and formula, many valuable facts about the optics can be determined, but the final quality of the image can only be estimated at best. It is stated.
[0031]
The invention is based on a lens that is as thin as possible, close enough to the theoretical zero thickness, but thick enough to support the optical structure. This allows the lens thickness to be neglected in the calculation. Thus, the present invention discloses a lens that approximates a theoretically perfect lens.
[0032]
Gauss's lens theory ("The Fundamentals of Optics," Jenkins and White, p. 48) states that the power of a lens is the difference between the refractive index of the lens material and the medium surrounding the lens as the radius of curvature of the lens surface. It is assumed to be equal to the divided value.
[0033]
As shown in FIG. 1, the present invention discloses a lens 10 having an optical unit 48 and a fixing unit 50. The optical section 48 has a first optical surface 49 and a second optical surface 51. In one embodiment, the optic 48 of the lens 10 has a biconvex structure, as best shown in FIGS. 2, 6, 8, 22, and 24A. In another embodiment, the optical section 48 of the lens 10 has a biconcave structure as shown in FIG. In yet another embodiment, the optical section 48 has a convex first optical surface 49 and a concave second optical surface 151, as shown in FIG. 24B. It should be noted that in one embodiment, as shown in FIG. 24A, the convex second optical surface 51 further comprises a convex central disk 12 and an annular ring 54 having a convex outer surface 59. is there. In another embodiment, as shown in FIG. 24B, the convex second optical surface 151 further includes a concave central disk 112 and an annular ring 54 having a concave outer surface 159. Predetermined protrusions or recesses on the outer surface 59 of the annulus 54 adjust the focal length of the annulus so as to focus on the same point as the prime meridian of the lens. In another embodiment, as shown in FIG. 3, the optical section 48 has a concave first optical surface 149 and a convex second optical surface 51. Reference numeral 49 represents a convex first optical surface. Reference numeral 149 represents a concave first optical surface. The language of the claims referring to the first optical surface is applicable to any. Reference numeral 51 represents a convex second optical surface. Reference numeral 151 represents a concave second optical surface. The wording of the claims referring to the second optical surface applies to any.
[0034]
In another embodiment, as shown in FIG. 25, the first optical surface 49 of the optical section 48 and the center disk 12 are convex in order to obtain a specific degree of convergence. The outer surface 159 of the ring 154 has a predetermined concave shape. The shape of the outer surface 159 adjusts the focal length from the ring 154 so that it converges to the same point as the main meridian of the lens 10.
[0035]
In one embodiment, intraocular lens 10 has a convex first surface 46. Generally, as shown in FIGS. 1-8 and 22-24, the second surface 44 of the lens 10 includes a planar central disk surrounded by a series of concentric planar annular rings 54 of increasing diameter. It has 12. The annular rings 54 are parallel to each other and to the center disk. The center disk 12 and the annular ring 54 are also perpendicular to the radial axis through the vertex of the first surface. The combination of the central disk 12 and the series of annular rings 14 forms a series of steps extending radially from the disk across the second surface 44, maintaining an approximation to the first surface 46.
[0036]
In yet another embodiment, the thickness between the central disk of the second surface and the apex of the first surface must be less than a predetermined maximum thickness. The predetermined maximum thickness is such that the material can be rolled or folded without exceeding the elastic limit of the selected lens material.
[0037]
In yet another embodiment, the thickness of the lens at the outer edge of the center disk must be greater than a predetermined minimum thickness. The predetermined minimum thickness is a thickness that is greater than a thickness that allows the lens material to retain a pre-bent shape after bending. This minimum thickness is determined by the manufacturing process and the strength of the lens material.
[0038]
The radial width of the center disk 12 of the second surface 44 is also within a predetermined range. The thicker the lens is at its apex, the more the radial width can extend before the periphery of the center disk 12 approaches a predetermined minimum thickness. The particular shape of the radial width is determined by the convex shape of the first surface and the thickness at its apex.
[0039]
As with the center disk 12, the thickness between the first surface 46 and the second surface 44 of the lens 10 at the inner diameter of each annulus, i.e., at the furthest point, is not less than a predetermined maximum thickness. No. The thickness between the first surface and the second surface of the lens at the outer diameter of each annulus, ie, at the closest point, must be greater than or equal to a predetermined minimum thickness. The radial width of the annular ring is within a predetermined length range, which is determined by the convex shape of the first surface and the thickness at the inner diameter of the annular ring. The greater the thickness of the lens at the inner diameter of the annulus, the greater the radial length can be before the outer diameter approaches a predetermined minimum thickness.
[0040]
Drawing an imaginary line between the inner diameter of the annular ring on the second surface, which is the point furthest from the front surface, and the center of the center disk, this imaginary line will be an arc or an arc, depending on the various thicknesses selected. Form a parabola. This imaginary line forms an effective second surface 44. By changing the thickness and width of the center disk and the annular ring, the effective second surface can be formed into a desired shape. This is particularly relevant for applications where the implant lens is implanted posterior to the iris. This is because the effective second surface is thereby configured into a predetermined shape, which allows the implanted lens to be suitably positioned near the front of the natural lens coating.
[0041]
As shown in FIG. 24A, in one alternative embodiment of the present invention, the center disk 12 of the second optical surface 51 and each annular ring 54 are not planar. Rather, each surface of the center disk 12 and the outer surface 59 of each annular ring 54 is convex. In a second alternative embodiment of the present invention, as shown in FIG. 24B, each surface of the center disk 112 and the outer surface 159 of each annular ring 154 is concave. Thereby, a specific degree of convexity or concaveness of each part of the second optical surface 151 can be selected, which helps to obtain a specific degree of convergence for different lenses. Reference numeral 59 represents the outer surface of the annular ring 54 of the lens 10 having a convex shape. Reference numeral 159 represents the outer surface of the annular ring 54 of the lens 10 having a concave shape. The wording of the claims referring to external surfaces applies to any. Reference numeral 12 represents a central disk of the lens 10 having a convex shape. Reference numeral 112 represents a central disk of the lens 10 having a concave shape. The wording of the claims referring to the central disk applies to any. In all of these embodiments, the central portion of the lens 10 and the annular ring 54 may have a symmetrical or asymmetrical oval shape for correcting spherical aberration.
[0042]
As best shown in FIGS. 4 and 22-24, the second surface 44 of the lens 10 comprises a central disk 12 that is radially surrounded by a series of annular And the series of annular rings 14 form a series of steps in the radial direction along the second surface 44. Each annular ring 54 has a first portion 56, a second portion 58, and an outer surface 59, as shown in FIGS. 4 and 22-24. The thickness of the lens 10, i.e., the separation between the first portion 56 of the annular ring 54 disposed on the second surface 44 of the lens 10 and the first surface 46 is less than a predetermined maximum thickness. is there. Also, the thickness of the lens 10, that is, the separation between the second portion 58 of the annular ring 54 disposed on the second surface 44 of the lens 10 and the first surface 46 is a predetermined minimum thickness. That is all. The minimum separation between the first surface 46 and the closest point of the second surface 44, ie, the second portion 58 of the annular ring 54, is 0.025 mm. The maximum separation from the first surface 46 to the farthest point of the second surface 44, i.e., the first portion 56 of the annular ring 54, is 0.45 mm. Reference numeral 46 represents the first surface of the lens 10 having a convex shape. Reference numeral 146 represents the first surface of the lens 10 having a concave shape. The wording of the claims referring to the first surface applies to any.
[0043]
In one embodiment, the outer edge of the optic comprises a parallel lenticular area. This parallel lenticular area has a uniform thickness. This parallel lenticular region prevents what is known as the edge effect that occurs when the optics of the lens do not adequately cover the outer edge of the pupil. This marginal effect occurs in a variety of situations, such as in a road tunnel, where there is low overhead lighting and overhead lighting.
[0044]
The first optical surface 49 of the lens 10 is a spherical surface as described by Gaussian lens theory. However, in practical application, spherical aberration as shown in FIG. 18 occurred in the lens design. FIG. 17 shows the rays 80, 82 and 84 incident on the standard lens 76. It should be noted that the spherical aberration increases with distance from the prime meridian of the eye and the lens. The practical consequence of this condition is that glare, halos or rings are visible. In particular, in low lighting conditions, such as driving at night, the pupil of the patient is wide open. Thus, patients often report glare, halos, and rings.
[0045]
When an extremely thin lens as disclosed herein is used, much of the spherical aberration generated by the standard lens is removed as shown in FIG. Spherical aberrations result in ghosts, i.e. images with a second image. The headlights of an oncoming vehicle at night look like the second headlights or look much larger than they actually are. The same effect applies to tail lights when approaching a car. Street lamps can produce the same effect. This condition is so severe for many patients that they refrain from driving at night. This is also true for people using contact lenses and eyeglasses.
[0046]
The following information is the calculation of spherical aberration for a 12 diopter lens made of a material with a refractive index of 1.47.
P = 20 degrees for all lenses
N_lens   = 1.47 Refractive index of material
N_aqueous  = 1.336 refractive index of aqueous humor of human eyes
R_total   = (N_lens-N_aqueous) * 1000 / P_s  Formula assuming one equivalent radius for the lens
R_total   = 6.7 Surface radius
F |_PM  = N_lens/ P_surface          Focal length of the lens along the prime meridian
= 73.5 calculated focal length
Sin Angle Angle in radians
F |_1mm                          Calculation of the focal length of light rays entering the eye
1mm from the prime meridian
φ₁     = 0.149254 0.149814 Angle 1 It is formed by a parallel ray incident on the lens and an angle formed by the radius of curvature of the lens at the contact point of the parallel ray. In this calculation, 1 mm from the prime meridian
φ_Two    = 0.135648 0.136068 Angle 2 It is formed by the light beam when refracted and bent at a part of the lens material and the refractive index of the waterproof.
φ_Three     = 0.013605 0.013746 Angle Angle formed between three prime meridians and refracted rays
F |_1mm  = 72.75212 72.74525 Focal length of light rays entering the eye at a position 1 mm from the prime meridian
DF |_1mm  = 0.747881 0.754754 Difference in focal length between the prime meridian and the light incident on the eye at a position 1 mm from the prime meridian
F |_2mm  = Calculation of the focal length for light rays incident on the eye at a position 2 mm from the prime meridian
φ₁     = 0.298507 0.303028 Angle 1 It is formed by the parallel light beam incident on the lens and the angle formed by the radius of curvature of the lens at the contact point of the parallel light beam. In this calculation, a position 2 mm from the prime meridian was selected as a contact point.
φ_Two    = 0.271297 0.27474 Angle 2 It is formed by a ray of light that is refracted and bent at a part of the lens material and the refractive index of the waterproof.
φ_Three     = 0.028389 Angle Angle between the three prime meridians and refracted rays
F |_2mm  = 70.45092 70.43199 Focal length of light rays entering the eye at a position 2 mm from the prime meridian
DF |_2mm  = 3.04908 3.068006 Difference in focal length between the prime meridian and the light incident on the eye at a position 1 mm from the prime meridian
[0047]
The refractive index of many polyhema materials is approximately 1.47. The calculations were based on a lens surface having all degrees without showing thickness. This is often done to easily calculate and represent the lens formula, and is almost accurate to prove the principle. Thus, all degrees are placed on one lens surface, and the radius of a 20 degree lens is 6.7 mm. This radius is determined by dividing the difference between the refractive index of the medium surrounding the lens and the refractive index of the lens by a desired degree. The result is multiplied by 1000 to convert from meters to millimeters. The focal length of the main meridian is the result of dividing the refractive index of the material by degrees and is 73.5 mm for given conditions. The angles 1 (82), 2 (84), and 3 (86) described above are shown in FIG. The angle between the given radius and the ray that contacts the lens at that point is angle 1 (82). The value of the angle 1 (82) changes according to the distance from the center of the lens at the point where the light beam to be evaluated contacts the lens. Angle 2 (84) is determined by the formula for determining the amount of refraction shown above. The amount of refraction is a measure of the percentage of the sine of the angle equal to the percentage of the refractive index of the material. Angle 2 (84) is obtained by multiplying the sine of angle 1 by the refractive index of the lens material and dividing the refractive index of aqueous humor by this value. It should be noted that for small angles, the sine of that angle is approximately equal to the angle. The calculation shows all angles in the radial direction. Angle 3 (86) is the angle formed by the refracted ray and the prime meridian 80, and is the result of subtracting angle 2 from angle 1. The focal length with respect to a light ray incident on a point 1 mm from the prime meridian is obtained by dividing 1 by the tangent of angle 3. The focal length of a light beam incident at a position 2 mm from the prime meridian can be obtained by a similar method. The difference in focal length between the prime meridian and the light beam incident at a distance of 1 mm from the prime meridian is approximately 0.75 mm shorter than the prime meridian. The difference in focal length between the prime meridian and a light beam incident at a distance of 2 mm from the prime meridian is approximately 3 mm shorter than the prime meridian.
[0048]
The present invention adjusts the radius of curvature of the second surface 44 of the lens 10 so that the focal point of the light beam can be approximately equal to the prime meridian. By doing so, much of the spherical aberration is eliminated.
[0049]
As best shown in FIG. 20, the second of the third order aberrations is coma ("Basics of Optics", Jenkins and White, p. 162). Coma is described as off-axis spherical aberration, which means that a ray enters the eye at an angle such that some of the rays pass through the lens along a longer path than other rays. I do. According to the textbook "Medical Optics" (Clinical Optics), a condition called coma is "spherical aberration applied to rays coming from points not on the main axis. Light passing through the edge of the lens is centered. Of the elephant formed by the different regions of the lens is non-uniform. "(A. E. Rickington) R. Elkington, HJ Frank and MJ Greeney, Clinical Optics, 3rd Edition, p. 96, Blackwell Science, Inc. Blackwell Science Ltd.) Commerce Place 350 Main Street, Malden, Mass. 021485018, British Library Number, ISBN 0-623-049889-8, Library of Congress 99-20296). Authors Jakeins and White state that this condition has a constrained overview, and thus the name is coma. Coma, like spherical aberration, causes the patient to see glare, halos, and rings. As described herein, in such a thin lens, since the path of light in the lens 10 is short, much of the coma is removed from the lens 10.
[0050]
Another third-order aberration is distortion. Distortion can come from many sources. One of them is outlined in FIG. As shown in FIG. 21, light 72 is refracted at a first surface 73 of a standard lens 76, and a refracted ray 74 travels through the lens material and reaches a second surface 75 of the standard lens 76. When the refracted ray 74 contacts the second surface 75, it is refracted again, and the refracted ray 77 is emitted from the standard lens 76. However, a part of the light traveling along the same optical path as the refracted ray 74 is reflected, and the reflected light 78 travels toward the first surface 73. Again, a portion of this light is reflected off the first surface 73 of the standard lens 76 and the reflected light 79 returns to the originally reflected second optical surface. It should be noted that light 81 exits the lens at a different phase than refracted light 77. Some of these harmonics can affect lens quality. The lens 10 described here hardly generates light having a different phase. Some phase shift is still present, but this shift is not as great for the lens 10 of the present invention.
[0051]
The fourth element of the Seidel sum and the third-order aberration is the astigmatism of the lens. Most astigmatism occurred during the polishing of old lenses. Most current intraocular lenses are tumble polished in a process similar to jewelry. If the cutting process is of excellent quality, there should be little astigmatism in current intraocular lenses.
[0052]
The last of the Seidel sums is the field curvature ("The Fundamentals of Optics", Jenkins and White, p. 170). In the previous discussion of this specification, we have stated that rays from the outer part of the standard lens converge faster than rays from the center of the standard lens. When projected onto the screen, the screen can be curved to correct aberrations due to field curvature. In the present invention, the correction on the second optical surface 51 for correcting the spherical aberration includes the correction of the curvature of field.
[0053]
All aberrations converge light to a point other than the point at which the prime meridian located along the central axis of the lens converges light. If all aberrations are present in the lens, the useful depth of field will decrease. Depth of field is defined as "the range (sharpness) of the image created by the optical system which is acceptable as permissible" ("Dictionary of Eye Terminology", 3rd amendment, Barbara Cassin) ) And Sheila AB Solomon, Triad Publishing Co., Gainesville, Florida, ISBN 0-937404-44-6. . It is easily concluded that removing aberrations increases the depth of field. A greater depth of field allows the patient to see the image more clearly over a larger area. Thus, removing aberrations increases the depth of field and allows the patient to clearly see near and far objects without additional correction.
[0054]
The following explanation of Hooke's Law is provided to explain why some materials bend without distortion before reaching their elastic limit. According to Hooke's law, when a force is applied along an axis, the quotient of the elongation due to the application of the force divided by the original length of the member along the axis where the force is applied is the strain. ("Mechanics of Materials", page 29, EP Popov, Civil Engineering University of California, California, California, Plenty's Hall, California) Professor, Englewood Cliffs, New Jersey (NJ), Copyright 1952 Eighth Edition 1958). Strain is a dimensionless amount and is very small except for materials such as rubber. Stress is the amount of force applied to a material divided by the cross-sectional area of the material where the stress is applied. Drawing the relationship between strain and stress becomes part of a linear chart. A bias in which the stress-strain diagram is linear does not result in permanent deformation of the stressed material. For certain materials, such as cast iron and concrete, the portion of the curve without permanent deformation is extremely small. For some alloyed steels, the curve is linear to almost the break point of the material. Up to a certain point, the relationship between stress and strain can be said to be linear for all materials. This is known as Hooke's law.
[0055]
Stress is directly proportional to strain, and this proportionality constant is called elastic modulus or Young's modulus. Modulus is bench tested, calculated for many materials, and published in the Engineering Handbook and other scientific handbooks. In the formula ("Standard Handbook for Mechanical Engineers", pages 5-42, Theodore Baumeister, edited by Lionel S. Marks). 1916-1951, McGraw-Hill Book Company, New York), the amount of deflection is the inertia coefficient and inertia of the biased material multiplied by the cube of the length of the biased object multiplied by the applied force. It is proportional to the quotient of the moment multiplied by the modulus of elasticity.
[0056]
This formula was used by the authors to calculate the maximum lens thickness without exceeding the elastic limit of the material. Since the lens is a flake or disk and is not an accurate beam, the value obtained in this calculation was theoretical. Further, the elastic modulus is used for acrylic resin, which is close to polymethyl methacrylate (PMMA). This theoretical calculation indicates that the maximum thickness of the lens is 0.25 mm. PMMA slices were made 0.25 mm by the authors. The flakes deformed somewhat permanently when wrapped around a 1/8 inch (3.175 mm) bar. In tests performed by the authors, the lens thickness was close to the correct one. Next, the authors provided the desired center disk 12 and a series of annular rings 14 and wrapped the lens around a 1/8 inch rod. Again some permanent deformation remained. The experiment continued until the authors succeeded in wrapping a lens 10 with a maximum thickness of 0.1 mm and a minimum thickness of 0.025 mm around a 1/16 inch (1.5875 mm) rod. Was done. A 0.1 mm thick lens 10 was wrapped around a 1/16 inch (1.5875 mm) rod 43 as shown in FIG. 16A. Thus, in one embodiment, a lens 10 having a maximum thickness of approximately 0.1 mm to a minimum thickness of approximately 0.025 mm is used in the invention disclosed herein. In another embodiment, lens 10 has a maximum thickness of about 0.45 mm to a minimum thickness of about 0.025 mm. In yet another embodiment, lens 10 has a maximum thickness of about 0.065 mm to a minimum thickness of about 0.025 mm. If the minimum thickness of the lens, measured from the front first surface to the nearest minimum point along the second surface, is less than 0.025, then this lens is used when using a tool to wind the lens. Is occasionally bent by the shear stress of The formula for thin lenses is 1 / f = (N1-1) (1 / R1-1 / R2) ("Basics of Optics", pages 67 and 70, Francis A. Jakins, Harvey E. White, 4th edition) McGraw-Hill Book Company, copyright 1950, revised 1965).
f = focal length of lens
N1 = refractive index of lens material
R1 is the radius of curvature in meters.
R2 is the second radius of curvature in meters.
[0057]
This formula is for lenses in air. If the lens is in a medium other than air, such as human aqueous humor or other intraocular fluid, the formula is
1 / f = (N1-N2) (1 / R1-1 / R2)
Here, N2 is the refractive index of the medium in which the lens is placed. In this case, it is the aqueous humor of the human eye.
[0058]
The magnification of the lens is P = 1 / f
Where P is diopter
N1 for polymethyl methacrylate is 1.492
N2 for aqueous humor is 1.336
[0059]
Here, Tc = central thickness at the vertex = 0.1 mm
Pa = forward magnification
Pp = backward magnification
Pn = Net magnification
[0060]
Shown below is information about the lens for which a negative magnification is displayed as the net magnification. First, a myopic lens, followed by a hyperopic lens:
Pn Pa Pp Central thickness Te_2 Te_3
-10 5 -15 0.1 0.23 0.40
-10 10 -20 0.1 0.23 0.41
-10 15 -25 0.1 0.24 0.43
-15 5 -20 0.1 0.30 0.56
-15 10 -25 0.1 0.30 0.58
-15 15 -30 0.1 0.31 0.61
-20 5 -25 0.1 0.37 0.72
-20 10 -30 0.1 0.37 0.76
-20 15 -35 0.1 0.38 0.82
−25 5 −30 0.1 0.44 0.91
-25 10 -35 0.1 0.45 0.97
-25 15 -40 0.1 0.46 1.07
[0061]
Cataract or hyperopic lens

[0062]
Te_2 is a distance along the edge of the lens parallel to the central axis, and is 2 mm from the central axis when the optical diameter is 4 mm. Te_3 is a distance along the edge of the lens parallel to the central axis, and is 3 mm from the central axis when the optical diameter is 6 mm. The distance from the vertex of the front surface to the edge of the front surface, measured in parallel and offset with respect to the central axis or the prime meridian, is represented by Tr1. The distance from the vertex of the front surface to the edge of the rear surface, measured in parallel and offset with respect to the central axis or the prime meridian, is represented by Tr2. Tc is the center thickness at the vertex. The last column shows the thickness of the edge of the lens. This edge thickness, at best, approximates the theoretical maximum thickness when the PMMA is wound. From actual experiments, this material does not completely return to its original shape. That is, at a thickness of 0.25 mm, there is some permanent deformation of the material. Therefore, this lens cannot be wound around a 1/8 inch dowel pin and is not a deformable refractive lens. In fact, previously designed lenses do not have a constant thickness along an optical surface whose front and back surfaces are parallel to each other. With a thin lens, the radii of each surface are close to each other, so that both surfaces have the same magnification. On the other hand, the front surface is positive and the rear surface is negative, and the magnifications of the lenses cancel each other. If the lenses are made of materials such as hydrogels, hydrophilic acrylics, or hydrophobic acrylics, these lenses will bend at a much greater thickness than PMMA. And this thickness can be increased to almost half or less of the standard lens. As a result, the present invention reduces bulk and requires smaller incisions.
[0063]
In a dissertation by Dr. Glasser (Glasser and Kaufman), "Presbyopia: A View", Ophthalmology Journal (The Medicine Medicine Journal, August 20, 2001). No. 8, pages 1-15), in the introduction, the author states that presbyopia is characterized by progressive, age-related loss of accommodative amplitude. Complete loss of accommodation, usually peaks at age 50. Patients with emmetropic eyes have adequate distance vision but need to correct near vision. The near vision of myopic patients is less problematic.
[0064]
In the aforementioned paper, Dr. Glasser discusses the theory of accommodation proposed by Helmholtz in 1909. This accommodation theory theorizes that accommodation occurs when the ciliary muscle contracts, releasing the resting zonules on the equatorial edge of the lens. Stated another way, as shown in FIG. 15, the ciliary body 40 can be viewed when the eye is looking far away compared to the size of the ciliary body while visualizing nearby objects. Become smaller. The general anatomy of the eye is shown in FIG. The small ciliary body 40 extends the zonules 42. The small band 42 is a form of a band. The stretched zonules 42, in turn, stretch the capsular bag 34 containing the natural lens. This makes the lens 11 flatter for viewing far away. The flatter lens causes the eye to see the image as it converges on a distant object. When the ciliary body 40 expands, the tension in the zonules 42 or bands is released, and the crystalline lens 11 assumes a more natural rounded shape and can converge to a close one. Dr. Glasser offers several theories about why accommodation decreases with age. Accommodation in the average person begins to disappear by the age of 35 and will completely disappear by the age of 60. By the age of 45 to 50, the average person will need glasses or contact lenses for reading, for near vision.
[0065]
In the last paragraph of section 2 of the preface, Dr. Grasser's paper states that during accommodation, the ciliary muscles move anteriorly and the equatorial rim of the lens moves away from the sclera. (Glasser and Kaufman, "Presbyopia: Sight", Journal of Ophthalmology, August 20, 2001, Vol. 2, No. 8, pp. 1-15). A video using an even-angle videograph was taken with accommodation, and the zonular fibers or bands were relaxed during accommodation. The paper further notes that the posterior zonular fibers that extend between the posterior junction of the ciliary muscle and the ciliary process are stretched during accommodation by anterior and axial movement of the ciliary muscle apex. States that the picture shows.
[0066]
In section 3, entitled Presbyopia, Dr. Glasser discusses some theories about why accommodation is lost (Glasser and Kaufman, "Presbyopia: Sight," Journal of Ophthalmology, August 20, 2001). Japan, Vol. 2, No. 8, pages 1-15). One of the two governing these theories is that the crystalline structure of natural lenses becomes brittle with age. Another theory is the loss of ciliary muscle and choroid elasticity. A similar theory is that the natural lens of the eye continues to grow over the years until the muscles cannot overcome the forces exerted by the lens and cannot change shape.
[0067]
If the surgeon removes the cataract early, it is easy to cut out the lens into small pieces and suck it out. If cataracts were allowed to mature, the surgeon would take a very long time to remove the lens. Aged cataracts are very hard. MRI measurements show that contraction of the diameter of the accommodative ciliary ring is reduced in older eyes compared to dedicated young eyes (Strenk et al., "Human Hair"). Age-related changes in human muscles and lenses: Magnetic resonance imaging studies "(Age-related changes in human and imaging: a medical resonance imaging study), ophthalmology (Invest Ophthalm. ) May 1999, 40 (6): 1162-1169, and Glasser and Kauffman, "Presbyopia: Sight", Journal of Ophthalmology, August 20, 2001, Vol. 2, No. 8, pp. 1-15. But is discussed). Aged ciliary muscles do not have much accommodation. Dr. Glasser has been working on Tamm's work in identifying several aspects that change with age (Tamm E, Croft MA, Jungkunz W, et al.) Age-related loss of ciliary muscle mobility in the rhesus monkey. Role of the choroid., The First Ophthalmology, "Loss of Ciliary Muscle with Age in Rhesus Monkeys. Role of Choroid." Jun. 1992, 110 (6): 871-6; Tam Y, Lutjen-Drecoll E, Jungkuntz W., et al .: "Young monkeys, coordinating old people." Ophthalmology, Visual Science, April, 1991, pp. 3292 (Postal Attachment of Ciliary Muscle in Young, accomodating old, presbyopic monkeys, Monkeys, Presbyopia monkeys). Tam S, Tam E, Loen JW (Rohen JW) "Aging of human ciliary muscle with aging. Quantitative external measurement study of the human ciliary muscle. Quantitative morphology" Proceeds to the summary of the development of mechanical aging (Mech Aging Dev), February 1992, 62 (2), 209-21. I. The overall area of the ciliary muscle is reduced. Its length is reduced to almost half that of adults aged 30 to 85 years, the area of the ciliary body in the longitudinal direction decreases, the area of the circle increases, and the length of the ciliary body increases. The connective tissue in the longitudinal section increases and the distance from the apex inside the ciliary body to the scleral spinous process decreases.
[0068]
From the summary of Helmholtz by Glasser, ciliary contraction releases the tension of the resting zonules on the equatorial rim of the lens, therefore the ciliary body diameter is small and the zonular tension is removed We learned that. Previously, from the discussion of Glasser in Section 3, the ciliary body moves forward, in the direction of the iris, and the direction of the equatorial edge of the lens away from the sclera during accommodation, under the mechanism of accommodation. We learned to move on. The zonular fibers relax during accommodation. Dr. Glasser subsequently states that the ciliary body and ciliary process extend during accommodative movement due to anterior and axial movement of the ciliary muscle apex.
[0069]
When an intraocular lens is implanted, known intraocular lenses create haptic forces and many lenses are curved or angled behind the eye. Even the tactile sensations that look like three whiskers exert force on the equatorial region of the lens capsule. The present invention is an intraocular lens that is exerted little or no force by a fixation. In one embodiment, lens 10 is placed in pressure on zonules 42 and posterior surface 32 of iris 28, as best shown in FIGS. 13A and 13B. In FIG. 13A, the fixing portion 50 is wound around the front of the eye. In FIG. 13B, the fixing portion 50 is wound around the rear area of the eye. In addition to the differently wound fixation portions 50, as described above, the lens 10 may have the first surface 46 of the lens 10 directed toward the anterior chamber 26 of the eye or the second The surface 44 can be directed toward the anterior chamber 26 of the eye or inserted in any manner.
[0070]
In another embodiment, the lens 10 is positioned to exert pressure on the front surface 36 of the bladder 34 and the rear surface 38 of the bladder 34, as best shown in FIGS. In this embodiment, the intraocular lens 10 sandwiches the tactile foot plate 20 that functions as a fixing portion and holds the lens 10 in a fixed position by lateral force from the rear surface 38 and the front surface 36 of the capsule 34. It is placed in the sac 34 in a state. The lens 10 has its first surface 46 directed toward the anterior chamber 26 of the eye by wrapping in a different direction as described above, in addition to the fixed portion 50 represented by the fixed foot plate 20 in the above figure. Can be inserted either with the second surface 44 facing the anterior chamber 26 of the eye.
[0071]
With the eyes converging on a distant object, the ciliary body 40 relaxes and the zonules are taut. Thus, the lens is stationary along the equator of the capsular bag. When looking at objects close to the eyes, the ciliary body 40 expands and relaxes the zonules. The expanding ciliary body 40 displaces the vitreous body, thereby exerting a small force on the posterior capsule and zonules, pushing them forward. The lens 10 keeps the equatorial region of the capsular bag 34 extended so that the zonules 42 are free to move forward. As shown in FIG. 14, the forward movement of the zonule 42, indicated by the axis of movement 37, causes the capsule 34 containing the lens to move forward, thereby causing the intraocular lens to move forward and accommodate. Is made.
[0072]
The invention disclosed herein provides surprising results for correcting light glare, halo and ring problems. The present invention also provides surprising results for correcting lack of accommodation.
[0073]
In some embodiments, the area of the haptics 18 can be tilted backwards, thereby placing the lens 10 behind the equator of the capsule 34 or in the direction of the retina. Anchor 50 may also be referred to as haptics 18, fixed footplate 20, plate haptics 22, or other similar structures. In other embodiments, the area of the haptics 18 can also be tilted forward, so that the lens 10 is placed in front of the equator of the capsule 34 or toward the iris 28. The area of the haptics 18 can also be flat, so that the lens 10 is located along the equator of the capsule 34. The area of the haptics 18 is thick enough to allow the optic 48 of the lens 10 and the haptics 18 to be rolled, crushed, or otherwise compressed for insertion into the incision. In some embodiments, the incision is smaller than 1.5 mm. In another embodiment, the incision is less than 2.5 mm. In another embodiment, the incision is about 1.5 mm. In one embodiment, the optic 48 of the lens 10 is made of a material different from the material used to construct the fixed portion 50, the haptics 18, or the fixed foot plate 20. In such embodiments, these materials can be melted, connected, or attached, as is commonly known in the art.
[0074]
In one embodiment, the fixed part 50 of the lens 10 is the plate haptic 22, as shown in FIG. In another embodiment, the fixed part 50 of the lens 10 is a plate haptic 22 with a sign 24 indicating the direction or orientation of the lens 10, as shown in FIG.
[0075]
The number of fixed footboards 20, also called tactile footboards, can vary from zero to eight. In certain embodiments without fixed footplate 20, lens 10 forms a dome structure. In another embodiment, best shown in FIG. 5, the lens 10 may have a plate haptic 22.
[0076]
By way of comparison, the optical edge of a standard negative 20 degree lens has an edge thickness of 0.360 mm at an optical diameter of 4 mm. For the same optical diameter at the same magnification, the invention has an edge thickness of 0.05 mm. No. 5,258,025 to Fedrob et al. Requires that the edge of the lens must be 0.348 mm to obtain a 20 diopter negative magnification lens having a center thickness of 0.1 mm. Be careful. The edge thickness of the present invention having the same optical diameter of 4 mm is 0.0323 mm. However, the present invention has a maximum thickness of 0.0776 mm for a 20 diopter negative power lens. As a result of the thickness of Fedrob and other lenses, it is too thick to roll because it exceeds the elastic limit of PMMA. Should Fedrob and other lenses be made of materials such as hydrogels, hydrophilic acrylics, etc., the lenses would curl or collapse. However, the required incision size will be much larger than the incision size of the present invention.
[0077]
U.S. Pat. No. 5,076,684 to Simpson et al. Describes a multifocal lens without any attempt to move the front and back surfaces closer together to obtain a minimum thickness. Simpson et al. Describe an annular ring, but not for thinning the lens. Simpson et al. State in claim 1 that at least part of the optical magnification is caused by diffraction. In the 1800's Fresnel developed a diffractive lens with an annular ring for use in a lighthouse. The use of an annulus to develop a multifocal lens appears to be the basis of the Simpson et al. Patent.
[0078]
The present invention uses an annulus to make a very thin lens 10. In one embodiment, the function of the annulus 54 allows the lens 10 to be folded or rolled for securing through a small incision. In another embodiment, the function of the annulus 54 is of an optical nature such that the presence of the annulus 54 reduces or eliminates glare, halo and annulus of light. The purpose of the intraocular lens 10 is to allow the material to be sufficiently thin so that it can be rolled without exceeding the elastic limit of the material and to reduce the size of the incision. None of the prior art discussed above discusses using an annular ring to obtain a lens that is thin enough to roll without exceeding the elastic limit of the material. In fact, none of the work referred to discusses making the lens sufficiently thin and rounding without exceeding the elastic limit of the material, nor making such a thin lens to reduce the size of the incision .
[0079]
Thin lenses are desirable to eliminate glare and halos and rings of light being visualized. This is considered to be a significant problem since patients who implanted the first intraocular lens spilled glare, halos and rings from the intraocular lens. Light is caught on the edge and reflected to the eyes. This light is out of focus, but the thick edges reflect light that appears to the patient as a ring or halo. This condition is more noticeable at night when the patient is in a dimly lit area with high overhead lighting, such as a streetlight or tunnel. This condition exists to some extent even in the daytime under bright sunlight. For the invention described herein, the thin edge 16 of the optic 48 is approximately 50 μm to approximately 200 μm thick. The thickness of the lens of the present invention is very thin when compared to a standard 6 mm optical lens with an optical edge greater than 1000 μm for a myopic lens.
[0080]
The present invention discloses lenses used to correct lack of accommodation and methods of using the same. By thinning the lens and removing the material present in the thick lens, the present invention provides that the fixing means 50, such as the fixed foot plate 20 or plate haptics 22, hold the lens in place and the lens 10 It allows to be flexible enough to move. This axial movement provides accommodation for the patient, as shown in FIG. In earlier designs, the concept of a hinge was used to move the lens, as in U.S. Pat. No. 6,197,059 to Cumming. In the present invention, the sac design allows the optical portion 48 of the lens 10 to be sufficiently light and the fixed foot plate 20 or plate haptic 22 to flex sufficiently with respect to the lens 10 to move with the natural movement of the capsule. I can do it. Natural movement can be caused by removing tension on the zonules. Thereby, the optical part 48 and the fixing means 50 can move forward in the axial direction, and a natural forward movement occurs.
[0081]
As shown in FIGS. 16A, 16B and 16C, prior to implantation, the lens 10 is rolled so that it can be inserted through a cut. As shown in FIG. 16A, it can be wrapped around something like a bar 43. In other embodiments, the lens 10 can simply be wound on itself.
[0082]
The lens 10 is warmed or heated before being rolled or deformed. In one embodiment, lens 10 is warmed to around 100 degrees Fahrenheit. In another embodiment, lens 10 is warmed from about 90 degrees Fahrenheit to about 150 degrees Fahrenheit. When the lens is cooled to room temperature, ie, dehydrates, the lens becomes brittle. In some embodiments, the temperature of lens 10 is reduced before lens 10 is inserted into the eye cut. When the lens 10 is rehydrated, ie, warmed, the lens 10 does not spread by itself when it contains water due to the fluid present in the eye.
[0083]
In one embodiment, a cut is made in the eye so that the lens can be placed in the eye. A common protocol is known in the art relating to a tool for making an incision and positioning the incision. In some embodiments, the cut is less than 1.5 mm. In another embodiment, the cut is less than 2.5 mm. The lens is inserted into the eye 15 through the cut as shown in FIG. 16B. FIG. 16C shows the lens 10 inserted into the eye 15, expanding, or deforming.
[0084]
As shown in FIG. 11, in one embodiment, the lens 10 is placed in the bladder 34 and pressed against the front 36 of the bladder 34 and the rear 38 of the bladder 34. In addition, as shown in FIG. 11, the fixing portion of the lens may be bent toward the front of the eyes. As shown in FIG. 12, the fixing portion may be bent toward the back of the eye. In other embodiments, lens 10 may be upside down. Further, other concave and convex lenses of the first optical surface and the second optical surface may be used as shown in the above-mentioned drawings.
[0085]
In another embodiment, as shown in FIGS. 13A and 13B, the fixing portion 50 is pressed against the small band 42 and the rear surface 32 of the iris 28. As described above, the fixing portion 50 of the lens 10 may be twisted forward as shown in FIG. 13A, or may be twisted backward as shown in FIG. 13B. In other embodiments, the orientation of lens 10 may be reversed such that the rear-facing surface, as shown in either FIG. 13A or 13B, faces the front. Further, other concave and convex lenses of the first optical surface and the second optical surface may be used as shown in the above-mentioned drawings. Further, the fixing portion may be an accordion. An accordion fixing portion 50, in this embodiment, a fixing foot plate 20, is shown in FIG.
[0086]
In one embodiment, following insertion, the lens 10 expands in the natural lens capsule 34 and opens until the fixed footplate 20, also referred to as the haptic footboard, hits the tissue. When the fixed footplate 20 hits the tissue, the lens stops spreading. The extremely thin tactile sensation 18 and stationary footplate 20 exert little force on the inside of the natural lens capsule 34 that originally held the natural lens of the eye. Following insertion and deployment of the lens 10, the cut does not require repair in most cases, as is well known in the art.
[0087]
The lens 10 can move within the natural lens capsule 34. As the front of the ciliary body 40 expands, the force on the front zonules decreases. The pressure in the eyes then pushes the lens 10 forward, allowing for axial movement. The thin optic 48 and the thin haptics 18 cause the lens 10 to move axially and accommodate. In another embodiment, a method of correcting the lack of accommodation involves twisting the haptic footplate 20 toward the front surface 36 of the natural lens capsule 34, as shown in FIG. In another embodiment, the method of correcting the lack of accommodation is to further twist the haptic footplate 20 toward the rear surface 38 of the natural lens capsule 34, as shown in FIG. In another embodiment, lens 10 is inserted into ciliary body 40 of the aphakic eye. In yet another embodiment, the lens 10 is inserted and attached to the back of the iris 32. When the ciliary muscle relaxes, the lens does not tension the capsule and the lens moves forward. In one embodiment, lens 10 is movable in anterior chamber 26 of the eye. This action results in accommodation of the patient.
[0088]
Artificial lenses are typically made of acrylic resin, which is a polymethyl methacrylate (PMMA) or hydrophobic material that has a low modulus of elasticity that allows the material to roll or bend without permanent deformation. It can be an acrylic resin. Other acrylic materials that can be used are hydrophobic materials such as hydroxyethyl ester of methacrylate acid and methyl methacrylate copolymer or hydrogel. Such hydrophobic materials have a very high modulus and are brittle when dry, but become soft and plastic when swollen with water ("Plastics Technology Handbook"). Third Edition, Manas Chanda and Salil K. Roy, Marcel Dekker, Inc. New York, p. 584). Such a material is a preferred material because it is biologically compatible with eye tissue and does not degrade spontaneously.
[0089]
The lens product material is any biologically compatible, optically suitable, flexible, processable or castable material having an index of refraction between 1.4 and 2.0. I do. Examples of materials that can be used for the lens product include, but are not limited to, acrylic resin, hydrophilic acrylic resin, hydrophobic acrylic resin, or polymethyl methacrylate (PMMA). Hydrophilic materials with water, including more than 75% to 18% water, for use in the products of the present invention are available from Contamac Ltd, Bearwarden Business Park, Saffron Walden. Available from Essex (Saffron Walden Essex), CB11, 4JX, UK. One material is polyhydroxyethyl methacrylate containing 38% water. The second material is a copolymer of N-vinylpyrrolidone and 2-hydroxyethyl methacrylate. A similar material contains about 76% water. Copolymers of alkali methacrylate and siloxyanil methacrylate and fluorine containing comonomer are available from the same supplier. For intraocular lenses, Contamac manufactures a copolymer of hydroxyethyl methacrylate and methyl methacrylate with an added ultraviolet blocking material. The water content can vary from 18.5% to 26%. The same company also makes PMMA buttons. Other suppliers also produce silicon compounds for lens casting.
[0090]
In one embodiment, the optical portion 48 is made of an acrylic resin, a hydrophilic acrylic resin, a hydrophobic acrylic resin, or a hydrogel. In another embodiment, the optical part is made of acrylic resin, and the fixed part is made of polymethyl methacrylate. In yet another embodiment, the optic is comprised of a hydrogel and the anchor is comprised of polymethyl methacrylate. In another embodiment, the optical part is made of a hydrogel, and the fixing part is made of an acrylic resin.
[0091]
Experience with cataract surgery has shown that making small incisions reduces astigmatism. For this reason, if the lens can be handled through a small cut, the severity of daily aberration will be reduced. However, in order to properly cover the pupil, the optic of the intraocular lens must have a diameter of at least approximately 6 mm. Therefore, the only way to pass the lens through the smaller cut is by first folding or rolling the lens into a U-shape so that the opposing edges overlap. However, currently designed hydrophobic or hydrophilic lenses may be too hard to roll or fold. Alternatively, when folded, they still require a cut of approximately 3 mm. This 3 mm cut causes astigmatism. It is known that a hard material at a given thickness can flex when thinned, but the maximum material thickness that PMMA can flex is about 0.25 mm. Other acrylic materials can bend more, but still require cuts large enough to cause astigmatism.
[0092]
Some lenses have a convex first surface through which incident light passes. The lens also has a second surface 44 facing the first surface from which the refracted light exits. Second surface 44 may be convex, planar, or concave. The magnification of the lens is determined by the curvature of the first surface 46 and the second surface 44.
[0093]
As shown in FIG. 2, the edge 16 of the optic 48 of the lens 10 must be very thin to prevent glare, halos and rings of light visible to the patient. In the preferred embodiment, the edge 16 of the lens is 200 μm. The haptics 18 must be thinner than the rim 16 to prevent bending of the optic 48. In one embodiment, the thickness of haptic footplate 20 is approximately 50 μm. In another embodiment, the thickness of haptic footplate 20 is less than 50 μm. In yet another embodiment, the thickness of haptic footplate 20 is from about 50 μm to about 200 μm. As discussed herein, the anchor 50 may be a haptic footboard 20, a plate haptic 22, or other type of haptic. The fixing part 50 has a thickness of about 10 μm to about 100 μm. In another embodiment, the fixing portion 50 has a thickness smaller than 100 μm. The haptics 18 may have from two to eight multi-haptic footboards 20. In a preferred embodiment, there are four tactile footboards 20, as shown in FIG. In a preferred embodiment, as shown in FIG. 11, the haptic footplate 20 is curled toward the anterior chamber 26 of the eye.
[0094]
Once the surgeon places the lens 10 in the center of the eye, the haptic force holds the lens centered. The thin structure of the antennae 18 provides little radial inward pressure on the inner surface of the eye.
[0095]
The exact diameter of lens 10 is determined by several factors. When the lens 10 is inserted into a natural lens capsule 34, also known as a capsular capsule, the diameter of the lens 10 is such that it fits snugly into the capsular bag 34 from which the natural lens has been removed. It is. Alternatively, the lens 10 can be placed in a ciliary cavity 45 between the back of the eye, the iris 32, and the zonular structure 42, also known as a ligament. When the lens 10 is placed in the capsular bag 34, the diameter of the lens 10 is from about 10 mm to about 14 mm, and in a preferred embodiment, about 11 mm. As shown in FIG. 1, the diameter of the lens 10 is about 10 mm to about 14 mm. As shown in FIGS. 6 and 8, the plate-like lens has an angle 94. Angle 94 can vary from +10 degrees to 0 degrees from 0 degrees for the anterior chamber lens, which is the preferred embodiment.
[0096]
In one embodiment, lens 10 is implanted into a human eye through a 1.5 mm incision in cornea 96 or sclera 98. The process of rolling the lens 10 and inserting it into the eye 15 and the lens 10 begins to spread is shown in FIG. This embodiment uses an extremely thin haptic 18 having an optical part 48 as shown in FIG. 2 or FIG. Known by those skilled in the art, manufactured by and stamped as such by some drug suppliers during implantation of this particular embodiment, or any of the other embodiments described above for implantation. And washed with a balanced salt solution (BSS). In one embodiment, the implantation was performed at about room temperature, and the lens raised the temperature of the intraocular fluid to a temperature in the range of 85 to 100 degrees F, preferably 98.6 degrees F. Sometimes spread. FIG. 16 shows the process of rolling the lens 10, inserting the rounded lens through the cut, and the lens begins to spread in the eye.
[0097]
There are many techniques used to get into the eyes to remove cataracts. The size and location of the incision affects the curvature of the cornea 96, potentially inducing astigmatism. By providing a smaller cut, the occurrence of astigmatism can be minimized. The cut in the sclera 98 (white part of the eye) is typically 6 mm long, but the cut in the transparent part of the cornea 96 can only be quite small (approximately 3 mm). These corneal cuts are so small that no sutures are required to close the wound. Furthermore, unlike the incision in the sclera 98, there is no bleeding associated with making the incision in the cornea 96. The present invention reduces the corneal incision to 1.5 mm or less. Many surgeons do what is called a two-handed technique of inserting two 1.5 mm incisions and removing the cataract through one incision using a lens ultrasonic liquefied aspirator. A lens ultrasound liquefied aspirator resembles an extremely small jack hammer that fits inside a 1 mm cannula. The second cut is used to insert an instrument for manipulation of the cataract natural lens. The instrument inserted into the second cut also has an opening for supplying a balanced salt solution to the eye. The natural lens of the cataract is chopped into small pieces that are sucked away and carried away. BSS replaces the lost body fluid in the eyes. Today's most modern cataract surgeons use a lens ultrasound liquefied suction system that requires an incision of 2.5 mm or less. To implant a standard cataract lens, the size of the cut must be increased.
[0098]
In one embodiment, a method of correcting or ameliorating either loss of accommodation or lack of accommodation involves cutting an incision less than 1.5 mm in length to reach the anterior chamber of the eye. Forming and providing a lens having the diameter disclosed herein with the lens disclosed herein; providing a support haptic for securing the lens integrally; without exceeding the elastic limit of the material. Rolling the lens and supporting haptics around the rolled unit, inserting the rolled unit through the cut into the anterior chamber, spreading the rolled unit in the anterior chamber, And fixing a cut in the eye if necessary.
[0099]
In another embodiment, a method of correcting or ameliorating either loss of accommodation or lack of accommodation comprises forming an incision less than 1.5 mm in length and having a thickness of 0.25 mm or less. Having a convex first surface and a second surface formed of an optical grade acrylic material having a diameter of 11 mm, the second surface being radially defined by a series of annular rings. A series of annular rings are found on the central disk in the series of annular rings, the series of annular rings being radially series of steps along this second surface. Providing a lens that forms the lens, and integrally providing a lens support and haptic fixing member for fixing the lens, and rolling the lens and the support haptic without exceeding the elastic limit of the material. Wound around the unit, And inserting into the eye a Tsu bets via the incision includes a widening the wound units, and securing the haptic.
[0100]
As described above, the series of annular rings 14 in the optic 48 of the lens 10 perform several functions. The series of annular rings 14 reduce the thickness of the lens 10, thereby reducing the weight of the lens 10. As the weight of the optics decreases, the fixing means, including, but not limited to, the haptics 18, the plate haptics 22, and / or the fixed footplates 20, are thinner and provide increased rigidity for correctly positioning the lens 10 in the eye. Can have. In addition, the thin haptics 18 including the plate haptics 22 allow the lens 10 to move forward based on the expanding tension of the ciliary body 40 that causes accommodation, as shown in FIG.
[0101]
One surface of the lens 10 is a continuous curved surface and spherical. All deviations from the paraxial ray formula of Gauss's theory to give an accurate image detail description ("Basics of Optics", Jenkins and White, p. 149) are known as spherical aberrations. Many commercial computer programmed lathes cut spherical patterns because spherical lenses introduce aberrations. Gauss's formula is based on spherical lenses, where rays incident on a spherical lens converge to a shorter focal length as the distance from the center of the lens increases. This effect is known as spherical aberration and causes glare in the lens from light rays that do not converge. The series of annular rings 14 are designed to correct spherical aberration from a continuous curve by adjusting the focal length from each ring 54 that converges to the same point as the prime meridian of the lens. The prime meridian of a lens is the focal length of the lens along the central axis of the lens. In addition to correcting for spherical aberration, the lens 10 disclosed herein corrects for coma. Coma is the second of the third order monochromatic aberrations. "The name comes from the comet-like appearance of an image of an object located slightly away from the lens axis," as described in Jenkins and White's "Basics of Optics" (pages 162, 163). . The authors further state that "different parts of the lens appear to have different magnifications."
[0102]
The lens design includes an extremely thin lens with all excess material removed from the optics 48, haptics 18 and fixed footplate 20 so that the lens 10 is extremely light and does not create excessive force on the eyes. Request more. Again, the thinness of the lens 10 reduces the mass of the lens 10 and thus allows the lens 10 to be folded, rolled, or crushed so as to pass through an incision smaller than 1.5 mm.
[0103]
The present invention can be practiced by modifying the lenses disclosed in Worst, US Pat. Nos. 5,192,319 and 4,215,440. For example, the optics of a worst lens can be modified using the optical surfaces of the present invention.
[0104]
In another embodiment, the optic 48 of the lens 10 has a convex first surface 46. The periphery of the optical section 48 has a parallel lens-shaped area. This parallel lenticular area has a uniform thickness and is intended to prevent a phenomenon known as edge effect. A non-optical transition region 52 surrounds the parallel lenticular region, as shown in FIG. In another embodiment, the anchor 50 extends from the transition region 52. In yet another embodiment, the fixing portion 50 includes a pair of haptics 18 that rotate the optical portion 48 of the lens 10. Each of the pair of haptics 18 has an outer circumferential haptic edge for pressing against eye tissue.
[0105]
The central disk 12 and the series of annular rings 14 form a series of radial steps across the second surface 44, maintaining an approximation to the first surface 46. The thickness of the central disk 12 at the apex of the first surface 46 is less than or equal to a predetermined maximum thickness so that the lens 10 can be rolled without exceeding the elastic limit of the lens material. The thickness around the center disk 12 is greater than or equal to a predetermined minimum thickness so that the lens 10 retains its pre-bent shape after being rounded.
[0106]
In one embodiment, the surface of the central disk 12 and the surface of each annular ring 54 are convex. The thickness of the central disk 12 at the apex of the first surface 46 is less than or equal to a predetermined maximum thickness. The thickness around the center disk 12 is equal to or greater than a predetermined minimum thickness.
[0107]
In another embodiment, the surface of the central disk 12 and the surface of each annular ring 54 are concave. The thickness of the center disk 12 around the center disk 12 is equal to or less than a predetermined maximum thickness. The thickness of the lens between the apex of the first surface 46 and the center disk 12 is greater than or equal to a predetermined minimum thickness.
[0108]
All patents and publications mentioned above are hereby expressly incorporated by reference in their entirety.
[0109]
Although the present invention has been described above, it should be apparent that the invention can be varied in many ways. Such modifications are not deemed to depart from the spirit and scope of the present invention, and all modifications obvious to those skilled in the art are intended to be included within the scope of the present invention.
[0110]
Thus, while specific embodiments of the present invention have been described in terms of new and useful small incision lenses and methods of use, such references, except as set forth in the appended claims, limit the scope of the present invention. It is not intended to be interpreted as such.
[Brief description of the drawings]
[0111]
FIG. 1 is a plan view of a lens 10 having extremely thin optical components and tactile sensation. Also shown is the central disk 12, the series of annular rings 14, the thin edges of the optics 16, the fixing portion 50, in this case the haptic 18, and the fixed foot plate 20, also called the haptic foot plate. The fixed part of the lens is thinner than the optical part. In this figure, there are five foot plates. The lens 10 is made of a material that is biologically compatible with human eye tissue. As shown, the haptics 18 wrap or surround the optic 48 of the lens 10. Each fixed foot plate 20 is pressed against a support structure used for attachment to the eye.
FIG. 2 is a cross-sectional view of a lens 10 having a convex first optical surface 49. This figure illustrates an extremely thin lens 10 including the fixing portion 50. In this figure, the haptics 18 have an angle greater than zero.
FIG. 3 is a cross-sectional view of a lens 10 having a concave first optical surface 149. Again, this figure shows the extreme thinness of the lens 10.
FIG. 4 is a cross-sectional view of the lens 10 showing details of a series of annular rings 14 including each individual annular ring 54, a first portion 56 of the annular ring, and a second portion 58 of the annular ring.
FIG. 5 is a plan view of the lens 10 having the tactile sensation 22. This figure shows one of the different types of extremely thin haptics that can be combined with a thin optic design to form a lens that fits through an incision smaller than 1.5 mm. Width 92 can vary from about 5 mm to about 8 mm. Length 90 can vary from about 10 mm to about 14 mm.
FIG. 6 is a sectional view of a plate lens. Although angle 94 is shown and represents an angle of +10 degrees, angle 94 can vary from about +10 degrees to about 0 degrees. The lens can be implanted with the smooth first surface 46 facing forward or backward. For a refractive lens, this continuous surface is typically implanted anteriorly toward the cornea 96. When used as a cataract lens, the lens is implanted with the continuous surface positioned posteriorly. Thus, when the haptics are angled, the angle is positive when the continuous surface is facing forward and negative when the continuous surface is facing backward. The figure also shows a biconvex lens having a convex first optical surface 49 and a convex second optical surface 51.
FIG. 7 is a modified plate lens in which the anchor 50 is shown as an extremely thin plate haptic. This fixture can be used with the thin optical design shown in FIGS. Indicia 24 during lens haptics are used for positioning and are well known in the art. Indicia 24, also referred to as a shaped aperture, in the haptics also indicate when the lens is in the correct position. In this figure, the mark 24 indicates the position clockwise. Therefore, the sign 24 indicates the direction.
FIG. 8 is a cross section of a modified extremely thin plate haptic 22 of the lens 10 used in the preferred embodiment.
FIG. 9 shows the lens 10 in the aphakic eye with a thinned portion of the haptic 20 curled up in the capsule 34. The lens 10 is positioned against the posterior surface of the capsule 34 and is held in place by the haptic footplate 20 supported on the posterior surface 38 of the capsule 34 and the anterior surface 36 of the capsule 34. Over time, the anterior and posterior capsules grow together, and the tissue from the anterior and posterior sections grow together via the locating markers 24, as shown in FIG. .
FIG. 10 shows the lens 10 in aphakic eyes where a thin portion of the haptics 20 can be folded in a bellows fashion in the capsule.
FIG. 11 shows details of a fixed foot plate 20 wound in the direction of the front of the eye. It should be noted that, in this embodiment, the fixed foot plate 20 functioning as a fixing part is pressed against the front surface 36 of the capsule 34 and the rear surface 38 of the capsule 34.
FIG. 12 shows details of a fixed foot plate 20 wound in the direction of the back of the eye. It should be noted that, in this embodiment, the fixed foot plate 20 functioning as a fixing part is pressed against the front surface 36 of the capsule 34 and the rear surface 38 of the capsule 34.
13A shows details of the fixing portion 50 of the lens 10 pressed against the zonule 42 and the rear surface 32 of the iris 28. FIG. The fixing portion 50 is bent toward the front of the eye.
13B shows details of the fixing portion 50 of the lens 10 pressed against the zonule 42 and the rear surface 32 of the iris 28. FIG. The fixing portion 50 is bent toward the back of the eye.
FIG. 14 shows a movement axis 37 of the lens 10 with respect to the eye.
FIG. 15 shows a sectional view of an eye. This figure shows the natural lens 11 of the eye, the anterior chamber 26 of the eye, the posterior chamber 27 of the eye, the iris 28, the anterior surface 30 of the iris, the posterior surface 32 of the iris, the anterior surface 36 of the natural lens capsule 34, The posterior surface 38, zonules 42 and ciliary body 40 of the natural lens capsule 34 are shown.
FIG. 16A is an intraocular lens 10, described according to the invention, rounded around a rod 43. FIG. Lens 10 has just been removed from a vial containing a balanced salt solution, BSS, heated to approximately 100 degrees Fahrenheit. The lens 10 must be wound immediately after removal from the warm BSS, as the material becomes hard when cooled or dehydrated.
FIG. 16B shows a lens 10 with a length of less than 1.5 mm of the eye 15 and lightly penetrating an incision also called a wound.
FIG. 16C shows the lens 10 in the eye 15. Once in the eye 15, the lens 10 contacts the warm water of the human eye 15, i.e. the intraocular fluid, and begins to spread immediately. It takes almost 15 seconds to spread.
FIG. 17 shows a standard lens 76 having a typical thickness for a given 20 diopter degree when using a material having a refractive index of 1.47. The figure shows a ray 80 along the central axis of the lens, known as the prime meridian, incident on the lens at the vertex of the lens and passing through the lens without refraction. A second ray 1 mm from the prime meridian and parallel to the prime meridian is shown, where there is refraction such that this ray passes through a focal point before the prime meridian. The calculations in Table 2 show that the focal point of the second ray 82 incident on the lens at 1 mm from the prime meridian converges about 1 mm before the focal point of the prime meridian. It is shown that a third ray 84 incident on the standard lens 76 at 2 mm from the prime meridian converges about 3 mm before the prime meridian.
FIG. 18 shows a ray 80 along the central axis of the lens, known as the prime meridian, entering the lens at the vertex of the lens 10 and passing through the lens without refraction. This figure shows the third optical element of the present invention incident on the lens 10 at the focal point of the prime meridian and 2 mm from the focal point of the primary meridian by adjusting the magnification on the second optical surface 51 having each ring 54. It also shows that ray 84 converges to the same point. Therefore, spherical aberration is reduced.
FIG. 19 provides a graphical representation of the angles described in the calculations for spherical aberration for a 20 diopter lens made from a material having a refractive index of 1.47.
FIG. 20 shows a state called coma aberration. In coma, light from ray 1 (68) travels in standard lens 76 for 2.2 mm or more, and light from ray 2 (70) passes through that lens a distance of 1.96 mm. Coma appears as a comet or ghost image. The extremely thin lens 10 of the present invention should eliminate much coma.
21 shows light 72 incident on a standard lens 76. FIG. Light 72 is refracted at first surface 73. The refracted light travels in the direction of the second surface 75. Most of the light 72 is refracted by the second surface of the standard lens 76, from which refracted light 77 exits. However, a very small portion becomes the reflected light 78 and travels toward the first surface 73 of the standard lens 76. Most of that light is refracted again at the first surface 73. However, a portion of the reflected light 78 is reflected again, and the reflected light 79 travels to the second surface 75 where it is refracted again and the light 81 exits the lens. Some distortion harmonics can occur. Each additional image projected from the second surface 75 is distorted because it is out of phase with the original refracted ray 77.
FIG. 22 shows a cross-sectional view of an embodiment of the present invention in which the first surface 46, the surface of the central disk 12 and the surface of each annular ring 54 are convex.
FIG. 23 shows a cross-sectional view of an embodiment of the present invention in which the first surface 149, the surface of the central disk 112 and the surface of each annular ring 154 are concave.
24A shows a cross-sectional view of one embodiment of the present invention in which the first surface 46 is convex and the surface of the center disk 12 and the surface of each annular ring 54 are convex.
FIG. 24B shows a cross-sectional view of one embodiment of the present invention in which the first optical surface 49 is convex and the surface of the central disk 112 and the surface of each annular ring 154 are concave.
FIG. 25 shows a cross-sectional view of an embodiment of the present invention in which the first optical surface 46 of the optical section 48 and the surface of the central disk 12 are convex. The outer surface 159 of each ring 154 is concave.
[Explanation of symbols]
[0112]
10 intraocular lens
12,112 center disk
18 Tactile sense
26 Anterior chamber
28, 32 iris
31 Forward Angle
40 ciliary body
42 Obi
44 Second surface
46 First Surface
48 Optical part
49, 149 first optical surface
50 fixing part
51, 151 second optical surface
54, 154 Ring
56 First part
58 Second part
59, 159 External surface
76 standard lens
80, 82, 84 rays
96 cornea

Claims (47)

An optical portion having a first optical surface, the optical portion comprising a material that is biologically compatible with human eye tissue and having a predetermined maximum thickness that can be rolled without exceeding the elastic limit of the material. An optical portion having a predetermined minimum thickness above which the material can maintain its normal shape, and having a length less than about 1.5 mm, such that the intraocular lens is placed in the eye. An optical portion such that the intraocular lens can be deformed to pass through the incision of
An optical portion having a second optical surface, the second optical surface comprising a central disk radially surrounded by a series of annular rings, wherein a focal length from one annular ring is the focal length of the lens. The central disk and the series of annular rings forming a series of radial steps along the second optical surface, such that the center disk is adjusted to converge to the same point as the prime meridian; An optical portion wherein the optical surface of the second and the first optical surface are separated by a minimum of 0.025 mm and a maximum of 0.45 mm;
An eye, comprising: a fixing portion attached to the optical portion, the fixing portion being made of a material that is biologically compatible with the tissue of the eye, and capable of being pressed against the supporting structure of the eye. Inner lens. 2. The intraocular lens according to claim 1, wherein the second optical surface and the first optical surface are separated by a minimum of 0.025 mm and a maximum of 0.065 mm. lens. 2. The intraocular lens according to claim 1, wherein the first optical surface and the second optical surface are convex to obtain a specific convergence. lens. 2. The intraocular lens according to claim 1, wherein the first optical surface and the second optical surface are concave to obtain a specific degree of convergence. lens. 2. The intraocular lens according to claim 1, wherein the first optical surface is convex in order to obtain a specific convergence, and the second optical surface obtains a specific convergence. An intraocular lens, wherein the intraocular lens has a predetermined concave shape. The intraocular lens according to claim 1, wherein the first optical surface is concave to obtain a specific convergence, and the second optical surface has a specific convergence. An intraocular lens, characterized in that it is convex to obtain. The intraocular lens according to claim 1, wherein the fixation portion has a thickness from about 10 μm to about 100 μm. The intraocular lens according to claim 7, wherein the fixing portion further includes a plurality of fixed foot plates. The intraocular lens according to claim 7, wherein the fixing portion further has a tactile sensation. The intraocular lens according to claim 1, wherein the optical portion is comprised of a material having a refractive index from about 1.4 to about 2.0. An optical portion having a first optical surface, wherein the first optical surface is convex to achieve a particular degree of convergence, and wherein the optical portion is biologically compatible with human eye tissue. Constructed of a compatible material, having a predetermined maximum thickness that can be rolled without exceeding the elastic limit of the material, and a predetermined minimum thickness above which the material can maintain its normal shape An optical portion, wherein the intraocular lens is deformable to pass through an incision having a length of less than about 1.5 mm, such that the intraocular lens is placed in the eye;
An optical portion having a second optical surface, the second optical surface comprising a central disk radially surrounded by a series of annular rings, wherein the focal length from one annular ring is the focal length of the lens. The central disk and the series of annular rings form a series of radial steps along the second optical surface so as to be adjusted to converge to the same point as the prime meridian, with each annular The annulus has an outer surface, the central disk is convex in order to obtain a certain degree of convergence, and the second optical surface and the first optical surface have a minimum of 0.025 mm and a maximum of An optical part separated by 0.065 mm;
A fixation portion attached to the optical portion and having a thickness of about 10 μm to about 100 μm, the fixation portion being made of a material that is biologically compatible with the tissue of the eye, and capable of being pressed against the support structure of the eye. And an intraocular lens comprising: The intraocular lens according to claim 11, wherein the intraocular lens is made of an acrylic resin material. The intraocular lens according to claim 11, wherein the intraocular lens is made of a hydrophilic acrylic resin material. The intraocular lens according to claim 11, wherein the intraocular lens is made of a hydrophobic acrylic resin material. The intraocular lens according to claim 11, wherein the intraocular lens is made of a polymethyl methacrylate material. The intraocular lens according to claim 11, wherein the intraocular lens is made of a hydrogel material. The intraocular lens according to claim 11, wherein the intraocular lens is made of a material selected from the group consisting of an acrylic resin, a hydrophilic acrylic resin, a hydrophobic acrylic resin, and a hydrogel. Intraocular lens. The intraocular lens according to claim 11, wherein the optical part is made of an acrylic resin material, and the fixed part is made of a polymethyl methacrylate material. 12. The intraocular lens according to claim 11, wherein the optical part is made of a hydrogel material and the fixed part is made of a polymethyl methacrylate material. 12. The intraocular lens according to claim 11, wherein the optical part is made of a hydrogel material, and the fixed part is made of an acrylic resin material. 12. The intraocular lens of claim 11, wherein the outer surface of each annulus adjusts a focal length from the annulus to converge to the same point as the prime meridian of the intraocular lens. An intraocular lens having a predetermined concave shape. 12. The intraocular lens of claim 11, wherein the outer surface of each annulus adjusts a focal length from the annulus to converge to the same point as the prime meridian of the intraocular lens. An intraocular lens having a predetermined convexity. The intraocular lens according to claim 11, wherein the fixing part further comprises a direction marker. An optical portion having a first optical surface, wherein the optical portion is a material that is biologically compatible with human eye tissue and has a refractive index from about 1.4 to about 2.0. The first optical surface is formed of a material, the first optical surface is a predetermined convex for obtaining a predetermined degree of convergence, and the optical portion has a predetermined maximum thickness that can be rounded without exceeding the elastic limit of the material. An optical portion having a predetermined minimum thickness above which the material can maintain its normal shape, and less than about 1.5 mm so that the intraocular lens is placed in the eye An optical portion such that the intraocular lens can be deformed to pass through a length cut;
An optical portion having a second optical surface, the second optical surface comprising a central disk radially surrounded by a series of annular rings, wherein a focal length from one annular ring is the focal length of the lens. The central disk and the series of annular rings form a series of radial steps along the second optical surface such that each annular ring is adjusted to converge to the same point as the prime meridian, and each annular An optical portion having an outer surface, wherein the second optical surface and the first optical surface are separated by a minimum of 0.025 mm and a maximum of 0.065 mm;
A fixation portion attached to the optical portion and having a maximum thickness of about 100 μm, the fixation portion being made of a material that is biologically compatible with the tissue of the eye, and capable of being pressed against the support structure of the eye. An intraocular lens comprising: 26. The intraocular lens according to claim 24, wherein the central disk is a predetermined convex for obtaining a certain degree of convergence, and the series of annular rings are predetermined convex. Inner lens. 26. The intraocular lens according to claim 24, wherein the central disk is a predetermined concave for obtaining a certain degree of convergence, and the series of annular rings are predetermined concave. Inner lens. 25. The intraocular lens of claim 24, wherein the fixation is capable of pressing against the front surface of the capsule and the posterior surface of the capsule, thereby producing minimal radial force on the eye. An intraocular lens, characterized in that: 25. The intraocular lens according to claim 24, wherein the fixation portion is capable of pressing against the zonules and the posterior surface of the iris, thereby producing a minimum radial force on the eye. Intraocular lens. An intraocular lens is provided, wherein the intraocular lens is an optical portion having a first optical surface, wherein the intraocular lens is comprised of a material that is biologically compatible with the tissue of the eye without exceeding the elastic limit of the material. An optical part having a predetermined maximum thickness that can be rolled up and a predetermined minimum thickness above which the material can maintain its normal shape, wherein the intraocular lens is placed in the eye An optical portion, such that the intraocular lens can be deformed to pass through an incision having a length of less than about 1.5 mm, the optical portion having a second optical surface; Comprises a central disk radially surrounded by a series of annular rings such that the focal length from one annular ring is adjusted to converge to the same point as the prime meridian of the lens. The central disk and the series of annular rings are connected to the second optical An optical portion forming a series of radial steps along a plane, wherein said second optical surface and said first optical surface are separated by a minimum of 0.025 mm and a maximum of 0.45 mm; A fixation portion attached to the optical portion, the fixation portion being made of a material that is biologically compatible with the tissue of the eye, and capable of being pressed against the support structure of the eye,
Warming the intraocular lens to a temperature from about 90 degrees Fahrenheit to about 150 degrees Fahrenheit;
Forming an incision with a length shorter than 1.5 mm in the eye,
Remove the natural lens of the eye,
Deforming the intraocular lens,
Cooling the intraocular lens to a temperature from about 60 degrees Fahrenheit to about 80 degrees Fahrenheit;
Inserting the intraocular lens through the incision into the eye,
As the intraocular lens warms and spreads, contacting the intraocular lens with intraocular fluid in the eye,
A method for correcting visual impairment, comprising arranging the intraocular lens such that the fixing portion is pressed against the supporting structure of the eye. 30. The method of claim 29, wherein, when positioning the intraocular lens, the fixation portion is pressed against a front surface of the capsule and a posterior surface of the capsule to produce minimal radial force on the eye. The method characterized by the above. 30. The method of claim 29, wherein placing the intraocular lens presses the fixation portion against a zonule and the posterior surface of the iris to produce minimal radial force in the eye. And how. Make a cut shorter than about 1.5 mm to approach the eyes,
Providing an intraocular lens, wherein the intraocular lens is an optical portion having a first optical surface, wherein the first optical surface is comprised of a material that is biologically compatible with the tissue of the eye; The optical portion has a predetermined maximum thickness that can be rolled without exceeding the elastic limit of the material and a predetermined minimum thickness above which the material can maintain its normal shape. An optical portion having a second optical surface, wherein the intraocular lens is deformable to pass through an incision having a length of less than about 1.5 mm, such that the intraocular lens is placed in the eye. Wherein the second optical surface comprises a central disk radially surrounded by a series of annular rings, the focal length from one annular ring converging to the same point as the prime meridian of the lens. The central disk and the series of rings so that The loops form a series of radial steps along the second optical surface, each annular ring having an outer surface, wherein the second optical surface and the first optical surface have a minimum of zero. .25 mm, up to 0.065 mm apart and an optical part attached to said optical part and having a maximum thickness of 100 μm, made of a material that is biologically compatible with the eye tissue Comprising a fixing portion that can be pressed against the eye support structure,
Warming the intraocular lens to a temperature from about 90 degrees Fahrenheit to about 150 degrees Fahrenheit;
Wrapping the intraocular lens around a rod,
Inserting the intraocular lens through the incision into the eye,
A method of correcting lack of accommodation, wherein the intraocular lens is fixed to the support structure of the eye. 33. The method of claim 32, further comprising using the intraocular lens to reduce glare and halo visualization. 33. The method of claim 32, further comprising using the intraocular lens to reduce coma. 33. The method of claim 32, wherein positioning the intraocular lens presses the intraocular lens against a front surface of the capsule and a posterior surface of the capsule. 36. The method of claim 35, wherein the positioning of the intraocular lens comprises twisting the fixation portion toward the anterior surface of the capsule. 36. The method of claim 35, wherein the positioning of the intraocular lens comprises bending the fixation portion in a posterior direction of the capsule. 33. The method of claim 32, wherein positioning the intraocular lens presses the intraocular lens against the zonules and the posterior surface of the iris. 39. The method according to claim 38, wherein, when positioning the intraocular lens, the anchor is twisted in a direction toward the front of the capsule. 39. The method of claim 38, wherein the positioning of the intraocular lens comprises bending the fixation portion in a posterior direction of the capsule. 33. The method of claim 32, further comprising using the intraocular lens to provide accommodation, wherein the intraocular lens is movable in the eye. 33. The method of claim 32, further comprising using the intraocular lens such that the series of annular rings of the second optical surface correct for spherical aberration. 33. The method according to claim 32, further comprising visualizing through the intraocular lens such that the increased depth of field provided by the intraocular lens corrects a lack of accommodation. how to. 33. The method of claim 32, further comprising: moving the intraocular lens toward the front of the eye when the ciliary muscles of the eye are relaxed. An intraocular lens is provided, wherein the intraocular lens is an optical portion having a first optical surface, the optical portion being comprised of a material that is biologically compatible with the tissue of the eye. An optical part having a predetermined maximum thickness that can be rolled without exceeding a limit and a predetermined minimum thickness above which the material can maintain its normal shape, wherein the intraocular lens is An optical portion having a second optical surface, wherein the intraocular lens is deformable to pass through an incision having a length of less than about 1.5 mm so as to be placed in the eye; The surface comprises a central disk radially surrounded by a series of annular rings, such that the focal length from one annular ring is adjusted to converge to the same point as the prime meridian of the lens. The central disk and the series of annular rings are connected to the second optical surface. An optical portion forming a series of radial steps along said optical portion such that said second optical surface and said first optical surface are separated by a minimum of 0.025 mm and a maximum of 0.065 mm; and A fixation portion attached to the eye and made of a material that is biologically compatible with the tissue of the eye, and capable of pressing against the support structure of the eye,
Heating the intraocular lens to a temperature from about 90 degrees Fahrenheit to about 150 degrees Fahrenheit;
Incising the eye to provide an incision less than 1.5 mm in length,
Deforming the intraocular lens so that the intraocular lens can pass through the incision,
Lowering the temperature of the intraocular lens to approximately room temperature so that the intraocular lens is cured;
Insert the intraocular lens into the cut,
The method for treating presbyopia, wherein the intraocular lens is arranged such that the fixing portion is pressed against the front surface and the rear surface of the capsule capsule. 46. The method of claim 45, wherein the first optical surface and the second optical surface are convex for obtaining a particular degree of convergence. 46. The method of claim 45, wherein the anchor has a thickness from about 10 [mu] m to about 100 [mu] m.

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