JP6794511B2 - 調節性眼内レンズデバイス - Google Patents
調節性眼内レンズデバイス Download PDFInfo
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- JP6794511B2 JP6794511B2 JP2019149597A JP2019149597A JP6794511B2 JP 6794511 B2 JP6794511 B2 JP 6794511B2 JP 2019149597 A JP2019149597 A JP 2019149597A JP 2019149597 A JP2019149597 A JP 2019149597A JP 6794511 B2 JP6794511 B2 JP 6794511B2
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- 230000002093 peripheral effect Effects 0.000 claims description 75
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- 239000000463 material Substances 0.000 claims description 24
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- NOKUWSXLHXMAOM-UHFFFAOYSA-N hydroxy(phenyl)silicon Chemical class O[Si]C1=CC=CC=C1 NOKUWSXLHXMAOM-UHFFFAOYSA-N 0.000 description 21
- 125000001997 phenyl group Chemical group [H]C1=C([H])C([H])=C(*)C([H])=C1[H] 0.000 description 15
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- ZUOUZKKEUPVFJK-UHFFFAOYSA-N phenylbenzene Natural products C1=CC=CC=C1C1=CC=CC=C1 ZUOUZKKEUPVFJK-UHFFFAOYSA-N 0.000 description 12
- 229920001577 copolymer Polymers 0.000 description 9
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- 208000002177 Cataract Diseases 0.000 description 8
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 8
- 230000008859 change Effects 0.000 description 7
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- NYMPGSQKHIOWIO-UHFFFAOYSA-N hydroxy(diphenyl)silicon Chemical class C=1C=CC=CC=1[Si](O)C1=CC=CC=C1 NYMPGSQKHIOWIO-UHFFFAOYSA-N 0.000 description 4
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- KPUWHANPEXNPJT-UHFFFAOYSA-N disiloxane Chemical class [SiH3]O[SiH3] KPUWHANPEXNPJT-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
- A61F2/1624—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside
- A61F2/1635—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside for changing shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2/1601—Lens body having features to facilitate aqueous fluid flow across the intraocular lens, e.g. for pressure equalization or nutrient delivery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
- A61F2/1648—Multipart lenses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
- A61F2002/1682—Intraocular lenses having supporting structure for lens, e.g. haptics having mechanical force transfer mechanism to the lens, e.g. for accommodating lenses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
- A61F2002/169—Surrounding optic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas
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- Health & Medical Sciences (AREA)
- Ophthalmology & Optometry (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
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Description
第2の態様によれば、キャビティは完全に密閉される。
第3の態様によれば、IOLは、キャビティ内にゲルをさらに含む。好ましくは、ゲルは、1.46以上、好ましくは1.48以上、最も好ましくは1.55以上の屈折率を有する。好ましくは、ゲルは、10psi(68.9kPa)以下、好ましくは5psi(34.5kPa)以下、より好ましくは1psi(6.89kPa)以下のヤング率を有する。特に好ましい実施形態では、ゲルは、0.5psi(3。45kPa)以下、好ましくは0.25psi(1.72kPa)以下、最も好ましくは0.01psi(0.069kPa)以下のヤング率を有する。好ましくは、ゲルは、高度分岐ポリマー、好ましくは架橋シリコーンである。
第5の態様によれば、第2のレンズは、第1のレンズよりも実質的に硬質である。
第13の態様によれば、円周ハプティックに沿った半径方向力の適用時に第1のレンズの対向する表面は互いから離れるように変位する。対向する表面は、中央領域および周辺領域を有し、周辺領域から中央領域へと漸増する厚さプロフィールを有する。
第2の態様によれば、円周部分の一部のみが第2のヤング率を有する材料で作られている。
第4の態様によれば、第2のヤング率は約100psi(689.5kPa)以上である。
第6の態様によれば、第1のレンズは、1対の対向する変形可能な表面およびそれらの間に画定されたキャビティを含み、第1のレンズは第1のレンズ直径を有し、ここで、主IOLキャビティは、第1のレンズ、第2のレンズおよび円周部分の間に画定されている。
第8の態様によれば、第1のレンズは、周縁部に沿った半径方向力の適用時に互いから離れるように変位する2つの対向する表面で構成されている。それらの2つの対向する表面は各々、中央領域および周辺領域を有し、ここで、中央領域は、周辺領域の厚さよりも少なくとも2倍、好ましくは少なくとも3倍、最も好ましくは少なくとも4倍大きい厚さを有する。
第2の態様によれば、中央領域は周辺領域よりも少なくとも4倍厚い。
第3の態様によれば、第1のレンズの密閉されたキャビティは、第1の屈折率を有するゲルを含む。
第5の態様によれば、ゲルはビニル末端フェニルシロキサンである。
記載される好ましい実施形態の他の目的、特徴および利点は、以下の詳細な説明から当業者に明らかになるであろう。しかしながら、詳細な説明および具体例は、本発明の好ましい実施形態を示すが、限定ではなく例示として示されるものと理解されるべきである。本発明の範囲内での多くの変更および改変がその趣旨から逸脱することなく行え、本発明はこのような全ての改変を包含する。
処方1:
100部20〜25モル%ビニル末端ジフェニルシロキサン−ジメチルシロキサンコポリマー(Gelest社製PDV 2335)。
0.35pphの水素化フェニルシロキサン架橋剤(Nusil社製XL−106)
弾性ヤング率=0.0033psi(22.75Pa)
処方2:
100部20〜25モル%ビニル末端ジフェニルシロキサン−ジメチルシロキサンコポリマー(Gelest社製PDV 2335)。
0.4pphの水素化フェニルシロキサン架橋剤(Nusil社製XL−106)
弾性ヤング率=0.0086psi(59.29Pa)
処方3:
100部20〜25モル%ビニル末端ジフェニルシロキサン−ジメチルシロキサンコポリマー(Gelest社製PDV 2335)。
0.5pphの水素化フェニルシロキサン架橋剤(Nusil社製XL−106)
弾性ヤング率=0.0840psi(0.58kPa)
処方4:
100部20〜25モル%ビニル末端ジフェニルシロキサン−ジメチルシロキサンコポリマー(Gelest社製PDV 2335)。
0.6pphの水素化フェニルシロキサン架橋剤(Nusil社製XL−106)
弾性ヤング率=2.6psi(17.9kPa)
レンズチャンバー110の壁112、114およびレンズキャビティ120内に含まれる流体またはゲルは、好ましくは、その流体またはゲルがレンズチャンバー110の壁112、114の外側へ移動することを防止するかまたはその可能性を低減するように選択される。従って、好ましい実施形態では、レンズチャンバー110の壁112、114および流体またはゲルの一方または両方は、レンズチャンバー110の壁112、114を超える流体またはゲルの透過性に対する抵抗性を最適化する生体適合性材料から選択される。
好ましい実施形態では、レンズチャンバー壁112、114およびゲルの一方または両方は、フェニル置換シリコーンのホモポリマーまたはコポリマーで作られている。
図11Aは、破嚢術(a capsulhorexis)の実施後およびIOLの移植前の眼10を示している。眼10は角膜20を含むものとして図示し、被膜嚢40に近づくためには角膜を通って外科的切開が行われる。被膜嚢40から除去される円形部分B−Bの直径は、各人の個々の解剖学的構造に依存し、典型的には、約4mm〜約9mmの範囲内である。ここでは、被膜嚢40から除去される円形部分B−Bの直径32は、瞳孔30の直径とほぼ一致する。好ましくは、可能な限り多くの被膜嚢40とその小帯連結部50が維持される。小帯50は被膜嚢40を毛様体筋60と連結し、調節力を伝達して、被膜嚢40の曲率または形状の変化をもたらす。一度被膜嚢40から水晶体が除去されると、IOLが挿入され、被膜嚢40に結合している小帯50と円周縁部が実質的に係合するように移植され得る。加えて、IOLは、光軸A−Aに沿って実質的に中央に配置され、中央から外れる可能性を低減するためには、IOLを小帯50と係合することが好ましい。ホールおよびスルーホールを含むIOLの実施形態では、ホールおよびスルーホールが光学部B−Bの外側に位置することが好ましい。さらに、ホールおよびスルーホールは、レシピエントによるグレアの知覚を防ぐために端部を丸める必要がある。
Claims (22)
- 眼内レンズ(IOL)デバイスであって、IOLデバイスは、
第1のレンズであって、両凸の外形を画定するために同第1のレンズの周辺部で接合された2つの相対向する表面およびそれらの間に画定されたキャビティを含み、前記相対向する表面のそれぞれが中央領域と周辺領域とを有し、かつ前記相対向する表面の少なくとも1つが前記周辺領域から前記中央領域へと漸増する厚さプロフィールを有する第1のレンズと、
第2のレンズと、
前記第1のレンズと前記第2のレンズを連結し、かつ外周縁部を有する円周ハプティックと、
前記円周ハプティック、前記第1のレンズおよび前記第2のレンズの間にある主IOLキャビティと
を備え、
前記IOLデバイスは、前記外周縁部に加わる半径方向の圧縮力の不在下で、前記IOLデバイスが第1の直径d1を有することによって特徴付けられる非調節状態に弾性的に付勢され、
前記IOLデバイスは、前記外周縁部に加わる半径方向の圧縮力に応じた、d1>d2である第2の直径d2によって特徴付けられる調節状態に作動させる、IOLデバイス。 - 前記キャビティが密閉されている、請求項1に記載のIOLデバイス。
- 前記キャビティ内に流体をさらに含む、請求項1に記載のIOLデバイス。
- 前記第2のレンズが、平凸レンズ、両凸レンズおよび正メニスカスレンズのうちの1つである、請求項1に記載のIOLデバイス。
- 前記第2のレンズが前記第1のレンズよりも実質的に硬質である、請求項1に記載のIOLデバイス。
- 前記円周ハプティックと前記第2のレンズとの間に配置されたヒンジをさらに含む、請求項1に記載のIOLデバイス。
- 前記外周縁部への圧縮力の存在下で前記ヒンジが前記圧縮力の大部分を前記第1のレンズ上へ向けて、前記第1のレンズの直径において前記第2のレンズの直径よりも大きな減少を引き起こす、請求項6に記載のIOLデバイス。
- 前記第1のレンズの前記少なくとも1つの表面が、前記第2のレンズの厚さの50%以下である厚さを有する、請求項1に記載のIOLデバイス。
- 前記円周ハプティック上に配置された複数の開口部の一方または両方をさらに含む、請求項1に記載のIOLデバイス。
- 前記複数の開口部が前記主IOLキャビティと流体連通している、請求項9に記載のIOLデバイス。
- 前記円周ハプティックが、前記第2のレンズを連結する複数のラジアルアームを含み、前記複数のラジアルアームは、前記主IOLキャビティとの流体連通を可能にするためにそれらの間に開口部を画定している、請求項1に記載のIOLデバイス。
- 眼内レンズ(IOL)デバイスであって、IOLデバイスは、
第1のヤング率を有する変形可能な弾性材料で作られている第1のレンズであって、両凸の外形を画定するために同第1のレンズの周辺部で接合された相対向する表面およびそれらの間に画定されたキャビティを含み、前記相対向する表面のそれぞれが中央領域と周辺領域とを有し、かつ前記相対向する表面の少なくとも1つが漸増する厚さプロフィールを有する第1のレンズと、
中心光軸に沿って前記第1のレンズに対して離間された第2のレンズと、
前記第1のレンズおよび前記第2のレンズを取り囲むとともに外周縁部を含む円周部分と、
前記第1のレンズと前記第2のレンズと前記円周部分との間にある主IOLキャビティと、
を備え、
前記第2のレンズの一部および前記円周部分の一部の少なくとも一方は、第2のヤング率を有する材料で作られており、かつ
前記第1のヤング率は前記第2のヤング率より小さく、かつ
前記第1のレンズの相対向する表面の少なくとも1つは、前記外周縁部に沿った力の適用時に相対向する表面の他方から変位する、IOLデバイス。 - 前記第2のレンズのみが、前記第2のヤング率を有する材料で作られている、請求項12に記載のIOLデバイス。
- 前記円周部分の一部のみが、前記第2のヤング率を有する材料で作られている、請求項12に記載のIOLデバイス。
- 前記第1のヤング率が約100psi(689.5kPa)以下である、請求項12に記載のIOLデバイス。
- 前記第2のヤング率が約100psi(689.5kPa)以上である、請求項12に記載のIOLデバイス。
- 前記第2のヤング率が約150psi(1034.2kPa)以上である、請求項16に記載のIOLデバイス。
- アクティブ型光学領域の外側に前記第2のレンズ上に近接するヒンジをさらに含む、請求項12に記載のIOLデバイス。
- 眼内レンズ(IOL)デバイスであって、IOLデバイスは、
対向する側面および前記対向する側面の間の密閉されたキャビティを含む第1のレンズであって、前記対向する側面は各々、中央領域および周辺領域を有し、前記中央領域は、光軸の周囲に配置され、前記周辺領域は、前記中央領域の周囲に配置される、第1のレンズと、
前記第1のレンズに対して離間された第2のレンズであって、前記第1のレンズの前記対向する側面のいずれか一方よりも大きい厚さを有する第2のレンズと、
前記第1のレンズと前記第2のレンズとを連結し、かつ外周縁部を有する円周ハプティックと、
前記円周ハプティック、前記第1のレンズおよび前記第2のレンズの間にある主IOLキャビティと、
を備え、
前記第1のレンズの前記相対向する側面の少なくとも一方は、前記外周縁部に沿った力の適用時に変位する、IOLデバイス。 - 前記中央領域が前記周辺領域よりも少なくとも2倍厚い、請求項19に記載のIOLデバイス。
- 前記中央領域が前記周辺領域よりも少なくとも3倍厚い、請求項19に記載のIOLデバイス。
- 前記第1のレンズの少なくとも1つの表面は、前記円周ハプティックに沿った半径方向の力の適用時に変位する、請求項1に記載のIOLデバイス。
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