JP2013540521A - 可逆的に変形可能な人工角膜および植え込むための方法 - Google Patents
可逆的に変形可能な人工角膜および植え込むための方法 Download PDFInfo
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- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/15—Implant having one or more holes, e.g. for nutrient transport, for facilitating handling
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- 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
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
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- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
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- A—HUMAN NECESSITIES
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- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
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- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
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- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
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- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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- A61F2230/0093—Umbrella-shaped, e.g. mushroom-shaped
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- A—HUMAN NECESSITIES
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- 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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
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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
- 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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0026—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in surface structures
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- A61F2250/0036—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in thickness
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- 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
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- A61F2250/0053—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in optical properties
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Abstract
Description
この出願は、米国特許法119の下、2010年9月30日に出願された米国仮特許出願第61/388,386号(この完全な開示は、参考として本明細書に援用される)の利益を主張する。
本発明は、一般に医療デバイスおよび方法に関する。より詳細には、本発明は、人工角膜の構造、およびインプラントを角膜内に挿入するための方法に関する。
Claims (27)
- 可逆的に変形可能な人工角膜であって、
リムによって囲まれた中央オプティクを含む、4mmと10mmの間の直径を有するモノリシック体を備え、前記中央オプティクが、3mmから9mmの範囲内の直径、および200μmから800μmの範囲内のオプティク高さを有し、前記リムが、0.5mmから4.5mmの範囲内の幅、および50μmから200μmの範囲内のメジアン厚さを有し、
前記モノリシック体が、完全に水和したとき0.3MPaから100MPaの範囲内のヤング率を有するポリマーヒドロゲルから構成される、可逆的に変形可能な人工角膜。 - 少なくとも1.5MPaの引張り強さを有する、請求項1に記載の人工角膜。
- 少なくとも100%の破断までの伸びを有する、請求項1に記載の人工角膜。
- 前記中央オプティクの前記オプティク高さが、±50μm未満で変動する、請求項1に記載の人工角膜。
- 前記中央オプティクと前記リムの間の角度が、±10°未満だけ変動する、請求項1に記載の人工角膜。
- 前記リムが、前記中央オプティクの後縁に外接する、請求項1に記載の人工角膜。
- 前記中央オプティクの少なくとも前表面が凸状に形作られ、天然角膜とほぼ等しい屈折力をもたらす、請求項1に記載の人工角膜。
- 中央オプティクが、角膜内に植え込まれたとき30ジオプトリから70ジオプトリの範囲内にある屈折力をもたらす、請求項7に記載の人工角膜。
- 前記中央オプティクの前表面および後表面が共に凸状に形作られる、請求項8に記載の人工角膜。
- 前記前表面が前記後表面より平坦である、請求項9に記載の人工角膜。
- 前記リムが、栄養素および酸素の通過を可能にするために孔を有する、請求項1に記載の人工角膜。
- 前記孔が、前記リムの環状エリアの10%から90%を占有する、請求項11に記載の人工角膜。
- 前記孔が、前記環状リム周りに均一に配置された丸い穴である、請求項9に記載の人工角膜。
- 前記ポリマーヒドロゲルが、親水性アクリル材料、疎水性アクリル材料、シリコーンポリマーヒドロゲル、コラーゲンポリマーヒドロゲル、および相互貫入網目構造ヒドロゲルからなる群より選択される材料を含む、請求項1に記載の人工角膜。
- 前記ポリマーヒドロゲルが、少なくとも3バーラーの酸素透過性を有する、請求項1に記載の人工角膜。
- 前記ポリマーヒドロゲルが、Lotrafilcon A、Lotrafilcon B、Balafilcon A、Comfilcon A、Senofilcon A、Enfilcon A、およびGalyfilcon Aからなる群より選択される材料を含む、請求項1に記載の人工角膜。
- 前記中央オプティクの前面の環状周辺領域が、上皮の成長を促進し、一方、前記環状周辺領域内の前記前面が、上皮の成長を妨げる、請求項1に記載の人工角膜。
- 前記環状周辺領域が、上皮成長促進材料で覆われるか、粗くされるか、または多孔性である、請求項17に記載の人工角膜。
- 前記環状周辺領域内の前記中央オプティクの前記前面が、上皮の成長を阻害する材料で覆われる、請求項17に記載の人工角膜。
- 障害のある中央領域を有する角膜内に人工角膜を植え込むための方法であって、
前記角膜内に、周辺側壁によって囲まれた後表面を有する中央前方開口部を形成する工程であって、前記開口部が、200μmから800μmの範囲内の均一な周辺深さを有する、工程、および
前記中央前方開口部内に人工角膜を植え込む工程であって、インプラントが、前記中央前方開口部の前記周辺深さの±50μm以内の均一なオプティク高さを有する周辺壁を備える中央オプティクを有する、工程
を含む、方法。 - 前記中央前方開口部の周辺側壁の少なくとも一部分の周りに表層ポケットを形成する工程、および
前記角膜インプラントに外接するリムを前記表層ポケット内に挿入し、前記インプラントを前記開口部内で固定する工程
をさらに含む、請求項20に記載の方法。 - 前記表層ポケットが、前記中央前方開口部の前記後表面の周辺部および前記角膜インプラントの前記中央オプティクの後縁を囲む前記リムの周りに形成される、請求項21に記載の方法。
- 前記中央前方開口部が、前記中央オプティクの直径より小さい直径を有するように形成され、前記角膜組織が、前記中央オプティクの前記周辺壁を封止し、上皮細胞の内方への成長、細菌の侵入、流体の喪失を阻害する、請求項20に記載の方法。
- 前記インプラントが、後方向に前記前方開口部を通って挿入される、請求項20に記載の方法。
- 前記角膜を通って前記中央前方開口部内に側方通路を形成する工程、および前記側方通路を通して前記角膜インプラントを挿入する工程をさらに含む、請求項20に記載の方法。
- 前記人工角膜が、縫合糸も接着剤も使用せずに固定される、請求項20に記載の方法。
- 最初に表層ポケットが中央角膜を横切って作られ、次いで前記中央前方開口部が、前記表層ポケットの前記領域の上に作られる、請求項20に記載の方法。
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