JP6685265B2 - 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
- Publication number
- JP6685265B2 JP6685265B2 JP2017202576A JP2017202576A JP6685265B2 JP 6685265 B2 JP6685265 B2 JP 6685265B2 JP 2017202576 A JP2017202576 A JP 2017202576A JP 2017202576 A JP2017202576 A JP 2017202576A JP 6685265 B2 JP6685265 B2 JP 6685265B2
- Authority
- JP
- Japan
- Prior art keywords
- artificial cornea
- cornea
- optic
- artificial
- central
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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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
- 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
-
- 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
-
- 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
- A61F2250/0036—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
-
- 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
- A61F2250/0053—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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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Transplantation (AREA)
- Ophthalmology & Optometry (AREA)
- Vascular Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
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。
例えば、本発明は、以下の項目を提供する:
(項目1)
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、上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、上記リムが、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、
上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。
(項目2)
少なくとも1.5MPaの引張り強さを有する、項目1に記載の人工角膜。
(項目3)
少なくとも100%の破断までの伸びを有する、項目1に記載の人工角膜。
(項目4)
上記中央オプティクの上記オプティク高さが、±50μm未満で変動する、項目1に記載の人工角膜。
(項目5)
上記中央オプティクと上記リムの間の角度が、±10°未満だけ変動する、項目1に記載の人工角膜。
(項目6)
上記リムが、上記中央オプティクの後縁に外接する、項目1に記載の人工角膜。
(項目7)
上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、項目1に記載の人工角膜。
(項目8)
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、項目7に記載の人工角膜。
(項目9)
上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、項目8に記載の人工角膜。
(項目10)
上記前表面が上記後表面より平坦である、項目9に記載の人工角膜。
(項目11)
上記リムが、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、項目1に記載の人工角膜。
(項目12)
上記孔が、上記リムの環状エリアの10%から90%を占有する、項目11に記載の人工角膜。
(項目13)
上記孔が、上記環状リム周りに均一に配置された丸い穴である、項目9に記載の人工角膜。
(項目14)
上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、項目1に記載の人工角膜。
(項目15)
上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、項目1に記載の人工角膜。
(項目16)
上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、項目1に記載の人工角膜。
(項目17)
上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、上記環状周辺領域内の上記前面が、上皮の成長を妨げる、項目1に記載の人工角膜。
(項目18)
上記環状周辺領域が、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、項目17に記載の人工角膜。
(項目19)
上記環状周辺領域内の上記中央オプティクの上記前面が、上皮の成長を阻害する材料で覆われる、項目17に記載の人工角膜。
(項目20)
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、
上記角膜内に、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、上記開口部が、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
上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、上記中央前方開口部の上記周辺深さの±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。
(項目21)
上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
上記角膜インプラントに外接するリムを上記表層ポケット内に挿入し、上記インプラントを上記開口部内で固定する工程
をさらに含む、項目20に記載の方法。
(項目22)
上記表層ポケットが、上記中央前方開口部の上記後表面の周辺部および上記角膜インプラントの上記中央オプティクの後縁を囲む上記リムの周りに形成される、項目21に記載の方法。
(項目23)
上記中央前方開口部が、上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、上記角膜組織が、上記中央オプティクの上記周辺壁を封止し、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、項目20に記載の方法。
(項目24)
上記インプラントが、後方向に上記前方開口部を通って挿入される、項目20に記載の方法。
(項目25)
上記角膜を通って上記中央前方開口部内に側方通路を形成する工程、および上記側方通路を通して上記角膜インプラントを挿入する工程をさらに含む、項目20に記載の方法。
(項目26)
上記人工角膜が、縫合糸も接着剤も使用せずに固定される、項目20に記載の方法。
(項目27)
最初に表層ポケットが中央角膜を横切って作られ、次いで上記中央前方開口部が、上記表層ポケットの上記領域の上に作られる、項目20に記載の方法。
Claims (13)
- 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、
前記中央オプティクの前面の環状周辺部は、上皮の成長を支援するように構成され、前記環状周辺部内の前記前面は、上皮の成長が阻害されるように構成され、
前記中央オプティク(12)は30ジオプトリから70ジオプトリの範囲内の屈折力を提供する、
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(12)と前記リム(14)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(14)が、前記中央オプティク(12)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(12)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。
- 前記中央オプティク(12)の前表面および後表面が共に凸状に形作られる、請求項6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7に記載の人工角膜。
- 前記リム(14)が、栄養素及び酸素の通過を可能にする孔(16)を有し、選択的に:
前記孔(16)は前記リムの環状の領域の10%から90%を占有する;又は、
前記孔(16)は環状の前記リム周りに均一に配置された丸い穴である;
のうち少なくとも1つである請求項1に記載の人工角膜。 - 前記ポリマーヒドロゲルが、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(12)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。
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