JP6113118B2 - 眼内インプラント、ならびにそのための方法およびキット - Google Patents
眼内インプラント、ならびにそのための方法およびキット Download PDFInfo
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- JP6113118B2 JP6113118B2 JP2014152575A JP2014152575A JP6113118B2 JP 6113118 B2 JP6113118 B2 JP 6113118B2 JP 2014152575 A JP2014152575 A JP 2014152575A JP 2014152575 A JP2014152575 A JP 2014152575A JP 6113118 B2 JP6113118 B2 JP 6113118B2
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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
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
- A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
-
- 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
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
- A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
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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
- 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
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
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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
- 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
- A61F2210/0014—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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- 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
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- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
Description
本発明はまた、以下の項目を提供する。
(項目1)
眼内圧を低減するための装置であって、該装置が、シュレム管内で周方向に埋込み可能な、該シュレム管の少なくとも一部の開放性を維持するように構成されている支持体を含み、上記支持体が、シュレム管の中核の少なくとも一部を占め、シュレム管を横切る通壁的流れに実質的に干渉しない、装置。
(項目2)
上記支持体が活性剤を含む、項目1に記載の装置。
(項目3)
上記支持体が上記活性剤で被覆または含浸される、項目2に記載の装置。
(項目4)
上記活性剤が上記支持体内に分散される、項目2に記載の装置。
(項目5)
上記活性剤が、プロスタグランジン、プロスタグランジン類似体、ベータ遮断薬、アルファ‐2アゴニスト、カルシウムチャネル遮断薬、炭酸脱水酵素阻害薬、成長因子、代謝拮抗物質、化学療法剤、ステロイド、成長因子の拮抗薬、およびそれらの組み合わせからなる群から選択される、項目2に記載の装置。
(項目6)
上記支持体が少なくとも1つの穿孔を有する、項目1に記載の装置。
(項目7)
上記支持体が、電磁放射線を用いて修正できる、項目1に記載の装置。
(項目8)
上記電磁放射線が、上記支持体の少なくとも1つの局所部分により吸収可能な波長を有するレーザを含む、項目7に記載の装置。
(項目9)
上記活性剤が、電磁放射線を用いて放出できる、項目2に記載の装置。
(項目10)
上記活性剤の放出が、時間放出方式を用いて制御可能である、項目2に記載の装置。
(項目11)
上記支持体が、シュレム管の周長とほぼ等しい周長を有する、項目1に記載の装置。
(項目12)
上記支持体が、シュレム管の周長の約半分と等しい周長、あるいは半分未満の周長を有する、項目1に記載の装置。
(項目13)
上記支持体が、シュレム管の周長の約4分の1と等しい周長、あるいは4分の1未満の周長を有する、項目1に記載の装置。
(項目14)
上記支持体が堅い弓形部材を含み、該弓形部材が、シュレム管の曲率半径よりも小さい曲率半径を有する、項目1に記載の装置。
(項目15)
上記支持体が堅い弓形部材を含み、該弓形部材が、シュレム管の曲率半径よりも大きい曲率半径を有する、項目1に記載の装置。
(項目16)
上記支持体の少なくとも一部が生体適合性ポリマー製である、項目1に記載の装置。
(項目17)
上記生体適合性ポリマーが、アクリル樹脂およびシリコーンからなる群から選択される、項目16に記載の装置。
(項目18)
上記生体適合性ポリマーが生分解性ポリマーを含む、項目16に記載の装置。
(項目19)
上記生分解性ポリマーが、コラーゲン、コラーゲン誘導体、ポリ(ラクチド);ポリ(グリコリド);ポリ(ラクチド‐コ‐グリコリド);ポリ(乳酸);ポリ(グリコール酸);ポリ(乳酸‐コ‐グリコール酸);ポリ(ラクチド)/ポリ(エチレングリコール)共重合体;ポリ(グリコリド)/ポリ(エチレングリコール)共重合体;ポリ(ラクチド‐コ‐グリコリド)/ポリ(エチレングリコール)共重合体;ポリ(乳酸)/ポリ(エチレングリコール)共重合体;ポリ(グリコール酸)/ポリ(エチレングリコール)共重合体;ポリ(乳酸‐コ‐グリコール酸)/ポリ(エチレングリコール)共重合体;ポリ(カプロラクトン);ポリ(カプロラクトン)/ポリ(エチレングリコール)共重合体;ポリ(オルトエステル);ポリ(ホスファゼン);ポリ(ヒドロキシブチレート)、またはポリ(ヒドロキシブチレート)を含む共重合体;ポリ(ラクチド‐コ‐カプロラクトン);ポリカーボネート;ポリ(エステルアミド);ポリ無水物;ポリ(ジオキサノン);ポリ(アルキル化アルキレン);ポリエチレングリコールとポリオルトエステルとの共重合体;生分解性ポリウレタン;ポリ(アミノ酸);ポリエーテルエステル;ポリアセタール;ポリシアノアクリレート;ポリ(オキシエチレン)/ポリ(オキシプロピレン)共重合体;ならびに、それらの混合物および共重合体からなる群から選択される、項目18に記載の装置。
(項目20)
上記支持体が、蛍光放射または燐光放射を用いて視覚的に強化できる、項目1に記載の装置。
(項目21)
上記支持体が、光源により励起されると蛍光または燐光を発する発色団を含む、項目20に記載の装置。
(項目22)
上記放射される蛍光または燐光が、約300nm〜約800nmの波長範囲である、項目20に記載の装置。
(項目23)
上記支持体の少なくとも一部が形状記憶材料製である、項目1に記載の装置。
(項目24)
上記形状記憶材料が形状記憶ポリマーを含む、項目23に記載の装置。
(項目25)
上記形状記憶材料が形状記憶合金を含む、項目23に記載の装置。
(項目26)
上記形状記憶合金がニッケル・チタン合金を含む、項目25に記載の装置。
(項目27)
上記支持体が、埋込み前および埋込み中に圧縮状態を、そして埋込み後に膨張状態を有する、項目23に記載の装置。
(項目28)
上記支持体の少なくとも一部がヒドロゲル製である、項目1に記載の装置。
(項目29)
上記支持体の少なくとも一部がポリメタクリル酸メチル製である、項目16に記載の装置。
(項目30)
上記支持体の少なくとも一部が生体適合性金属製である、項目1に記載の装置。
(項目31)
上記金属が金である、項目30に記載の装置。
(項目32)
上記支持体が、隣接する少なくとも2つのビーズを含む、項目1に記載の装置。
(項目33)
上記隣接する少なくとも2つのビーズが、異なる大きさである、項目32に記載の装置。
(項目34)
上記隣接する少なくとも2つのビーズが、異なる形状である、項目32に記載の装置。(項目35)
上記隣接する少なくとも2つのビーズの上記形状が、球形、回転楕円形、卵形、円筒形、直方形、立方形、円錐形、円板状、コイル状、ならびに、それらの組み合わせおよびセグメントからなる群から独立して選択される、項目32に記載の装置。
(項目36)
上記隣接する少なくとも2つのビーズを連結する接合具をさらに含む、項目32に記載の装置。
(項目37)
上記接合具が可撓性である、項目36に記載の装置。
(項目38)
隣接する少なくとも3つのビーズをさらに含み、各ビーズが、接合具によってその隣接するビーズに連結される、項目36に記載の装置。
(項目39)
各接合具が、異なる長さを有する、項目38に記載の装置。
(項目40)
上記接合具が、上記ビーズと同一の材料を含む、項目36に記載の装置。
(項目41)
上記接合具が、上記ビーズとは異なる材料を含む、項目36に記載の装置。
(項目42)
上記支持体が少なくとも2つのディスクを含み、該ディスクが、接合具により分離され、この接合具に結合している、項目1に記載の装置。
(項目43)
上記ディスクの少なくとも1つが、少なくとも1つの穿孔を有する、項目42に記載の装置。
(項目44)
上記支持体が、シュレム管の壁に、少なくとも2つの地点にて接触するように構成されている、項目1に記載の装置。
(項目45)
上記支持体が、シュレム管の壁に、少なくとも3つの地点にて接触するように構成されている、項目44に記載の装置。
(項目46)
上記支持体が中実である、項目1に記載の装置。
(項目47)
上記支持体の少なくとも一部が中空である、項目1に記載の装置。
(項目48)
上記支持体の少なくとも一部が多孔性である、項目1に記載の装置。
(項目49)
上記支持体の少なくとも一部がメッシュ製である、項目1に記載の装置。
(項目50)
上記接合具が、隣接するビーズ間に空間を提供するように構成されるスペーサでもある、項目36に記載の装置。
(項目51)
上記支持体が、1つ以上の棒状部材を含む、項目1に記載の装置。
(項目52)
上記支持体を組織に取付けることができる、項目1に記載の装置。
(項目53)
眼内圧を低減するためのキットであって、該キットが、
シュレム管内で周方向に埋込み可能な、該シュレム管の少なくとも一部の開放性を維持するように構成されている支持体であって、シュレム管の中核の少なくとも一部を占め、シュレム管を横切る通壁的流れに実質的に干渉しない支持体と、
上記支持体を送達するための導入器と、
を含む、キット。
(項目54)
上記キットの使用に関するインストラクションをさらに含む、項目53に記載のキット。
(項目55)
活性剤をさらに含む、項目53に記載のキット。
(項目56)
少なくとも2つの支持体を含む、項目53に記載のキット。
(項目57)
上記少なくとも2つの支持体を送達するための、少なくとも2つの導入器を含む、項目56に記載のキット。
(項目58)
上記少なくとも2つの支持体が、異なる形状である、項目56に記載のキット。
(項目59)
上記少なくとも2つの支持体が、異なる大きさである、項目56に記載のキット。
(項目60)
上記少なくとも2つの支持体が、異なる材料を含む、項目56に記載のキット。
(項目61)
上記少なくとも2つの支持体が共に結合される、項目56に記載のキット。
(項目62)
上記支持体を組織に取付けるための固定装置をさらに含む、項目53に記載のキット。(項目63)
上記支持体を視覚的に強化するためのシステムをさらに含む、項目53に記載のキット。
(項目64)
上記支持体を位置決めするための位置決め装置をさらに含む、項目53に記載のキット。
(項目65)
支持体をシュレム管内で周方向に挿入するステップを含む、眼内圧を低減するための方法であって、該支持体が、該シュレム管の少なくとも一部の開放性を維持するように構成されており、該支持体が、シュレム管の中核の少なくとも一部を占め、シュレム管を横切る通壁的流れに実質的に干渉しない、方法。
(項目66)
上記支持体の挿入前にシュレム管を拡張するステップをさらに含む、項目65に記載の方法。
(項目67)
上記支持体を組織に係止するステップをさらに含む、項目65に記載の方法。
(項目68)
少なくとも2つの支持体を挿入するステップを含む、項目65に記載の方法。
(項目69)
上記少なくとも2つの支持体を、シュレム管内で周方向に相互に隣接させて位置決めするステップを含む、項目68に記載の方法。
(項目70)
上記少なくとも2つの支持体を、シュレム管内で周方向に相互に対向して位置決めするステップを含む、項目68に記載の方法。
(項目71)
上記少なくとも2つの支持体が共に結合される、項目68に記載の方法。
(項目72)
上記支持体の位置を視覚的に強化するために、光源を用いて上記支持体を照射するステップをさらに含む、項目65に記載の方法。
(項目73)
電磁放射線を用いて上記支持体を修正するステップをさらに含む、項目65に記載の方法。
(項目74)
上記支持体の修正が、上記支持体が埋込まれた後に実施される、項目73に記載の方法。
(項目75)
上記電磁放射線が、上記支持体の少なくとも1つの局所部分により吸収可能な波長を有するレーザを含む、項目73に記載の方法。
(項目76)
上記修正が、上記支持体内での少なくとも1つの孔の生成または拡大を含む、項目73に記載の方法。
ここでは、シュレム管の少なくとも一部の開放性を維持するための、管内で周方向に埋込むことのできる支持体を含む、眼内圧を低減する装置が記載される。支持体は、シュレム管の中核の少なくとも一部を占め、管を横切る通壁的流れに実質的に干渉しない。管の少なくとも一部の「開放性を維持する」とは、支持体が、管の通壁的流れを少なくとも部分的に遮るものがないようにしておくように作動する結果、分泌液が、1)線維柱帯網から出て、2)管を横断し、3)集水チャネルを介して排出できるということを意味する。支持体は、周方向流れに関して、管の開放性を維持するために管を遮るものがないようにしておくということが不要である。通壁的流れに「実質的に干渉しない」とは、支持体が、線維柱帯網からの分泌液流出、または集水チャネルへの分泌液流出のいずれをも著しく遮断しないということを意味する。多くの変更態様において、支持体により、眼から線維柱帯網および集水チャネルを通る毎分約0.1〜約5マイクロリットルの間の房水の流出が可能になる。「シュレム管の中核」というのは、管腔の内部空間における管の断面中心の周りの領域のことであり、すなわち管の周縁部上にある領域のことではない。従って、シュレム管の中核の少なくとも一部を占める装置というのは、管腔の少なくとも一部を横断することができる。
眼内圧を低減するためのキットが提供され、キットは、シュレム管内で周方向に埋込むことのできる少なくとも1つの支持体を包含し、支持体は、シュレム管の少なくとも一部の開放性を維持するように構成されている。支持体は、シュレム管の中核の少なくとも一部を占め、管を横切る通壁的流れに実質的に干渉しない。キットは、支持体を管内に埋込むための導入器または送達装置をも提供する。支持体および導入器は、キット内で、一括に組み合わせて提供される。キットは、例えば支持体を埋込んで検査するのに使用するためのインストラクションも含む。
眼内圧を低減するための方法も提供される。概して、本方法は、支持体がシュレム管の少なくとも一部の開放性を維持するように、支持体を管内で周方向に挿入するステップを含む。支持体は、シュレム管の中核の少なくとも一部を占め、シュレム管を横切る通壁的流れには実質的に干渉しない。
Claims (15)
- 装置であって、
シュレム管の内腔内に縦方向に挿入可能な支持体であって、前記支持体は、一体の構造体と、前記支持体を通る少なくとも1つの穿孔とを有し、前記管内に挿入する際に、シュレム管を少なくとも部分的に開けておき、そしてこれにより、前記管の少なくとも一部分の開放性を維持し、その結果、前記支持体が前記管を横切る通壁的流れに実質的に干渉せずに流体が前記管を横断することが可能となるために十分な断面寸法を有している、支持体
を含み、
前記支持体がシュレム管の内腔内に配置された場合、前記支持体と前記管の壁との間の接触が、前記管の前記内腔の外辺部に沿って不連続的であり、前記支持体が、内壁表面積Cを有する前記管の前記内腔の円筒形セクション内に配置された場合、前記支持体は、Cの30%未満に接触する、装置。 - 前記支持体は、リブ付き縁部を含む、請求項1に記載の装置。
- 前記支持体の外側周辺縁部のみが、前記支持体が前記管の前記内腔内に配置された場合、管壁と接触する、請求項2に記載の装置。
- 前記支持体は、前記支持体が前記管の前記内腔内に配置された場合に管壁と周期的な接触を行う要素を含む、請求項1に記載の装置。
- 前記支持体は、生体適合性金属を含む、請求項1に記載の装置。
- 前記支持体は、生体適合性ポリマーを含む、請求項1に記載の装置。
- 前記支持体は、形状記憶材料を含む、請求項1に記載の装置。
- 前記支持体は、ニッケル・チタン合金を含む、請求項7に記載の装置。
- 前記支持体は、第1の構成に圧縮可能であり、かつ、第2の構成に膨張可能である、請求項7に記載の装置。
- 前記支持体は、前記第2の構成に膨張されるように熱的に活性化されるように適合されている、請求項9に記載の装置。
- 前記支持体は、シュレム管内に完全に配置されるように構成されている、請求項1に記載の装置。
- 前記支持体の少なくとも一部分は、多孔性である、請求項1に記載の装置。
- 前記支持体は、Cの10%未満に接触する、請求項1に記載の装置。
- 前記支持体は、Cの1%未満に接触する、請求項1に記載の装置。
- 前記支持体の少なくとも一部分は、多面体形状である、請求項1に記載の装置。
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US7867186B2 (en) | 2002-04-08 | 2011-01-11 | Glaukos Corporation | Devices and methods for treatment of ocular disorders |
US6638239B1 (en) | 2000-04-14 | 2003-10-28 | Glaukos Corporation | Apparatus and method for treating glaucoma |
CA2683224C (en) | 2001-04-07 | 2014-12-02 | Glaukos Corporation | System and methods thereof for treatment of ocular disorders |
US7431710B2 (en) | 2002-04-08 | 2008-10-07 | Glaukos Corporation | Ocular implants with anchors and methods thereof |
US7331984B2 (en) | 2001-08-28 | 2008-02-19 | Glaukos Corporation | Glaucoma stent for treating glaucoma and methods of use |
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US10314742B2 (en) | 2019-06-11 |
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US9486361B2 (en) | 2016-11-08 |
US20110130831A1 (en) | 2011-06-02 |
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