JP2015506748A - 緑内障を治療するための方法、外科キット及び器具 - Google Patents
緑内障を治療するための方法、外科キット及び器具 Download PDFInfo
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- 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
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- A—HUMAN NECESSITIES
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- 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
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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
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- 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
- A61F9/008—Methods or devices for eye surgery using laser
- A61F2009/00885—Methods or devices for eye surgery using laser for treating a particular disease
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- 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
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Abstract
Description
−眼球運動に障害が生じ、結果としてものが二重に見えること(複視)。
−低眼圧(網膜剥離を招くおそれのある低IOP)になること。
−結膜の侵食及び感染、並びに侵食を防止するために死体強膜を使用する高い関連コスト。さらに死体強膜は米国外で得ることが難しく、いくつかの宗教では死体組織を使用することを禁止している。
−プレートのカプセル封入が難しく、このことは適切な流体濾過を妨げ、IOP制御の不良を招く。
BAB又はABA(線状トリブロック)、
B(AB)n又はa(BA)n(線状交互ブロック)、又は
X−(AB)n又はX−(BA)n(ジブロック、トリブロック、及び他のラジアル・ブロック・コポリマーを含む)(Aはエラストマーポリオレフィンブロックであり、Bは熱可塑性ブロックであり、nは正の整数であり、そしてXは開始シード分子である)
を有している。
このような材料は、星形ブロック・コポリマー(n=3又は4以上)、又は多樹状突起状のブロック・コポリマーであってよい。ガラス状セグメントに加えて、架橋剤をポリマー中に組み込むことによりSIBSの熱硬化性バージョンを提供することができる。これらの架橋剤を組み込んだ模範的なポリマーは米国特許出願公開第20090124773号明細書に詳述されている。上記明細書はそれぞれ参照することにより本明細書中に全体的に組み込まれる。これらの材料は、SIBS材料と呼ばれる高分子材料に集合的に属する。
− ブロック・コポリマー相のうちの1つと混和可能なホモポリマーとともにブレンドを形成することができる。例えばポリフェニレンオキシドは、ポリスチレン−ポリイソブチレン−ポリスチレンコポリマーのスチレンブロックと混和可能である。これは、ポリスチレン−ポリイソブチレン−ポリスチレンコポリマーとポリフェニレンオキシドとから形成された成形部分又は被膜の強度を高めることになる。
− ブロック・コポリマーのブロックと完全には混和することのできない付加ポリマー又は他のコポリマーとともにブレンドを形成することができる。付加ポリマー又はコポリマーは、例えば別の治療薬と適合性がある点、又はブロック・コポリマー(例えばポリスチレン−ポリイソブチレン−ポリスチレンコポリマー)からの治療薬の放出を変化させる点において有利である。
− 器具201(又は器具部分)から浸出することができる糖(上記リスト参照)のような成分とともにブレンドを形成し、器具又は器具構成部分をより多孔質にし、多孔質構造を通る放出速度を制御することができる。
− ブロック・コポリマーの分子量を変える。
− ブロック・コポリマーのエラストマー部分及び熱可塑性部分のために選択される特定成分、並びにこれらの成分の相対量を変える。
− ブロック・コポリマーを処理する際に使用される溶媒のタイプ及び相対量を変える。
− ブロック・コポリマーの多孔率を変える。
− ブロック・コポリマーに境界層を被せる。
− ブロック・コポリマーと他のポリマー又はコポリマーとをブレンドする。
Claims (44)
- 眼の前房内部の上昇した眼内圧を外科治療するためのキットであって、
前記前房に接続する通路を画定すべく組織を通して挿入されるニードル本体を有する機器と、
可撓性チューブ及び組織シーリング手段を含む房水排出器具と
を含み、
前記ニードル本体はその長さに沿って第1最大断面寸法を有しており、
前記チューブは、前記前房から房水を迂回させるためのダクトを画定しており、且つ、互いに反対側の近位端及び遠位端と、前記第1最大断面寸法よりも小さな第2最大断面寸法を有する第2外面とを有しており、前記組織シーリング手段は、前記チューブの前記近位端及び前記遠位端から離間された少なくとも1つのエレメントを含み、前記少なくとも1つのエレメントは、前記チューブの第2外面を超えて半径方向外側に向かって延びていて、前記組織と該少なくとも1つのエレメントとの間にシールを形成すべく、前記第1最大断面寸法よりも大きい第3最大断面寸法を有している、眼の前房内部の上昇した眼内圧を外科治療するためのキット。 - 前記少なくとも1つのエレメントの第2最大断面寸法が、少なくとも1つの鈍い面によって画定されている、請求項1に記載のキット。
- 前記少なくとも1つのエレメントが、テーパされた遠位部分を有している、請求項1に記載のキット。
- 前記少なくとも1つのエレメントが、前記チューブの両側で前記チューブから半径方向に延びる第1タブと第2タブとを含み、前記第1タブは第1外縁部を画定し、前記第2タブは第2外縁部を画定し、前記第3最大断面寸法は、前記第1外縁部と前記第2外縁部との間の最大距離によって画定されている、請求項1に記載のキット。
- 前記第1及び第2タブが、前記チューブの中心軸の周りに反映された互いの鏡像である、請求項4に記載のキット。
- 前記第1及び第2タブが、ほぼ平面的な形状を成しており、前記チューブの中心軸に対して横方向に延びる共通平面内に位置している、請求項4に記載のキット。
- 前記1及び第2タブの最大厚が、前記チューブの第2最大断面直径以下である、請求項6に記載のキット。
- 前記1及び第2タブがそれぞれ、それぞれのテーパされた遠位部分を有している、請求項4に記載のキット。
- 前記第1最大断面寸法が0.4mm〜0.7mmである、請求項1に記載のキット。
- 前記第2最大断面寸法が0.4mm以下である、請求項9に記載のキット。
- 前記第3最大断面寸法が少なくとも0.9mmである、請求項10に記載のキット。
- 前記チューブが均質な高分子材料から実現されている、請求項1に記載のキット。
- 前記房水排出器具は、高分子材料から実現された単一の成形部分である、請求項1に記載のキット。
- 前記高分子材料が、SIBS材料、シリコーンゴム、ポリオレフィンポリマー、ポリウレタンポリマー、アクリルポリマー、フルオロポリマー、ポリアミドポリマー、ヒドロゲルポリマー、生物学に基づく構造、軟質ポリマー発泡体材料、多孔質ポリマー材料、及びこれらの組み合わせから成る群から選択される、請求項13に記載のキット。
- さらに、
前記房水排出器具のチューブを受容するようにサイズ設定された導管を含む器具を含み、前記導管は、前記房水排出器具のチューブの通過を可能にするスロットを有している、請求項1に記載のキット。 - 前記スロットが前記導管の一部に沿って延びており、前記導管を位置決めするために、前記スロットの近位端に隣接してタブが配置されている、請求項15に記載のキット。
- さらに、
前記房水排出器具を位置決めするために、前記房水排出器具のチューブ内に挿入されるようにサイズ設定されたスタイレットを含む、請求項1に記載のキット。 - 前記ニードル本体が曲げ形態を有している、請求項1に記載のキット。
- 前記機器が、前記ニードル本体から近位側に配置された平刃部分を有しており、前記平刃部分は、前記平刃部分の両側に配置された2つのカッティング面を有している、請求項1に記載のキット。
- 眼の上昇した眼内圧を外科治療する方法であって、
第1最大断面寸法をその長さに沿って有するニードル本体を、組織を通して挿入することにより、眼の前房に接続された通路を画定するステップと、
可撓性チューブ及び組織シーリング手段を含む房水排出器具を用意するステップであって、前記チューブは、前記前房から房水を迂回させるためのダクトを画定しており、且つ、互いに反対側の近位端及び遠位端と、前記第1最大断面寸法よりも小さな第2最大断面寸法を有する第2外面とを有しており、前記組織シーリング手段は、前記チューブの前記近位端及び前記遠位端から離間された少なくとも1つのエレメントを含み、前記少なくとも1つのエレメントは、前記チューブの前記第2外面を超えて半径方向外側に向かって延びていて、前記第1最大断面寸法よりも大きい第3最大断面寸法を有している、ステップと、
前記チューブの遠位端が前記眼の前房内に位置し、前記組織シーリング手段が前記通路内に配置されて前記組織と前記器具との間のシールを形成し、房水が前記前房から排出されるように、前記房水排出器具を前記通路内に挿入するステップと
を含む、眼の上昇した眼内圧を外科治療する方法。 - 前記少なくとも1つのエレメントの第2最大断面寸法が、少なくとも1つの鈍い面によって画定されている、請求項20に記載の方法。
- 前記少なくとも1つのエレメントが、前記通路内への前記組織シーリング手段の挿入を容易にする、テーパされた遠位部分を有している、請求項20に記載の方法。
- 前記少なくとも1つのエレメントが、前記チューブの両側で前記チューブから半径方向に延びる第1タブと第2タブとを含み、前記第1タブは第1外縁部を画定し、前記第2タブは第2外縁部を画定し、前記第3最大断面寸法は、前記第1外縁部と前記第2外縁部との間の最大距離によって画定されている、請求項20に記載の方法。
- 前記第1及び第2タブが、前記チューブの中心軸の周りに反映された互いの鏡像である、請求項23に記載の方法。
- 前記1及び第2タブの最大厚が、前記チューブの第2最大断面直径以下である、請求項23に記載の方法。
- 前記1及び第2タブがそれぞれ、それぞれのテーパされた遠位部分を有している、請求項23に記載の方法。
- 前記第1及び第2タブが、ほぼ平面的な形状を成しており、前記チューブの中心軸に対して横方向に延びる共通平面内に位置している、請求項23に記載の方法。
- 前記第1最大断面寸法が0.4mm〜0.7mmである、請求項20に記載の方法。
- 前記第2最大断面寸法が0.4mm以下である、請求項28に記載の方法。
- 前記第3最大断面寸法が少なくとも0.9mmである、請求項29に記載の方法。
- さらに、前記ニードル本体によって画定された前記通路の一部を広げるために平らなナイフを使用するステップを含む、請求項20に記載の方法。
- 前記ニードル本体と前記平らなナイフとが単一の外科用機器の一部である、請求項31に記載の方法。
- 前記房水排出器具は、前記房水排出器具のチューブ内に挿入されたスタイレットを使用して、前記ニードルによって画定された前記通路内に挿入される、請求項20に記載の方法。
- さらに、
前記房水排出器具のチューブを受容するようにサイズ設定されて、前記房水排出器具のチューブの通過を可能にするスロットを有する導管を含む器具を、前記ニードル本体によって画定された前記通路内に挿入するステップと、
前記房水排出器具を前記導管内に挿入するステップと、
前記房水排出器具を残しながら、前記ニードル本体によって画定された前記通路から前記導管を取り外すステップであって、この際に前記導管のスロットが前記取り外し中に前記房水排出器具のチューブの通過を可能にする、ステップと
を含む、請求項20に記載の方法。 - 前記導管は、前記ニードル本体の近位部分の周りに配置され、前記ニードル本体の遠位部分によって前記通路が画定されると、前記ニードル本体によって画定された前記通路内に挿入される、請求項34に記載の方法。
- 前記スロットが前記導管の遠位部分に沿って延びており、前記ニードル本体によって画定された前記通路内部に前記導管を位置決めするために、前記スロットの近位端に隣接してタブが配置されており、前記通路内部に前記導管の遠位部分を残したままにするために、前記器具が前記通路内部に位置決めされた状態で前記タブから遠位側で切断される、請求項34に記載の方法。
- 眼の前房内部の上昇した眼内圧を治療するための埋め込み可能な器具であって、
可撓性チューブ及び組織シーリング手段を含み、
前記チューブは、前記前房から房水を迂回させるためのダクトを画定しており、且つ、互いに反対側の近位端及び遠位端と、第1最大断面寸法を有する外面とを有しており、前記組織シーリング手段は、前記チューブの前記近位端及び前記遠位端から離間された少なくとも1つのエレメントを含み、前記少なくとも1つのエレメントは、前記チューブの外面を超えて半径方向外側に向かって延びていて、前記第1最大断面寸法よりも大きい第2最大断面寸法を有しており、前記第2最大断面寸法は少なくとも1つの鈍い面によって画定されている、眼の前房内部の上昇した眼内圧を治療するための埋め込み可能な器具。 - 前記少なくとも1つの鈍い面が長円形の断面プロフィールを有する、請求項37に記載の器具。
- 前記少なくとも1つの鈍い面が楕円形又は円形の断面プロフィールを有する、請求項37に記載の器具。
- 前記少なくとも1つのエレメントが、テーパされた遠位部分を有している、請求項37に記載の器具。
- 前記少なくとも1つのエレメントが、前記チューブの両側で前記チューブから半径方向に延びる第1タブと第2タブとを含み、前記第1タブは第1外縁部を形成し、前記第2タブは第2外縁部を形成し、前記第2最大断面寸法は、前記第1外縁部と前記第2外縁部との間の最大距離によって画定されている、請求項37に記載の器具。
- 前記第1最大断面寸法が0.4mm以下であり、前記第2最大断面寸法が少なくとも0.9mmである、請求項37に記載の器具。
- 前記器具は、SIBS材料、シリコーンゴム、ポリオレフィンポリマー、ポリウレタンポリマー、アクリルポリマー、フルオロポリマー、ポリアミドポリマー、ヒドロゲルポリマー、生物学に基づく構造、軟質ポリマー発泡体材料、多孔質ポリマー材料、及びこれらの組み合わせから成る群から選択された高分子材料から実現された単一の成形部分である、請求項37に記載の器具。
- 前記器具の少なくとも一部のための前記高分子材料に、少なくとも1種の治療薬が装填されている、請求項43に記載の器具。
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