JP7458446B2 - 緑内障治療のための統合房水シャント(aqueous shunt) - Google Patents
緑内障治療のための統合房水シャント(aqueous shunt) Download PDFInfo
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- JP7458446B2 JP7458446B2 JP2022126214A JP2022126214A JP7458446B2 JP 7458446 B2 JP7458446 B2 JP 7458446B2 JP 2022126214 A JP2022126214 A JP 2022126214A JP 2022126214 A JP2022126214 A JP 2022126214A JP 7458446 B2 JP7458446 B2 JP 7458446B2
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- aqueous humor
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Description
房水は、眼の前房を満たす流体であり、眼圧又は眼内の流体圧に寄与する。緑内障は、眼圧の上昇を特徴とする進行性の眼疾患である。眼圧のこの増加は、通常、体に再吸収される房水の量が不十分であることによって生じる。幾つかの場合には、房水は十分に速く吸収されないか又は全く吸収されず、他の場合には、房水は追加的又は代替的に急速に生成されすぎる。眼圧の増加は罹患した眼の緩やかなそして時に永久的な視力喪失に関連する。
添付の図面は本開示の実施形態のさらなる理解を提供するために含まれ、本明細書に取り込まれ、本明細書の一部を構成し、例を示し、記載とともに本開示の原理を説明する役割を果たす。
本開示で提供される発明概念の様々な実施形態は、意図された機能を発揮するように構成された任意の数の方法及び装置によって実現できることを当業者は容易に理解するであろう。また、本明細書で言及される添付の図面は必ずしも縮尺通りに描かれているわけではなく、本開示の様々な態様を示すために誇張されている可能性があり、その点で、図面は限定するものとして解釈されるべきではないことにも留意されたい。本明細書で使用されるときに、用語「拡散膜」は1つ以上の増殖性拡散膜及び/又は1つ以上の狭窄性拡散膜を包含することが意図される。
メディカルデバイスは、以下の方法に従って構築された。PTFE膨張テープの小さなクーポンをレーザ切断することにより、厚い膨張PTFEテープの底部犠牲圧縮層を調製した。特に、犠牲PTFE層からレーザ切断された緑内障ドレナージデバイスの形状は、図10に示された第一の層9010の形状に対応していた。すべてのチャドを取り除き、犠牲層を位置合わせし、小さなクーポンを収容するように構成されたジグプレートに配置した。次いで、微孔質拡散材料の第一のクーポン(例えば、多層ePTFE)を、犠牲PTFE材料の小さなクーポンの上に置いた。緑内障ドレナージデバイスの形状は、微孔質拡散材料の第一のクーポンへとレーザ切断されなかった。微孔質拡散材料の第一のクーポンは、微孔質拡散材料の第一のクーポンの組織内部成長側が犠牲PTFEクーポンに向かって下向きになるように配向された。
メディカルデバイスは、以下の方法に従って構築された。PTFE膨張テープの小さなクーポンをレーザ切断することにより、厚い膨張PTFEテープの底部犠牲圧縮層を調製した。上記と一貫している緑内障ドレナージデバイスの形状は小さなクーポンからレーザ切断され、約8mm円形寸法を備えた。特に、小さなクーポンからレーザ切断された緑内障ドレナージデバイスの形状は、図10に示された第二の層9020の形状に対応していた。すなわち、小さなクーポンからレーザ切断された緑内障ドレナージデバイスの形状は卵型の房水拡散領域、及び、上記と一貫する矩形侵食要素を含んだ。すべてのチャドを取り除き、犠牲層を位置合わせし、小さなクーポンを収容するように構成されたジグプレートに配置した。次いで、微孔質拡散材料の第一のクーポン(例えば、多層ePTFE)を、犠牲PTFE材料の小さなクーポンの上に置いた。緑内障ドレナージデバイスの形状は、微孔質拡散材料の第一のクーポンへとレーザ切断されなかった。微孔質拡散材料の第一のクーポンは、微孔質拡散材料の第一のクーポンの組織内部成長側が犠牲PTFEクーポンに向かって下向きになるように配向された。
例1又は2からの疎水性ePTFEデバイスアセンブリを以下のように親水性コーティングした。ePTFEは、デバイスの流体導管(例えば、シリコンチューブ)を通して約1mlの100%イソプロピルアルコールを直接デリバリーすることで湿潤化され、ePTFEリザーバを通してフラッシュされた。次に、流体導管及びePTFEリザーバを通して約1mlの脱イオン水(公称抵抗、約106オーム)で過剰なアルコールをデバイスから洗い流した。次に、約1mlの0.2wt%ポリビニルアルコール水溶液を流体導管及びePTFEリザーバに通して直接洗い流し、約10分間平衡化させた。約1mlの蒸留水を、流体導管及びePTFEリザーバに通して洗い流した。約1mlの架橋性水溶液(約0.3モル濃度の塩酸中の2vol%グルタルアルデヒド)を約40℃に昇温し、デバイスを通して直接洗い流し、約15分間平衡化させた。約2.5mlの脱イオン水を流体導管及びePTFEリザーバに通して洗い流した。次に、約40mlの新鮮な脱イオン水のビーカで材料を平衡化した。
例3からのデバイスを、ニュージーランド白ウサギの結膜下平面の側頭上部四分円(superotemporal quadrant)に移植し、14日間の生存期間について評価した。移植中に、25ゲージの針を使用して角膜輪部にトンネルを作成し、ここで、流体導管を前房に通した。房水のリザーバを視覚化するために、0.01%フルオレセインナトリウム水溶液を使用した。注入されたフルオレセインは紫外線によって励起され、強力な蛍光を発し、暗くした環境で容易に見える。犠牲の前に、0.01%フルオレセインナトリウム水溶液を、約10μL/分の公称流量で約10分間、30ゲージ針を通して、移植された眼の前房に注入した。14日の時点で、強い蛍光のリザーバは、移植リザーバ領域から発する蛍光導管とともに観察された。
(態様)
(態様1)
第一の微孔質膜、第二の微孔質膜、第三の微孔質膜及び第四の微孔質膜をスタック構成で含む本体であって、前記第二及び第三の微孔質膜は前記第一及び第四の微孔質膜の間に配置されており、そして膨張可能なリザーバは前記第二及び第三の微孔質膜の間に画定されており、ここで、前記第二及び第三の微孔質膜は組織の内部成長に抵抗するように構成されており、そして前記第一及び第四の微孔質膜は組織の内部成長を許容するように構成されている、本体と、
第一の端部及び第二の端部を有する流体導管であって、前記第一の端部は前記リザーバに流体結合されており、前記第二の端部は前記本体の外部に延在しており、流体が満たされた体腔からの流体が前記リザーバに移動可能であるように、前記流体が満たされた体腔に挿入可能である、流体導管と、
を含む、生体流体ドレナージデバイス。
(態様2)
前記第二及び第三の微孔質膜は、前記第二及び第三の微孔質膜の一部が自由に互いに対して摺動するか又は互いから分離するように、部分的に互いに結合している、態様1記載のデバイス。
(態様3)
前記第二及び第三の微孔質膜はそれぞれ、前記第一及び第四の微孔質膜の各々の透過性とは異なる透過性を有する、態様1又は2のいずれか1項記載のデバイス。
(態様4)
前記第一、第二、第三及び第四の微孔質膜の少なくとも1つは延伸ポリテトラフルオロエチレンを含む、態様1~3のいずれか1項記載のデバイス。
(態様5)
前記本体に隣接して配置されている第五の微孔質膜をさらに含み、前記第五の微孔質膜は前記本体と前記流体導管の第二の端部との間に延在している、態様1~4のいずれか1項記載のデバイス。
(態様6)
前記第五の微孔質膜は組織の内部成長を許容するように構成されている、態様5記載のデバイス。
(態様7)
前記第五の微孔質膜は前記流体導管に結合されている、態様5~6のいずれか1項記載のデバイス。
(態様8)
前記第五の微孔質膜は、前記第一、第二、第三又は第四の微孔質膜の1つと一体化されている、態様5~7のいずれか1項記載のデバイス。
(態様9)
前記第五の微孔質膜及び第一の微孔質膜は同じ微孔質膜である、態様8記載のデバイス。
(態様10)
前記本体に隣接して配置されている第六の微孔質膜をさらに含み、前記第六の微孔質膜は前記本体と前記流体導管の第二の端部との間に延在している、態様5~9のいずれか1項記載のデバイス。
(態様11)
前記第六の微孔質膜及び第四の微孔質膜は同じ微孔質膜である、態様10記載のデバイス。
(態様12)
前記第六の微孔質膜は、移植時に、前記流体導管が穿孔を通って流体で満たされた体腔内に延在されうるように流体導管を収容するサイズの穿孔を含む、態様10~11のいずれか1項記載のデバイス。
(態様13)
前記第一及び第四の微孔質膜はそれぞれ、組織の内部成長が前記第一及び第四の微孔質膜で起こった後に、前記流体に対して透過性を維持するように構成されている、態様1~12のいずれか1項記載のデバイス。
(態様14)
前記リザーバは前記流体がリザーバに移送されると膨張するように構成されている、態様1~13のいずれか1項記載のデバイス。
(態様15)
前記本体はリザーバの膨張の結果として所定のプロファイルを採用するように構成されている、態様14記載のデバイス。
(態様16)
前記第一、第二、第三及び第四の微孔質膜はそれぞれ複数の小孔を含み、ここで、前記第二及び第三の微孔質膜の複数の小孔は組織の内部成長に抵抗するサイズであり、前記第一及び第四の微孔質膜の複数の小孔は組織の内部成長を許容するサイズである、態様1~15のいずれか1項記載のデバイス。
(態様17)
組織の内部成長を許容するように構成された第一の増殖性拡散膜と、
組織の内部成長に抵抗するように構成された第一の狭窄性拡散膜であって、前記第一の増殖性拡散膜に結合されている第一の狭窄性拡散膜と、
組織の内部成長に抵抗するように構成された第二の狭窄性拡散膜であって、前記第二の狭窄性拡散膜の第一の領域が前記第一の狭窄性拡散膜に結合されるように、そして前記第二の狭窄性拡散膜の第二の領域が前記第一の狭窄性拡散膜から非結合となるように前記第一の狭窄性拡散膜に結合され、前記非結合の第二の領域が膨張性リザーバを画定している、第二の狭窄性拡散膜と、
組織の内部成長を許容するように構成された第二の増殖性拡散膜であって、前記第二の狭窄性拡散膜に結合されている第二の増殖性拡散膜と、
を含む、房水拡散デバイス。
(態様18)
前記第一及び第二の増殖性拡散膜は組織の内部成長を許容するように構成された複数の小孔を含み、前記第一及び第二の狭窄性拡散膜は組織の内部成長に抵抗するように構成された複数の小孔を含む、態様17記載のデバイス。
(態様19)
前記第二の狭窄性拡散膜の第一の領域は前記第二の狭窄性拡散膜の周縁領域であり、前記第二の狭窄性拡散膜の第一の領域は前記第一の狭窄性拡散膜の周縁領域に結合され、前記第二の狭窄性拡散膜の第二領域は前記第二の狭窄性拡散膜の周縁領域の内側の領域である、態様17~18のいずれか1項記載のデバイス。
(態様20)
第一の端部及び第二の端部を有する流体導管をさらに含み、前記第一の端部は前記リザーバと流体連通されており、前記第二の端部は第一及び第二の狭窄性拡散膜から離れるように延在しており、流体が満たされた体腔からの流体が前記リザーバに移動可能であるように、流体が満たされた体腔内に挿入可能である、態様17~19のいずれか1項記載のデバイス。
(態様21)
組織の内部成長を許容するサイズの複数の細孔を含む第三の増殖性拡散膜をさらに含み、前記第三の増殖性拡散膜は前記第一の増殖性拡散膜に隣接して配置され、前記第一の増殖性拡散膜と前記流体導管の第二の端部との間で流体導管に沿って延在している、態様20記載のデバイス。
(態様22)
前記第三の増殖性膜及び第一の増殖性拡散膜は同じ増殖性拡散膜である、態様21記載のデバイス。
(態様23)
前記第三の増殖性拡散膜は前記流体導管に結合されている、態様21~22のいずれか1項記載のデバイス。
(態様24)
組織の内部成長を許容するサイズの複数の細孔を含む第四の増殖性拡散膜をさらに含み、前記第四の増殖性拡散膜は前記第二の増殖性拡散膜に隣接して配置され、前記第二の増殖性拡散膜と前記流体導管の第二の端部との間で流体導管に沿って延在している、態様20~23のいずれか1項記載のデバイス。
(態様25)
前記第四の増殖性膜及び第二の増殖性拡散膜は同じ増殖性膜である、態様24記載のデバイス。
(態様26)
前記第四の増殖性拡散膜は、移植時に、流体導管が穿孔を通って流体が満たされた体腔中に延在できるように流体導管を収容するサイズの穿孔を含む、態様24~25のいずれか1項記載のデバイス。
(態様27)
前記流体が満たされた体腔は目の前房であり、前記流体は房水である、態様1~26のいずれか1項記載のデバイス。
(態様28)
第一の増殖性拡散膜及び第二の増殖性拡散膜を提供すること、
第一の狭窄性拡散膜及び第二の狭窄性拡散膜を提供すること、
前記第一の増殖性拡散膜を前記第一の狭窄性拡散膜に結合することと、前記第二の狭窄性拡散膜の第一の界面表面の第一の領域が前記第一の狭窄性拡散膜に結合されるように、そして前記第一の界面表面の第二の領域が前記第一の狭窄性拡散膜に結合されないように、前記第一の狭窄性拡散膜を前記第二の狭窄性拡散膜に結合することと、前記第二の増殖性拡散膜を前記第二の狭窄性拡散膜に結合することと、により房水拡散部材を形成すること、および
流体導管が排出された房水をリザーバにデリバリーするように動作可能となるように前記導管が前記リザーバと流体結合されるように前記流体導管を前記房水拡散部材に結合すること、
を含み、
ここで、前記第一及び第二の増殖性拡散膜はそれぞれ、組織の内部成長を許容するように構成されており、
前記第一及び第二の狭窄性拡散膜は組織の内部成長に抵抗するように構成されており、
前記結合されていない第二の領域は膨張可能なリザーバを画定する、
緑内障ドレナージデバイスを形成する方法。
(態様29)
前記房水拡散部材は組織の内部成長を許容するように構成された第三の増殖性拡散膜をさらに含み、前記第三の増殖性膜は前記第一の増殖性拡散膜に隣接して配置され、前記流体導管に沿って延在している、態様28記載の方法。
(態様30)
前記房水拡散部材は組織の内部成長を許容するように構成された第四の増殖性拡散膜をさらに含み、前記第四の増殖性膜は前記第二の増殖性拡散膜に隣接して配置され、前記流体導管に沿って延在している、態様29記載の方法。
(態様31)
組織の内部成長を許容するサイズの複数の細孔を含むように、前記第一、第二、第三又は第四の増殖性拡散膜の1つを穿孔させることをさらに含む、態様28~30のいずれか1項記載の方法。
(態様32)
前記第三の増殖性拡散膜及び第一の増殖性拡散膜は同じ増殖性拡散膜である、態様3
0~31のいずれか1項記載の方法。
(態様33)
前記第四の増殖性拡散膜及び第二の増殖性拡散膜は同じ増殖性拡散膜である、態様30~32のいずれか1項記載の方法。
(態様34)
前記第四の増殖性拡散膜は、移植時に、前記流体導管が穿孔を通って前房中に延在することができるように流体導管を収容するサイズの穿孔を含む、態様30~33のいずれか1項記載の方法。
Claims (19)
- 流体が満たされた体腔から流体を排出するための生体流体ドレナージデバイスであって、
第一の微孔質拡散材料および第二の微孔質拡散材料を含む本体であって、前記第一の微孔質拡散材料は、第一の微孔質膜における第一の組織の内部成長増殖側および第二の微孔質膜における第一の組織の内部成長拡散側を形成するように第二の微孔質膜に対して配置された第一の微孔質膜を含み、第二の微孔質拡散材料は第四の微孔質膜において第二の組織の内部成長増殖側および第三の微孔質膜において第二の組織の内部成長拡散側を形成するように第四の微孔質膜に対して配置された第三の微孔質膜を含み、前記第一の組織の内部成長増殖側および前記第二の組織の内部成長増殖側が互いから外に向いておりおよび前記第一の組織の内部成長拡散側および前記第二の組織の内部成長拡散側が互いに内向きに向いているように、前記第二の微孔質膜および前記第三の微孔質膜は前記第一の微孔質膜と前記第四の微孔質膜との間に配置されており、および前記第二の微孔質膜および前記第三の微孔質膜が前記第一の微孔質拡散材料および前記第二の微孔質拡散材料の周縁に沿ってそれらの間でシール係合を形成して、前記第二の微孔質膜と前記第三の微孔質膜との間に配置された膨張可能なリザーバを画定する、本体と、
第一の端部及び第二の端部を有する流体導管であって、前記第一の端部は前記リザーバに流体結合されており、前記第二の端部は前記本体の外部に延在しており、前記流体が満たされた体腔からの前記流体が前記リザーバに移動可能であるように、前記流体が満たされた体腔に挿入可能である、流体導管と、
を含む、生体流体ドレナージデバイス。 - 前記第二及び第三の微孔質膜の第一の部分は前記膨張可能なリザーバ内で互いに部分的に結合しており、および前記第二及び第三の微孔質膜の隣接する第二の部分は前記膨張可能なリザーバ内で互いから分離している、請求項1記載のデバイス。
- 前記第二及び第三の微孔質膜はそれぞれ、前記第一及び第四の微孔質膜の各々の透過性とは異なる透過性を有する、請求項1又は2のいずれか1項記載のデバイス。
- 前記第一、第二、第三及び第四の微孔質膜の少なくとも1つは延伸ポリテトラフルオロエチレンを含む、請求項1~3のいずれか1項記載のデバイス。
- 前記本体は前記本体に隣接して配置されている第五の微孔質膜をさらに含み、前記第五の微孔質膜は前記本体と前記流体導管の第二の端部との間に延在している、請求項1~4のいずれか1項記載のデバイス。
- 前記第五の微孔質膜は組織の内部成長を許容するように構成されている、請求項5記載のデバイス。
- 前記第五の微孔質膜は前記流体導管に結合されている、請求項5~6のいずれか1項記載のデバイス。
- 前記第五の微孔質膜は、前記第一、第二、第三又は第四の微孔質膜の1つと一体化されている、請求項5~7のいずれか1項記載のデバイス。
- 前記第五の微孔質膜及び第一の微孔質膜は同じ微孔質膜である、請求項8記載のデバイス。
- 前記本体は前記本体に隣接して配置されている第六の微孔質膜をさらに含み、前記第六の微孔質膜は前記本体と前記流体導管の第二の端部との間に延在している、請求項5~9のいずれか1項記載のデバイス。
- 前記第六の微孔質膜及び第四の微孔質膜は同じ微孔質膜である、請求項10記載のデバイス。
- 前記第六の微孔質膜は、移植時に、前記流体導管が穿孔を通って流体で満たされた体腔内に延在されるように構成された流体導管を収容するサイズの穿孔を含む、請求項10~11のいずれか1項記載のデバイス。
- 前記第一及び第四の微孔質膜はそれぞれ、組織の内部成長が前記第一及び第四の微孔質膜で起こった後に、前記流体に対して透過性を維持するように構成されている、請求項1~12のいずれか1項記載のデバイス。
- 前記リザーバは前記流体がリザーバに移送されると膨張するように構成されている、請求項1~13のいずれか1項記載のデバイス。
- 前記本体はリザーバの膨張の結果として所定のプロファイルを採用するように構成されている、請求項14記載のデバイス。
- 前記第一、第二、第三及び第四の微孔質膜はそれぞれ複数の小孔を含み、ここで、前記第二及び第三の微孔質膜の複数の小孔は組織の内部成長に抵抗するサイズであり、前記第一及び第四の微孔質膜の複数の小孔は組織の内部成長を許容するサイズである、請求項1~15のいずれか1項記載のデバイス。
- 流体で満たされた体腔から流体を排水するための生体流体ドレナージデバイスであって、
シール係合を提供しおよび第一の微孔質膜および第二の微孔質の間に配置された内部リザーバを画定するように第二の微孔質膜に結合された第一の微孔質膜を含む本体であって、前記第一の微孔質膜は第一の微孔質膜側および反対側の第二の微孔質膜側を含み、前記第一の微孔質膜側は第一の多孔度を有しおよび前記第二の微孔質膜側は前記第一の多孔度と異なる第二の多孔度を有し、前記第二の微孔質膜は第三の微孔質膜側および反対側の第四の微孔質膜側を含み、前記第三の微孔質膜側は第三の多孔度を有しおよび前記第四の微孔質膜側は前記第三の多孔度と異なる第四の多孔度を有し、前記第二の微孔質膜側および前記第三の微孔質膜側はリザーバを画定するように互いに向かって向いている、本体と、
第一の端部および第二の端部を有する流体導管であって、前記第一の端部は前記リザーバに流体結合しておりおよび前記第二の端部は前記本体の外側へ延びておりおよび前記流体で満たされた体腔に挿入可能であって、それによって前記流体で満たされた体腔から前記流体は前記リザーバに移動可能である、流体導管と、
を含む、
前記シール係合は、前記第一の微孔質膜側および前記第四の微孔質膜側の周縁においてまたは周縁の近くにおいて生体流体の排出を可能にするように、前記第一の微孔質膜側が前記第四の微孔質膜側と非結合であるようになっている、デバイス。 - 前記第一の多孔度は、前記第四の多孔度と等しい、請求項17記載のデバイス。
- 前記第二の多孔度は、前記第三の多孔度と等しい、請求項17記載のデバイス。
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