JP7209439B2 - 眼科用送達装置および眼科用薬物組成物 - Google Patents
眼科用送達装置および眼科用薬物組成物 Download PDFInfo
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- JP7209439B2 JP7209439B2 JP2018548417A JP2018548417A JP7209439B2 JP 7209439 B2 JP7209439 B2 JP 7209439B2 JP 2018548417 A JP2018548417 A JP 2018548417A JP 2018548417 A JP2018548417 A JP 2018548417A JP 7209439 B2 JP7209439 B2 JP 7209439B2
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- A61M2005/31598—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing having multiple telescopically sliding coaxial pistons encompassing volumes for components to be mixed
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Description
本発明の一実施態様に係る装置は、柔軟性のあるカニューレを、眼の上脈絡膜腔内または上毛様体腔内に展開するように作製した。筒要素は、0.5 mLインスリンシリンジの近位末端を、30 mmの筒長まで切断することにより作製した。一体化された針を筒から取り外し、標準的なルアーハブ針の取り付けを可能にした。筒の先端は、ルアーハブ針を確実に保持することができるルアーテーパーの残存部分を残して切断した。筒端キャップは、4.5 mmのねじ長を有するナイロン10-32穴付きねじから作製した。直径1.86 mmの貫通穴を、筒端キャップを通して穿穴し、プランジャーが筒端キャップを自由に摺動できるようにした。プランジャーシャフトは、外径1.8 mmおよび内径0.8 mmならびに長さ43 mmの筒状のテフロンコーティングしたステンレス鋼ロッドから作製した。シャフトの遠位末端は、直径1.74 mmへと細くし、外径4.1 mmおよび内径1.70 mmならびに厚さ0.5 mmのステンレス鋼製ワッシャーをロッドに圧入して、プランジャースプリングのための末端止め具を与えた。ロッドの近位末端は、直径1.55 mmまで穿穴した。外径3.1 mmおよびワイヤ直径0.18 mmならびに長さ31.8 mmの圧縮スプリングを、プランジャーシャフト上に配置した後、筒端キャップを、スプリングの近位にあるプランジャーシャフト上に滑り込ませた。プランジャーアセンブリは、筒筐体内に配置し、端末キャップは、筒内でプランジャーアセンブリを固定する筒近位末端内に圧入した。
本発明の一実施態様に係る装置を作製した。装置は、カニューレ要素、末端シールを有する針、カニューレ支持要素、力要素および筺体本体を備えた。
組織接点は、実施例1に記載した方法と同様の方法で作製した。外径が直径1.75 mmおよび直径2.50 mmと異なる、2種の組織接点を作製した。それぞれの直径の組織接点のサンプルは、ショア10A、30A、50Aおよび70Aの4種の異なるデュロメータの液体シリコーンエラストマーを用いて作製した。
半固体薬物組成物を製造した。平均分子量700万ダルトンのポリエチレンオキシド(PolyOx(登録商標)、WSR-301)を、1.5重量%で脱イオン水に分散させた。平均直径2ミクロンのデキサメタゾン結晶を、ポリエチレンオキシド分散液中に8重量%の濃度で混合した。半固体組成物は、分散したデキサメタゾン結晶のために不透明であった。
Claims (31)
- 遠位末端に中空斜角針を有する細長状体;
非侵襲性先端を有する細長管状要素を備えるカニューレであって、管状要素の少なくとも一部が、展開前に針管腔に含まれるカニューレ;
針管腔を通って管状要素を前進させるための展開力を付与する力要素;
力要素と管状要素との機械的連結要素;
(i) 活性成分含有組成物を送達するための、管状要素の近位末端に連通する連結器または注入ポート;または
(ii) 管状要素の近位末端に連通して、投与用の活性成分含有組成物を含む容器;および
針の先端の眼内への配置前または配置と同時にあるいは配置直後に作動する力要素機構;を備える、活性成分含有組成物を眼に投与するための挿管装置であって、
力要素からの展開力が、管状要素を、針の遠位末端から上脈絡膜腔または上毛様体腔へ前進させる役割を果たす;
挿管装置。 - さらに容器から組成物を投与するためのプランジャーに機械的に結合された第二の力要素を含む、請求項1に記載の装置。
- プランジャーに作用する第二の力要素の作動は、投与のために組成物に送達力を提供する、請求項2に記載の装置。
- 装置の遠位末端に遠位要素をさらに取り付けた、請求項1~3のいずれか1項に記載の装置であって、
展開力下であっても、針から抜ける管状要素の前進から、管腔を密閉または封鎖し;
末端要素は末端シールを備え、末端シールは組織接点としての機能を果たし、また、末端シールは装置の遠位末端による眼表面の加圧により針先端により貫通され;
カニューレ挿入装置の力要素は、針による遠位シールの貫通および針先の組織への前進の前または同時に作動し、
貫通された末端要素は針の上を摺動可能となり、針を組織内に前進させ;および、
貫通された末端シールは、針の先端からの管状要素の前進経路を開き、管状要素の展開を作動させる;
装置。 - 針が、管状要素を針の長軸から斜めに方向づけるための湾曲した先端を備える、請求項1~4のいずれか1項に記載の装置。
- 管状要素を針の長軸から斜めに方向づけるために、針が、針斜角において針管腔に内部偏向要素を備える、請求項1~5のいずれか1項に記載の装置。
- 末端シールが、展開力下で管状要素の展開を防止するのに十分で、針の遠位末端で管腔内に伸びる変形可能な突起、または、遠位末端から管腔の末端突起内に伸びる変形可能な突起を備える、請求項4~6のいずれか1項に記載の装置。
- 装置本体と末端要素との間に折り畳み可能要素をさらに備える、請求項4~7のいずれか1項に記載の装置であって、折り畳み可能要素が、展開力による末端要素の遠位移動を防止するように構成される、装置。
- 折り畳み可能要素が、細長い支柱を備える、請求項8に記載の装置。
- 折り畳み可能要素が、ニチノールまたはポリイミドを含む、請求項8または9に記載の装置。
- 針の先端が末端シールを貫通中に、折り畳み可能要素が、末端要素に前方に向けられた力を付与するように構成される、請求項8~10のいずれか1項に記載の装置。
- 前方に向けられた力が、40~82グラム力の範囲にある、請求項11に記載の装置。
- 折り畳み可能要素が、最初の力の後に一定の力を付与するように構成された、請求項11に記載の装置であって、最初の力が、末端要素が針に沿って近位に最初に0.5 mm移動する間に加えられる、装置。
- 装置本体と末端要素との間に第三の力要素をさらに備える、請求項11~13のいずれか1項に記載の装置であって、第三の力要素が、針の先端が末端シールを貫通中に、末端要素に前方に向けられた力を付与するように構成された、装置。
- 末端シールが組織接点としての機能を果たす、請求項4~14のいずれか1項に記載の装置であって、末端シールが10~30ショアAの硬度のエラストマーを含む、装置。
- 末端シールが、管状の末端筺体に取り付けられた、請求項4~15のいずれか1項に記載の装置。
- 力要素が、プランジャーまたはプッシュロッドに機械的に連結されたスプリングである、請求項1~16のいずれか1項に記載の装置。
- 力要素が加圧ガスである、請求項4~16のいずれか1項に記載の装置。
- カニューレの展開速度を制限する制動機構をさらに備える、請求項1~18のいずれか1項に記載の装置。
- 展開力が、装置の外部から力要素を圧縮する機能により作動される、請求項1~19のいずれか1項に記載の挿管装置。
- 使用前は、力要素が束縛されており、束縛された力要素を機械的に解放することにより、展開力が作動する、請求項1~20のいずれか1項に記載の挿管装置。
- 針の有効全長が1~4 mmであり、上脈絡膜腔または上毛様体腔に活性成分含有組成物を投与するための、請求項1~21のいずれか1項に記載の挿管装置。
- 針の有効全長が10~15 mmであり、硝子体腔に活性成分含有組成物を投与するための、請求項1~21のいずれか1項に記載の挿管装置。
- 針の有効全長が0.35~2 mmであり、結膜下腔に活性成分含有組成物を投与するための、請求項1~21のいずれか1項に記載の挿管装置。
- 活性剤含有組成物をさらに含む請求項1に記載の装置であって、該組成物が液体または半固体である、装置。
- 活性剤含有組成物は、複数の薬物含有粒子を含む、請求項25に記載の装置。
- さらに機械的結合要素上の力要素の動作を起動して、管状要素を前進させるアクチュエータを備える、請求項1~4のいずれか1項に記載の装置。
- 管状要素を針の長軸から眼の後方領域に向けて斜めに方向づけるために、針が湾曲した先端を備える、請求項27に記載の装置。
- 管状要素を針の長軸から眼の後方領域に向けて斜めに方向づけるために、針が針斜角において針管腔に内部偏向要素を備える、請求項27に記載の装置。
- 管状要素の近位管腔への液体通路を与えるために、細長状体に連結器または注入ポートをさらに備える、請求項27~29のいずれか1項に記載の装置。
- 細長状体の内部に液体容器を、および、液体容器から管状要素の近位管腔への液体通路をさらに備える、請求項27~29のいずれか1項に記載の装置。
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GB201704205D0 (en) | 2017-05-03 |
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AU2017235845A1 (en) | 2018-10-18 |
US20200330269A1 (en) | 2020-10-22 |
EP3429519A2 (en) | 2019-01-23 |
CN109640899B (zh) | 2022-04-08 |
EP3429518B1 (en) | 2023-04-26 |
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GB2548988A (en) | 2017-10-04 |
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JP2019509122A (ja) | 2019-04-04 |
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WO2017158366A3 (en) | 2017-11-30 |
ES2950350T3 (es) | 2023-10-09 |
GB2548987A (en) | 2017-10-04 |
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