JP2018534083A - 持続放出性薬物送達機器用の多孔質構造体 - Google Patents
持続放出性薬物送達機器用の多孔質構造体 Download PDFInfo
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- A61M2205/00—General characteristics of the apparatus
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- A61M2205/125—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated filters
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Abstract
Description
本出願は、それらの全内容が参照により完全に本明細書に援用される、「Porous Structures for Extended Release Drug Delivery Devices」と題した、2015年11月20日出願の米国仮特許出願第62/258,054号および「Porous Structures for Extended Release Drug Delivery Devices」と題した、2015年11月20日出願の第62/258,127号の優先権を主張するものである。
Claims (45)
- 持続放出性薬物送達のための治療用機器であって、
治療薬を受け取るように構成され、前記治療薬をリザーバから患者へ長時間かけて送達するための出口を有する、補充可能なリザーバと、
前記リザーバの出口付近に連結された、焼結材料から形成させる、多孔質構造体と、
前記多孔質構造体の表面上のまたはそれに隣接する前記リザーバに連結され、それにより前記治療薬が出口を通じて前記リザーバから送達される際に前記多孔質構造体および障壁層の両方を通過するようになっている、障壁層と
を備え、
前記多孔質構造体が、ある拡散率で前記治療薬を送達するように調節され、前記障壁層が、前記多孔質構造体に遮断される平均粒径範囲外の平均粒径範囲内の平均粒径を有する粒子の通過を遮断するように適合される、前記治療用機器。 - 障壁層に遮断される平均粒径範囲が、約0.01μmより大きい、請求項1に記載の治療用機器。
- 障壁層に遮断される平均粒径範囲が、約1nmより大きい、請求項1に記載の治療用機器。
- 多孔質構造体が、約3ミクロンから約50ミクロンの間の平均細孔径を有し、障壁層が、約0.01ミクロンから約0.1ミクロンの間の平均細孔径を有する、請求項1に記載の治療用機器。
- 多孔質構造体の表面が、前記多孔質構造体の内側対向面および前記多孔質構造体の外側対向面の一方または両方であり、前記内側対向面はリザーバに面し、前記外側対向面は前記リザーバの外側にある、請求項1〜4のいずれか一項に記載の治療用機器。
- 障壁層がリザーバ内で連結され、多孔質構造体の内側対向面に近位の距離で間隔をあけている、請求項1〜5のいずれか一項に記載の治療用機器。
- 障壁層が、金属銀、酢酸セルロース、セラミック、ガラス繊維、ホウケイ酸塩繊維、混合セルロースエステル(MCE)、ナイロン、ポリアクリロニトリル(PAN)、ポリカーボネートトラックエッチ(PCTE)、ポリエーテルスルホン(PES)、ポリエステルトラックエッチ(PETE)、ポリプロピレン(PP)、PTFE、およびPVDFからなる群から選択される材料で形成されたフィルター膜である、請求項1〜6のいずれか一項に記載の治療用機器。
- 焼結材料がステンレス鋼またはチタンである、請求項1〜7のいずれか一項に記載の治療用機器。
- 多孔質構造体が、第1の平均細孔径を有する細孔を有し、障壁層が、第2の平均細孔径の細孔を有するフィルター膜であり、前記第1の平均細孔径が、前記第2の平均細孔径と同等または前記第2の平均細孔径より大きい、請求項1に記載の治療用機器。
- フィルター膜の存在下で多孔質構造体を通る治療薬の拡散率が、フィルター膜の不在下で多孔質構造体を通る治療薬の拡散率と実質的に同じである、請求項9に記載の治療用機器。
- 第2の平均細孔径が、平均粒径範囲内の平均粒径を有する粒子の通過を遮断するのに有効であり、障壁層の平均粒径範囲が0.2ミクロン以下であり、治療薬の平均粒径範囲より大きい、請求項9に記載の治療用機器。
- 障壁層によって遮断された粒子が、微生物、細菌、真菌胞子、免疫細胞、または抗体の1つ以上を含む、請求項1〜11のいずれか一項に記載の治療用機器。
- 多孔質構造体が第1の多孔率を有し、障壁層が第2の多孔率を有し、前記第1の多孔率が前記第2の多孔率より高く、前記第1の多孔率が約16%から約30%であり、前記第2の多孔率が約1%から約15%である、請求項1に記載の治療用機器。
- 多孔質構造体が、約70ミクロンから約5000ミクロンの厚さを有し、障壁層が、約10nmから約150ミクロンの厚さを有する、請求項1に記載の治療用機器。
- 障壁層が、リザーバ内への陽圧の適用において、多孔質構造体を通る治療薬のボーラス放出を軽減する、請求項1〜14のいずれか一項に記載の治療用機器。
- 持続放出性薬物送達用の治療用機器であって、前記機器が、
治療薬を受け取るように構成され、前記治療薬をリザーバから患者へ送達するための出口を有する補充可能なリザーバと、
前記リザーバの出口付近に連結され、焼結材料から形成される多孔質構造体と、
前記多孔質構造体の表面上のまたはそれに隣接する前記リザーバに連結され、それにより治療薬が出口を通じて前記リザーバから送達される際に前記多孔質構造体および障壁層の両方を通過するようになっている障壁層と
を含み、
前記障壁層が、通過する汚染物質が多孔質構造体を通じて眼に入るのを遮断するように構成されている、または通過する汚染物質が多孔質構造体を通じてリザーバに入るのを遮断するように構成されている、または通過する汚染物質が多孔質構造体を通じて眼およびリザーバに入るのを遮断するように構成されている、前記治療用機器。 - 汚染物質が、微生物、細菌、真菌胞子、免疫細胞、および抗体の1つ以上を含む、請求項16に記載の治療用機器。
- 前記障壁層が、リザーバ内の圧力が上昇した際に治療薬のボーラス放出を軽減する、請求項16に記載の治療用機器。
- 持続放出性薬物送達用の治療用機器であって、前記機器が、
1種以上の治療薬を受け取るように構成され、治療薬をリザーバから患者へ送達するための出口を有する補充可能なリザーバと、
前記リザーバの出口付近に連結され、焼結材料から形成され、第1の多孔率および第1の平均細孔径を有する多孔質構造体と、
多孔質構造体の表面上のまたはそれに隣接するリザーバに連結され、それにより治療薬が出口を通じて前記リザーバから送達される際に前記多孔質構造体および障壁層の両方を通過するようになり、第2の多孔率および第2の平均細孔径を有するフィルター膜である障壁層と
を含み、
前記第1の多孔率が、前記第2の多孔率より高く、前記第1の平均細孔径が、第2の平均細孔径と同等または第2の平均細孔径より大きい、前記治療用機器。 - 持続放出性薬物送達用の治療用機器の製造方法であって、前記方法が、
多孔率(P)、表面積(A)、ねじれ(T)、および厚さ(L)を含めた特定の特性を有する第1の多孔質構造体を選択すること、ここで前記特定の特性は、放出率指数=PA/TLに従って第1の多孔質構造体を通る分子の分子拡散率に影響する、と、
第1の多孔質構造体に対して非破壊試験を実施し、性能結果を得ること、前記非破壊試験は、ガス流量試験、泡立ち点試験、および圧減衰試験からなる群から選択される、と、
受動的濃度勾配によって駆動される分子拡散に従って第2の多孔質構造体を通る分子の拡散率を測定し、測定拡散率を得ること、ここで前記第2の多孔質構造体が、前記第1の多孔質構造体と同じ特定の特性を有する、と、
性能結果と前記測定拡散率を相関させ、相互関係を形成することと、
前記相互関係を使用して、少なくとも特定の特性を有する第3の多孔質構造体を通る分子の測定拡散率を推定することと
を含む、方法。 - 前記第1の多孔質構造体および前記第2の多孔質構造体が、同じ多孔質構造体または異なる多孔質構造体である、請求項20に記載の方法。
- 特定の特性を有する多孔質構造体上に多孔質コーティングを形成することをさらに含む請求項20に記載の方法であって、多孔質コーティングの形成が、
(a)キャリア流体中に易焼結性粒子の懸濁液を形成する工程、
(b)超音波スプレーノズルを使用して前記懸濁液で前記多孔質構造体を被覆する工程、および
(c)前記多孔質構造体に易焼結性粒子を焼結し、被覆多孔質構造体を形成する工程
を含む、前記方法。 - 易焼結性粒子が、50ナノメートルから350ナノメートルの平均粒径を有するステンレス鋼粒子である、請求項22に記載の方法。
- 被覆多孔質構造体に対して非破壊試験を実施し、被覆構造体の性能結果を得ることをさらに含む、請求項22に記載の方法。
- 被覆構造体の性能結果が、第1の多孔質構造体の性能結果と有意に異なるかを判定することをさらに含む、請求項24に記載の方法。
- 被覆多孔質構造体を通る分子の拡散率を測定し、被覆構造体の拡散率を得ることをさらに含む、請求項24に記載の方法。
- 被覆構造体の性能結果に基づいて被覆多孔質構造体を通る分子の測定拡散率を推定することをさらに含む、請求項24に記載の方法。
- 持続放出性薬物送達用の治療用機器であって、前記機器が、
1種以上の治療薬を保持するように構成され、前記1種以上の治療薬をリザーバから患者へ送達するための出口を有する補充可能なリザーバと、
出口付近のリザーバに連結され、焼結材料から形成され、第1の多孔率および第1の平均細孔径を有する多孔質構造体と、
多孔質構造体の表面上にあり、またはそれに隣接し、それにより1種以上の治療薬が出口を通じてリザーバから送達される際に前記多孔質構造体および障壁層の両方を通過するようになり、前記障壁層が第2の多孔率および第2の平均細孔径を有し、ここで第1の多孔率が第2の多孔率より高く、第1の平均細孔径が第2の平均細孔径と同じまたはそれより大きい障壁層と
を含み、
ここで前記障壁層が、前記多孔質構造体の表面に焼結されたステンレス鋼粒子のコーティングまたはチタン粒子のコーティングから形成される、前記機器。 - 多孔質構造体の表面が、多孔質構造体の内側対向面および多孔質構造体の外側対向面の一方または両方を含み、内側対向面が前記リザーバに面し、外側対向面がリザーバの外側にある、請求項28に記載の機器。
- 多孔質構造体の第1の平均細孔径が、約3ミクロンから約50ミクロンの間である、請求項28に記載の機器。
- 障壁層を有する多孔質構造体を通る1種以上の治療薬の拡散率が、障壁層が無い多孔質構造体を通る1種以上の治療薬の拡散率と実質的に同じである、請求項28に記載の機器。
- 第2の平均細孔径が、第2のサイズ分子の通過の遮断に有効であり、前記第2のサイズ分子が0.2ミクロンと等しいかまたはそれより大きい、請求項28に記載の機器。
- 第2の平均細孔径が0.2ミクロンである、請求項28に記載の機器。
- 障壁層が、第2のサイズ分子の通過を遮断し、前記第2のサイズ分子がリザーバから機器の外側を通過するのを阻害し、前記第2のサイズ分子が1種以上の微生物を含む、請求項28に記載の機器。
- 障壁層が、第2のサイズ分子の通過を遮断し、第2のサイズ分子が機器の外側からリザーバ内に入るのを阻害し、前記第2のサイズ分子が1種以上の微生物または免疫細胞を含む、請求項28に記載の機器。
- 第1の多孔率が約16%から約30%であり、第2の多孔率が約1%から約15%である、請求項28に記載の機器。
- 多孔質構造体が、約70ミクロンから約5000ミクロンの厚さを有し、障壁層が約10nmから約150ミクロンの厚さを有する、請求項28に記載の機器。
- 障壁層が、リザーバ内に陽圧を適用する際、多孔質構造体を通る1種以上の治療薬のボーラス放出を軽減する、請求項28に記載の機器。
- 持続放出性薬物送達用の治療用機器の製造方法であって、前記方法が、
チタン粒径、多孔率および厚さを含む特定の特性を有する第1の多孔質構造体を選択することと、
第1の多孔質構造体に対して非破壊試験を実施し、性能結果を得ること、前記非破壊試験は、ガス流量試験、泡立ち点試験、および圧減衰試験からなる群から選択される、と、
受動的濃度勾配によって駆動される分子拡散に従って第2の多孔質構造体を通る分子の拡散率を測定し、測定拡散率を得ること、前記第2の多孔質構造体が、前記第1の多孔質構造体と同じ特定の特性を有する、と、
性能結果と測定拡散率を相関させ、相互関係を形成することと、
前記相互関係を使用して、少なくとも特定の特性を有する第3の多孔質構造体を通る分子の測定拡散率を推定することと
を含む、方法。 - 第1の多孔質構造体および第2の多孔質構造体が、同じ多孔質構造体または異なる多孔質構造体である、請求項39に記載の方法。
- 特定の特性を有する多孔質構造体上に多孔質コーティングを形成することが、プラズマ化学気相成長法を使用する多孔質構造体上に薄膜チタンコーティングを堆積し、被覆多孔質構造体を得ることをさらに含む、請求項39に記載の方法。
- 被覆多孔質構造体に対して非破壊試験を実施し、被覆構造体の性能結果を得ることをさらに含む、請求項41に記載の方法。
- 前記被覆構造体の性能結果が、第1の多孔質構造体の性能結果と有意に異なるかを判定することをさらに含む、請求項42に記載の方法。
- 被覆多孔質構造体を通る分子の拡散率を測定し、被覆構造体の拡散率を得ることをさらに含む、請求項42に記載の方法。
- 被覆構造体の性能結果に基づいて、被覆多孔質構造体を通る分子の測定拡散率を推定することをさらに含む、請求項42に記載の方法。
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EP3377009A4 (en) | 2019-07-24 |
JP2021175512A (ja) | 2021-11-04 |
US20210205130A1 (en) | 2021-07-08 |
BR112018010063A2 (pt) | 2018-11-13 |
KR20180084104A (ko) | 2018-07-24 |
CA3005238A1 (en) | 2017-05-26 |
EP3377009A1 (en) | 2018-09-26 |
AU2016355345A1 (en) | 2018-05-31 |
JP6912475B2 (ja) | 2021-08-04 |
IL259273A (en) | 2018-07-31 |
US11432959B2 (en) | 2022-09-06 |
CN113069681A (zh) | 2021-07-06 |
CN113069681B (zh) | 2022-12-23 |
CN108430405B (zh) | 2021-04-13 |
WO2017087902A1 (en) | 2017-05-26 |
CN108430405A (zh) | 2018-08-21 |
MX2018006234A (es) | 2018-08-14 |
EP3377009B1 (en) | 2020-10-28 |
US20230072346A1 (en) | 2023-03-09 |
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