JP2018516096A - 上部尿路への薬剤の局所的な送達装置及び方法 - Google Patents
上部尿路への薬剤の局所的な送達装置及び方法 Download PDFInfo
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Abstract
【選択図】図1A
Description
本願は、2015年3月30日に出願された、米国仮特許出願第62/140,077号に対する優先権を主張し、その全体的な内容が、参照により本明細書に組み込まれる。
Claims (40)
- 薬剤の投与を必要とする患者に薬剤を投与する方法であって、
膀胱端部、腎臓端部、及び前記膀胱端部と前記腎臓端部との間に延在する薬剤管腔を有する可撓性の細長い本体を備える薬剤送達装置を、前記患者の尿道及び膀胱を通して、前記患者の尿管のうちの少なくとも1つへと挿入することであって、その結果、前記装置の前記膀胱端部が前記患者の前記膀胱内に配置され、前記装置の前記腎臓端部が前記患者の腎臓内に配置され、前記膀胱端部が、半透過性の壁によって少なくとも部分的に画定され、かつ薬剤を含有する薬剤リザーバを備える、挿入することと、
前記薬剤リザーバから前記薬剤管腔を通して、かつ前記装置から前記装置の前記腎臓端部にある開口を通して、腎盂へと前記薬剤を圧送するための浸透圧を生成するように、前記膀胱内の水が前記装置の前記半透過性の壁を通して拡散することを可能にすることと、を含む、方法。 - 前記薬剤が、1日〜90日の治療期間にわたって継続的に腎盂へと放出される、請求項1に記載の方法。
- 前記装置が前記患者へと挿入された後に、前記装置の前記薬剤リザーバを液体で充填するステップを含まない、請求項1に記載の方法。
- 前記薬剤送達装置が、前記患者内の腎臓結石の治療のために体外衝撃波結石破砕術により前記患者を治療した後に挿入される、請求項1に記載の方法。
- 前記患者が、尿路感染症または腎盂腎炎の治療または予防を必要としている、請求項1に記載の方法。
- 前記薬剤が、抗菌剤を含む、請求項5に記載の方法。
- 前記薬剤が、アミノグリコシド、ペネム、または鉄模倣物を含む、請求項5に記載の方法。
- 前記薬剤が、抗生剤、抗菌剤、抗真菌剤、抗ウィルス剤、抗寄生虫剤、消毒剤、または防腐剤を含む、請求項5に記載の方法。
- 前記薬剤が、トリメトプリム/スルファメトキサゾール、トリメトプリム、シプロフロキサシン、レボフロキサシン、ノルフロキサシン、ガチフロキサシン、オフロキサシン、ニトロフラントイン、ホスホマイシン、ピブメシリナム、セフポドキシムプロキセチル、セフチブテン、セフォタキシム、セフトリアキソン、セフタジジム、セフェピム、アモキシシリン/クラブラン酸、ピペラシリン/タゾバクタム、ゲンタマイシン、アミカシン、エルタペネム、イミペネム/シラスタチン、メロペネム、ドリペネム、アズトレオナム、ガリウム系鉄模倣物、及びそれらの組み合わせからなる群から選択される、請求項5に記載の方法。
- 前記薬剤が、再発性の尿路感染症または腎盂腎炎を予防するために非病原性の細菌を尿生殖路に定着させるための弱毒化された細菌/病原体を含む、請求項5に記載の方法。
- 前記患者が、腎細胞癌の治療を必要としている、請求項1に記載の方法。
- 前記薬剤が、エベロリムス、アルデスロイキン、ベバシズマブ、アキシチニブ、ソラフェニブトシラート、塩酸パゾパニブ、アルデスロイキン、スニチニブリンゴ酸塩、テムシロリムス、及びそれらの組み合わせからなる群から選択される、請求項11に記載の方法。
- 前記患者が、上部尿路上皮癌の治療を必要としている、請求項1に記載の方法。
- 前記薬剤が、カルメットゲラン菌(BCG)、マイトマイシンC、BCG/インターフェロン、インターフェロン−2a、エピルビシン、ドキソルビシン、チオテパ、ゲムシタビン、及びそれらの組み合わせからなる群から選択される、請求項13に記載の方法。
- 前記患者が、線溶活性亢進の治療を必要としている、請求項1に記載の方法。
- 前記薬剤が、トラネキサム酸、アミノカプロン酸、及びそれらの組み合わせからなる群から選択される、請求項15に記載の方法。
- 前記患者が、尿路結石の治療を必要としている、請求項1に記載の方法。
- 前記薬剤が、抗菌剤、アルカリ化剤、酸性化剤、ウレアーゼ阻害剤、及びそれらの組み合わせからなる群から選択される、請求項17に記載の方法。
- 前記薬剤が、抗炎症剤または抗線維化剤を含む、請求項1に記載の方法。
- 前記薬剤送達装置の挿入が、前記薬剤送達装置を尿管ステント内に、またはこれに隣接して位置付けることを含む、請求項1〜19のいずれか一項に記載の方法。
- 前記可撓性の細長い本体が、尿管ステントであり、前記膀胱端部と前記腎臓端部との間に延在する排出管腔をさらに含む、請求項1〜19のいずれか一項に記載の方法。
- 腎盂に薬剤を投与するための薬剤送達装置であって、
膀胱端部、腎臓端部、及び前記膀胱端部と前記腎臓端部との間に延在する薬剤管腔を有する可撓性の細長い本体と、
前記膀胱端部に配置され、薬剤を含有し、かつ半透過性の壁によって少なくとも部分的に画定された薬剤リザーバと、を備え、
前記薬剤管腔が、前記薬剤リザーバへの第1の端開口及び前記可撓性の細長い本体の前記腎臓端部にある第2の端開口を有し、
前記装置が、使用時に、前記薬剤リザーバから前記薬剤管腔を通して、かつ前記装置から前記第2の端開口を通して、前記薬剤を圧送するための浸透圧を生成するように、水が前記半透過性の壁を通して前記薬剤リザーバに進入することを可能にするように構成されている、薬剤送達装置。 - 前記可撓性の細長い本体が、前記膀胱端部において、前記腎臓端部におけるより大きい外径を有する、請求項22に記載の装置。
- 前記膀胱端部が、カール/コイル構成で付勢されている保形ワイヤをさらに備える、請求項22に記載の装置。
- 前記可撓性の細長い本体の前記膀胱端部が、前記保形ワイヤが配置されるワイヤ管腔を備える、請求項24に記載の装置。
- 前記膀胱端部が、カール/コイル構成で前記膀胱端部を付勢するように設定された形状設定ポリマーを含む、請求項22に記載の装置。
- 前記薬剤が、固形状または半固形状であり、使用時に、前記半透過性の壁を通して前記薬剤リザーバに進入することを可能にされた前記水が、前記薬剤を可溶化し、前記浸透圧が、前記薬剤リザーバから前記薬剤管腔を通して、かつ前記装置から前記第2の端開口を通して、前記可溶化された薬剤を圧送する、請求項22に記載の装置。
- 前記薬剤リザーバが、1つ以上の薬学的に許容可能な賦形剤をさらに含有する、請求項22に記載の装置。
- 前記1つ以上の薬学的に許容可能な賦形剤が、浸透圧剤を含む、請求項28に記載の装置。
- 前記半透過性の壁が、シリコーン、ポリウレタン、またはそれらの組み合わせを含む、請求項22に記載の装置。
- 前記薬剤が、尿路感染症、腎盂腎炎、腎細胞癌、線溶活性亢進、上部尿路上皮癌、または結石の治療または予防に有効な薬剤から選択される、請求項22に記載の装置。
- 前記可撓性の細長い本体が、前記膀胱端部と前記腎臓端部との間に略直線状の中央部分を有し、前記膀胱端部及び腎臓端部のうちの1つまたは両方がコイル状である、請求項22に記載の装置。
- 前記薬剤リザーバが、前記薬剤送達装置が患者へと挿入される前に、前記薬剤が充填されるように構成されている、請求項22に記載の装置。
- 前記薬剤送達装置が、尿管ステント内に、またはこれに隣接して展開されるように構成される、請求項22〜33のいずれか一項に記載の装置。
- 前記可撓性の細長い本体が、尿管ステントであり、前記膀胱端部と前記腎臓端部との間に延在する排出管腔をさらに備える、請求項22〜33のいずれか一項に記載の装置。
- 前記薬剤管腔が、前記可撓性の細長い本体内に画定され、前記排出管腔と平行に延在している、請求項35に記載の装置。
- 前記薬剤リザーバが、環状形状を有し、前記排出管腔を囲んでいる、請求項35に記載の装置。
- 前記薬剤リザーバが、非環状であり、前記排出管腔の片側に沿って位置付けられている、請求項35に記載の装置。
- 前記可撓性の細長い本体が、前記排出管腔に対して開かれている複数の側排出口を有する側壁を有する、請求項35に記載の装置。
- 部品のキットであって、
膀胱滞留端及び腎臓滞留端を有する尿管ステントを備える第1の部品と、
前記膀胱滞留端で、またはこの周りで前記尿管ステントに取り付けるように構成された薬剤リザーバを備える薬剤送達装置を備える第2の部品であって、前記薬剤リザーバが、薬剤を含有し、前記薬剤リザーバに接続された第1の端及び前記尿管ステントの前記腎臓滞留端に、またはこの周りに位置付け可能な対向する第2の端を有する毛細管と流体連通している、第2の部品と、を備える、キット。
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PCT/US2016/024935 WO2016160934A1 (en) | 2015-03-30 | 2016-03-30 | Devices and methods for local delivery of drug to upper urinary tract |
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