JP5918700B2 - 膨張可能な器具上の生分解性突起 - Google Patents
膨張可能な器具上の生分解性突起 Download PDFInfo
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Landscapes
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- Materials For Medical Uses (AREA)
Description
本発明は、2010年1月29日に出願された米国仮特許出願第61/299,584号明細書の優先権を主張し、この特許は参照によりその内容全体が本明細書に援用される。
はその誘導体;セロトニンおよび/またはその誘導体;セロトニン遮断薬および/またはその誘導体;ストレプトキナーゼおよび/またはその誘導体;スルファサラジンおよび/またはその誘導体;スルホンアミドおよび/またはその誘導体(例えば、スルファメトキサゾール等);硫酸化キチン誘導体;硫酸化多糖類ペプチドグリカン複合体および/またはその誘導体;TH1および/またはその誘導体(例えば、インターロイキン−2、インターロイキン−12、およびインターロイキン−15、γインターフェロン等);チオプロテーゼ阻害剤および/またはその誘導体;タキソールおよび/またはその誘導体(例えば、タキソテール、バッカチン、10−デアセチルタキソール、7−キシロシル−10−デアセチルタキソール、セファロマンニン、10−デアセチル−7−エピタキソール、7−エピタキソール、10−デアセチルバッカチンIII、10−デアセチルセファロマンニン等)、チクリドおよび/またはその誘導体;チクロピジンおよび/またはその誘導体;ダニ抗凝固ペプチドおよび/またはその誘導体;チオプロテーゼ抑制剤および/またはその誘導体;甲状腺ホルモンおよび/またはその誘導体;メタロプロテイナーゼ−1の組織阻害剤および/またはその誘導体;メタロプロテイナーゼ−2の組織阻害剤および/またはその誘導体;組織血漿活性化因子;TNFおよび/またはその誘導体;トコフェロールおよび/またはその誘導体;毒素および/またはその誘導体;トラニラストおよび/またはその誘導体;トランスフォーミング成長因子αおよびβおよび/またはその誘導体;トラピジルおよび/またはその誘導体;トリアゾロピリミジンおよび/またはその誘導体;バピプロストおよび/またはその誘導体;ビンブラスチンおよび/またはその誘導体;ビンクリスチンおよび/またはその誘導体;ジドブジンおよび/またはその誘導体が挙げられるが、これらに限定されるものではない。理解され得るように、生物学的薬剤は、前述の化合物および/または他の化合物の1種類以上の誘導体を含み得る。また、理解され得るように、2種類以上の生物学的薬剤を使用してもよい。典型的には、1つ以上の微細表面構造および/または表面構造、および/または、微細表面構造および/または表面構造上の1つ以上のコーティング上に含まれる、その中に含まれる、および/またはそれと併用される生物学的薬剤の量は、約0.01〜100μg/mm2であるが、他の量を使用してもよい。医療用器具上の、医療用器具内の、および/または医療用器具と併用される2種類以上の生物学的薬剤の量は同じであっても、または異なってもよい。1種類以上の生物学的薬剤は、スプレー(例えば、霧化スプレー法等)、ディップコート、ロールコート、超音波処理、はけ塗り、プラズマ蒸着、蒸着による堆積などの様々な機構により、1つ以上の微細表面構造および/または表面構造、および/または、微細表面構造および/または表面構造上の1つ以上のコーティング上にコーティングされてもよい、および/またはその中に含浸されてもよい。理解され得るように、1つ以上の微細表面構造および/または表面構造が1種類以上の生物学的薬剤を含む場合、1つ以上の微細表面構造および/または表面構造は、1種類以上の生物学的薬剤から部分的にまたは完全に成長形成されてもよい。
[付記1]
身体通路に挿入され、拡張される医療用器具であって、前記身体通路内に配置されている時、膨張および収縮するように設計されている膨張可能な器具を備える医療用器具であり、前記膨張可能な器具は、前記膨張可能な器具の内部空洞内に流体を挿入することによって膨張可能であり、前記膨張可能な器具は、前記膨張可能な器具が膨張するとき、前記身体通路の内壁に少なくとも部分的に貫入するように設計されている表面構造または微細表面構造を備える外面を備える、医療用器具。
[付記2]
前記表面構造または微細表面構造が頂部を備え、前記頂部が生分解性または生体吸収性材料で形成され、前記頂部が生物学的薬剤を含む、付記1に記載の医療用器具。
[付記3]
前記表面構造または微細表面構造が内部通路を備え、前記内部通路が前記膨張可能な器具の前記内部空洞と流体接続し、前記表面構造または微細表面構造が前記身体通路の内壁に貫入するとき、流体が前記内部空洞から流出し、前記内部通路を通って前記身体通路の内壁に入ることを可能にする、付記1に記載の医療用器具。
[付記4]
前記表面構造または微細表面構造が内部通路を備え、前記内部通路が前記膨張可能な器具の前記内部空洞と流体接続し、前記表面構造または微細表面構造が前記身体通路の内壁に貫入するとき、流体が前記内部空洞から流出し、前記内部通路を通って前記身体通路の内壁に入ることを可能にする、付記2に記載の医療用器具。
[付記5]
前記頂部が、前記表面構造または微細表面構造の本体部分から脱離または破断分離するように構成されている、付記2に記載の医療用器具。
[付記6]
前記頂部が、前記表面構造または微細表面構造の本体部分から脱離または破断分離するように構成されている、付記2〜4のいずれか一項に記載の医療用器具。
[付記7]
前記頂部が、a)前記内部空洞内の流体からある一定量の流体圧力を受けた後、b)電流を受けた後、c)電磁放射線を受けた後、d)化学反応を受けた後、e)超音波を受けた後、またはa)〜e)のいずれかの組み合わせの後、前記表面構造または微細表面構造の本体部分から脱離または破断分離するように構成されている、付記2に記載の医療用器具。
[付記8]
前記頂部が、a)前記内部空洞内の流体からある一定量の流体圧力を受けた後、b)電流を受けた後、c)電磁放射線を受けた後、d)化学反応を受けた後、e)超音波を受けた後、またはa)〜e)のいずれかの組み合わせの後、前記表面構造または微細表面構造の本体部分から脱離または破断分離するように構成されている、付記3〜6のいずれか一項に記載の医療用器具。
[付記9]
前記頂部が前記身体通路の壁に貫入した後、前記頂部が前記身体通路から脱離しにくいように構成されており、前記頂部がa)洋こま形の部分を有する、b)矢じり形の部分を有する、c)とげを備える、d)非平滑面を備える、e)角度のついた繊維を備える、f)スパイクを備える、または、前記頂部が前記身体通路から脱離しにくくなることを容易にするa)〜f)のいずれかの組み合わせである、付記2に記載の医療用器具。
[付記10]
前記頂部が前記身体通路の壁に貫入した後、前記頂部が前記身体通路から脱離しにくいように構成されており、前記頂部がa)洋こま形の部分を有する、b)矢じり形の部分を有する、c)とげを備える、d)非平滑面を備える、e)角度のついた繊維を備える、f)スパイクを備える、または、前記頂部が前記身体通路から脱離しにくくなることを容易にするa)〜f)のいずれかの組み合わせである、付記3〜8のいずれか一項に記載の医療用器具。
[付記11]
前記表面構造または微細表面構造の前記本体部分が、a)切欠き、b)狭窄部、c)組成の違い、または、前記頂部が前記本体部分から破断分離することを容易にするa)〜c)のいずれかの組み合わせを備える、付記5に記載の医療用器具。
[付記12]
前記表面構造または微細表面構造の前記本体部分が、a)切欠き、b)狭窄部、c)組成の違い、または、前記頂部が前記本体部分から破断分離することを容易にするa)〜c)のいずれかの組み合わせを備える、付記6〜10のいずれか一項に記載の医療用器具。
[付記13]
前記膨張可能な器具の前記外面が複数の前記表面構造または微細表面構造を備え、前記複数の前記表面構造または微細表面構造がa)前記膨張可能な器具の前記外面に配置され、等間隔で離間している、b)前記膨張可能な器具の前記外面に配置され、不等間隔で離間している、c)前記膨張可能な器具の前記外面の特定の領域にのみ配置されている、d)前記膨張可能な器具の前記外面に帯状に配置されている、またはa)〜d)のいずれかの組み合わせである、付記1に記載の医療用器具。
[付記14]
前記膨張可能な器具の前記外面が複数の前記表面構造または微細表面構造を備え、前記複数の前記表面構造または微細表面構造がa)前記膨張可能な器具の前記外面に配置され、等間隔で離間している、b)前記膨張可能な器具の前記外面に配置され、不等間隔で離間している、c)前記膨張可能な器具の前記外面の特定の領域にのみ配置されている、d)前記膨張可能な器具の前記外面に帯状に配置されている、またはa)〜d)のいずれかの組み合わせである、付記2〜12のいずれか一項に記載の医療用器具。
[付記15]
生物学的薬剤を身体通路に送達する方法であって、
少なくとも1つの表面構造または微細表面構造を有する膨張可能な器具を提供する工程、前記少なくとも1つの表面構造または微細表面構造;
前記膨張可能な器具を前記身体通路内に配置する工程;
前記膨張可能な器具を拡張させて、前記表面構造または微細表面構造の少なくとも1つを前記身体通路の内面の壁に貫入させる工程;
前記少なくとも1つの表面構造または微細表面構造で生物学的薬剤を前記身体通路の前記内面の壁に局所送達する工程;および、
前記膨張可能な器具を前記身体通路から抜去する工程;
を含む方法。
[付記16]
前記表面構造または微細表面構造が頂部を備え、前記頂部が生分解性または生体吸収性材料で形成されており、前記頂部が生物学的薬剤を含む、付記15に記載の方法。
[付記17]
前記表面構造または微細表面構造が内部通路を備え、前記内部通路が前記膨張可能な器具の前記内部空洞と流体接続し、前記表面構造または微細表面構造が前記身体通路の内壁に貫入するとき、流体が前記内部空洞から流出し、前記内部通路を通って前記身体通路の内壁に入ることを可能にし、さらに、流体を前記内部空洞に流入させ、内部空洞を通して流出させ、前記内部通路に流入させた後、前記身体通路の前記内壁に入れる工程を含む、付記15に記載の方法。
[付記18]
前記表面構造または微細表面構造が内部通路を備え、前記内部通路が前記膨張可能な器具の前記内部空洞と流体接続し、前記表面構造または微細表面構造が前記身体通路の内壁に貫入するとき、流体が前記内部空洞から流出し、前記内部通路を通って前記身体通路の内壁に入ることを可能にし、さらに、流体を前記内部空洞に流入させ、内部空洞を通して流出させ、前記内部通路に流入させた後、前記身体通路の前記内壁に入れる工程を含む、付記16に記載の方法。
[付記19]
前記頂部が、前記表面構造または微細表面構造の本体部分から脱離するまたは破断分離するように構成されている、付記16に記載の方法。
[付記20]
前記頂部が、前記表面構造または微細表面構造の本体部分から脱離するまたは破断分離するように構成されている、付記17または18に記載の方法。
[付記21]
前記頂部が、a)前記内部空洞内の流体からある一定量の流体圧力を受けた後、b)電流を受けた後、c)電磁放射線を受けた後、d)化学反応を受けた後、e)超音波を受けた後、またはa)〜e)のいずれかの組み合わせの後、前記表面構造または微細表面構造の本体部分から脱離または破断分離するように構成されており、さらに、前記頂部を前記表面構造または微細表面構造の前記本体部分から分離させて、前記膨張可能な器具を前記身体通路から抜去した後、前記身体通路の前記壁の中に留置させる工程を含む、付記16に記載の方法。
[付記22]
前記頂部が、a)前記内部空洞内の流体からある一定量の流体圧力を受けた後、b)電流を受けた後、c)電磁放射線を受けた後、d)化学反応を受けた後、e)超音波を受けた後、またはa)〜e)のいずれかの組み合わせの後、前記表面構造または微細表面構造の本体部分から脱離または破断分離するように構成されており、さらに、前記頂部を前記表面構造または微細表面構造の前記本体部分から分離させて、前記膨張可能な器具を前記身体通路から抜去した後、前記身体通路の前記壁の中に留置させる工程を含む、付記17〜20のいずれか一項に記載の方法。
[付記23]
前記頂部が前記身体通路の壁に貫入した後、前記頂部が前記身体通路から脱離しにくいように構成されており、前記頂部がa)洋こま形の部分を有する、b)矢じり形の部分を有する、c)とげを備える、d)非平滑面を備える、e)角度のついた繊維を備える、f)スパイクを備える、または、前記頂部が前記身体通路から脱離しにくくなることを容易にするa)〜f)のいずれかの組み合わせである、付記16に記載の方法。
[付記24]
前記頂部が前記身体通路の壁に貫入した後、前記頂部が前記身体通路から脱離しにくいように構成されており、前記頂部がa)洋こま形の部分を有する、b)矢じり形の部分を有する、c)とげを備える、d)非平滑面を備える、e)角度のついた繊維を備える、f)スパイクを備える、または、前記頂部が前記身体通路から脱離しにくくなることを容易にするa)〜f)のいずれかの組み合わせである、付記17〜22のいずれか一項に記載の方法。
[付記25]
前記表面構造または微細表面構造の前記本体部分が、a)切欠き、b)狭窄部、c)組成の違い、または、前記頂部が前記本体部分から破断分離することを容易にするa)〜c)のいずれかの組み合わせを備え、さらに、前記頂部を前記表面構造または微細表面構造の前記本体部分から破断分離させて、前記膨張可能な器具を前記身体通路から抜去した後、前記身体通路の前記壁の中に留置させる工程を含む、付記19に記載の方法。
[付記26]
前記表面構造または微細表面構造の前記本体部分が、a)切欠き、b)狭窄部、c)組成の違い、または、前記頂部が前記本体部分から破断分離することを容易にするa)〜c)のいずれかの組み合わせを備え、さらに、前記頂部を前記表面構造または微細表面構造の前記本体部分から破断分離させて、前記膨張可能な器具を前記身体通路から抜去した後、前記身体通路の前記壁の中に留置させる工程を含む、付記20〜24のいずれか一項に記載の方法。
[付記27]
前記膨張可能な器具の前記外面が複数の前記表面構造または微細表面構造を備え、前記複数の前記表面構造または微細表面構造がa)前記膨張可能な器具の前記外面に配置され、等間隔で離間している、b)前記膨張可能な器具の前記外面に配置され、不等間隔で離間している、c)前記膨張可能な器具の前記外面の特定の領域にのみ配置されている、d)前記膨張可能な器具の前記外面に帯状に配置されている、またはa)〜d)のいずれかの組み合わせである、付記15に記載の方法。
[付記28]
前記膨張可能な器具の前記外面が複数の前記表面構造または微細表面構造を備え、前記複数の前記表面構造または微細表面構造がa)前記膨張可能な器具の前記外面に配置され、等間隔で離間している、b)前記膨張可能な器具の前記外面に配置され、不等間隔で離間している、c)前記膨張可能な器具の前記外面の特定の領域にのみ配置されている、d)前記膨張可能な器具の前記外面に帯状に配置されている、またはa)〜d)のいずれかの組み合わせである、付記16〜26のいずれか一項に記載の方法。
Claims (8)
- 身体通路に挿入され、拡張される医療用器具であって、前記身体通路内に配置されている時、膨張および収縮するように設計されている膨張可能な器具を備える医療用器具であり、
前記膨張可能な器具は、前記膨張可能な器具の内部空洞内に流体を挿入することによって膨張可能であり、
前記膨張可能な器具は、前記膨張可能な器具が膨張するとき、前記身体通路の内壁に少なくとも部分的に貫入するように設計されている表面構造または微細表面構造を備える外面を備え、
前記表面構造または微細表面構造が頂部及び基部を備え、
前記頂部が、前記頂部の底面領域に接続されている脚を有し、
前記脚が前記底面領域に接続されている場所での前記脚の幅は、前記底面領域の横断面に比べ横断面が狭く、
前記基部は前記脚を係脱可能に保持するように構成されている、医療用器具。 - 前記頂部が生分解性または生体吸収性材料で形成され、前記頂部が生物学的薬剤を含む、請求項1に記載の医療用器具。
- 前記表面構造または微細表面構造が内部通路を備え、前記内部通路が前記膨張可能な器具の前記内部空洞と流体接続し、前記表面構造または微細表面構造が前記身体通路の内壁に貫入するとき、流体が前記内部空洞から流出し、前記内部通路を通って前記身体通路の内壁に入ることを可能にする、請求項1又は2に記載の医療用器具。
- 前記頂部が、a)前記内部空洞内の流体からある一定量の流体圧力を受けた後、b)電流を受けた後、c)電磁放射線を受けた後、d)化学反応を受けた後、e)超音波を受けた後、またはa)〜e)のいずれかの組み合わせの後、前記表面構造または微細表面構造の本体部分から脱離または破断分離するように構成されている、請求項1から3のいずれか1項に記載の医療用器具。
- 前記頂部が前記身体通路の壁に貫入した後、前記頂部が前記身体通路から脱離しにくいように構成されており、前記頂部がa)洋こま形の部分を有する、b)矢じり形の部分を有する、c)とげを備える、d)非平滑面を備える、e)角度のついた繊維を備える、f)スパイクを備える、または、前記頂部が前記身体通路から脱離しにくくなることを容易にするa)〜f)のいずれかの組み合わせである、請求項1から4のいずれか1項に記載の医療用器具。
- 前記膨張可能な器具の前記外面が複数の前記表面構造または微細表面構造を備え、前記複数の前記表面構造または微細表面構造がa)前記膨張可能な器具の前記外面に配置され、等間隔で離間している、b)前記膨張可能な器具の前記外面に配置され、不等間隔で離間している、c)前記膨張可能な器具の前記外面の特定の領域にのみ配置されている、d)前記膨張可能な器具の前記外面に帯状に配置されている、またはa)〜d)のいずれかの組み合わせである、請求項1から5のいずれか1項に記載の医療用器具。
- 前記表面構造または微細表面構造の前記頂部が、矢じり形の断面形状を有する円錐形状または逆洋こま形状を有する、請求項1から6のいずれか1項に記載の医療用器具。
- 前記基部は、前記脚に嵌合する通路を有し、
前記通路は、前記膨脹可能な器具の前記内部空洞に流体接続している、請求項1から7のいずれか1項に記載の医療用器具。
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