JP6172725B2 - 少なくとも1種のポリエステルブロック及びポリ(エチレングリコール)ブロックを含むブロックコポリマー - Google Patents
少なくとも1種のポリエステルブロック及びポリ(エチレングリコール)ブロックを含むブロックコポリマー Download PDFInfo
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Description
[0001]本発明は、埋込型デバイス用のコーティングからの薬物の放出を制御するための少なくとも1種のポリエステルブロック(複数可)及びポリ(エチレングリコール)ブロックを含むブロックコポリマーに関する。
[0002]経皮冠動脈インターベンション(PCI)は、心臓病の一治療手技である。バルーン部分を有するカテーテルアッセンブリーを、橈骨動脈、上腕動脈又は大腿動脈を介して患者の心血管系に経皮的に導入する。カテーテルアッセンブリーを、冠動脈血管系を通してバルーン部分が閉塞性病変を通る位置まで進める。閉塞性病変を通る位置に進むと、バルーンを所定のサイズに膨らませて、病変の動脈硬化性プラークを放射状に加圧して管腔壁を再形成する。次いで、カテーテルを患者の血管系から引き抜けるように、バルーンをより小さな断面に収縮させる。
[0007]本発明の一態様によれば、埋込型デバイスが提供される。埋込型デバイスは、少なくとも1種のポリエステルブロック及び少なくとも1種のポリ(エチレングリコール)(PEG)ブロックを含むブロックコポリマーを含む。PEGブロックは、約1,000ダルトン〜約30,000ダルトンの重量平均分子量(Mw)を有する。ブロックコポリマーは、生体溶解性であり、生理環境に曝されると、ブロックコポリマーの80質量%が約1日〜約90日の期間に溶解する。
[0019]本発明は、ポリ(エチレングリコール)(PEG)ブロック及び少なくとも1種のポリエステルブロックを含むブロックコポリマーを提供する。ブロックコポリマーは、コーティングからの薬物の放出を制御するためのコーティングを、埋込型デバイス上に形成し得る。ポリエステルブロックは、疎水性であり、ブロックコポリマーに疎水性を付与し、PEGブロックは、親水性であり、ブロックコポリマーに親水性を付与する。ブロックコポリマーは、一般的に、約60,000ダルトン以上、より好ましくは、約100,000ダルトン以上の重量平均分子量(Mw)を有する。
[0032]適用可能な限りは、以下に提供される本発明の説明を通して使用されるいくつかの用語に対する定義が適用されるものとする。
ポリマー及びコーティングに関して、「生分解性(biologically degradable)」(又は「生分解性(biodegradable)」)、「生体侵食性(biologically erodable)」(又は「生体侵食性(bioerodable)」)、「生体吸収性(biologically absorbable)」(又は「生体吸収性(bioabsorbable)」)、及び「生体再吸収性(biologically resorbable)」(又は「生体再吸収性(bioresorbable)」)という用語は、互換的に使用され、生理的状態に曝露された場合、時間とともに完全に又は実質的に完全に分解、溶解、及び/又は侵食され得る、身体によって徐々に再吸収、吸収及び/又は排出され得る、又は動物(例えば、ヒト)の腎臓膜を通して透過し得る断片、例えば、約40,000ダルトン(40Kダルトン)又はこれを下回る分子量を有する断片に分解され得るポリマー及びコーティングを意味する。ポリマー又はコーティングの分解及び結果としての吸収及び排出の過程は、例えば、加水分解、代謝過程、酸化、酵素過程、バルク又は表面侵食などによって引き起こされ得る。反対に、「生体安定性(biostable)」ポリマー又はコーティングは、耐久性のある生分解性ではないポリマー又はコーティングを意味する。
[0051]いくつかの実施形態において、本明細書に記載された埋込型デバイスは、少なくとも1種の生物活性(biologically active)(「生物活性(bioactive)」)剤を場合によって含むことができる。少なくとも1種の生物活性剤は、患者のために治療、予防又は診断効果を発揮し得る任意の物質を含むことができる。
[0073]本明細書に記載された1つ又は複数の他の実施形態と場合によって組み合わせた、本発明のいくつかの実施形態によれば、埋込型デバイス(例えば、ステント)上に配置されたコーティングは、コーティングの任意の設計による層中に、本明細書に記載されたブロックコポリマーを含むことができる。コーティングは、以下に記載される層(2)である少なくとも1つの貯蔵層を含み、以下の(1)、(3)、(4)及び(5)層又はこれらの組合せのうちのいずれかを含むことができる多層構造であり得る。
(1)プライマー層、(場合による)
(2)少なくとも1種のポリマーを含む薬物−ポリマー層(薬物−ポリマー層)又は、代わりにポリマーを含まない薬物層であり得る貯蔵層(「マトリックス層」又は「薬物マトリックス」とも呼ばれる)、
(3)放出制御層(「律速層」とも呼ばれる)(場合による)、
(4)トップコート層、及び/又は(場合による)、
(5)仕上げコート層、(場合による)。
いくつかの実施形態において、本発明のコーティングは、2つ以上の上記の貯蔵層を含むことができ、この貯蔵層の各々は、本明細書に記載された生物活性剤を含むことができる。
[0086]本明細書に記載の1つ又は複数の他の実施形態と場合によって組み合わせた、本発明の他の実施形態は、埋込型デバイスの製作方法に関する。一実施形態において、上記方法は、場合によって1種又は複数の他の生分解性又は生体安定性ポリマー又はコポリマーとともに、本明細書に記載のブロックコポリマーを含む材料で埋込型デバイスを形成することを含む。
[0092]本発明による埋込型デバイスを用いて、種々の状態又は障害を治療、予防又は診断することができる。このような状態又は障害の例には、それだけには限らないが、アテローム性動脈硬化、血栓症、再狭窄、出血、血管解離、血管穿孔、血管動脈瘤、不安定プラーク、慢性完全閉塞、卵円孔開存、跛行、血管及び人工グラフトの吻合部増殖、動静脈吻合、胆管閉塞、尿道閉塞及び腫瘍性閉塞が含まれる。埋込型デバイスの1部分又は全体のデバイス自体を、本明細書に記載の材料で形成することができる。例えば、上記材料はデバイスの少なくとも1部分上に配置されたコーティングであり得る。
Claims (16)
- ブロックコポリマーを含み、前記ブロックコポリマーは少なくとも1種のポリエステルブロック及び少なくとも1種のポリ(エチレングリコール)(PEG)ブロックを含む埋込型デバイスであって、
前記PEGブロックは1,000ダルトン〜30,000ダルトンの重量平均分子量(Mw)を有し、
前記ブロックコポリマーは生体溶解性であり、
前記ブロックコポリマーが、前記埋込型デバイスの本体構造の少なくとも1部分を形成しており、
前記ポリエステルブロックがグリコリドを含み、前記ポリエステルブロック中の前記グリコリドが、10%〜75%の間のモル濃度を有し、
前記ブロックコポリマーが、ポリアンヒドリド、ポリ(エステルアミド)、ポリチオエステル、及びこれらの組合せからなる群から選択される生分解性サイドブロックを含む、埋込型デバイス。 - 前記ポリエステルブロックがラクチドを含む、請求項1に記載の埋込型デバイス。
- 前記ラクチドがD,L−ラクチド、L−ラクチド、D−ラクチド、メソ−ラクチド又はこれらの組合せを含む、請求項2に記載の埋込型デバイス。
- 前記ポリエステルブロック中の前記ラクチドが、少なくとも60%のモル濃度を有する、請求項3に記載の埋込型デバイス。
- 前記ポリエステルブロック中の前記ラクチドが、少なくとも80%のモル濃度を有する、請求項4に記載の埋込型デバイス。
- 前記ポリエステルブロックがカプロラクトンからの単位を含む、請求項1に記載の埋込型デバイス。
- 前記ブロックコポリマーが60,000ダルトン以上のMwを有する、請求項1に記載の埋込型デバイス。
- 前記ブロックコポリマーが100,000ダルトン以上のMwを有する、請求項1に記載の埋込型デバイス。
- 前記埋込型デバイスの本体構造が生物活性剤をさらに含む、請求項1〜8のいずれか一項に記載の埋込型デバイス。
- 前記生物活性剤が、パクリタキセル、ドセタキセル、エストラジオール、17−ベータ−エストラジオール、一酸化窒素供与体、超酸化物不均化酵素、超酸化物不均化酵素模倣薬、4−アミノ−2,2,6,6−テトラメチルピペリジン−1−オキシル、バイオリムス、タクロリムス、デキサメタゾン、酢酸デキサメタゾン、コルチコステロイド、ラパマイシン、ラパマイシン誘導体、40−O−(2−ヒドロキシ)エチル−ラパマイシン(エベロリムス)、40−O−(3−ヒドロキシ)プロピル−ラパマイシン、40−O−[2−(2−ヒドロキシ)エトキシ]エチル−ラパマイシン、40−O−テトラゾール−ラパマイシン、40−エピ−(N1−テトラゾリル)−ラパマイシン、ゾタロリムス、40−O−(2−エトキシ)エチル−ラパマイシン、デホロリムス、γ−ヒリダン、クロベタゾール、ピメクロリムス、メシル酸イマチニブ、ミドスタウリン、cRGD、フェノフィブレート、及びこれらの組合せから選択される、請求項9に記載の埋込型デバイス。
- ステントである、請求項1に記載の埋込型デバイス。
- 生体吸収性ステントである、請求項1に記載の埋込型デバイス。
- ステントである、請求項9に記載の埋込型デバイス。
- ステントである、請求項10に記載の埋込型デバイス。
- 請求項1〜14のいずれか一項に記載の埋込型医療デバイスの製作方法。
- 再狭窄、アテローム性動脈硬化、血栓症、出血、血管解離又は血管穿孔、血管動脈瘤、不安定プラーク、慢性完全閉塞、跛行、吻合部増殖(血管及び人工グラフトに対する)、胆管閉塞、尿道閉塞、腫瘍性閉塞、又はこれらの組合せからなる群から選択される病態を治療、又は改善するための、請求項1〜14のいずれか一項に記載の埋込型デバイス。
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US12/106,212 US8916188B2 (en) | 2008-04-18 | 2008-04-18 | Block copolymer comprising at least one polyester block and a poly (ethylene glycol) block |
US12/106,212 | 2008-04-18 |
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US20080243228A1 (en) | 2007-03-28 | 2008-10-02 | Yunbing Wang | Implantable medical devices fabricated from block copolymers |
US20130230564A1 (en) | 2007-10-10 | 2013-09-05 | Abbott Cardiovascular Systems Inc. | Semi-Crystalline Composition For Coating |
US20090110713A1 (en) | 2007-10-31 | 2009-04-30 | Florencia Lim | Biodegradable polymeric materials providing controlled release of hydrophobic drugs from implantable devices |
US8642062B2 (en) | 2007-10-31 | 2014-02-04 | Abbott Cardiovascular Systems Inc. | Implantable device having a slow dissolving polymer |
US8916188B2 (en) | 2008-04-18 | 2014-12-23 | Abbott Cardiovascular Systems Inc. | Block copolymer comprising at least one polyester block and a poly (ethylene glycol) block |
US20090297584A1 (en) | 2008-04-18 | 2009-12-03 | Florencia Lim | Biosoluble coating with linear over time mass loss |
US20090285873A1 (en) | 2008-04-18 | 2009-11-19 | Abbott Cardiovascular Systems Inc. | Implantable medical devices and coatings therefor comprising block copolymers of poly(ethylene glycol) and a poly(lactide-glycolide) |
US20090297578A1 (en) | 2008-06-03 | 2009-12-03 | Trollsas Mikael O | Biosoluble coating comprising anti-proliferative and anti-inflammatory agent combination for treatment of vascular disorders |
-
2008
- 2008-04-18 US US12/106,212 patent/US8916188B2/en not_active Expired - Fee Related
-
2009
- 2009-04-17 EP EP09732729.0A patent/EP2276516B1/en not_active Not-in-force
- 2009-04-17 WO PCT/US2009/041031 patent/WO2009129503A2/en active Application Filing
- 2009-04-17 EP EP16177016.9A patent/EP3108905A1/en not_active Withdrawn
- 2009-04-17 JP JP2011505243A patent/JP5424428B2/ja not_active Expired - Fee Related
-
2013
- 2013-11-21 JP JP2013241159A patent/JP5900928B2/ja not_active Expired - Fee Related
-
2014
- 2014-12-22 US US14/580,101 patent/US20150174300A1/en not_active Abandoned
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2016
- 2016-03-02 JP JP2016040076A patent/JP6172725B2/ja not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
JP5424428B2 (ja) | 2014-02-26 |
JP2011518248A (ja) | 2011-06-23 |
US8916188B2 (en) | 2014-12-23 |
US20150174300A1 (en) | 2015-06-25 |
EP3108905A1 (en) | 2016-12-28 |
WO2009129503A3 (en) | 2010-09-16 |
EP2276516B1 (en) | 2016-07-20 |
WO2009129503A2 (en) | 2009-10-22 |
JP5900928B2 (ja) | 2016-04-06 |
EP2276516A2 (en) | 2011-01-26 |
JP2014057876A (ja) | 2014-04-03 |
JP2016144649A (ja) | 2016-08-12 |
US20090263457A1 (en) | 2009-10-22 |
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