JP5475950B2 - 制御された薬物送達および調節された生体適合性のための多孔質高分子領域を有する医療機器 - Google Patents
制御された薬物送達および調節された生体適合性のための多孔質高分子領域を有する医療機器 Download PDFInfo
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- JP5475950B2 JP5475950B2 JP2007553364A JP2007553364A JP5475950B2 JP 5475950 B2 JP5475950 B2 JP 5475950B2 JP 2007553364 A JP2007553364 A JP 2007553364A JP 2007553364 A JP2007553364 A JP 2007553364A JP 5475950 B2 JP5475950 B2 JP 5475950B2
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L31/125—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L31/129—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing macromolecular fillers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L27/48—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with macromolecular fillers
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- A—HUMAN NECESSITIES
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Description
ナノ多孔質表面をはじめとする多孔質表面は、細胞受容体と直接相互作用することができ、それにより細胞の多孔質表面への接着または非接着が制御されるということも分かっている。
本発明は、相分離高分子領域、および移植可能なまたは挿入可能な医療機器と関連したそれらの使用に関する。
本発明のいくつかの態様では、(a)少なくとも1つの生体安定性高分子相と、(b)相分離高分子領域がin vivoでナノ多孔質高分子領域となるように生体崩壊を受ける、ナノスケール規模の、少なくとも1つの生体崩壊性高分子相とを含む相分離高分子領域が提供される。
本発明の利点は、多孔質高分子領域が準備された医療機器をin vivoまたはex vivoのいずれかで提供することができるということである。
さらに、患者への投与後に生物活性薬剤を放出する医療機器を提供することができる。例えば、本発明によれば、治療薬が、制御された条件下でex vivoで形成された孔を有する領域の内部にまたは真下に準備された医療機器を提供することができる。もう1つの例として、本発明によれば、高分子領域の内部にまたは真下に準備された治療薬を送達するために生物学的条件下で分解または水和を受け得る相分離高分子領域を含む医療機器を提供することができる。
本発明のこれらの実施態様、および多くの他の実施態様、並びに利点は、以下の詳細な説明、および特許請求の範囲の検討により当業者にはすぐに明らかになるであろう。
本発明は、相分離高分子領域、および移植可能なまたは挿入可能な医療機器と関連したそれらの使用に関する。
本発明のいくつかの態様では、(a)少なくとも1つの生体安定性高分子相と、(b)相分離高分子領域がin vivoでナノ多孔質高分子領域となるように生体崩壊を受ける、ナノスケール規模の、少なくとも1つの生体崩壊性高分子相とを含む相分離高分子領域が提供される。
本発明の他の態様は、少なくとも1つのナノ多孔質高分子領域を有する移植可能なまたは挿入可能な医療機器を作製する方法に向けられる。これらの方法は、(a)安定性高分子相と、ナノスケール規模の崩壊性高分子相とを含む相分離高分子領域を準備すること、(b)その崩壊性高分子相を選択的に除去し、それによりナノ多孔質高分子領域を作り出すことを含む。
本発明と関連して用いる高分子領域は、例えば、機器全体(例えば、ステント、グラフトまたは再生医療用スキャフォールド)に相当するか、または医療機器の一部のみ(例えば、織り込まれた繊維または医療機器基材を覆う被膜層)に相当する。
例えば、ナノ多孔質表面をはじめとするナノ構造表面は、細胞受容体と直接相互作用することができ、それにより細胞および組織のナノ構造表面への接着または非接着が制御されるということが分かっている。
である。本明細書において「コポリマー」とは、少なくとも2個の異なる構成単位を含むポリマーである。
例えば、1以上の安定性高分子相と1以上の崩壊性高分子相は、互いに相分離される少なくとも1つの安定性ブロックと少なくとも1つの崩壊性ブロックとを含む(すなわち、それらは不混和性である)ブロックコポリマーを含めることにより、高分子領域に提供することができる。ブロックコポリマーの安定性ブロックと崩壊性ブロックは、例えば、ホモポリマーブロック(例えば、反復する一連の、単一種類の構成単位)として、またはコポリマーブロック(例えば、例えば、周期的、ランダム、統計的、またはグラジエント分布に配置された2種類以上の構成単位)として存在してよい。ブロックコポリマーは、環状、線形および分岐構成を含む様々な構成で提供され得る。少なくとも1つの安定性ブロック(または少なくとも1つの崩壊性ブロック)は、コポリマー中に、例えば、1つの末端ブロックとして(例えば、ジブロックコポリマーの1つの末端ブロックとして)、複数の末端ブロックとして(例えば、トリブロックコポリマーまたは星型コポリマーの末端ブロックとして)、1つの中間ブロックとして(例えば、トリブロックコポリマーまたは星型コポリマーの1つの中間ブロックとして)、1つの主鎖として(例えば、櫛型コポリマー内の1つの主鎖として)、1つの側鎖として(例えば、櫛型コポリマー内の1つの側鎖として)など、存在し得る。
本発明の相分離高分子領域の安定性相および崩壊性相の各々は、独立に、同じモノマー組成のポリマーブロックを含んでよく、または異なるモノマー組成のポリマーブロックが互いに混和性である限り、異なるモノマー組成のポリマーブロックを含むことができる。
もう1つの具体的な例として、異なる組成の2つ以上の分離された安定性高分子相は、例えば、それ自身が内部で相分離する安定性ポリマー(例えば、2つの安定性相分離ブロックを含む1つのブロックコポリマー)を含めることによるか、または2つの不混和性の安定性ポリマー(例えば、2つの安定性ホモポリマー、2つの安定性非ブロックコポリマー、1つの安定性ホモポリマーと1つの安定性非ブロックコポリマー、など)を含めることにより高分子領域に提供され得る。
この時点で、多種多様なポリマーを用いて、分離された安定性高分子相および崩壊性高分子相を提供することができるということは分かるはずである。
本明細書に記載のもののようなポリマーは、ポリマー技術で公知の数多くの手法により形成することができる。
「担体領域」とは、治療薬をさらに含み、その治療薬が放出される高分子領域を意味する。例えば、いくつかの実施態様では、担体領域は医療機器全体を構成する。他の実施態様では、機器の一部のみに相当する、例えば、層形態の医療機器基材の全体または一部に配置されている担体領域が提供される。
溶媒に基づく技術を用いて高分子領域を形成する場合には、溶媒種を除去するために、適用後に高分子領域を乾燥させることが好ましい。高分子領域は、一般には、乾燥処理中にいずれの支持構造の表面にもさらに適合する。
治療薬の放出速度が、主として、細孔を通じた拡散により起こる場合、その放出速度は、多孔性マトリックスの孔径および屈曲度、並びに多孔質高分子領域の他の物理的および化学的特性により制御され得る。
ポリ(カプロラクトン)-ポリイソブチレン-ポリ(カプロラクトン)ブロックコポリマーの合成および特性付け
ブロックコポリマー合成.
1. ヒドロキシル末端官能性ポリイソブチレン高分子開始剤の合成
リビングカチオン重合過程によって、カルボン酸末端基を有するポリイソブチレンを合成する。ヘキサン/塩化メチル(MeCl)(60/40 v/v)中の、[イソブチレン]=0.09M、プロトントラップとしての[2,6-ジ-tert-ブチルピリジン(DTBP, Aldrich)]=3x10-3M、および開始剤としての[2-クロロ-2,4,4-トリメチルペンタン(TMPCl)]=2x10-3Mを、予冷した400mL丸底フラスコに添加する。-80℃でTiCl4原液([TiCl4]=3.6x10-2M)を添加することによりイソブチレンの重合を開始し、1時間重合する。そのリビングポリイソブチレンに、2当量の1,1-ジフェニルエチレン(DPE, Aldrich)または1,1-p-ジトリルエチレン(DTE, Aldrich)原液を添加することによりin-situでキャップして、ポリイソブチレン鎖末端を官能基化する。1時間キャッピングした後、反応混合物に2当量の[(2-メチル-1-メトキシ-1-トリメチルシロキシ-プロペン(MTSP)原液を添加する。1時間反応させた後、反応混合物を予冷したメタノールでクエンチし、それをNH4OH/メタノール(10/90 v/v)に注いで、反応混合物を中和する。得られたメトキシカルボニル末端官能基化ポリイソブチレンを、ヘキサンからメタノールへと沈殿を繰り返し、その後、真空乾燥を行うことにより精製する。
3. ポリ(カプロラクトン-b-イソブチレン)ジブロックコポリマーの合成.
4. ポリ(カプロラクトン-b-イソブチレン-カプロラクトン)トリブロックコポリマーの合成.
特性付け.
ポリ(乳酸)-ポリイソブチレン-ポリ(乳酸)トリブロックコポリマーの合成および特性付け
ブロックコポリマー合成.
1. ジヒドロキシル末端官能性ポリイソブチレン高分子開始剤の合成
ポリイソブチレンのリビングカチオン重合の開始剤として、2つのヒドロキシル末端官能基を有するポリイソブチレンを合成する。上記合成方法の別法として、ジ-アルデヒド-テレケリックポリイソブチレンの調製により、ジヒドロキシル末端官能性ポリイソブチレン高分子開始剤を処方する。
2. ポリ(乳酸)-ポリイソブチレン-ポリ(乳酸)コポリマーの合成
ステント被膜
1. 被膜の調製
25重量%テトラヒドロフラン(THF)、74重量%トルエン、および1重量%固体(パクリタキセルおよびポリマー)を含む溶液を準備する。パクリタキセルおよびTHFを、パクリタキセルが十分に溶解するまで混合し、その後、ポリマー、続いてトルエンを添加し、十分に(例えば、一晩)混合し、濾過することにより、全体の溶液を調製する。
2. ステント被膜からのパクリタキセルの放出
Claims (11)
- 生体安定性ポリマーブロック及び生体崩壊性ポリマーブロックを含むブロックコポリマーを含むナノ多孔質相分離高分子領域を含む移植可能なまたは挿入可能な医療機器であって、該ナノ多孔質相分離高分子領域が(a)生体安定性高分子相、(b)in vivoで生体崩壊を受ける、ナノスケール規模の、生体崩壊性高分子相及び(c)該生体崩壊性高分子相のin vivoでの生体崩壊により形成されるナノ多孔質高分子領域とを含む、移植可能なまたは挿入可能な医療機器であって、前記ブロックコポリマーがポリイソブチレン中間ブロックと、複数のポリ(カプロラクトン)末端ブロックとを含み、
ブロックコポリマーの量がナノ多孔質相分離高分子領域の全量に対し50質量%を超える、
前記移植可能な又は挿入可能な医療機器。 - 前記生体崩壊性高分子相と前記生体安定性高分子相が前記高分子領域の少なくとも一部において共連続的である、請求項1記載の移植可能なまたは挿入可能な医療機器。
- 前記生体崩壊性高分子相が前記高分子領域の少なくとも一部において前記高分子領域の厚さ全体にわたっている、請求項1記載の移植可能なまたは挿入可能な医療機器。
- ガイドワイヤー、バルーン、大静脈フィルター、ステント、ステントグラフト、血管グラフト、脳動脈瘤フィラーコイル、心筋プラグ、心臓弁、血管弁、および再生医療用スキャフォールドから選択される、請求項1記載の移植可能なまたは挿入可能な医療機器。
- 前記ブロックコポリマーが36−66kDaのMnを有するポリイソブチレン中間ブロックと、複数のポリ(カプロラクトン)末端ブロックとを含む、請求項1記載の移植可能なまたは挿入可能な医療機器。
- 前記ブロックコポリマーがポリイソブチレン中間ブロックと、4.9−18kDaのMnを有する複数のポリ(カプロラクトン)末端ブロックとを含む、請求項1記載の移植可能なまたは挿入可能な医療機器。
- 前記高分子領域が医療機器基材に対する被膜である、請求項1に記載の移植可能なまたは挿入可能な医療機器。
- 前記高分子領域の真下にまたは内部に配置された治療薬をさらに含む、請求項1記載の移植可能なまたは挿入可能な医療機器。
- 前記高分子領域が高分子層形態であり、かつ、該高分子層が前記治療薬を含む領域上に配置されているか、あるいは該高分子層が治療薬を含む、請求項1記載の移植可能なまたは挿入可能な医療機器。
- 前記相分離高分子領域内部に配置され、in vivoで放出される治療薬をさらに含む、請求項1記載の移植可能なまたは挿入可能な医療機器。
- 請求項1記載の移植可能なまたは挿入可能な医療機器の製造方法であって、(a)生体安定性高分子相と、ナノスケール規模の生体崩壊性高分子相とを含む相分離高分子領域を準備すること、(b)該生体崩壊性高分子相を選択的に除去し、それにより該ナノ多孔質高分子領域を作り出すことを含む、前記製造方法であって、該ナノ多孔質高分子領域が人間において形成されるのではない、前記方法。
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-
2005
- 2005-02-01 US US11/048,616 patent/US8535702B2/en active Active
-
2006
- 2006-02-01 EP EP06720017.0A patent/EP1846056B1/en not_active Not-in-force
- 2006-02-01 JP JP2007553364A patent/JP5475950B2/ja not_active Expired - Fee Related
- 2006-02-01 WO PCT/US2006/003455 patent/WO2006083904A2/en active Application Filing
- 2006-02-01 CA CA002611454A patent/CA2611454A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
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WO2006083904A3 (en) | 2007-04-05 |
CA2611454A1 (en) | 2006-08-10 |
US8535702B2 (en) | 2013-09-17 |
EP1846056B1 (en) | 2014-10-08 |
US20060171985A1 (en) | 2006-08-03 |
JP2008528212A (ja) | 2008-07-31 |
WO2006083904A2 (en) | 2006-08-10 |
EP1846056A2 (en) | 2007-10-24 |
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