JP5185263B2 - 治療薬および金属材料を含む医療装置用コーティング - Google Patents
治療薬および金属材料を含む医療装置用コーティング Download PDFInfo
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- JP5185263B2 JP5185263B2 JP2009518236A JP2009518236A JP5185263B2 JP 5185263 B2 JP5185263 B2 JP 5185263B2 JP 2009518236 A JP2009518236 A JP 2009518236A JP 2009518236 A JP2009518236 A JP 2009518236A JP 5185263 B2 JP5185263 B2 JP 5185263B2
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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
- 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
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
-
- 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
- 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
- A61L31/08—Materials for coatings
- A61L31/082—Inorganic materials
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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
- 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
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30317—The prosthesis having different structural features at different locations within the same prosthesis
- A61F2002/30322—The prosthesis having different structural features at different locations within the same prosthesis differing in surface structures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0026—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in surface structures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/606—Coatings
- A61L2300/608—Coatings having two or more layers
-
- 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
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/08—Coatings comprising two or more layers
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Vascular Medicine (AREA)
- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
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- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Surgery (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Inorganic Chemistry (AREA)
- Materials For Medical Uses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Description
ポリマーを実質的に含まない(substantially free of any polymer)」という語句は、組
成物の体積で、50%以下のポリマーを有していることを意味する。そのようなコーティングにより、ポリマーの体内管腔との接触が低減または排除される。
内腔側面」と称する)または内腔側の表面(adluminal surface)(以下、「内腔側面」と
称する)であり得る。特定の実施形態において、コーティングは反内腔側面の少なくとも一部の上に配置されている。他の実施形態において、第1コーティング組成物は内腔側面の少なくとも一部の上に配置されており、第2コーティング組成物は、内腔側面上に配置された第1コーティング組成物の少なくとも一部の上に配置されている。さらに別の実施形態において、第1コーティング組成物は内腔側面の少なくとも一部の上に配置され、その内腔側面は第2コーティング組成物を有さない。
組成物であって、第1コーティング組成物はストラットの反内腔側面の表面の一部の上に配置されているときには外面を有する、第1コーティング組成物と、(ii)第1コーティング組成物の少なくとも一部の上に配置された金属材料を含有する第2コーティング組成物とを含み、第2コーティング組成物はいかなるポリマーも実質的に含まず、第2コーティング組成物は、第2コーティング組成物が第1コーティング組成物の一部に適用された後には外面および複数の細孔を備え、前記細孔は第1コーティング組成物の外面から第2コーティング組成物の外面に延在することと、(c)第1コーティング組成物を備える少なくとも1つのストラットの内腔側面の少なくとも一部の上に配置された第2コーティングとを備える埋め込み可能な血管内ステントに関する。
た第1コーティング組成物の少なくとも一部の上に配置されている。
ス、ピメクロリムス、エベロリムスまたはゾタロリムスを含み得る。
タクリレート−ブチルアクリレート−メチルメタクリレート)が挙げられるが、これらに限定されるものではない。
本発明は以下の図面に関連して説明される。
ング組成物24も含む。第2コーティング組成物24は、金属材料を含み、かつポリマーを実質的に含まない。第2コーティング組成物24は、第1コーティング組成物22の一部または全体の上に配置され得る。
グステン、モリブデン、ニッケル−クロム、またはElgiloy(登録商標)およびPhynox(登録商標)のようなコバルト−クロム−ニッケル合金を含む特定のコバルト合金、PERSS(Platinum EnRiched Stainless Steel(白金富化ステンレス鋼))お
よびニオブに基づく金属および合金が挙げられるが、これらに限定されるものではない。前記金属材料としてはまた、国際特許出願第WO94/16646号に開示されているもののような、クラッド複合フィラメント(clad composite filaments)も挙げられる。好ましい金属材料としては、白金富化ステンレス鋼、並びにジルコニウムおよびニオブ合金が挙げられる。加えて、本発明のコーティングには、2種以上の金属または合金の組み合わせを使用することができる。
得、一方、内腔側面はコーティングを有さなくてもよい。
本発明に適した医療装置としては、ステント、外科用ステープル、人工内耳、塞栓コイル、中心静脈カテーテルおよび動脈カテーテルのようなカテーテル、ガイドワイヤ、カニューレ、心臓ペースメーカーのリードまたはリードチップ、細動除去器のリードまたはリードチップ、埋め込み可能な血管アクセスポート、血液保存用バッグ、血液チューブ、脈管グラフトまたは他のグラフト、大動脈内バルーンポンプ、心臓弁、心臓血管用縫合糸、完全人工心臓および心室補助ポンプ、並びに血液酸素付加装置、血液フィルタ、血液透析ユニット、血液灌流ユニットまたは血漿交換ユニットのような体外装置が挙げられるが、これらに限定されるものではない。
号に示されている。好ましい実施形態において、本発明に適したステントはエクスプレス(Express)ステントである。より好ましくは、エクスプレスステントは、Express
(商標)ステント、またはExpress2(商標)ステント(マサチューセッツ州ナティック所在のボストン サイエンティフィック インコーポレイテッド)である。
れ得る。骨組は、連続した構造体を形成するために、溶接、成形、レーザーカット、または電鋳(electro-formed)されてもよいし、あるいは相互に巻回または編組されるフィラメントまたは繊維から成ってもよい。
げられるが、これらに限定されるものではない。前記金属材料としてはまた、国際特許出願第WO94/16646号に開示されているもののような、クラッド複合フィラメント(clad composite filaments)が挙げられる。好ましい金属材料としては、白金富化ステンレス鋼、並びにジルコニウムおよびニオブ合金が挙げられる。
ビニル、ポリオレフィン、セルロース誘導体、ポリアミド、ポリエステル、ポリスルホン、ポリテトラフルオルエチレン(polytetrafluorethylenes)、ポリカーボネート、アクリ
ロニトリルブタジエンスチレンコポリマー、アクリル樹脂、ポリ乳酸、ポリグリコール酸、ポリカプロラクトン、ポリ乳酸−ポリエチレンオキシドコポリマー、セルロース、コラーゲンおよびキチンが挙げられるが、これらに限定されるものではない。
、ポリグリコール酸、ポリウレタン、またはそれらの誘導体、すなわち、例えば、付着部位または架橋基、例えばRGD、を備えるように修飾されたポリマーが挙げられるが、これらに限定されるものではない。前記ポリマーは、タンパク質、核酸などのような細胞および分子の付着を可能にしながらも、それらの構造の完全性を保持している。
ン酸グリセリル、トリデセン酸グリセリル(glyceryl tridecenoate)、トリステアリン酸
グリセリン(glycerol tristearate)のようなC18〜C36モノ−、ジ−、トリ−アシルグリセリドおよびそれらの混合物;ジステアリン酸スクロースおよびパルミチン酸スクロースのようなショ糖脂肪酸エステル;モノステアリン酸ソルビタン、モノパルミチン酸ソルビタンおよびトリステアリン酸ソルビタンのようなソルビタン脂肪酸エステル;セチルアルコール、ミリスチルアルコール、ステアリルアルコールおよびセトステアリルアルコールのようなC16〜C18脂肪族アルコール;パルミチン酸セチルおよびパルミチン酸セテアリル(cetearyl palmitate)のような脂肪族アルコールと脂肪酸とのエステル;ステアリン酸無水物のような脂肪酸の無水物;ホスファチジルコリン(レシチン)、ホスファチジルセリン、ホスファチジルエタノールアミン、ホスファチジルイノシトール、およびそれらのリゾ誘導体(lysoderivatives)を含むリン脂質;スフィンゴシンおよびその誘導
体;ステアリルスフィンゴミエリン、パルミトイルスフィンゴミエリンおよびトリコサニルスフィンゴミエリンのようなスフィンゴミエリン;ステアリルセラミドおよびパルミトイルセラミドのようなセラミド;グリコスフィンゴリピッド;ラノリンおよびラノリンアルコール;並びにそれらの組み合わせおよび混合物が挙げられる。非ポリマー材料はまた、埋め込みの前に医療装置に播種され得る幹細胞(stem sells)のような生体材料を含み得る。好ましい非ポリマー材料としては、コレステロール、モノステアリン酸グリセリル、トリステアリン酸グリセリン、ステアリン酸、ステアリン酸無水物、モノオレイン酸グリセリル、モノリノール酸グリセリルおよびアセチル化モノグリセリドが挙げられる。
本発明において使用される「治療薬」という用語は、薬剤、遺伝物質および生体物質を包含し、「生物活性物質」と区別なく用いられ得る。一実施形態において、治療薬は抗再狭窄剤である。他の実施形態において、治療薬は平滑筋細胞の増殖、収縮、遊走または活動過多を抑制する。適当な治療薬の限定されない例としては、ヘパリンおよびヘパリン誘導体、ウロキナーゼ、デキストロフェニルアラニンプロリンアルギニンクロロメチルケトン(PPack)、エノキサプリン、アンギオペプチン、ヒルジン、アセチルサリチル酸、タクロリムス、エベロリムス、ゾタロリムス、ラパマイシン(シロリムス)、ピメクロリムス、アムロジピン、ドキサゾシン、グルココルチコイド、ベータメタゾン、デキサメタゾン、プレドニゾロン、コルチコステロン、ブデソニド、スルファサラジン、ロシグリタゾン、ミコフェノール酸、メサラミン、パクリタキセル、5−フルオロウラシル、シスプラチン、ビンブラスチン、ビンクリスチン、エポチロン、メトトレキサート、アザチオプリン、アドリアマイシン、マイトマイシン(mutamycin)、エンドスタチン、アンギオス
タチン、チミジンキナーゼ阻害剤、クラドリビン、リドカイン、ブピバカイン、ロピバカイン、D−Phe−Pro−Argクロロメチルケトン、血小板受容体アンタゴニスト、
抗トロンビン抗体、抗血小板受容体抗体、アスピリン、ジピリダモール、プロタミン、ヒルジン、プロスタグランジン阻害剤、抗血小板薬、トラピジル、リプロスチン(liprostin)、マダニ抗血小板ペプチド(tick antiplatelet peptides)、5−アザシチジン、血管内
皮細胞成長因子、成長因子受容体、転写活性化因子、翻訳促進剤、抗増殖剤、成長因子阻害剤、成長因子受容体アンタゴニスト、転写抑制因子、翻訳抑制因子、複製阻害剤、遮断抗体、成長因子に対する抗体、成長因子および細胞毒素から成る二官能分子、抗体および細胞毒素から成る二官能分子、コレステロール降下剤、血管拡張剤、内因性の血管作用機構に干渉する薬剤、抗酸化剤、プロブコール、抗生物質製剤、ペニシリン、セホキシチン、オキサシリン、トブラナイシン(tobranycin)、血管新生物質(angiogenic substances)
、線維芽細胞成長因子、エストロゲン、エストラジオール(E2)、エストリオール(E3)、17−ベータエストラジオール、ジゴキシン、ベータブロッカー、カプトプリル、エナロプリル(enalopril)、スタチン、ステロイド、ビタミン、パクリタキセル(並びに
その誘導体、類似体、または、例えばアブラキサン(Abraxan)(商標)のようなタンパク
質に接着したパクリタキセル)、2’−スクシニル−タキソール、2’−スクシニル−タキソールトリエタノールアミン、2’−グルタリル−タキソール、2’−グルタリル−タキソールトリエタノールアミン塩、N−(ジメチルアミノエチル)グルタミンとの2’−O−エステル、N−(ジメチルアミノエチル)グルタミド塩酸塩との2’−O−エステル、ニトログリセリン、亜酸化窒素、酸化窒素、抗生物質、アスピリン、ジギタリス、エストロゲン、エストラジオールおよびグリコシドが挙げられる。一実施形態において、治療薬は平滑筋細胞阻害剤または抗生物質である。好ましい実施形態において、治療薬はタキソール(例えばTaxol(登録商標))、またはその類似体もしくは誘導体である。別の好
ましい実施形態において、治療薬はパクリタキセル、またはその類似体もしくは誘導体である。さらに別の好ましい実施形態において、治療薬はエリスロマイシン、アムホテリシン、ラパマイシン、アドリアマイシンなどのような抗生物質である。
粒球マクロファージコロニー刺激因子(GM−CSF)、増殖分化因子(growth differentiation factor)(GDF)、インテグリン修飾因子(IMF)、カルモジュリン(Ca
M)、チミジンキナーゼ(TK)、腫瘍壊死因子(TNF)、成長ホルモン(GH)、骨形成タンパク質(bone morphogenic protein(BMP)(例えばBMP−2、BMP−3
、BMP−4、BMP−5、BMP−6(Vgr−1)、BMP−7(PO−1)、BMP−8、BMP−9、BMP−10、BMP−11、BMP−12、BMP−14、BMP−15、BMP−16、など)、マトリックスメタロプロテイナーゼ(MMP)、マトリックスメタロプロテイナーゼの組織阻害剤(TIMP)、サイトカイン、インターロイキン(例えばIL−1、IL−2、IL−3、IL−4、IL−5、IL−6、IL−7、IL−8、IL−9、IL−10、IL−11、IL−12、IL−15、等)、リンホカイン、インターフェロン、インテグリン、コラーゲン(すべての種類)、エラスチン
、フィブリン、フィブロネクチン、ビトロネクチン、ラミニン、グリコサミノグリカン、プロテオグリカン、トランスフェリン、サイトタクチン(cytotactin)、細胞接着ドメイン(例えばRGD)およびテナスシン(tenascin)が挙げられる。現在のところ好ましいBMPは、BMP−2、BMP−3、BMP−4、BMP−5、BMP−6、BMP−7である。これらの二量体タンパク質は、ホモダイマー、ヘテロダイマーまたはそれらの組み合わせとして、単独でまたは他の分子と一緒に提供することができる。細胞は、ヒト由来(自己由来または同種異型)の細胞であってもよいし、または動物源(異種)の細胞であってもよく、それらの細胞は、所望により、移植部位において注目中のタンパク質を送達するように遺伝子操作されている。送達媒体は、細胞の機能および生存能力を維持するために必要であるように調剤され得る。細胞としては、始原細胞(例えば内皮始原細胞)、幹細胞(例えば、間充織幹細胞、血液生成幹細胞、ニューロン幹細胞)、間質細胞、実質細胞、未分化細胞、繊維芽細胞、マクロファージおよび衛星細胞が挙げられる。
・ヘパリン、ヘパリン誘導体、ウロキナーゼおよびPPack(デキストロフェニルアラニンプロリンアルギニンクロロメチルケトン)のような抗血栓症剤;
・平滑筋細胞増殖を阻止することができるエノキサプリン(enoxaprin)、アンギオペ
プチンまたはモノクローナル抗体、ヒルジン、アセチルサリチル酸、タクロリムス、エベロリムス、アムロジピンおよびドキサゾシンのような抗増殖剤;
・グルココルチコイド、ベータメタゾン、デキサメタゾン、プレドニゾロン、コルチコステロン、ブデソニド、エストロゲン、スルファサラジン、ロシグリタゾン、ミコフェノール酸およびメサラミンのような抗炎症剤;
・パクリタキセル、5−フルオロウラシル、シスプラチン、ビンブラスチン、ビンクリスチン、エポチロン、メトトレキサート、アザチオプリン、アドリアマイシンおよびマイトマイシンのような抗腫瘍/抗増殖/抗縮瞳剤;エンドスタチン、アンギオスタチンおよびチミジンキナーゼ阻害剤、クラドリビン、タキソールおよびその類似体または誘導体;
・リドカイン、ブピカインおよびロピバカインのような麻酔剤;
・D−Phe−Pro−Argクロロメチルケトン、RGDペプチド含有化合物、ヘパリン、抗トロンビン化合物、血小板受容体アンタゴニスト、抗トロンビン抗体、抗血小板受容体抗体、アスピリン(アスピリンは鎮痛、解熱、および抗炎症薬としても分類される)、ジピリダモール、プロタミン、ヒルジン、プロスタグランジン阻害剤、抗血小板薬、トラピジルまたはリプロスチン(liprostin)のような抗血小板剤、およびマダニ抗血小板
ペプチドのような抗凝血剤;
・特定の癌細胞において細胞増殖を抑制し、細胞死を引き起こすRNAまたはDNA代謝物質としても分類される、5−アザシチジンのようなDNA脱メチル化剤;
・成長因子、血管内皮細胞成長因子(VEGF、VEGF−2を含む全種類)、成長因子受容体、転写活性化因子および翻訳促進物質(translational promoters)のような血管
細胞増殖促進物質;
・抗増殖剤、成長因子阻害剤、成長因子受容体アンタゴニスト、転写抑制因子、翻訳抑制因子、複製阻害剤、遮断抗体、成長因子に対する抗体、成長因子および細胞毒素から成る二官能分子、並びに抗体および細胞毒素から成る二官能分子のような血管細胞成長阻害剤;
・コレステロール降下剤、血管拡張剤、および内因性血管作用機構(endogenous vasoactive mechanisms)に干渉する薬剤;
・プロブコールのような抗酸化剤;
・ペニシリン、セホキシチン、オキサシリン、トブラナイシン(tobranycin)、ラパマイシン(シロリムス)のような抗生物質製剤;
・酸性線維芽細胞成長因子および塩基性線維芽細胞成長因子、並びにエストラジオール(E2)エストリオール(E3)および17−ベータエストラジオールを含むエストロゲンのような血管新生物質;
・ジゴキシン、β−遮断薬、カプトプリルおよびエナロプリル(enalopril)を含むアン
ギオテンシン変換酵素(ACE)阻害剤、スタチンおよび関連化合物のような心不全用薬剤;並びに
・シロリムス、エベロリムスまたはゾタロリムスのようなマクロライドが挙げられる。
stabilizing agents)が挙げられる。例えば、本発明において使用するのに適した誘導体としては、2’−スクシニル−タキソール、2’−スクシニル−タキソールトリエタノールアミン、2’−グルタリル−タキソール、2’−グルタリル−タキソールトリエタノールアミン塩、N−(ジメチルアミノエチル)グルタミンとの2’−O−エステル、パクリタキセル2−N−メチルピリジニウムメシレート(paclitaxel 2-N-methypyridinium mesylate)、およびN−(ジメチルアミノエチル)グルタミド塩酸塩との2’−O−エステル
が挙げられる。本発明において使用するのに適したパクリタキセル結合体としては、ドコサヘキサエン酸(docosahexanoic acid)(DHA)と結合したパクリタキセル、ポリグル
タメート(polyglutimate)(PG)ポリマーと結合したパクリタキセル、およびパクリタ
キセルポリグルメックス(paclitaxel poliglumex)が挙げられる。
剤;ホスホランバン阻害剤;またSerca2遺伝子/タンパク質が挙げられる。
任意でコーティングに使用するのに適したポリマーは、好ましくは生体適合性であるポリマーであるが、非生体適合性ポリマーを使用してもよい。そのようなポリマーの例としては、ポリウレタン、ポリイソブチレンおよびそのコポリマー、シリコーン、およびポリエステルが挙げられるが、これらに限定されるものではない。他の適当なポリマーとしては、ポリオレフィン、ポリイソブチレン、エチレン−α−オレフィンコポリマー、アクリルポリマーおよびコポリマー、ポリ塩化ビニルのようなハロゲン化ビニルポリマーおよびコポリマー、ポリビニルメチルエーテルのようなポリビニルエーテル、ポリフッ化ビニリデンおよびポリ塩化ビニリデンのようなハロゲン化ポリビニリデン、ポリアクリロニトリル、ポリビニルケトン、ポリスチレンのようなポリビニル芳香族化合物、ポリ酢酸ビニルのようなポリビニルエステル、ビニルモノマーのコポリマー、エチレン−メチルメタクリレートコポリマー、アクリロニトリル−スチレンコポリマー、ABS樹脂、エチレン−酢酸ビニルコポリマーのようなビニルモノマーとオレフィンとのコポリマー、ナイロン66およびポリカプロラクトンのようなポリアミド、アルキド樹脂、ポリカーボネート、ポリオキシエチレン、ポリイミド、ポリエーテル、エポキシ樹脂、ポリウレタン、レーヨン−トリアセテート、セルロース、酢酸セルロース、酪酸セルロース、酢酸酪酸セルロース、セロハン、硝酸セルロース、プロピオン酸セルロース、セルロースエーテル、カルボキシメチルセルロース、コラーゲン、キチン、ポリ乳酸、ポリグリコール酸およびポリ乳酸−ポリエチレンオキシドコポリマーが挙げられる。
リ(1,1−ジヒドロ−ペンタデカフルオロオクチルアクリレート)ポリ(ヘプタフルオ
ロイソプロピルアクリレート)、ポリ5−(ヘプタフルオロイソプロポキシ)ペンチルアクリレート、ポリ11−(ヘプタフルオロイソプロポキシ)ウンデシルアクリレート、ポリ2−(ヘプタフルオロプロポキシ)エチルアクリレート、およびポリ(ノナフルオロイソブチルアクリレートのようなアクリルポリマー;ポリ(ベンジルメタクリレート)、ポリ(n−ブチルメタクリレート)、ポリ(イソブチルメタクリレート)、ポリ(t−ブチルメタクリレート)、ポリ(t−ブチルアミノエチルメタクリレート)、ポリ(ドデシルメタクリレート)、ポリ(エチルメタクリレート)、ポリ(2−エチルヘキシルメタクリレート)、ポリ(n−ヘキシルメタクリレート)、ポリ(フェニルメタクリレート)、ポリ(n−プロピルメタクリレート)、ポリ(オクタデシルメタクリレート)、ポリ(1,1−ジヒドロペンタデカフルオロオクチルメタクリレート)、ポリ(ヘプタフルオロイソプロピルメタクリレート)、ポリ(ヘプタデカフルオロオクチルメタクリレート)、ポリ(1−ヒドロテトラフルオロエチルメタクリレート)、ポリ(1,1−ジヒドロテトラフルオロプロピルメタクリレート)、ポリ(1−ヒドロヘキサフルオロイソプロピルメタクリレート)、およびポリ(t−ノナフルオロブチルメタクリレート)のようなメタクリルポリマー(methacrylic polymers);ポリ(エチレンテレフタレート)およびポリ(ブチレンテレフタレート)のようなポリエステル;ポリウレタンおよびシロキサン−ウレタンコポリマーのような縮合タイプポリマー;ポリオルガノシロキサン、すなわちRaSiO4−a/2によって示され、前記式中、Rは、1価の置換または非置換の炭化水素ラジカルであり、aの値は1または2である、反復したシロキサン基を特徴とするポリマー材料;並びにゴムのような天然の疎水性ポリマーが挙げられるが、これらに限定されるものではない。
びマレイン酸のような重合されたエチレン性不飽和カルボン酸、およびこれらの酸とアルキレングリコールのような多価アルコールとから誘導された部分エステル;アクリルアミドから誘導されたホモポリマーおよびコポリマー;並びにビニルピロリドンのホモポリマーおよびコポリマーが挙げられるが、これらに限定されるものではない。
ロゲン化ビニルポリマーおよびコポリマー、ポリビニルメチルエーテルのようなポリビニルエーテル、ポリフッ化ビニリデンおよびポリ塩化ビニリデンのようなハロゲン化ポリビニリデン、ポリアクリロニトリル、ポリビニルケトン、ポリスチレンのようなポリビニル芳香族化合物、ポリ酢酸ビニルのようなポリビニルエステル、ビニルモノマーのコポリマー、エチレン−メチルメタクリレートコポリマーのような、ビニルモノマーとオレフィンとのコポリマー、アクリロニトリル−スチレンコポリマー、ABS(アクリロニトリル−ブタジエン−スチレン)樹脂、エチレン酢酸ビニルコポリマー、ナイロン66およびポリカプロラクトンのようなポリアミド、アルキド樹脂、ポリカーボネート、ポリオキシメチレン、ポリイミド、ポリエーテル、ポリエーテルブロックアミド、エポキシ樹脂、レーヨン−トリアセテート、セルロース、酢酸セルロース、酪酸セルロース、酢酸酪酸セルロース、セロハン、硝酸セルロース、プロピオン酸セルロース、セルロースエーテル、カルボキシメチルセルロース、コラーゲン、キチン、ポリ乳酸、ポリグリコール酸、ポリ乳酸−ポリエチレンオキシドコポリマー、EPDM(エチレン−プロピレン−ジエン)ゴム、フルオロポリマー、フルオロシリコーン、ポリエチレングリコール、多糖類、リン脂質および前述のものの組み合わせが挙げられるが、これらに限定されるものではない。
わせが挙げられるが、これらに限定されるものではない。
本発明はまた、コーティングを備えた医療装置を製造する方法にも関する。前記コーティングは、治療薬を含有する第1コーティング組成物と、金属材料を含有する第2コーティング組成物とを含む。任意で、第1コーティング組成物はポリマーをさらに含むことができる。特定の実施形態において、前記方法は、(a)表面を有する医療装置を提供する工程と、(b)前記表面の少なくとも一部の上に、治療薬を含有する第1コーティング組成物を配置する工程と、(c)第1コーティング組成物の少なくとも一部の上に、金属材料を含み、かつポリマーを実質的に含まない第2コーティング組成物を配置する工程とを有する。
ノズルまたは超音波ノズルの使用による噴霧、浸漬、ローリング、静電沈着、スピンコーティング、プラズマ堆積、凝縮(condensation)、電気化学堆積、静電沈着、蒸着(evaporation)、プラズマ蒸着、陰極アーク蒸着、スパッタリング、イオン注入、または気中懸濁
、パンコーティング、もしくは超音波ミスト噴霧のような流動床もしくはバッチ処理の使用のような、しかしこれらに限定されない任意の適当な方法によって医療装置の表面上に配置され得る。
いて、細孔の形成を促進する特定のプロセスパラメータ下において細孔を形成してもよい
。
おいて、金属材料を含有する第2コーティング組成物は、二次相材料と組み合わされて組成物を形成する。二次相材料は、ポリスチレンのように溶出され得るポリマーのような非金属の二次原料であり得る。二次相材料は、様々な大きさの中空球体または切断されたチューブのような粒子の形態であり得る。形成される細孔の大きさおよび形状は、二次相材料の大きさおよび形状によって決定されるであろう。例えば、二次相材料が球形である場合、形成される細孔は球形であるであろう。
る場合、金属材料を含有する第2コーティング組成物および二次相材料を含有する組成物で被覆された装置は、二次相材料が液体となって第2コーティング組成物から除去可能であるような温度に加熱することができる。第2コーティング組成物に適した金属の例としては、アルミニウム、バリウムおよびビスマスのような低融点二次相材料と組み合わされた、白金、金、ステンレス鋼、チタン、タンタルおよびイリジウムのような高融点の第1金属うちの1つが挙げられる。
Claims (14)
- (a)表面を有するステント側壁構造と、
(b)コーティングと、前記コーティングは、
(i)前記ステント側壁構造の表面の少なくとも一部の上に同表面と接触するように配置された、ポリマー及び治療薬、又は治療薬からなる第1コーティング組成物であって、第1コーティング組成物は第1厚さを有する、第1コーティング組成物と、
(ii)前記ステント側壁構造の表面の少なくとも一部の上に同表面と接触するように配置された金属材料を含有する第2コーティング組成物とを含み、第2コーティング組成物は第2厚さを有し、かつ、いかなるポリマーも実質的に含まず、第2コーティング組成物の第2厚さは、第1コーティング組成物の第1厚さと同一であるか、または第1厚さより大きいこととを備える埋め込み可能な血管内ステント。 - 第2コーティング組成物の第2厚さは、第1コーティング組成物の第1厚さより大きい、請求項1に記載のステント。
- 第1コーティング組成物の第1厚さは、第2コーティング組成物の第2厚さと等しい、請求項1に記載のステント。
- 前記第1コーティング組成物が治療薬およびポリマーを含み、同ポリマーがスチレン−イソブチレンコポリマー、ポリ乳酸、ポリ(メチルメタクリレート−ブチルアクリレート−メチルメタクリレート)のうちから選択される請求項1に記載のステント。
- 前記ポリマーが、前記第1コーティング組成物の1〜80重量%である請求項1乃至4のいずれか一項に記載のステント。
- 前記ポリマーが、前記第1コーティング組成物の60〜90%である請求項1乃至4のいずれか一項に記載のステント。
- 第2コーティング組成物は、前記ステント側壁構造の表面上に、第1コーティング組成物にステントの長手方向において隣接して配置されている、請求項1に記載のステント。
- 前記ステント側壁構造は複数のストラットおよび開口を備え、前記ステント側壁構造の表面はステントの反内腔側面である、請求項1に記載のステント。
- 前記第2コーティング組成物が細孔を有する請求項1に記載のステント。
- 前記第1コーティング組成物の第1厚さが1〜30ミクロンであり、第2コーティングの第2厚さが0.1〜50ミクロンである請求項1に記載のステント。
- 前記治療薬は、平滑筋細胞増殖を抑制する薬剤、抗血栓形成剤、抗血管形成剤、抗増殖剤、抗生物質、抗再狭窄剤、成長因子、免疫抑制剤、放射性同位元素添加製品、パクリタキセル、シロリムス、タクロリムス、ピメクロリムス、エベロリムスまたはゾタロリムスのうちの1つ以上を含む、請求項1に記載のステント。
- 前記金属材料は、ステンレス鋼、ニッケル、チタン、クロムおよびそれらの合金のうちから選択される、請求項1に記載のステント。
- 前記金属材料が、前記第2コーティング組成物の1〜80重量%である請求項1乃至12のいずれか一項に記載のステント。
- 前記金属材料が、前記第2コーティング組成物の50〜100重量%である請求項1乃至12のいずれか一項に記載のステント。
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US11/478,095 US8815275B2 (en) | 2006-06-28 | 2006-06-28 | Coatings for medical devices comprising a therapeutic agent and a metallic material |
US11/478,095 | 2006-06-28 | ||
PCT/US2007/014851 WO2008002586A2 (en) | 2006-06-28 | 2007-06-25 | Coatings for medical devices comprising a therapeutic agent and a metallic material |
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JP2009542326A JP2009542326A (ja) | 2009-12-03 |
JP2009542326A5 JP2009542326A5 (ja) | 2010-08-12 |
JP5185263B2 true JP5185263B2 (ja) | 2013-04-17 |
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JP2009518236A Expired - Fee Related JP5185263B2 (ja) | 2006-06-28 | 2007-06-25 | 治療薬および金属材料を含む医療装置用コーティング |
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US (2) | US8815275B2 (ja) |
EP (1) | EP2051750B1 (ja) |
JP (1) | JP5185263B2 (ja) |
CA (1) | CA2657109A1 (ja) |
WO (1) | WO2008002586A2 (ja) |
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2006
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- 2007-06-25 JP JP2009518236A patent/JP5185263B2/ja not_active Expired - Fee Related
- 2007-06-25 WO PCT/US2007/014851 patent/WO2008002586A2/en active Application Filing
- 2007-06-25 EP EP07796472.4A patent/EP2051750B1/en not_active Not-in-force
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US8815275B2 (en) | 2014-08-26 |
WO2008002586A3 (en) | 2008-05-29 |
EP2051750A2 (en) | 2009-04-29 |
US20120323308A1 (en) | 2012-12-20 |
US20080003251A1 (en) | 2008-01-03 |
WO2008002586A2 (en) | 2008-01-03 |
JP2009542326A (ja) | 2009-12-03 |
CA2657109A1 (en) | 2008-01-03 |
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