JP5602432B2 - 経皮的冠動脈インターベンション用の多剤溶出冠動脈ステント - Google Patents
経皮的冠動脈インターベンション用の多剤溶出冠動脈ステント Download PDFInfo
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- JP5602432B2 JP5602432B2 JP2009545686A JP2009545686A JP5602432B2 JP 5602432 B2 JP5602432 B2 JP 5602432B2 JP 2009545686 A JP2009545686 A JP 2009545686A JP 2009545686 A JP2009545686 A JP 2009545686A JP 5602432 B2 JP5602432 B2 JP 5602432B2
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- 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
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
-
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- 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
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- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
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- 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
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- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00976—Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
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- 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
- A61L2300/41—Anti-inflammatory agents, e.g. NSAIDs
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- 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
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- A—HUMAN NECESSITIES
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- 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
- A61L2300/42—Anti-thrombotic agents, anticoagulants, anti-platelet agents
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- A—HUMAN NECESSITIES
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- 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
- A61L2300/61—Coatings having two or more layers containing two or more active agents in different layers
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- A—HUMAN NECESSITIES
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- 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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- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Physics & Mathematics (AREA)
- Optics & Photonics (AREA)
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- Transplantation (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Description
本発明は、一般に血管インプラント、より具体的には多剤溶出管状血管インプラント、ならびに、心疾患および他の血管状態の処置用に経皮経管冠動脈形成術を行うために本インプラントを使用する方法に関する。
経皮経管冠動脈形成術(PCTA)は、冠動脈および他の血管などの体管腔に存在し得る、閉塞、病変、狭窄、血栓などの処置用に確立された手法である。
[本発明1001]
(a)抗増殖薬および抗炎症薬を含む第1の外層コーティング;
(b)少なくとも1つの抗成長因子薬を含む第2の中間層コーティング;ならびに
(c)少なくとも1つの非血栓形成性細胞外マトリックス(ntECM)分子を含む第3の底層コーティング
を含む管状血管インプラントであって、
第1の外層コーティングが移植による抗増殖薬および抗炎症薬の即時および持続放出用に製剤され、第2の中間層コーティングが少なくとも1つの抗成長因子薬の遅延および持続放出用に製剤され、かつ少なくとも1つのntECM分子がインプラントの1つまたは複数の表面に恒久的に固定されている、
管状血管インプラント。
[本発明1002]
中間層コーティングが第3の底層に介入している、本発明1001の管状血管インプラント。
[本発明1003]
少なくとも1つの抗成長因子薬が、インプラントの1つまたは複数の表面に共有結合している、本発明1002の管状血管インプラント。
[本発明1004]
少なくとも1つの抗成長因子薬が、インプラントをコーティングする1つまたは複数のポリマーに共有結合している、本発明1001の管状血管インプラント。
[本発明1005]
抗増殖薬がパクリタキセル、アクチノマイシン、タキサン、ダウノルビシン、メトトレキサート、シクロホスファミド、ブレオマイシン、ブスファン(busufane)、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、ハロフジノン、アドリアマイシン、アクチノマイシン、およびムタマイシン(mutamycin);エンドスタチン、アンジオスタチン、ならびにチミジンキナーゼ阻害剤からなる群より選択される、本発明1001の管状血管インプラント。
[本発明1006]
抗増殖薬がパクリタキセルである、本発明1005の管状血管インプラント。
[本発明1007]
抗炎症薬がカルシニューリン阻害剤である、本発明1001の管状血管インプラント。
[本発明1008]
抗炎症薬がシロリムス、タクロリムス、エベロリムス、およびゾタトロリムス(zotatrolimus)からなる群より選択される、本発明1007の管状血管インプラント。
[本発明1009]
抗炎症薬がシロリムスである、本発明1007の管状血管インプラント。
[本発明1010]
少なくとも1つの抗成長薬が抗VEGFポリクローナルもしくはモノクローナル抗体、および抗PDGFポリクローナルもしくはモノクローナル抗体からなる群、またはそれらの組み合わせより選択される、本発明1001の管状血管インプラント。
[本発明1011]
少なくとも1つの抗成長薬が抗VEGFモノクローナル抗体である、本発明1010の管状血管インプラント。
[本発明1012]
少なくとも1つの抗成長薬が抗PDGFモノクローナル抗体である、本発明1010の管状血管インプラント。
[本発明1013]
少なくとも1つのntECM分子がラミネン(laminen)、ヘパリン、ヘパリン硫酸プロテオグリカン(HSP)、エラスチン、およびフィブロネクチン、コンドロイチンからなる群、またはそれらの組み合わせより選択される、本発明1001の管状血管インプラント。
[本発明1014]
少なくとも1つのntECM分子がフィブロネクチンである、本発明1013の管状血管インプラント。
[本発明1015]
ステントである、本発明1001の管状血管インプラント。
[本発明1016]
コーティングがインプラントの外表面上に施されている、本発明1001の管状血管インプラント。
[本発明1017]
コーティングがインプラントの両端に施されている、本発明1001の管状血管インプラント。
[本発明1018]
コーティングがインプラントの一端に施されている、本発明1001の管状血管インプラント。
[本発明1019]
(a)パクリタキセルおよびシロリムスを含む第1の外層コーティング;ならびに
(b)少なくとも1つの抗成長因子薬を含む第2の中間層コーティング
を含む管状血管インプラントであって、
第1の外層コーティングが移植によるパクリタキセルおよびシロリムスの即時および持続放出用に製剤され、かつ第2の中間層コーティングが少なくとも1つの抗成長因子薬の遅延および持続放出用に製剤されている、
管状血管インプラント。
[本発明1020]
少なくとも1つの非血栓形成性細胞外マトリックス(ntECM)分子を含む第3の底層コーティングをさらに含み、少なくとも1つのntECM分子がインプラントの1つまたは複数の表面に恒久的に固定されている、本発明1019の管状血管インプラント。
[本発明1021]
中間層コーティングが第3の底層に介入している、本発明1020の管状血管インプラント。
[本発明1022]
少なくとも1つの抗成長因子薬がインプラントの1つまたは複数の表面に共有結合している、本発明1020の管状血管インプラント。
[本発明1023]
少なくとも1つの抗成長因子薬が、インプラントをコーティングする1つまたは複数のポリマーに共有結合している、本発明1019の管状血管インプラント。
[本発明1024]
少なくとも1つの抗成長薬が抗VEGFポリクローナルもしくはモノクローナル抗体、および抗PDGFモノクローナルもしくはポリクローナル抗体からなる群、またはそれらの組み合わせより選択される、本発明1019の管状血管インプラント。
[本発明1025]
少なくとも1つの抗成長薬が抗VEGFモノクローナル抗体である、本発明1024の管状血管インプラント。
[本発明1026]
少なくとも1つの抗成長薬が抗PDGFモノクローナル抗体である、本発明1024の管状血管インプラント。
[本発明1027]
少なくとも1つのntECM分子がラミネン、ヘパリン、ヘパリン硫酸プロテオグリカン(HSP)、エラスチン、およびフィブロネクチン、コンドロイチンからなる群、またはそれらの組み合わせより選択される、本発明1019の管状血管インプラント。
[本発明1028]
少なくとも1つのntECM分子がフィブロネクチンである、本発明1027の管状血管インプラント。
[本発明1029]
ステントである、本発明1019の管状血管インプラント。
[本発明1030]
コーティングがインプラントの外表面上に施されている、本発明1019の管状血管インプラント。
[本発明1031]
コーティングがインプラントの両端に施されている、本発明1019の管状血管インプラント。
[本発明1032]
コーティングがインプラントの一端に施されている、本発明1019の管状血管インプラント。
[本発明1033]
管状血管インプラントを挿入する段階を含む、心臓動脈が閉塞した患者における標的病変再狭窄(TLR)または標的血管再狭窄(TVR)を予防する方法であって、
該インプラントが、
(a)抗増殖薬および抗炎症薬を含む第1の外層コーティング;
(b)少なくとも1つの抗成長因子薬を含む第2の中間層コーティング;ならびに
(c)少なくとも1つの非血栓形成性細胞外マトリックス分子(ntECM)を含む第3の底層コーティング
を含み、
第1の外層コーティングが移植による抗増殖薬および抗炎症薬の即時放出用に製剤され、第2の中間層コーティングが少なくとも1つの抗成長因子薬の遅延放出用に製剤され、かつ少なくとも1つのntECM分子がインプラントの1つまたは複数の表面に恒久的に固定されている、
方法。
[本発明1034]
中間層コーティングが第3の底層に介入している、本発明1033の方法。
[本発明1035]
少なくとも1つの抗成長因子薬がインプラントの1つまたは複数の表面に共有結合している、本発明1034の方法。
[本発明1036]
少なくとも1つの抗成長因子薬が、インプラントをコーティングする1つまたは複数のポリマーに共有結合している、本発明1033の方法。
[本発明1037]
抗増殖薬がパクリタキセル、アクチノマイシン、タキサン、ダウノルビシン、メトトレキサート、シクロホスファミド、ブレオマイシン、ブスファン、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、ハロフジノン、アドリアマイシン、アクチノマイシン、およびムタマイシン;エンドスタチン、アンジオスタチン、ならびにチミジンキナーゼ阻害剤からなる群より選択される、本発明1033の方法。
[本発明1038]
抗増殖薬がパクリタキセルである、本発明1037の方法。
[本発明1039]
抗炎症薬がカルシニューリン阻害剤である、本発明1033の方法。
[本発明1040]
抗炎症薬がシロリムス、タクロリムス、エベロリムス、およびゾタトロリムスからなる群より選択される、本発明1039の方法。
[本発明1041]
抗炎症薬がシロリムスである、本発明1039の方法。
[本発明1042]
少なくとも1つの抗成長薬が抗VEGFポリクローナルもしくはモノクローナル抗体、および抗PDGFポリクローナルもしくはモノクローナル抗体からなる群、またはそれらの組み合わせより選択される、本発明1033の方法。
[本発明1043]
少なくとも1つの抗成長薬が抗VEGFモノクローナル抗体である、本発明1042の方法。
[本発明1044]
少なくとも1つの抗成長薬が抗PDGFモノクローナル抗体である、本発明1042の方法。
[本発明1045]
少なくとも1つのntECM分子がラミネン、ヘパリン、ヘパリン硫酸プロテオグリカン、エラスチン、およびフィブロネクチンからなる群、またはそれらの組み合わせより選択される、本発明1026の方法。
[本発明1046]
少なくとも1つのntECM分子がフィブロネクチンである、本発明1045の方法。
[本発明1047]
管状血管インプラントがステントである、本発明1033の方法。
本組成物、方法、および処置方法論を説明する前に、本発明は記載されている特定の組成物、方法、および実験条件に限定されるわけではなく、これはそのような組成物、方法、および条件が変動し得るためであるということを理解すべきである。本明細書で使用する用語法は、特定の態様のみを記載するためのものであり、限定を意図するものではなく、これは本発明の範囲が添付の特許請求の範囲にのみ限定されるためであるということも理解すべきである。
(1)DMACおよびメタノール(例えば質量比50:50混合物);
(2)水、i-プロパノール、およびDMAC(例えば質量比10:3:87混合物);
(3)i-プロパノールおよびDMAC(例えば質量比80:20、50:50、または20:80混合物);
(4)アセトンおよびシクロヘキサノン(例えば質量比80:20、50:50、または20:80混合物);
(5)アセトンおよびキシレン(例えば質量比50:50混合物);
(6)アセトン、FLUX REMOVER AMS、およびキシレン(例えば質量比10:50:40混合物);ならびに
(7)1,1,2-トリクロロエタンおよびクロロホルム(例えば質量比80:20混合物)。
薬剤:パクリタキセル、シロリムス、フィブロネクチン、および抗PDGFモノクローナル抗体
送達方法:
1.実験的ステント送達方法−ポリマーマトリックスからの送達:
ポリマー担体溶液と混和性のある溶媒中で調製した、異なる層の薬剤の溶液を、ポリマーの溶液と、パクリタキセルおよびシロリムスの最終濃度範囲0.001重量%〜30重量%で混合する。ラクトン系ポリエステルもしくはコポリエステル、例えばポリラクチド、ポリカプロラクトン-グリコリド、ポリオルトエステル、ポリ無水物;ポリ-アミノ酸;多糖;ポリホスファゼン;ポリ(エーテル-エステル)共重合体、例えばPEO-PLLA、またはそのブレンドなどのポリマーは、生体適合性であり(すなわち、任意の負の組織反応を誘発しないか、または壁在血栓の形成を促進しない)、生分解性である。非吸収性の生体適合性ポリマーも好適な候補である。ポリジメチルシオルキサン(polydimethylsiolxane);ポリ(エチレン-酢酸ビンジル(vingylacetate));アクリレート系ポリマーまたは共重合体、例えばポリ(ヒドロキシエチルメチルメタクリレート、ポリビニルピロリジノン;フッ素化ポリマー、例えばポリテトラフルオロエチレン;セルロースエステルなどのポリマー。
ステントを316Lステンレス鋼から作製し、超音波洗浄器内でのアニオン系洗剤中で1回目の洗浄を行って洗浄および不動態化した後、撹拌しながら熱硝酸に浸し、続いて脱イオン水による最終リンスを行う。
Claims (10)
- (a)抗増殖薬、抗炎症薬、またはそれらの組み合わせを含む外層コーティング;ならびに
(b)フィブロネクチンである非血栓形成性細胞外マトリックス(ntECM)分子を含む底層コーティング
を含む管状血管インプラントであって、
外層コーティングが移植による抗増殖薬または抗炎症薬の即時および持続放出用に製剤され、かつ少なくとも1つのntECM分子がインプラントの1つまたは複数の表面に恒久的に固定され、内皮細胞の内殖(in-growth)を促進し、かつ生体組織において再狭窄を阻害する、
管状血管インプラント。 - 少なくとも1つの抗成長因子薬を含む中間層コーティングをさらに含む、請求項1記載の管状血管インプラント。
- 中間層コーティングが少なくとも1つの抗成長因子薬の遅延および持続放出用に製剤されている、請求項2記載の管状血管インプラント。
- 中間層コーティングが底層に介入している、請求項3記載の管状血管インプラント。
- 少なくとも1つの抗成長因子薬が、インプラントの1つまたは複数の表面に共有結合している、請求項4記載の管状血管インプラント。
- 少なくとも1つの抗成長因子薬が、インプラントをコーティングする1つまたは複数のポリマーに共有結合している、請求項4記載の管状血管インプラント。
- 抗増殖薬がパクリタキセル、アクチノマイシン、タキサン、ダウノルビシン、メトトレキサート、シクロホスファミド、ブレオマイシン、ブスルファン(busulfane)、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、アザチオプリン、ハロフジノン、アドリアマイシン、アクチノマイシン、およびムタマイシン(mutamycin);エンドスタチン、アンジオスタチン、ならびにチミジンキナーゼ阻害剤からなる群より選択される、請求項1記載の管状血管インプラント。
- 抗炎症薬がシロリムス、タクロリムス、エベロリムス、およびゾタロリムス(zotarolimus)からなる群より選択される、請求項1記載の管状血管インプラント。
- 少なくとも1つの抗成長因子薬が抗VEGFポリクローナルもしくはモノクローナル抗体、および抗PDGFポリクローナルもしくはモノクローナル抗体からなる群、またはそれらの組み合わせより選択される、請求項2記載の管状血管インプラント。
- ステントである、請求項1記載の管状血管インプラント。
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US88042007P | 2007-01-11 | 2007-01-11 | |
US60/880,420 | 2007-01-11 | ||
US90133807P | 2007-02-13 | 2007-02-13 | |
US60/901,338 | 2007-02-13 | ||
PCT/US2008/050789 WO2008086490A2 (en) | 2007-01-11 | 2008-01-10 | Multiple drug-eluting coronary artery stent for percutaneous coronary artery intervention |
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JP2010515545A JP2010515545A (ja) | 2010-05-13 |
JP2010515545A5 JP2010515545A5 (ja) | 2012-03-01 |
JP5602432B2 true JP5602432B2 (ja) | 2014-10-08 |
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JP2009545686A Active JP5602432B2 (ja) | 2007-01-11 | 2008-01-10 | 経皮的冠動脈インターベンション用の多剤溶出冠動脈ステント |
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US (1) | US20080172124A1 (ja) |
EP (1) | EP2101683A4 (ja) |
JP (1) | JP5602432B2 (ja) |
WO (1) | WO2008086490A2 (ja) |
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JP2010515545A (ja) | 2010-05-13 |
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EP2101683A4 (en) | 2014-12-03 |
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