JP4832787B2 - 薬物溶出式の医療装置における酸化を防ぎ薬物の劣化を減少するための酸化防止剤の使用 - Google Patents
薬物溶出式の医療装置における酸化を防ぎ薬物の劣化を減少するための酸化防止剤の使用 Download PDFInfo
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- BPICBUSOMSTKRF-UHFFFAOYSA-N xylazine Chemical compound CC1=CC=CC(C)=C1NC1=NCCCS1 BPICBUSOMSTKRF-UHFFFAOYSA-N 0.000 description 1
- 229960001600 xylazine Drugs 0.000 description 1
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 description 1
- PAPBSGBWRJIAAV-UHFFFAOYSA-N ε-Caprolactone Chemical compound O=C1CCCCCO1 PAPBSGBWRJIAAV-UHFFFAOYSA-N 0.000 description 1
Images
Classifications
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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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
-
- 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
- A61L31/143—Stabilizers
-
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- 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
- 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
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
-
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/065—Y-shaped blood vessels
- A61F2002/067—Y-shaped blood vessels modular
-
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/077—Stent-grafts having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
- B23K—SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
- B23K2103/00—Materials to be soldered, welded or cut
- B23K2103/30—Organic material
- B23K2103/42—Plastics
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
- B23K—SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
- B23K2103/00—Materials to be soldered, welded or cut
- B23K2103/50—Inorganic material, e.g. metals, not provided for in B23K2103/02 – B23K2103/26
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgery (AREA)
- Epidemiology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Chemical & Material Sciences (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Materials For Medical Uses (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
キャンベル(Campbell)およびキャンベル(Campbell),1985年 キャンベル(Campbell)およびキャンベル(Campbell),1987年 クロウズ(Clowes)およびシュワルツ(Schwarts),1985年 タナカ(Tanaka)他,1993年 エデルマン(Edelman)他,1998年 クロウズ,A.W.(Clowes, A.W.)およびカルノブスキー,M(Karnovsky, M),ネイチャー(Nature),265巻,p.25−26,1977年 ガイトン,J.R.(Guyton, J.R.)他、サーキュレーション・リサーチ(Circ. Res.),46巻,p.625−634,1980年 クロウズ,A.W.(Clowes, A.W.)およびクロウズ,M.M.(Clowes, M.M.)、ラボラトリー・インベスティゲーション(Lab. Invest.),52巻,p.611−616,1985年 クロウズ,A.W.(Clowes, A.W.)およびクロウズ,M.M.(Clowes, M.M.),サーキュレーション・リサーチ(Circ. Res.),58巻,p.839−845,1986年 マジェスキー(Majesky),サーキュレーション・リサーチ(Circ. Res.),61巻,p.296−300,1987年 スノー(Snow)他,アメリカン・ジャーナル・オブ・パソロジー(Am. J. Pathol.),137巻,p.313−330,1990年 オカダ,T(Okada, T),ニューロサージェリー(Neurosurgery),25巻,p.92−98,1989年 クーリエ,J.W.(Currier, J.W.)他,サーキュレーション(Circ.),80巻,p.11−66,1989年 ソロット,S.J.(Sollot, S.J.)他,ジャーナル・オブ・クリニカル・インベスティゲーション(J. Clin. Invest.),95巻,p.1869−1876,1995年 パウエル,J.S.(Powell, J.S.)他,サイエンス(Science),245巻,p.186−188,1989年 ランデルガン,C.F.(Lundergan, C.F.)他,アメリカン・ジャーナル・オブ・カージオロジー(Am. J. Cardiol.),17巻(増刊B),p.132B−136B,1991年 ジョナッソン,L.(Jonasson, L.)他,プロシーディング・ナチュラル・アカデミック・ソサイエテイ(Proc. Natl. Acad. Sci.),85巻,p.2303,1988年 ファーンズ,G.A.A(Ferns, G.A.A.)他,サイエンス(Science),253巻,p.1129−1132,1991年 ネメセック,G.M.(Nemecek, G.M.)他,ジャーナル・オブ・ファーマコロジカル・エクスペリメンタル・セラピー(J. Pharmacol. Exp. Thera.),248巻,p.1167−1174,1989年 リウ,M.W.(Liu, M.W.)他,サーキュレーション(Circ.),81巻,p.1089−1093,1990年 フクヤマ,J.(Fukuyama, J.)他,ヨーロピアン・ジャーナル・オブ・ファーマコロジー(Eur. J. Parmacol. ),318巻,p.327−332,1996年 ハンソン,G.K.(Hansson, G.K.)およびホルム,J.(Holm, J.),サーキュレーション(Circ.),84巻,p.1266−1272,1991年 マークス,S.O.(Marx, S.O.)他,サーキュレーション・リサーチ(Circ. Res.),76巻,p.412−417,1995年 コルバーン,M.D.(Colburn, M.D.)他,ジャーナル・オブ・バスキュラー・サージェリー(J. Vasc. Surg.),15巻,p.510〜518,1992年 バーク,B.C.(Berk, B.C.)他,ジャーナル・オブ・アメリカン・コル・カージオロジー(J. Am. Coll. Cardiol.),17巻,p.111B−117B,1991年 ウエインバーガー,J.(Weinberger, J.)他,インターナショナル・ジャーナル・オブ・ラディオロジカル・オンコロジカル・バイオロジカル・フィジオロジー(Int. J. Rad. Onc. Biol. Phys.),36巻,p.767−775,1996年 ファーブ,A.(Farb, A.)他,サーキュレーション・リサーチ(Circ. Res.),80巻,p.542−550,1997年 シモンズ,M.(Simons, M.)他,ネイチャー(Nature),359巻,p.67−70,1992年 チャン,M.W.(Chang, M.W.)他,ジャーナル・オブ・クリニカル・インベスティゲーション(J. Clin. Invest.),96巻,p.2260−2268,1995年 マック(Mak)およびトポル(Topol),1997年 ラング(Lang)他,1991年 ポプマ(Popma)他,1991年 フランクリン(Franklin)およびファクソン(Faxon),1993年 セリュイズ,P.W.(Serruys, P.W>)他,1993年 タージフ(Tardif)他,1997年 ヨコイ(Yokoi)他,1997年 テイルスタイン(Teirstein)他,1997年 セリュイズ(Serruys)他,1994年 フィッシュマン(Fischman)他,1994年 セリュイズ(Serruys)他,1996年
実施例1:
それぞれF19NMRにより決定した場合に92/8重量%および91/9重量%のフッ化ビニリデン/HFPである、一定のPVDFホモポリマー(テキサス州ヒュートンのソルベイ・アドバンスド・ポリマーズ社(Solvay Advanced Polymers)から入手可能なソレフ(Solef)(登録商標)1008、融点は約175℃)およびポリ(フッ化ビニリデン/HFP)のポリフルオロ・コポリマー(それぞれ、例えば、テキサス州ヒュートンのソルベイ・アドバンスド・ポリマーズ社(Solvay Advanced Polymers)から入手可能なソレフ(Solef)(登録商標)11010および11008、融点は約159℃および160℃)を種々のステント用の可能性のある被膜として調べた。上記のポリマーはDMAc、N,N−ジメチルホルムアミド(DMF)、ジメチルスルホキシド(DMSO)、N−メチルピロリドン(NMP)、テドラヒドロフラン(THF)およびアセトンを含むがこれらに限らない種々の溶媒中において溶ける。これらのポリマーを一定のプライマーとしてアセトン中に5重量%で溶解するか、そのポリマーを一定の上部被膜として50/50DMAc/アセトン中に30重量%で溶解することによりそれぞれのポリマー被膜を調製した。この場合に、浸漬によりステントに供給して、数時間にわたり空気中において60℃で乾燥した後に、100mmHg(1.33×104 パスカル)以下の一定の真空中において3時間にわたり60℃で乾燥した種々の被膜は白色の発泡体状のフィルムを形成した。供給時において、これらのフィルムはステントに対する接着性が欠けており、剥がれ落ちて、過度に脆いことが分かった。さらに、上記の様式で被覆したステントを175℃を超える温度、すなわち、そのポリマーの融点を超える温度に加熱すると、一定の透明で付着性のフィルムが形成された。それゆえ、高品質のフィルムを達成するためには、種々の被膜は高い温度を、例えば、ポリマーの融点を超える温度を必要とする。上述したように、このような高温の熱処理は大部分の薬剤配合物においてこれらの熱に対する影響の受けやすさにより許容し得ない。
F19NMRで決定した場合に14.5重量%のHFPと共重合している85.5重量%のフッ化ビニリデンを含有しているおポリフルオロ・コポリマー(ソレフ(Solef)(登録商標)21508)を評価した。このコポリマーは上記実施例1において記載されているポリフルオロ・ホモポリマーおよびコポリマーよりも結晶性が低い。さらに、このコポリマーは約133℃であると報告されている低い融点も有している。この場合も同様に、約20重量%の上記ポリフルオロ・コポリマーを含む一定の被膜を50/50のDMAc/MEK中における一定のポリマー溶液により供給した。数時間にわたり60℃で(空気中において)乾燥した後に、100mmHg(1.33×104 パスカル)以下の真空中において3時間にわたり60℃で乾燥することにより透明な付着性のフィルムを得た。この方法は高品質のフィルムを達成するための一定の高温の熱処理の必要性を排除している。このようにして得られた被膜は上記実施例1の被膜よりも滑らかであり且つ付着性が高かった。膨張処理を受けた一部の被覆型ステントはフィルムが金属から離れるためにある程度の付着性の低下と「テント状化(tenting)」を示した。そこで、必要である場合には、上記の各コポリマーを含有している被膜の改質を、例えば、種々の可塑剤等をその被膜配合物に添加する等により行なうことができる。このような被膜により調製される種々のフィルムは、特に、これらの装置が種々のステントの程度まで膨張することに対して影響を受けにくい場合に、それぞれのステントおよびその他の医療装置を被覆するために使用できる。
その後、上記よりもさらに高いHFP含有量のポリフルオロ・コポリマーを試験した。この系列のポリマーは半結晶質ではなく、エラストマーとして市販されている。一例のこのようなコポリマーはフルオレル(Fluorel)(商標)FC2261Q(ミネソタ州オークデールのダイニオン社(Dyneon)、3M−ホエストエンタープライズの1社(3M-Hoecht Enterprise))、すなわち、フッ化ビニリデン/HFPの60.6/39.4(重量/重量)のコポリマーである。このコポリマーは室温よりも十分に低いTg(ガラス転移点)(このTgは約−20℃)を有しているが、室温または60℃でも粘着性にならない。このポリマーは示差走査熱量計(DSC)または広角X線回折法により測定した場合に、検出可能な結晶質を持たない。上述したようなステント上に形成されるフィルムは非粘着性で、透明であり、ステントの拡張時に問題を生じることなく膨張する。
図3は85.5/14.5のフッ化ビニリデン/HFPのポリフルオロ・コポリマーに関するデータをプロットしたグラフ図であり、上部被膜の無い場合における一定の時間の関数として放出される薬剤のフラクションを示している。また、図4は一定の上部被膜が配置されている同一のポリフルオロ・コポリマーについてのデータをプロットしたグラフ図であり、放出速度に対する最も大きな影響が一定の透明な上部被膜を伴う場合に生じていることを示している。図示のように、TC150は150マイクログラムの上部被膜を有する一定の装置を示しており、TC235は235マイクログラムの上部被膜を示している。上部被膜を備える前の各ステントは30%のラパマイシンを含有している平均で750マイクログラムの被膜を有していた。さらに、図5は60.6/39.4のフッ化ビニリデン/HFPポリフルオロ・コポリマーについてのデータをプロットしたグラフ図であり、一定の時間の関数としての放出される薬剤のフラクションを示しており、一定の上部被膜を伴わない場合の被膜からの放出速度の有意義な調整を示している。すなわち、この放出は薬剤をフィルム中に装填することにより調整されている。
通常の食事をしている9匹のニュージーランド種の白うさぎ(2.5kg乃至3.0kg)に手術の24時間前、さらに手術の直前に、およびこの調査の残りの部分においてアスピリンを与えた。手術時に、各動物体にアセプロマジン(0.1乃至0.2mg/kg)をあらかじめ投薬し、一定のケタミン/キシラジン混合物(それぞれ40mg/kgおよび5mg/kg)で麻酔をかけた。さらに、各動物体にヘパリンの1回分の処置間投与量(150IU/kg、静脈内(i.v.))を与えた。
上記のフルオレル(Fluorel)(商標)FC2261Qコポリマーを約10重量%でMEK中に溶解して、14:1のエタノール/水とMEK溶液との溶液比率においてエタノール/水の50/50混合物中において洗浄した。その後、このポリマーは沈澱し、遠心処理によりこの溶剤相から分離した。さらに、このポリマーを再びMEK中に溶解して、洗浄処理を繰り返し行なった。その後、このポリマーを各洗浄工程の後に一晩にわたり一定の真空オーブン(200ミリトール(mtorr)以下)内において60℃で乾燥した。
クロスフレックス(CrossFlex)(登録商標)ステント(コーディス(Cordis)、ジョンソン・アンド・ジョンソン・カンパニー社(Johnson & Johnson Company)の1社から入手可能)を上記の「受け入れられた(as received)」フルオレル(Fluorel)(商標)FC2261QPVDFコポリマーおよび上記実施例6において浄化したポリフルオロ・コポリマーにより、浸漬処理および拭き取り方式を用いて被覆した。その後、これらの被覆したステントをエチレン・オキシドおよび一定の標準的な処理工程により滅菌処理した。さらに、これらの被覆したステントおよび無被覆状態の金属ステント(対照品)をブタの各冠動脈に移植して、これらを28日間にわたりその状態に維持した。
細胞増殖を阻止するクラドリビンの能力を評価するために、人間の平滑筋または内皮の細胞(クロネテイクス社(Clonetics)、ウォーカースビル、MD)を2000個の細胞/cm2 の一定の密度(約3600個の細胞/ウェル)で接種して12個ウェル型のプレートのそれぞれの中に入れた後に、5パーセントのウシ胎児血清(FCS)を含有している1.5mlの増殖培地により培養した。24時間後に、上記の増殖培地を変えて、10ng/mlの血小板由来型増殖因子AB(PDGF・AB、ライフ・テクノロジー社(LIFE Technologies)ならびに種々の濃度のクラドリビン(0.001乃至10,000nM)を含有している新鮮な培地を3回にわたり各ウェルに加えた。すなわち、培地を3日後に新鮮なクラドリビンを含有している培地に交換した。さらに、6日目において、細胞をトリプシン処理することにより分離して一定の細胞懸濁液を得て、軽く延伸処理することによりペレットにして、一定のノイバウアー(Neubauer)血球計システムを用いて手動により計数した。その後、細胞の生活能力をトリパン・ブルー除外処理により評価した。
H>(OM(r)−IM(r))−WT
(1)薬物溶出方式の医療装置において、
一定の移植可能な内腔内構造、
前記移植可能な内腔内構造の少なくとも一部分に固定されている治療の用量における一定の薬剤として活性な物質、および
酸化による前記薬剤として活性な物質の劣化を実質的に妨げるためにその薬剤として活性な物質と共に混合されている一定の安定化剤を備えている医療装置。
(2)前記移植可能な内腔内構造が一定のステントを含む実施態様1に記載の薬物溶出式の医療装置。
(3)前記薬剤として活性な物質が一定のラパマイシンを含む実施態様1に記載の薬物溶出式の医療装置。
(4)前記薬剤として活性な物質がシロリムスを含む実施態様1に記載の薬物溶出式の医療装置。
(5)前記安定化剤が一定の酸化防止剤を含む実施態様1に記載の薬物溶出式の医療装置。
(7)前記酸化防止剤がトコフェロールを含む実施態様5に記載の薬物溶出式の医療装置。
(8)前記酸化防止剤がアスコルビン酸を含む実施態様5に記載の薬物溶出式の医療装置。
(9)前記酸化防止剤がパルミチン酸アスコルビルを含む実施態様5に記載の薬物溶出式の医療装置。
(10)薬物溶出式の医療装置において、
一定の移植可能な内腔内構造、
一定の高分子の溶液、
前記高分子の溶液中に混合されている治療の用量における一定の薬剤として活性な物質を備えており、この結果として得られる混合物が前記移植可能な内腔内構造の少なくとも一部分に固定されており、さらに、酸化による前記薬剤として活性な物質の劣化を実質的に妨げるために前記結果として得られる混合物中に混合されている一定の安定化剤を備えている医療装置。
(12)前記薬剤として活性な物質が一定のラパマイシンを含む実施態様10に記載の薬物溶出式の医療装置。
(13)前記薬剤として活性な物質がシロリムスを含む実施態様10に記載の薬物溶出式の医療装置。
(14)前記安定化剤が一定の酸化防止剤を含む実施態様10に記載の薬物溶出式の医療装置。
(15)前記酸化防止剤がブチル化ヒドロキシトルエンを含む実施態様14に記載の薬物溶出式の医療装置。
(17)前記酸化防止剤がアスコルビン酸を含む実施態様14に記載の薬物溶出式の医療装置。
(18)前記酸化防止剤がパルミチン酸アスコルビルを含む実施態様14に記載の薬物溶出式の医療装置。
(19)薬物溶出式の医療装置において、
一定の移植可能な内腔内構造、
一定の高分子の溶液、
前記高分子の溶液中に混合されている治療の用量における一定の薬剤として活性な物質を備えており、この結果として得られる混合物が前記移植可能な内腔内構造の少なくとも一部分に固定されており、さらに、酸化による前記薬剤として活性な物質の劣化を実質的に妨げるために前記結果として得られる混合物中に混合されている一定の安定化剤を備えており、この安定化剤が前記薬剤として活性な物質の近くに存在するように前記結果として得られる混合物中に混合されている医療装置。
(20)前記移植可能な内腔内構造が一定のステントを含む実施態様19に記載の薬物溶出式の医療装置。
(22)前記薬剤として活性な物質がシロリムスを含む実施態様19に記載の薬物溶出式の医療装置。
(23)前記安定化剤が一定の酸化防止剤を含む実施態様19に記載の薬物溶出式の医療装置。
(24)前記酸化防止剤がブチル化ヒドロキシトルエンを含む実施態様23に記載の薬物溶出式の医療装置。
(25)前記酸化防止剤がトコフェロールを含む実施態様23に記載の薬物溶出式の医療装置。
(27)前記酸化防止剤がパルミチン酸アスコルビルを含む実施態様23に記載の薬物溶出式の医療装置。
(28)前記安定化剤が前記薬剤として活性な物質に対して一定の親和性を有している実施態様19に記載の薬物溶出式の医療装置。
(29)前記安定化剤が前記薬剤として活性な物質の近くに存在するように前記結果として得られる溶液と共に混合されている実施態様19に記載の薬物溶出式の医療装置。
(30)薬物溶出式の医療装置において、
一定のステント、
一定の生体適合性の高分子の溶液、
前記高分子の溶液中に混合されている治療の用量におけるラパマイシンを備えており、この結果として得られる混合物が前記ステントの少なくとも一部分に固定されており、さらに
前記ラパマイシンの劣化を防ぐために前記結果として得られる混合物の中に混合されている一定の酸化防止剤を備えている医療装置。
(32)前記酸化防止剤が約0.048乃至約0.102%(重量/容量)の範囲内のトコフェロールを含む実施態様30に記載の薬物溶出式の医療装置。
(33)前記酸化防止剤が約0.022乃至約0.508%(重量/容量)の範囲内のアスコルビン酸を含む実施態様30に記載の薬物溶出式の医療装置。
(34)前記酸化防止剤が約0.01乃至約0.02%(重量/容量)の範囲内のパルミチン酸アスコルビルを含む実施態様30に記載の薬物溶出式の医療装置。
(35)前記酸化防止剤が約250ppmのブチル化ヒドロキシトルエンを含む実施態様30に記載の薬物溶出式の医療装置。
102 帯域部分
104 連結部分
106 貯蔵部分
200 吻合装置
202 固定用フランジ
204 ステープル部材
300 装置
302 縫合線
308 針
400 バルーン
402 潤滑性の被膜
500 潤滑性の被膜
502 基部被膜
504 上部被膜
600 潤滑性の被膜
700 プライマー層
702 二次的な層
704 薬物含有基材
706 上部被膜
800 ステント移植片
900 ステント移植片
1000 動脈瘤治療システム
3000 外科ステープル
3002 貫通穴
3006 被膜
4000 縫合糸材料
4002 被膜
4004 薬物
5010 装置
5012 軸部
5014 シース
5028 先端部分
5060 外側層
5062 内側層
5064 補強層
5070 被膜
5200 起立部分
7000 ステント
7002 フープ
7006 ループ
7008 架橋部
7210 外科装置
7212 アクチュエータ
7214 スリット
7216 リード端部
7218 チップ端部
7220 カテーテル
7222 保持リング
7224 中央部分
7226 開口領域
7228 導管
7230 メッシュ様構造
7232 静脈
7234 標的領域
7236 ガイドワイヤ
8000 ガイドワイヤ
9000 血管
Claims (6)
- 薬物溶出方式の医療装置において、
ステント、
前記ステントの少なくとも一部分に固定されている治療の用量におけるラパマイシン、および
酸化によるラパマイシンの劣化を実質的に妨げるためにラパマイシンと共に混合されている酸化防止剤を備え、当該酸化防止剤が、
(i)約0.006乃至約0.02%(重量/容量)の範囲内のブチル化ヒドロキシトルエンまたは、
(ii)約0.048乃至約0.102%(重量/容量)の範囲内のトコフェロールまたは、
(iii)0.022乃至約0.508%(重量/容量)の範囲内のアスコルビン酸または、
(iv)約250ppmのブチル化ヒドロキシトルエンまたは、
(v)約0.01乃至約0.02%(重量/容量)の範囲内のパルミチン酸アスコルビル
を含む、
医療装置。 - 請求項1に記載の薬物溶出方式の医療装置において、ラパマイシンが、前記ステントの外表面にのみ固定されている医療装置。
- 薬物溶出式の医療装置において、
ステント、
高分子の溶液、
前記高分子の溶液中に混合されている治療の用量におけるラパマイシンを備えており、この結果として得られる混合物が前記ステントの少なくとも一部分に固定されており、さらに、酸化によるラパマイシンの劣化を実質的に妨げるために前記結果として得られる混合物中に混合されている酸化防止剤を備え、当該酸化防止剤が、
(i)約0.006乃至約0.02%(重量/容量)の範囲内のブチル化ヒドロキシトルエンまたは、
(ii)約0.048乃至約0.102%(重量/容量)の範囲内のトコフェロールまたは、
(iii)0.022乃至約0.508%(重量/容量)の範囲内のアスコルビン酸または、
(iv)約250ppmのブチル化ヒドロキシトルエンまたは、
(v)約0.01乃至約0.02%(重量/容量)の範囲内のパルミチン酸アスコルビル
を含む、
医療装置。 - 請求項3に記載の薬物溶出方式の医療装置において、前記酸化防止剤が、ラパマイシンの近くに存在するように、前記結果として得られる混合物中に混合されている、医療装置。
- 請求項3または4に記載の薬物溶出式の医療装置において、前記酸化防止剤がラパマイシンに対して親和性を有している、医療装置。
- 請求項3〜5のいずれか1項に記載の薬物溶出方式の医療装置において、ラパマイシンが、前記ステントの外表面にのみ固定されている、医療装置。
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CA2504258C (en) | 2015-06-30 |
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