JP6038912B2 - シロリムスを制御放出するためのシロリムスコーティングされたカテーテルバルーンを有するバルーンカテーテル - Google Patents
シロリムスを制御放出するためのシロリムスコーティングされたカテーテルバルーンを有するバルーンカテーテル Download PDFInfo
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- JP6038912B2 JP6038912B2 JP2014519507A JP2014519507A JP6038912B2 JP 6038912 B2 JP6038912 B2 JP 6038912B2 JP 2014519507 A JP2014519507 A JP 2014519507A JP 2014519507 A JP2014519507 A JP 2014519507A JP 6038912 B2 JP6038912 B2 JP 6038912B2
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- sirolimus
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- 238000010257 thawing Methods 0.000 description 1
- 229920001169 thermoplastic Polymers 0.000 description 1
- 239000004416 thermosoftening plastic Substances 0.000 description 1
- 229960001196 thiotepa Drugs 0.000 description 1
- 229960004072 thrombin Drugs 0.000 description 1
- NZVYCXVTEHPMHE-ZSUJOUNUSA-N thymalfasin Chemical compound CC(=O)N[C@@H](CO)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](C)C(=O)N[C@@H](C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(N)=O)C(O)=O NZVYCXVTEHPMHE-ZSUJOUNUSA-N 0.000 description 1
- 229960004231 thymalfasin Drugs 0.000 description 1
- 229960000187 tissue plasminogen activator Drugs 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
- 239000010936 titanium Substances 0.000 description 1
- 229960000707 tobramycin Drugs 0.000 description 1
- NLVFBUXFDBBNBW-PBSUHMDJSA-N tobramycin Chemical compound N[C@@H]1C[C@H](O)[C@@H](CN)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O[C@@H]2[C@@H]([C@@H](N)[C@H](O)[C@@H](CO)O2)O)[C@H](N)C[C@@H]1N NLVFBUXFDBBNBW-PBSUHMDJSA-N 0.000 description 1
- 229960001295 tocopherol Drugs 0.000 description 1
- 229930003799 tocopherol Natural products 0.000 description 1
- 235000010384 tocopherol Nutrition 0.000 description 1
- 239000011732 tocopherol Substances 0.000 description 1
- 229930190170 tomenphantopin Natural products 0.000 description 1
- UCFGDBYHRUNTLO-QHCPKHFHSA-N topotecan Chemical compound C1=C(O)C(CN(C)C)=C2C=C(CN3C4=CC5=C(C3=O)COC(=O)[C@]5(O)CC)C4=NC2=C1 UCFGDBYHRUNTLO-QHCPKHFHSA-N 0.000 description 1
- 229960000303 topotecan Drugs 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 230000014616 translation Effects 0.000 description 1
- 230000032258 transport Effects 0.000 description 1
- 230000000472 traumatic effect Effects 0.000 description 1
- 150000003626 triacylglycerols Chemical class 0.000 description 1
- 229960005294 triamcinolone Drugs 0.000 description 1
- GFNANZIMVAIWHM-OBYCQNJPSA-N triamcinolone Chemical compound O=C1C=C[C@]2(C)[C@@]3(F)[C@@H](O)C[C@](C)([C@@]([C@H](O)C4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 GFNANZIMVAIWHM-OBYCQNJPSA-N 0.000 description 1
- YWBFPKPWMSWWEA-UHFFFAOYSA-O triazolopyrimidine Chemical compound BrC1=CC=CC(C=2N=C3N=CN[N+]3=C(NCC=3C=CN=CC=3)C=2)=C1 YWBFPKPWMSWWEA-UHFFFAOYSA-O 0.000 description 1
- YKUJZZHGTWVWHA-UHFFFAOYSA-N triptolide Natural products COC12CC3OC3(C(C)C)C(O)C14OC4CC5C6=C(CCC25C)C(=O)OC6 YKUJZZHGTWVWHA-UHFFFAOYSA-N 0.000 description 1
- 229960000875 trofosfamide Drugs 0.000 description 1
- UMKFEPPTGMDVMI-UHFFFAOYSA-N trofosfamide Chemical compound ClCCN(CCCl)P1(=O)OCCCN1CCCl UMKFEPPTGMDVMI-UHFFFAOYSA-N 0.000 description 1
- 229960005041 troleandomycin Drugs 0.000 description 1
- LQCLVBQBTUVCEQ-QTFUVMRISA-N troleandomycin Chemical compound O1[C@@H](C)[C@H](OC(C)=O)[C@@H](OC)C[C@@H]1O[C@@H]1[C@@H](C)C(=O)O[C@H](C)[C@H](C)[C@H](OC(C)=O)[C@@H](C)C(=O)[C@@]2(OC2)C[C@H](C)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)OC(C)=O)[C@H]1C LQCLVBQBTUVCEQ-QTFUVMRISA-N 0.000 description 1
- WFKWXMTUELFFGS-UHFFFAOYSA-N tungsten Chemical compound [W] WFKWXMTUELFFGS-UHFFFAOYSA-N 0.000 description 1
- 229910052721 tungsten Inorganic materials 0.000 description 1
- 239000010937 tungsten Substances 0.000 description 1
- 108010012374 type IV collagen alpha3 chain Proteins 0.000 description 1
- 239000005483 tyrosine kinase inhibitor Substances 0.000 description 1
- 150000004917 tyrosine kinase inhibitor derivatives Chemical class 0.000 description 1
- 238000009281 ultraviolet germicidal irradiation Methods 0.000 description 1
- ORHBXUUXSCNDEV-UHFFFAOYSA-N umbelliferone Chemical compound C1=CC(=O)OC2=CC(O)=CC=C21 ORHBXUUXSCNDEV-UHFFFAOYSA-N 0.000 description 1
- HFTAFOQKODTIJY-UHFFFAOYSA-N umbelliferone Natural products Cc1cc2C=CC(=O)Oc2cc1OCC=CC(C)(C)O HFTAFOQKODTIJY-UHFFFAOYSA-N 0.000 description 1
- YYSFXUWWPNHNAZ-PKJQJFMNSA-N umirolimus Chemical compound C1[C@@H](OC)[C@H](OCCOCC)CC[C@H]1C[C@@H](C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@](O)(O2)[C@H](C)CC[C@H]2C[C@H](OC)/C(C)=C/C=C/C=C/[C@@H](C)C[C@@H](C)C(=O)[C@H](OC)[C@H](O)/C(C)=C/[C@@H](C)C(=O)C1 YYSFXUWWPNHNAZ-PKJQJFMNSA-N 0.000 description 1
- 229960005356 urokinase Drugs 0.000 description 1
- 229940096998 ursolic acid Drugs 0.000 description 1
- PLSAJKYPRJGMHO-UHFFFAOYSA-N ursolic acid Natural products CC1CCC2(CCC3(C)C(C=CC4C5(C)CCC(O)C(C)(C)C5CCC34C)C2C1C)C(=O)O PLSAJKYPRJGMHO-UHFFFAOYSA-N 0.000 description 1
- 229910052720 vanadium Inorganic materials 0.000 description 1
- GPPXJZIENCGNKB-UHFFFAOYSA-N vanadium Chemical compound [V]#[V] GPPXJZIENCGNKB-UHFFFAOYSA-N 0.000 description 1
- 230000003966 vascular damage Effects 0.000 description 1
- 239000002525 vasculotropin inhibitor Substances 0.000 description 1
- 229940124549 vasodilator Drugs 0.000 description 1
- 239000003071 vasodilator agent Substances 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
- 229960001722 verapamil Drugs 0.000 description 1
- OGWKCGZFUXNPDA-XQKSVPLYSA-N vincristine Chemical compound C([N@]1C[C@@H](C[C@]2(C(=O)OC)C=3C(=CC4=C([C@]56[C@H]([C@@]([C@H](OC(C)=O)[C@]7(CC)C=CCN([C@H]67)CC5)(O)C(=O)OC)N4C=O)C=3)OC)C[C@@](C1)(O)CC)CC1=C2NC2=CC=CC=C12 OGWKCGZFUXNPDA-XQKSVPLYSA-N 0.000 description 1
- 229960004528 vincristine Drugs 0.000 description 1
- OGWKCGZFUXNPDA-UHFFFAOYSA-N vincristine Natural products C1C(CC)(O)CC(CC2(C(=O)OC)C=3C(=CC4=C(C56C(C(C(OC(C)=O)C7(CC)C=CCN(C67)CC5)(O)C(=O)OC)N4C=O)C=3)OC)CN1CCC1=C2NC2=CC=CC=C12 OGWKCGZFUXNPDA-UHFFFAOYSA-N 0.000 description 1
- UGGWPQSBPIFKDZ-KOTLKJBCSA-N vindesine Chemical compound C([C@@H](C[C@]1(C(=O)OC)C=2C(=CC3=C([C@]45[C@H]([C@@]([C@H](O)[C@]6(CC)C=CCN([C@H]56)CC4)(O)C(N)=O)N3C)C=2)OC)C[C@@](C2)(O)CC)N2CCC2=C1N=C1[C]2C=CC=C1 UGGWPQSBPIFKDZ-KOTLKJBCSA-N 0.000 description 1
- 229960004355 vindesine Drugs 0.000 description 1
- GBABOYUKABKIAF-GHYRFKGUSA-N vinorelbine Chemical compound C1N(CC=2C3=CC=CC=C3NC=22)CC(CC)=C[C@H]1C[C@]2(C(=O)OC)C1=CC([C@]23[C@H]([C@]([C@H](OC(C)=O)[C@]4(CC)C=CCN([C@H]34)CC2)(O)C(=O)OC)N2C)=C2C=C1OC GBABOYUKABKIAF-GHYRFKGUSA-N 0.000 description 1
- 229960002066 vinorelbine Drugs 0.000 description 1
- 230000003612 virological effect Effects 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 229960005080 warfarin Drugs 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
- 239000010497 wheat germ oil Substances 0.000 description 1
- 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
- 229960002555 zidovudine Drugs 0.000 description 1
- HBOMLICNUCNMMY-XLPZGREQSA-N zidovudine Chemical compound O=C1NC(=O)C(C)=CN1[C@@H]1O[C@H](CO)[C@@H](N=[N+]=[N-])C1 HBOMLICNUCNMMY-XLPZGREQSA-N 0.000 description 1
- CGTADGCBEXYWNE-JUKNQOCSSA-N zotarolimus Chemical compound N1([C@H]2CC[C@@H](C[C@@H](C)[C@H]3OC(=O)[C@@H]4CCCCN4C(=O)C(=O)[C@@]4(O)[C@H](C)CC[C@H](O4)C[C@@H](/C(C)=C/C=C/C=C/[C@@H](C)C[C@@H](C)C(=O)[C@H](OC)[C@H](O)/C(C)=C/[C@@H](C)C(=O)C3)OC)C[C@H]2OC)C=NN=N1 CGTADGCBEXYWNE-JUKNQOCSSA-N 0.000 description 1
- 229950009819 zotarolimus Drugs 0.000 description 1
- WHNFPRLDDSXQCL-UAZQEYIDSA-N α-msh Chemical compound C([C@@H](C(=O)N[C@@H](CO)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1NC=NC=1)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](C(C)C)C(N)=O)NC(=O)[C@H](CO)NC(C)=O)C1=CC=C(O)C=C1 WHNFPRLDDSXQCL-UAZQEYIDSA-N 0.000 description 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
Classifications
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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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/439—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom the ring forming part of a bridged ring system, e.g. quinuclidine
-
- 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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
- A61L29/085—Macromolecular materials
-
- 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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
- A61L29/16—Biologically active materials, e.g. therapeutic substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- 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
- A61L2420/02—Methods for coating medical devices
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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
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/08—Coatings comprising two or more layers
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Pharmacology & Pharmacy (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Urology & Nephrology (AREA)
- Materials For Medical Uses (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Polymers & Plastics (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Description
バルーンまたはカテーテルバルーンという用語は、基本的には、通常カテーテルと共に使用される、すべての膨張可能な、および再圧縮可能な、ならびに一時的に膨張可能な医療機器を指す。カテーテルバルーンは、現在流通している材料、特に以下に記載のポリマー、特に例えばPA12のようなポリアミド、ポリエステル、ポリウレタン、ポリアクリレート、ポリエーテルからなることができる。
少なくとも1つの油は、オリーブ油、大麻油、トウモロコシ油、クルミ油、キャノーラ油、大豆油、ヒマワリ油、ケシ油、ベニバナ油、小麦胚芽油、ブドウ種子油、月見草油、ボラージ油、ブラッククミン油、チーア、藻油、魚油、タラ肝油、および/または上述の油類の混合物を含む、またはそれらからなる群から選択されることが好ましい。特に適するのは、純粋な不飽和化合物の混合物である。
魚油およびタラ肝油は、α‐リノレン酸(ALA C18:3)をほとんど含有せず、エイコサペンタエン酸(EPA C20:5)およびドコサヘキサエン酸(DHA C22:6)を主として含有する。オメガ‐3脂肪酸は魚油だけでなく、植物油中にも見つけることができる。オメガ‐6脂肪酸などのさらなる不飽和脂肪酸は、草本由来の油類にも存在し、一部では動物性脂肪中よりもより高い割合を占める。ゆえに、必須脂肪酸の含有量がそのように高いアマニ油、クルミ油、フラックスオイル、月見草油などの種々の植物油は、特に高品質で貴重な食用油として薦められる。特に、アマニ油はオメガ‐3およびオメガ‐6脂肪酸の貴重な供給源であり、数十年にわたって高品質食用油として知られている。
オメガ‐9脂肪酸の中では、以下の種類が好ましい:オレイン酸、エライジン酸、エイコセン酸、およびミード酸。
ベルベリン、リリオデニン、オキソウシンスニン、ダフノレチン、ラリシレシノール、メトキシラリシレシノール(methoxylariciresinol)、シリンガレシノール、ウンベリフェロン、アフロモソン(afromoson)、アセチルビスミオンB、デスアセチルビスミオン(desacetylvismione)A、ビスミオンA、ビスミオンB、および硫黄含有アミノ酸、ならびに、上述の活性薬剤の塩および/または混合物。
[3S‐[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]‐5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a‐ヘキサデカヒドロ‐5,19‐ジヒドロキシ‐3‐[2‐(4‐ヒドロキシ‐3‐メトキシシクロヘキシル)‐1‐メチルエテニル]‐14,16‐ジメトキシ‐4,10,12,18‐テトラメチル‐8‐(2‐プロペニル)‐15,19‐エポキシ‐3H‐ピリド[2,1‐c][1,4]‐オキサアザシクロトリコシン‐1,7,20,21(4H,23H)‐テトロン一水和物(tetron monohydrate)。
‐シードラック ‐脱脂セラック
‐手製セラック ‐脱脂漂白セラック
‐機械製セラック ‐アロイリチン酸
セラックの主要な特性:
‐セラックは硬質天然樹脂である、
‐セラックは溶媒への良好な耐性を有する、
‐セラックは炭化水素を主成分とする、
‐セラックは無毒性である、
‐セラックは熱可塑性である、
‐セラックは生理学的に無害である、
‐セラックは食品産業において様々な適用を承認されている、
‐セラックは紫外線抵抗性ではない、
‐セラックは低級アルコールに溶解する、
‐セラックは優れた誘電特性、高い誘電耐力、低い誘電率、良好な耐トラッキング性などを有する、
‐セラックは低い融点(65‐85℃)を有する、
‐セラックはアルカリ性水溶液において水溶性である、
‐コーティングは紫外線照射下でもその電気的特性を変化させない、
‐セラックは優れた膜形成特性を有する、
‐セラックは低い熱伝導性及び低い膨張係数を有し、平滑で高光沢な膜および表面を形成する、
‐セラックコーティングは多くのコーティングへの接着性に優れ、研磨することができる。
a)オメガ脂肪酸、特にオメガ‐3およびオメガ‐6脂肪酸などの少なくとも1つの脂肪酸、油、または脂肪、およびシロリムスと、溶媒とを混合すること、
b)ディッピング法、スプレー法、スプレッド法、またはピペット法により、溶媒中のオメガ脂肪酸、特に特にオメガ‐3およびオメガ‐6脂肪酸などの少なくとも1つの脂肪酸、油、または脂肪、およびシロリムスの混合物を堆積させること、および、
c)コーティングを乾燥すること。
a)オメガ脂肪酸、特にオメガ‐3およびオメガ‐6脂肪酸などの少なくとも1つの脂肪酸、油、または脂肪、シロリムス、および、セラックまたはポリエトキシル化ヒマシ油のような少なくとも1つの添加物と、溶媒とを混合すること、
b)ディッピング法、スプレー法、スプレッド法、またはピペット法により、溶媒中のオメガ脂肪酸、特にオメガ‐3およびオメガ‐6脂肪酸などの少なくとも1つの脂肪酸、油、または脂肪、シロリムス、および、セラックまたはポリエトキシル化ヒマシ油のような少なくとも1つの添加剤の混合物を堆積させること、および、
c)コーティングを乾燥すること。
d)カテーテルバルーンを折りたたむこと。
工程d)は、カテーテルバルーンが拡張状態、または部分拡張状態でコーティングされるのであれば、特に重要である。
e)コーティングされた、または未コーティングのステントを、折りたたまれたカテーテルバルーンへ圧着すること。
実施例1:シロリムスおよびα‐リノレン酸によるコーティング
シロリムスを、約10体積%の水を含有するジメチルスルホキシド(DMSO)に溶解する。α‐リノレン酸およびセラックをこの溶液に加え、カテーテルバルーンをスプレー法(例えば、ハーダー&ステンベック(Harder & Steenbeck)社製エボリューション(EVOLUTION)スプレーピストル)を用いて数回この溶液でコーティングし、コーティング後に乾燥させる。
α‐リノレン酸、ポリエトキシル化ヒマシ油(2:1)、およびシロリムスの混合物をエタノールおよび水に溶かしたものを調製し、ピペットに充填してピペットで多重折畳みバルーンの折り目の下に噴出させる。乾燥後、折畳み部の隙間に粉末状コーティングが生じ、粉末状コーティングはバルーン拡張時に容易に離脱する。
α‐リノレン酸およびセラック(3:1)の混合物をエタノールおよび水に溶かしたものを調製し、ピペットに充填してピペットでカテーテルバルーンの表面全体に噴出させる。その後、カテーテルをバルーン24時間室温で乾燥させた。
血管拡張術に使用されてもよい、拡張式カテーテルバルーンを有する一般的なバルーンカテーテルは、アセトンおよびエタノールを用いて超音波槽内で15分間脱脂され、アセトンおよびエタノールが蒸発するまで乾燥炉内で100℃で乾燥される。続いて、カテーテルバルーンは脱塩水を用いて12時間洗浄される。シロリムス10mgを1mLのステアリドン酸(ケイマンケミカル(Cayman Chemical)社)のエタノール溶液に溶解する。混合物は、エアブラシスプレーピストルで5.8cmの距離から、回転する18mmLVMバルーンカテーテルにスプレーされる。その後、コーティングされたバルーンは30℃で24時間乾燥された。任意選択的には、コーティングされたカテーテルバルーンは折りたたまれてよく、未コーティングの、または活性薬剤でコーティングされたステントは折りたたまれたカテーテルバルーンに圧着されてもよい。
実施例3によりコーティングされたカテーテルバルーンは、エタノール1mlにシロリムス300μgの溶液に浸漬され、膨潤された。コーティングの膨潤プロセスの完了後、カテーテルバルーンは溶液から引き出され、120分間室温で風乾され、折りたたまれた。任意選択的には、未コーティングの、または活性薬剤でコーティングされたステントは折りたたまれたカテーテルバルーンに圧着されてもよい。
血管拡張術に使用されてもよい、拡張式カテーテルバルーンを有する一般的なバルーンカテーテルは、アセトンおよびエタノールを用いて超音波槽内で15分間脱脂され、アセトンおよびエタノールが蒸発するまで乾燥炉内で100℃で乾燥される。続いて、バルーンカテーテルは脱塩水を用いて14時間洗浄された。アマニ油、シロリムス、およびパクリタキセル (80:10:10重量パーセント)を混合し、混合された堆積を計測後、クロロホルムに1:1の混合比で溶解する。その後、混合物は連続的に回転するバルーンカテーテルのバルーン表面にスプレーされる。穏やかな気流でクロロホルムを蒸発させた後、バルーンカテーテルは80℃で乾燥される。任意選択的には、コーティングされたカテーテルバルーンは折りたたまれてもよく、未コーティングの、または活性薬剤でコーティングされたステントは折りたたまれたカテーテルバルーンに圧着されてもよい。
血管拡張術に使用されてもよい、拡張式カテーテルバルーンを有する一般的なバルーンカテーテルは、アセトンおよびエタノールを用いて超音波槽内で15分間脱脂され、乾燥炉内で100℃で乾燥される。続いて、バルーンカテーテルは脱塩水を用いて14時間洗浄された。アマニ油、シロリムス、およびエタノールのスプレー溶液を調製し、自軸の周りを回転するバルーンカテーテルのバルーン表面に、スプレーピストルで連続的にスプレーする。コーティングされたバルーンを有するバルーンカテーテルは70℃で13時間乾燥される。平均コーティング質量は0.20mg±0.04mgである。任意選択的には、コーティングされたカテーテルバルーンは折りたたまれてもよく、未コーティングの、または活性薬剤でコーティングされたステントは折りたたまれたカテーテルバルーンに圧着されてもよい。
実施例6で既に記載のとおりカテーテルバルーンを洗浄した後、0.25%のガンマ‐リノレン酸および0.1%のポリエトキシル化ステアリン酸を含有するエタノールスプレー溶液を調製する。続いて、シロリムスをこのエタノール溶液に溶解する。エタノール溶液は、血管拡張術に適した回転するバルーンカテーテルのバルーン表面に、スプレーピストルで連続的にスプレーされる。次に、バルーンカテーテルは70℃で15時間乾燥される。平均コーティング質量は0.3mg±0.06mgである。任意選択的には、コーティングされたカテーテルバルーンは折りたたまれてもよく、未コーティングの、または活性薬剤でコーティングされたステントは折りたたまれたカテーテルバルーンに圧着されてもよい。
バルーンカテーテルのバルーンは、実施例6に記載のとおり洗浄される。洗浄後、DMSOに溶解した0.25重量%のシロリムス、α‐リノレン酸、およびセラックの第1層は、回転するバルーンカテーテルのバルーン表面に、連続的にスプレーされる。この層は室温で4.5時間乾燥される。続いて、0.1%のポリビニルアルコール‐ポリエチレングリコールグラフト共重合体を含むエタノール溶液の第2層がこの第1層上にスプレーされる。コーティングされたバルーンを有するバルーンカテーテルは50℃で24時間以上乾燥される。平均コーティング質量は0.25mg±0.02mgであると測定される。任意選択的には、コーティングされたカテーテルバルーンは折りたたまれてもよく、未コーティングの、または活性薬剤でコーティングされたステントは折りたたまれたカテーテルバルーンに圧着されてもよい。
バルーンカテーテルのバルーンは、実施例6に記載のとおり洗浄される。バルーンの洗浄後、エタノールに溶解した0.3重量%のセラックの第1層は、バルーンカテーテルのバルーン表面にスプレーされる。この層は室温で12.5時間以上乾燥される。続いて、0.25重量%のシロリムス、α‐リノレン酸、およびセラックを含むDMSO溶液の第2層がセラックのベースコート上にスプレーされる。30℃で20時間以上乾燥した後、コーティング質量は0.42mg±0.07mgであると測定される。任意選択的には、コーティングされたカテーテルバルーンは折りたたまれてもよく、未コーティングの、または活性薬剤でコーティングされたステントは折りたたまれたカテーテルバルーンに圧着されてもよい。
血管拡張術に使用されてもよい、拡張式カテーテルバルーンを有する一般的なバルーンカテーテルは、アセトンおよびエタノールを用いて超音波槽内で15分間脱脂され、アセトンおよびエタノールが蒸発するまで乾燥炉内で100℃で乾燥される。次に、エタノールに溶解した0.20重量%のアマニ油、および0.5重量%のα‐リノレン酸の混合物が調製される。この混合物は、回転するバルーンカテーテルのバルーン表面に連続的にスプレーされる。乾燥工程は70℃で14時間以上行われる。平均コーティング質量は0.3mg±0.04mgである。任意選択的には、コーティングされたカテーテルバルーンは折りたたまれてもよく、未コーティングの、または活性薬剤でコーティングされたステントは折りたたまれたカテーテルバルーンに圧着されてもよい。
血管拡張術に適したバルーンカテーテルのバルーン表面は表9に記載のとおりコーティングされた。乾燥後、一般的な、未コーティングの金属製ステントが各バルーンカテーテルに圧着された。ステントを伴うバルーンカテーテルは滅菌され保護カバーに梱包され、常温で使用されるまで保管された。
血管造影後、実施例12の動物を安楽死させ、組織診断のために冠動脈組織試料を採取した。炎症程度を以下の分類を用いて評価した。
1 中膜または内膜の血管領域の25%未満の弱い浸潤または中程度の炎症性病変
2 中膜または内膜の血管領域の25%から50%の間の中程度の浸潤または著しい炎症性病変
3 中膜または内膜の血管領域の50%を超える強い浸潤または著しい炎症性病変
4 動脈のすべての層における肉芽腫性炎症反応
28日後の炎症程度の測定結果を表11に示す。数値は平均値±標準偏差を表す。未コーティングのバルーンを有するバルーンカルーテルで治療された群1との差は、P値<0.05で有意と認められた。調べたコーティングはすべて、28日後に炎症程度の著しい増加を示さなかった。
血管拡張術に使用されてもよい、拡張式の折りたたみ式バルーンを有する一般的なバルーンカテーテルは、アセトンおよびエタノールを用いて超音波槽内で15分間脱脂され、アセトンおよびエタノールが蒸発するまで乾燥炉内で100℃で乾燥される。続いて、折りたたみ式バルーンは脱塩素水を用いて12時間以上洗浄される。85重量%のオレイン酸と15重量%のシロリムスとの混合物を作製し、得られた混合物に同じ体積のエタノールを加える。折りたたみ式バルーンは回転可能な軸に水平につながれ、そのため充たされるべき折畳み部が常に上側になる。こうして各折畳み部が、ニードルシリンジが拡大されたものであるテフロンカニューレにより、折畳み部の始まりから終わりまで少しずつコーティング溶液で充たされる。続いて、コーティングされたバルーンカテーテルは、溶媒が完全に蒸発するまで一晩室温で乾燥される。次に、コーティングされた、または未コーティングのステントが、必要であれば圧着されてもよい。
バルーンカテーテルの折りたたみ式バルーンを、実施例13に記載のとおり洗浄し、コーティングする。しかし、コーティング溶液は40重量%のオレイン酸、40重量%のセラック、および20重量%シロリムスを用いて作製される。得られた混合物に同じ体積のエタノールを加える。
1‐材料および方法
体重35−42kgの8頭のポーランド飼育ブタが実験に含まれ、実験では24のシロリムスおよびパクリタキセル溶出バルーン(上記参照)が使用された。ポーランドのアメリカ心臓研究センター(Center for Cardiovascular Research of American Heart of Poland)において処置が行われた。地域の生命倫理委員会の適切な承認を得た。各動物の3本の冠動脈(LAD、LCx、RCA(右冠動脈))が、1:1:1の割合で試験群または参照群に無作為に割り当てられた。すべての動物は、処置の3日前に開始され最終処置まで続けられる、経口アセチルサリチル酸(325mg)およびクロピドグレル(初回量300mg、およびその後に75mg)からなる二重抗血小板療法を受けた。プロポフォールによる麻酔導入後、動物は挿管され、人工呼吸で維持された。外科的水準の麻酔の維持のために、プロポフォールの継続投与が開始された。続いて、経皮的セルディンガー法を用いて、動脈シースが左または右大腿動脈に挿入された。ヘパリンの初期ボーラス投与(〜400U/kg)が行われ、活性化凝固時間(ACT)が、少なくとも300秒のACT時間を維持するように30分ごとに計測された。冠動脈内ニトログリセリン投与(200μg)後に冠血管造影が行われた。対象部位の選択は、解剖の目視評価および定量的冠動脈造影(QCA)解析に基づき行われた。これらの部位は、ステントコーティングと動脈壁との均一な相互作用を確実にするために、10%より大きいテーパーを有する側枝およびセグメントを避けて選定された。次に、バルーンを1.2:1(許容範囲1.15:1から1.25:1)のバルーン対動脈比を達成するのに十分な圧力まで一定速度で膨張させた。
以下のコーティングを有する3つの実験用カテーテルが評価された:
1. 試験群1: 3.0μg/mm2シロリムス+シェロール酸++0.5μg/mm2α‐リノレン酸でコーティングされたバルーン
2. 試験群2: 3.0μg/mm2シロリムス+シェロール酸でコーティングされたバルーン
3. 参照群: =3.0μg/mm2パクリタキセル+3.0μg/mm2セラックでコーティングされたバルーン
使用されたバルーンはすべて直径が3.0または3.5mm、長さが20mmであった。
オフラインのメディス(MEDIS)社のソフトウェア、QAngioX7.2を使用して、盲検化された状態で技師により定量的冠動脈造影(QCA)解析が行われ、血管造影図がダイコム(DICOM)フォーマットで記録された。バルーン配置部位を評価するために、2つの対側投影図が選ばれた。
血漿、LAD、LCx、およびRCAのパクリタキセルまたはシロリムス濃度を高速液体クロマトグラフィーで測定した(ドイツ・ベルリン、AnaKat Institut fur Biotechnologie GmbH社、試料の出所について盲検下で分析)。簡潔に言えば、解凍後、組織を大気温度下で秤量し、重さに応じて、異なる体積のエタノールを試料に加えた(組織を完全に覆うのに十分なエタノール)。試料は次に、超音波で40分間処理された。およそ200mlの試料が遠心分離された。検量線が50と5000ng/mlの間の範囲で作成された。検量線のための試料は、1000mg/mlの濃度の原液を希釈して調製された。すべての試料のアリコート(組織および検量線からの試料)をオートサンプラー用バイアル瓶に移し、同体積の0.1%のギ酸を加えた。ODSハイパーシル(ODS Hypersil)(アメリカ・マサチューセッツ州・ウォルトハム、サーモエレクトロンコーポレーション(ThermoElectron Corporation)社、サーモサイエンティフィック(Thermo Scientific)のカラムを通った、高速液体クロマトグラフィーシステムの流速は0.2ml/min、粒子径は5m、孔径は120Åであった。アイソクラティック移動相は、ギ酸(0.1%)を含有する70%のメタノールからなった。質量分析法の多重反応モニタリングモードで、パクリタキセルの854から105AMUへの変化が検出された。パクリタキセル/シロリムス組織濃度はμg/gで表された。
動物は、表12に従い、1時間、1日、3日、および7日を予定された(各期間につきブタ2頭ずつ)。
結果は平均±標準偏差(SD)で表される。変数の正規分布はコルモゴロフ・スミルノフ検定で確認された。等分散性はレーベン検定で確認された。血管造影およびHPLC解析データは分散分析(ANOVA)試験を使用して解析された。非対称な分布、または不均一な分散の場合には、ノンパラメトリックなクラスカルウォリス(Kruskal‐Wallis)検定およびマンホイットニー(Mann‐Whitney)のU検定が使用された。p値<0.05が統計的に有意であると認められた。統計解析はスタットソフト(StatSoft)社のソフトウェア、Statistica7.0を用いて行われた。
術前処置
1晩の絶食の後、動物に体重に基づいた混合剤を麻酔前投薬した。これらの活性薬剤は以下を含む:アトロピン(1mg/20kg sc(皮下注射))、ケタミン(1ml/10kg im(筋肉内注射))、およびキシラジン(1ml/10kg im)。注射は、資格を有する動物技師が首または後四半部筋肉の筋肉内に(im)おこなわれた。動物は準備室に移され、そこで心耳辺縁静脈で静脈路が確保され、静脈内液(乳酸化リンゲル、または0.9%の生理食塩水)が処置を通じて投与された。抗不整脈薬がこれらIV(静脈内)液(リドカイン200mg/リットル、メトプロロール5mg/リットル)に加えられた。(プロポフォールのボーラス投与で)動物が適切な麻酔水準に達した後、動物は適切なサイズの気管内チューブを挿管され、チューブは所定の場所にくくりつけ、漏出を防ぐためにカフを膨らませた。動物は次にカテーテル実験室へ移され、実験台の上に配置され、麻酔および人工呼吸装置につながれた。
表12に示すように、8つの試験群1用(3.5mmを5つ、3.0mmを3つ)、8つの試験群2用(3.5mmを3つ、3.0mmを5つ)、および8つの参照群用の、合計24のバルーンが使用された。それら各々が提供前に検品された。構造異常の兆候は認められなかった。コーティングは目に見えなかった。バルーンは選択された動脈セグメント内に大腿動脈アクセスにより容易に導入され、1.2:1のバルーン/動脈比を保証するためのQCAライブガイダンス後に所要セグメントに首尾よく配置された。テストされたバルーンはすべて60秒間膨らまされた。1つのケースで過拡張により解離、限定的出血が起こった。このためテスト部位の近位へのステント留置が必要となった。
試験群間において、各期間内においてだけでなく全体においても、ベースライン参照血管径、最小管腔径、バルーン径、およびステント対動脈比などのベースラインのQCA結果に差はなかった(表13)。平均過拡張は、110‐120%であり、群間で再現性があった。テストされたバルーンはすべて、3分±20秒間循環内にとどめられた。
全フォローアップ期間内に、死亡も主要有害事象や心臓の事象も認められなかった。動物はすべて、安楽死まで良好な全身状態にあった。参照群(参照バルーン)の送達されたパクリタキセルの濃度は1−12μg/gの範囲内であり、7日間に渡り着実に減少した(図1)。
テストされたバルーンはすべて容易に導入され、実験部位に配置された。送達や回収の問題は起こらなかった。膨張時のバルーン径は所定の径に達した。処置後にもフォローアップ時にも有害事象は認められなかった。死体解剖時に、実験部位内に心筋梗塞または炎症の肉眼で見える兆候は認められなかった。観察が非常に短期間であったことと、実験の設計により、実験用バルーンカテーテルの安全性がエンドポイントではなかったことに留意しなければならない。
1. Gray WA. Granada JF. 血管再狭窄予防のための薬剤コーティングバルーン(Drug−coated balloons for the prevention of vascular restenosis). Circulation;121:2672−80.
2. Posa A. Hemetsberger R. Petnehazy O. et al. ブタ冠動脈におけるパクリタキセル溶出バルーンによる局所薬剤送達の達成(Attainment of local drug delivery with paclitaxel−eluting balloon in porcine coronary arteries). Coron artery Dis 2008;19:243−7.
3. Scheller B. Speck U. Schmitt A. Bohm M. Nickenig G. パクリタキセルの造影剤への添加が冠動脈ステント留置術後の再狭窄を防止する(Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation). J Am Coll Cardiol 2003;42:1415−20.
実施例17:健康なウサギモデルにおけるシロリムス溶出バルーンの活性薬剤伝達の原理証明実験
シロリムス(3μg/mm2)、セラック(3μg/mm2)、およびα‐リノレン酸(1.5μg/mm2)の混合物でコーティングされたシロリムス溶出バルーン(3.0×20mm)(本実施例でDEBと呼ぶ)は、バルーンの膨張の間の動脈組織へのシロリムスの効果的な伝達に関して評価された。
合計4つのシロリムス溶出バルーンが2匹の健康なニュージーランド白ウサギに使用された。このために、動物はプロポフォールで麻酔され、手術の間の無痛がフェンタニルの反復したボーラス投与により保証された。動物は挿管され、人工呼吸され、常時バイタルサイン(パルスオキシメトリーおよびカプノグラフィー)を管理された。500IUのヘパリンおよび40mgのアスピリンの静脈内投与で抗凝血を達成した。動脈アクセスは総頸動脈を切開して行われた。スワンガンツカテーテルを蛍光透視ガイダンス下で大動脈弓を超えて腹部大動脈の総腸骨動脈の分岐のすぐ手前へ進め、最初の血管造影が行われた。次にガイドワイヤーが外腸骨動脈に配置された。動脈損傷を誘発し、健康な動脈の血管壁内へのシロリムスの取り込みを促進するために、外腸骨動脈の中央部内で、一回のバルーン膨張[3,0x10mmサイズのバルーン(Biotronik SE & Co. KG社製エレクト(Elect))を通常圧(7atm)で30秒間保持]によるワイヤー誘導バルーン損傷(POBA(バルーン拡張術))が行われた。その後、シロリムス溶出バルーンは誘発損傷の全長を覆って配置された。シロリムス溶出バルーンを公称圧(6atm)で60秒間膨張させた。処置の5分後に最終血管造影が行われ、動物は1時間の実験終了まで麻酔下に置かれた。実験終了のために、動物にペントバルビタールを静脈内過量投与して安楽死させた。安楽死に続き、腹部を切り開き、腹部大動脈および後大静脈を露出し、動脈シースでアクセスした。続いて、血液が取り除かれるまで動脈シースを介して血管を500mlのヘパリン化リンゲル液で洗い流した。処置された外腸骨動脈は次に、注意深く切り離され、体外培養され、液体窒素でスナップ凍結された。続いて、処置された腸骨動脈(n=4)は、ドライアイスを使用して分析試験場へ輸送されるまで−70℃で保管された。試験場で、体外培養された処置血管は秤量され、均質化され、無希釈ホモジネートのシロリムス含有量が計測された。常時、バッチ試料が明確に識別され、同日に同抽出法を用いて処理された。無希釈試料はすべて、検出範囲を超えるシロリムス含有量を示し、1:10および1:20に希釈された後に繰り返し計測された。
シロリムス溶出バルーンの配置後に動物は毒性の兆候を示さず、膨張後の血管造影は開存血管を示し、血管壁解離の兆候を示さなかった。肉眼で見て、血管の体外培養時にも血管損傷または解離の兆候はなかった。HPLCに基づく結果は、血管壁へのシロリムスの著しい取り込みがあり、その結果、平均濃度が35.00±33.37ng/mgであったことを示している。シロリムス組織濃度は8から82ng/mgの範囲であった。
本実験はシロリムス溶出バルーン使用1時間後のシロリムスの組織濃度を調べることを目的とした。本実験で適用したシロリムス溶出バルーンは処置動脈内で著しいシロリムス濃度を示す結果となった。我々の知る限りでは、これが組織1mg当り最大82ngのシロリムスの動脈壁組織濃度を達成することのできる最初のシロリムス溶出バルーンである。これに関し、適用されたセラックおよびオメガ脂肪酸の担体製剤は、シロリムスを動脈組織へ送達するための、期待の持てる新しいコーティング技術である。
Claims (10)
- 少なくとも1つのオメガ脂肪酸、およびセラック、およびシロリムスによりコーティングされ、前記少なくとも1つのオメガ脂肪酸が、オメガ‐3脂肪酸、またはオメガ‐6脂肪酸、またはオメガ‐7脂肪酸、またはオメガ‐9脂肪酸である、カテーテルバルーン。
- 前記少なくとも1つのオメガ‐3脂肪酸は、エイコサペンタエン酸、エイコサトリエン酸、エイコサテトラエン酸、ドコサヘキサエン酸、ヘキサデカトリエン酸、ステアリドン酸、ヘンエイコサペンタエン酸、ドコサペンタエン酸、テトラコサペンタエン酸、テトラコサヘキサエン酸、およびα‐リノレン酸、ならびに上述の脂肪酸の混合物からなる群から選択される、請求項1に記載のカテーテルバルーン。
- 前記少なくとも1つのオメガ‐6脂肪酸は、リノール酸、ガンマ‐リノレン酸、エイコサジエン酸、ジホモ‐ガンマ‐リノレン酸、アラキドン酸、ドコサジエン酸、ドコサペンタエン酸、アドレン酸、テトラコサテトラエン酸、テトラコサペンタエン酸、およびカレンド酸、ならびに上述の脂肪酸の混合物からなる群から選択される、請求項1に記載のカテーテルバルーン。
- 前記少なくとも1つのオメガ‐7脂肪酸は、5−ドデセン酸、7−テトラデセン酸、パルミトレイン酸、バクセン酸、パウリン酸、15−ドコセン酸、および17−テトラコセン酸からなる群から選択される、請求項1に記載のカテーテルバルーン。
- 前記少なくとも1つのオメガ‐9脂肪酸は、オレイン酸、エライジン酸、エイコセン酸、ミード酸、エルカ酸、およびネルボン酸からなる群から選択される、請求項1に記載のカテーテルバルーン。
- 前記コーティングはさらにトップコートを含む、請求項1から5のいずれか1項に記載のカテーテルバルーン。
- 前記トップコートは、ポリアクリル酸、およびポリメチルメタクリレート、ポリブチルメタクリレートなどのポリアクリレート、ポリアクリルアミド、ポリアクリロニトリル、ポリアミド、ポリエーテルアミド、ポリエチレンアミン、ポリイミド、ポリカーボネート、ポリカーボウレタン、ポリビニルケトン、ポリビニルハロゲン化物、ポリビニリデンハロゲン化物、ポリビニルエーテル、ポリビニルアロメート、ポリビニルエステル、ポリビニルピロリドン、ポリビニルアルコール、ポリビニルアルコール‐ポリエチレングリコールグラフト共重合体、ポリオキシメチレン、ポリエチレン、ポリプロピレン、ポリテトラフルオロエチレン、ポリウレタン、ポリオレフィンエラストマー、ポリイソブチレン、EPDMゴム、フルオロシリコーン、カルボキシメチルキトサン、ポリエチレンテレフタレート、ポリバレレート、カルボキシメチルセルロース、セルロース、レーヨン、レーヨントリアセテート、セルロースナイトレート、セルロースアセテート、ヒドロキシエチルセルロース、セルロースブチレート、セルロースアセテート‐ブチレート、エチルビニルアセテート共重合体、ポリスルホン、ポリエーテルスルホン、エポキシ樹脂、ABS樹脂、EPDMゴム、シリコーンプレポリマー、ポリシロキサンなどのシリコーン、ポリビニルハロゲンおよび共重合体、セルロースエーテル、セルローストリアセテート、キトサン、キトサン誘導体、天然ポリマー、アマニ油などの重合性油、ならびに、それらの共重合体および/または混合物からなる群から選択される、請求項6に記載のカテーテルバルーン。
- 前記トップコートは、ポリビニルアルコール‐ポリエチレングリコールグラフト共重合体からなる群から選択される、請求項6または7に記載のカテーテルバルーン。
- 請求項1から8のいずれか1項に記載のカテーテルバルーンを含むバルーンカテーテル。
- 再狭窄を防止または低減するのに適した、請求項9に記載のバルーンカテーテル。
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DE202011002713U1 (de) * | 2011-02-14 | 2011-04-14 | Sellin, Lothar | Biologisch abbaubare medizinische Beschichtung und deren Verwendung |
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2011
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Also Published As
Publication number | Publication date |
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PT2729195E (pt) | 2015-12-18 |
WO2013007273A1 (en) | 2013-01-17 |
ES2554519T3 (es) | 2015-12-21 |
WO2013007653A1 (en) | 2013-01-17 |
US20140350464A1 (en) | 2014-11-27 |
US9579423B2 (en) | 2017-02-28 |
JP2014527421A (ja) | 2014-10-16 |
WO2013007666A1 (en) | 2013-01-17 |
JP6097748B2 (ja) | 2017-03-15 |
JP2014526916A (ja) | 2014-10-09 |
ES2620527T3 (es) | 2017-06-28 |
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