药物洗脱冠脉支架现状和发展趋势ppt课件

1、药物洗脱冠脉支架现状和开展趋势药物洗脱冠脉支架现状和开展趋势 蒲忠杰蒲忠杰 Ph.D.Ph.D.乐普北京医疗器械股份乐普北京医疗器械股份目目 录录 药物支架的现状药物支架的现状 存在的平安性问题存在的平安性问题 处理的能够途径处理的能够途径 降低高分子载体的平安性风险降低高分子载体的平安性风险 开展完全可降解支架开展完全可降解支架 优化血小板治疗优化血小板治疗 开展趋势开展趋势国产药物支架国产药物支架 微创：微创： 乐普：乐普： 吉威：吉威： 垠亿：垠亿：FirebirdFirebird PartnerNano (R&D)Excel紫杉醇支架紫杉醇支架Background: break

2、through technologiesDriver of restenosisrecoilneointima formationimplantation techniquemechanical stabilization of acute resultlocal delivery of anti-proliferative agents5%BMSPTCADESNeed for revascularization40%20%fool-proof delivery system ?药物支架的现状药物支架的现状 根本处理了再狭窄的问题根本处理了再狭窄的问题 终了了二十年来介入器械与再狭终了了二十年

3、来介入器械与再狭窄作斗争的历史窄作斗争的历史 存在远期血栓的平安性风险存在远期血栓的平安性风险技术变革处理临床问题技术变革处理临床问题平安性问题平安性问题再狭窄问题再狭窄问题BMSPESSESBMSConclusions:BMS showed far greater endothelialization than DESLack of coverage highlighted in areas of overlapLess surface coverage by endothelial cells in PES than SESDelayed endothelializationFinn et

4、 al. Circulation. 2019;112:270-278.内皮化延迟是问题的中心内皮化延迟是问题的中心 缺乏系统性的根底研讨：缺乏系统性的根底研讨： 未明确延迟内皮化的关键要素药物、未明确延迟内皮化的关键要素药物、载体、交互作用载体、交互作用 促进内皮化的能够途径促进内皮化的能够途径 减少与药物支架相关的平安要素和促减少与药物支架相关的平安要素和促进内皮化的途径如何接合进内皮化的途径如何接合处理远期血栓的途径处理远期血栓的途径 支架设计支架设计 药物：有效成分药物：有效成分 高分子载体：非绝对有效成分高分子载体：非绝对有效成分 支架平台：无直接关联支架平台：无直接关联新一代药物支架

5、的开展方向新一代药物支架的开展方向 减少高分子载体的有害作用减少高分子载体的有害作用 开展完全可降解支架开展完全可降解支架Directional Drug Delivery (ablumenal preference) Selective coating on the outside surface of the stent Reduced drug/polymer Lumenal surface BMS Drug only where neededLabcoat JACoating TechnologyBiodegradable Drug/Carrier:Biolimus A9 / Poly

6、 (Lactic Acid) 50:50 mixabluminal surface only (contacts vessel wall)15 meter coating thicknessdegrades in 9 months releasing CO2+ waterStent Platform: stainless steel (112 m) corrugated ring, quadrature-link designradius link enhances axial fatigue lifeParylene Durable Primer Coating:5 meter thick,

7、 encapsulates stentprevents surface metal ion migrationbiostable + athrombogenic*BioMatrix II Stent Platform DesignBIOFLEX IBioFlex I stent* Data per NHLBI sponsored study, available from BSIConor Drug Release Technology Drug ReservoirLuminalBarrier LayerSimple Drug ReservoirUniform ReleaseSingleDru

8、gStructureMultipleDrugStructuresDrug A releasedto arterial wallBarrier layerDrug B releasedinto bloodstreamTwo Drugs, One WellTwo Drugs, Two WellsTwo DirectionsLuminal BarrierMural BarrierMural SideA Completely Polymer-Free StrategyTranslumina YUKON ChoiceDES Polymer-free coating Unique roughened su

9、rface Adjustable dosage for individualized treatment Free choice of drugsMIV Polymer-free DES乐乐 普普 公公 司司Nano无载体药物洗脱支架无载体药物洗脱支架 纳米微孔载药纳米微孔载药载药后，支架外表载药后，支架外表均匀一致均匀一致Results from Nano FIM clinical study: LL at 6-8 MonthsNanoTMPartnerTMl与裸金属支架一样的平安性，与药物支架一样的有效性与裸金属支架一样的平安性，与药物支架一样的有效性0.370.260.340.30Des

10、ign Principle of EPC Capturing and Drug Eluting Combination StentEPC Capturing and Drug Eluting Combination Stent外外表已喷涂雷帕霉素外外表已喷涂雷帕霉素Inner surface-CD34 antibodyOuter surface-RapamycinRAPAMYCINAdsorption principal of CD34 antibody on the stents surfacePorous adsorptionCharge adsorptionYYYYY YYCD34 an

11、tibody coatingPatents：PCT/CN2019/002964The activity of CD34 antibody of the inner surface The inner surface of BMSImmerse in KG-1a cell suspension stained by DAPI (CD34+ Cell,ATCC) BMSCombination stentThe inner surface of Combination stentPhoto by microscopeEndothelium Appraisement EM Morphology on the 7th dayBMS CD34 stent Combination stentAnimal Experimental Results in porcine-QCAP0.05REVA Bioresorbable Coronary Stent开展趋势开展趋势新一代药物支架将在保证有效性的根底上着新一代药物支架将在保证有效性的根底上着重处理平安性问题。重处理平安性问题。减少高分子的有害作