藥物洗脫冠脈支架現(xiàn)狀和發(fā)展趨勢(shì)

藥物洗脫冠脈支架現(xiàn)狀和發(fā)展趨勢(shì)

蒲忠杰Ph.D.樂(lè)普（北京）醫(yī)療器械股份有限公司當(dāng)前第1頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)目錄藥物支架的現(xiàn)狀存在的安全性問(wèn)題解決的可能途徑降低高分子載體的安全性風(fēng)險(xiǎn)發(fā)展完全可降解支架優(yōu)化血小板治療發(fā)展趨勢(shì)當(dāng)前第2頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)當(dāng)前第3頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)國(guó)產(chǎn)藥物支架微創(chuàng)：樂(lè)普：吉威：垠億：Firebird

FirebirdⅡPartner

Nano(R&D)

Excel紫杉醇支架當(dāng)前第4頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)Background:

breakthroughtechnologiesDriverofrestenosisrecoilneointimaformationimplantationtechniquemechanicalstabilizationofacuteresultlocaldeliveryof

anti-proliferativeagents5%BMSPTCADESNeedforrevascularization40%20%‘fool-proof’deliverysystem

?當(dāng)前第5頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)藥物支架的現(xiàn)狀基本解決了再狹窄的問(wèn)題

結(jié)束了二十年來(lái)介入器械與再狹窄作斗爭(zhēng)的歷史存在遠(yuǎn)期血栓的安全性風(fēng)險(xiǎn)當(dāng)前第6頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)技術(shù)變革解決臨床問(wèn)題安全性問(wèn)題再狹窄問(wèn)題當(dāng)前第7頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)BMSvsDESBMSPESSESBMSConclusions:BMSshowedfargreaterendothelializationthanDESLackofcoveragehighlightedinareasofoverlapLesssurfacecoveragebyendothelialcellsinPESthanSESDelayedendothelializationFinnetal.Circulation.2005;112:270-278.當(dāng)前第8頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)內(nèi)皮化延遲是問(wèn)題的核心缺乏系統(tǒng)性的基礎(chǔ)研究：未明確延遲內(nèi)皮化的關(guān)鍵因素（藥物、載體、交互作用）促進(jìn)內(nèi)皮化的可能途徑減少與藥物支架相關(guān)的安全因素和促進(jìn)內(nèi)皮化的途徑如何接合當(dāng)前第9頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)解決遠(yuǎn)期血栓的途徑支架設(shè)計(jì)藥物：有效成分高分子載體：非絕對(duì)有效成分支架平臺(tái)：無(wú)直接關(guān)聯(lián)當(dāng)前第10頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)新一代藥物支架的發(fā)展方向減少高分子載體的有害作用發(fā)展完全可降解支架當(dāng)前第11頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)DirectionalDrugDelivery(ablumenalpreference)Selectivecoatingonthe

outsidesurfaceofthestentReduceddrug/polymerLumenalsurfaceBMSDrugonlywhereneededLabcoatJA?CoatingTechnology當(dāng)前第12頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)Biodegradable

Drug/Carrier:BiolimusA9?/Poly(LacticAcid)50:50mixabluminalsurfaceonly(contactsvesselwall)15μmetercoatingthicknessdegradesin9monthsreleasingCO2+waterStentPlatform:stainlesssteel(112m)

corrugatedring,quadrature-link?designradiuslinkenhancesaxialfatiguelifeParyleneDurablePrimerCoating:5μmeterthick,encapsulatesstentpreventssurfacemetalionmigrationbiostable+athrombogenic*BioMatrix?IIStentPlatformDesignBIOFLEX?IBioFlexIstent*DataperNHLBIsponsoredstudy,availablefromBSI當(dāng)前第13頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)ConorDrugReleaseTechnology

DrugReservoirLuminalBarrierLayerSimpleDrugReservoirUniformReleaseSingleDrugStructureMultipleDrugStructuresDrugAreleased

toarterialwallBarrierlayerDrugBreleased

intobloodstreamTwoDrugs,OneWellTwoDrugs,TwoWellsTwoDirectionsLuminalBarrierMuralBarrierMuralSide當(dāng)前第14頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)ACompletelyPolymer-FreeStrategy

TransluminaYUKON?ChoiceDES

Polymer-freecoatingUniqueroughenedsurfaceAdjustabledosageforindividualizedtreatmentFreechoiceofdrugs當(dāng)前第15頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)當(dāng)前第16頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)MIVPolymer-freeDES當(dāng)前第17頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)樂(lè)普公司

Nano無(wú)載體藥物洗脫支架

納米微孔載藥載藥后，支架表面

均勻一致當(dāng)前第18頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)ResultsfromNanoFIMclinicalstudy:

LLat6-8MonthsNanoTMPartnerTM與裸金屬支架相同的安全性，與藥物支架相同的有效性0.370.260.340.30當(dāng)前第19頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)DesignPrincipleofEPCCapturingand

DrugElutingCombinationStent當(dāng)前第20頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)EPCCapturingandDrugElutingCombinationStent外表面已噴涂雷帕霉素Inner

surface-CD34antibodyOutersurface-RapamycinRAPAMYCIN當(dāng)前第21頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)AdsorptionprincipalofCD34antibody

onthestent’ssurfacePorousadsorptionChargeadsorption＋＋＋＋＋＋＋＋YYYYYYYCD34antibodycoatingPatents：PCT/CN2007/002964當(dāng)前第22頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)TheactivityofCD34antibodyoftheinnersurface

TheinnersurfaceofBMSImmerseinKG-1acellsuspensionstainedbyDAPI(CD34+Cell,ATCC)

BMSCombinationstentTheinnersurfaceofCombinationstentPhotobymicroscope當(dāng)前第23頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)EndotheliumAppraisement

EMMorphologyonthe7thdayBMSCD34stentCombinationstent當(dāng)前第24頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)AnimalExperimentalResultsinporcine-QCAP<0.05當(dāng)前第25頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)REVABioresorbableCoronaryStent當(dāng)前第26頁(yè)\共有28頁(yè)\編于星期四\12點(diǎn)發(fā)展趨勢(shì)新一代藥物支架將在保證有效性的基礎(chǔ)上著重解決安全性問(wèn)題。減少高分子