Axium-弹簧圈

ev3Confidential~Forpresentationuseonly~DoNotDistributeTrainingModule2009DetachableCoilSystem研发的历史……简短回顾…•ev3Sapphire:Dec2002•USSapphire:Jun2003•NXT:Feb2004•Nexus:Jul2005•Morpheus:Oct2006•AXIUM™:June2007高峰会:July2006GlobalDiscoveryProcess•5US关键客户,市场部,R&D,,质量部门•Helpedusframekeyquestions,keyperformancecriteria,customerevolution+expectations•25globalKOLs•12countries•14pages•40questions•300beers,20hangovers•100hoursofjetlag高峰会:Nov2006•PhysicianInterviewteamconsistingofseveralteammembersfromallovertheworld•Fullday:animallabatUCLA,followedbyextensivelabsmovingforward(16total)•Completereviewofdesign,productpositioning•Reviewofcompetition•Commitmentandbuy-in•WeeklyCalls•Monthlyreviewmeetings•Sixphysicianevaluators结果•全球医生自行设计的–优异的表现–简单的选择–多样性•Designedfor12monthsahead:Design=Acuteperformance,Feel,Durability•Globalcommercialstrategy•Fundamentalshiftinproductdevelopmentprocessev3Confidential~Forpresentationuseonly~DoNotDistributeCoil的基础ev3Confidential~Forpresentationuseonly~DoNotDistributeCoil的基础:K-因子•要了解弹簧圈的工作原理,首先要了解弹簧的工作原理•栓塞用的弹簧圈是非常小的,高度复杂的弹簧制成的ev3Confidential~Forpresentationuseonly~DoNotDistribute•当你压缩一个弹簧时是从它的自然长度开始的•从自然长度开始压缩,你越压它就越要返回自然长度(给的力量越大,返回的力量也越大)Coil的基础:K-因子ev3Confidential~Forpresentationuseonly~DoNotDistribute•一个叫做“K”的常数（弹性系数）,决定了压缩弹簧所需的力量•这个概念被定义为“胡克定律”（力学的基本定律，适用于一切固体材料的弹性定律）Coil的基础:K-因子)(21kFNDGdk34ev3Confidential~Forpresentationuseonly~DoNotDistribute让我们把它运用到栓塞的弹簧圈上…•弹簧圈的三个变量决定K:oPrimarywirediameter(D1)oOuterdiameter(D2)oLoopdiameter(D3)Coil的基础:K-因子ev3Confidential~Forpresentationuseonly~DoNotDistributek(弹簧圈的柔软度或柔顺性)是与初级丝的厚度及缠绕的紧密度成比例。Coil的基础:K-因子ev3Confidential~Forpresentationuseonly~DoNotDistribute•K值越小,弹簧圈越软(一般说来,柔顺性越好)•初级丝细的弹簧圈比初级丝粗的弹簧圈柔韧度好o对于微小弹簧圈初级丝的范围:0.00175”to0.003”•相同直径金属丝缠绕的直径越大弹簧圈越柔软•弹簧圈初级丝越细，但直径越大，那么它能提供更大的填充体积，并且更软*WhiteJB,etal.,CoilsinaNutshell:AReviewofCoilPhysicalProperties,AJNRAmJNeuroradiol29:1242-46,Aug2008.Coil的基础:K-因子ev3Confidential~Forpresentationuseonly~DoNotDistributeAxium设计理念ev3Confidential~Forpresentationuseonly~DoNotDistributeHypotube技术PositiveLoadIndicatorPolymericStrainReliefPTFEOuterJacketTearDropCoinReleaseElementShieldCoilDoublePolypropyleneStretchResistantElementFloatingDetachmentLinkIDInstantDetacher160cmPTFELinedev3Confidential~Forpresentationuseonly~DoNotDistributeImplant浮动的解脱链接–衔接灵活，减少导管的外踢效应ActualAssemblyDistalEndActualAssemblyProximalEnd双层聚丙烯抗解旋丝–可以多次重复定位防止解旋，抗压缩聚丙烯柔软和减少损伤的顶端–使植入体远端部分更柔顺，灵活ev3Confidential~Forpresentationuseonly~DoNotDistribute释放Implantballnexttohumanhair咬合点:•这种灵活的链接和咬合方式,尽量减少导管的移动•浮动的小孔设计使近端植入物柔软和减少损伤双重聚丙烯抗解旋丝:•更自信•定位/重新定位•提供更强的抗压能力0.030”long0.012”longev3Confidential~Forpresentationuseonly~DoNotDistribute•无需电线,电源盒及电池•单手操作•快速,简单连接解脱ReleaseElementReleaseElementDistalPusherBeforeDetachmentAfterDetachmentPolypropyleneStretchResistanceFloatingDetachmentLink*USandInternationalPatentsPendingev3Confidential~Forpresentationuseonly~DoNotDistribute解脱系统是怎样即刻解脱的呢?1.LoadPusher2.DetachProximalInterfaceCouplerTubePawlAnvilEndcapShoulder1.TheInstantDetacherusesaPawlandAnviltograbandpullontheProximalInterfaceofthePusher.a)ThePawlrotatesonapinattachedtothethumbslideassembly.b)ThepusherisloadedbyadvancingtheDetacheruntilthecouplertubebottomsoutonashoulderatthebottomoftheEndcapnozzle.2.WhentheThumbSlideisretracted,thepawlrotatescounterclockwise,pinchingtheProximalInterfacetubebetweenthePawlandtheAnvil.a)TheThumbSlidepullsbacki.TheweldthatjoinstheinterfacetubetotheCouplertubebreaksii.TheInterfacetubetoslidefreelyanddisplacethereleaseelement.iii.Theimplanthasnowbeendetached.ev3Confidential~Forpresentationuseonly~DoNotDistributeCoil的定位标记新弹簧圈的定位标记符合市场标准ev3Confidential~Forpresentationuseonly~DoNotDistributeAxium增强型的弹簧圈直径ev3Confidential~Forpresentationuseonly~DoNotDistributeAxium增强型的弹簧圈直径Axium是带有抗解旋系统的一条完整的产品线，它同时提供了柔软的“10”系列弹簧圈，也同时提供了具有稳定性能的“18”系列弹簧圈用于动脉瘤的治疗。成功始于栓塞密度ev3Confidential~Forpresentationuseonly~DoNotDistributeAxium增强型的弹簧圈直径渐进的Axium弹簧圈系统利用K-因子，创立了一个弹簧圈的系统，通过增加初级丝和外径来平衡弹簧圈的柔软度和稳定性，从而达到更大的栓塞体积。1)J.B.White,C.G.M.Ken,H.J.Cloft,D.F.Kallmes.CoilsinaNutshell:AReviewofCoilPhysicalProperties.PublishedJune12,2008as10.3174/ajnr.A1067ev3Confidential~Forpresentationuseonly~DoNotDistribute我们的优化设计Axium:通过设计优势平衡稳定性和柔软度AxiumCoilCoilDetailCoilODPrimaryWireSizeSlightlyWIDERCoilODSMALLERPrimaryWireSizeSlightlyNARROWERCoilODLARGERPrimaryWireSizeSoftnessforSmallerSpacesStabilityforLargerSpacesev3Confidential~Forpresentationuseonly~DoNotDistributeCoils的现状现状•使人困惑的一系列产品•ProliferationofSKU’s•微导管的限制Length1cm50cm18-Based10-BasedSoftStable25mm2mmDiameterev3Confidential~Forpresentationuseonly~DoNotDistributeAXIUM增强型的弹簧圈直径Dw0.0015”OD0.0115”Dw0.0020”OD0.0125”Dw0.00225”OD0.0135”Dw0.00275”OD0.0145”StableSoftLength1cm50cmDiameter25mm1.5mm3mm6mm10mm8cm20cm30cm25X5022X5020X5020X4018X4016X4016X3014X4014X3012X4012X3010X3010X209X309X208X308X207X307X206X206X155X205X155X104X124X104X83X83X63X42X82X62X42X32X22X11.5X2OptimizedCoilOffering能够与14“的微导管相匹配OD*0.0165”ev3Confidential~Forpresentationuseonly~DoNotDistributeAxium和Micrus的比较:单一产品系列和多条产品系列Helipaq18Presidio18Helipaq10Presidio10UltipaqCashmereStabl