冠状动脉介入治疗的球囊和支架的应用高展

冠状动脉介入治疗的 球囊和支架的应用 中国医学科学院阜外心血管病医院 高展 冠状动脉介入治疗球 囊的选择 球囊分类 n整体交换球囊（OTW- over the wire) n快速交换球囊 (monorail) Rapid ExchangeRapid Exchange GuidewireGuidewire Inflation lumenInflation lumen same ultra-low 0.017“ profile nOptiLEAP Balloon with reduced waist thickness provides great sizing flexibility with lower profiles nNano-composite materials adds structure and pushability to the outer shaft Quantum Maverick Balloon nLow profile, full length 1.8F or 2.0F Monorail shaft nLow profile 3.2F proximal over- the-wire shaft nBioslide Coating on a PEBAX Distal Shaft nLaser bonding technology nQuantum LEAP Balloon Material nTapered TrakTip Design with .017“ lesion entry profile* Quantum Maverick Balloon NC sprinter n外形细小的FasTrac头端技术-可在遇到 较难通过的病变时提供极佳的通过能力； n柔软耐用的Fulcrum Plus球囊材料和MiniWrap 折叠技术提供细小的外径和出色的再回抱能力； n 选择性的Dura-Trac涂层使球囊在到达和通过 病变的过程中保持持久的润滑，在球囊扩张 时保持稳定； n 渐细钢丝设计的推送杆增强了球囊的跟踪能 力和通过远端病变能力； n 光滑细小的导丝交换口使3.5mm以下的任何 两个球囊可在6F（0.070“）的指引导管里对吻。 nSunflex Tip is superbly engineered to give a perfect balance between flexibility and kink resistance. Zero transition between the tip and wire for smoothest entry profile. nTapered Tip:The tapered soft tip combined with advanced laser welding technology provides the most competitive tip profile nSlidematrix dual coating is specially formulated with two unique proprietary blends. Hydrophilic and Invio coatings are applied to the distal leading tip section and the balloon/shaft section, respectively to provide an optimal balance between lubricious crossing and minimizing watermelon seeding nTight Fold processing results in a slender primary profile for enhanced crossability through tight lesions. nSapphire NC OrbusNeich nThe IP Transition Zone of the Avita PTCA Dilatation Catheter provides intensified pushability. nThe new tapered tip design with soft material exhibits a flexible tip for smooth lesion entry and minimal vessel trauma. nThe Invio coating on the inner lumen eliminates friction between the catheter and guidewire. Invio is also applied to the outer distal segment from the tip to the exit marker zone for lubricious crossability. nAvita HP OrbusNeich Rugin nCrossTipTM 确保Ryugin通过性可以达到的最高性能。CrossTipTM 是 由特殊混合的弹性塑料聚合物制作而成。0.017 英寸(0.043毫米)的入口 外径确保了Ryugin 在完全闭塞的病变的复杂管腔里的通过性。 CrossTipTM 中等长度的柔韧前端能较易地通过移植支架处的病变并绷 紧其钙化病变。 n亲水涂层M-Coating，塑料聚合物的复合层和新一代金属合金的 Hypotube。使用Ryugin通过过度弯曲和大弯曲血管时，它能顺滑的到达 目标病变部位，并且成功的处理其复杂闭塞病变。 n提供广泛有效的球囊直径选择范围从超细的1.25毫米直径到4.0毫米 直径不等。 n薄型聚酰胺球囊确保了其卓越的通过性Ryugin CrossTip 是从尖端到薄 型聚合物球囊的一段平滑过度部分，平滑柔韧的联合体能够通过各种 复杂病变部位。 n泰尔茂新一代FC(Flexible Corrugate) 轴管成为连接高弹性的前端轴 管和具备强硬金属的Hypotube 轴管之间的桥梁。 FC-shaft 是指经过加 工的柔软的胶质轴，该技术实现了通过一个平衡轴加强力量的传输性 和弹性。 Voyager nSuperb Cross Tapered Tip Design nNew tapered tip with .017” tip entry profile designed to cross tight lesions nImproved tip-to-wire conformability1 for confident track and cross nPolyurethane tip material is flexible yet durable for tough lesions nFlexible tungsten marker technology allows catheter to conform to tortuous anatomy nMore Options Low Profile Shaft Design nVersatile treatment in a 6F guide nExcellent track and push in tortuous anatomy with new hypotube design nReinforced mid-shaft design provides flexibility and additional support nFlexibility with Visibility Proprietary Tungsten Marker nNew marker material comprised of tungsten polymer nFlexible marker design allows the catheter to conform more easily to tortuous anatomy nIncreased marker flexibility helps to reduce resistance when crossing tight lesions nPrecise Dilatation Proven Balloon Performance nShort tapers allow for precise dilatation nImproved LOFOLD Balloon Technology processes allows for excellent rewrap and recross1 nXCELON S Balloon Material achieves superb flexibility Powersail nPLATEAU Balloon Material nProvides non-compliance at high pressure without compromising performance nFlexibility and conformability for excellent deliverability nLOFOLD Balloon Technology nProvides a low crossing profile for exceptional lesion cross nLOFOLD balloon technology for improved balloon rewrap nSoft Tip Design nTapered tip design creates a low entry profile and excellent tip-to-wire conformability for easy lesion access nSoft tip provides flexibility for negotiating tortuosity and crossing stent struts nDual Swaged Markers nProvide lower profiles than conventional markers nSafeCut uses dual wire mechanism to create focused force. It has a built-in 0.011 integral wire external to the balloon to help track tortuous vessels with great efficiency. nA standard 0.014 guidewire that delivers the catheter to the target lesion also participates in the dilatation process. The guidewire exit port is located at the proximal part of the balloon. nDuring balloon dilatation, the standard guidewire and integral wire apply controlled force to facilitate plaque fractures at low inflation pressures. The same application also helps minimize balloon slippage. nSafeCuts distal leading tip profile is 0.032“ tapered to 0.028“ which is smaller than those of other focused force balloons. nBalloons with embedded blades for scoring the vessel have high crossing profiles due to the nature of the balloon materials and blades. nThe integral wire and standard guidewire apply evenly distributed force to facilitate controlled plaque at low pressures, reducing trauma to the vessel wall. nOther balloons using the same focused force technology use blades which are much more traumatic to the vessel wall. OrbusNeich Cutting Balloon nThe Flexibility You Want nNylon balloon material designed to provide flexibility, superb compliance and improved puncture resistance nOverall better deliverability to treat more complex lesions. nThe Deliverability You Need n30% more Deliverable than the Cutting Balloon Ultra2 Device* n50% improvement in re-cross compared to the Cutting Balloon Ultra2 Device* nThe Predictability You Rely On nPrecise dilatation nScoring the plaque by severing the elastic and fibrotic continuity of the vessel wall nDilating the lesion at lower pressures with less recoil nLumen gain through plaque compression instead of vessel wall expansion 冠状动脉介入治疗支 架的选择 冠状动脉支架广泛应用的原因 n植入支架后影像好，急性期结果好 n支架能够治疗急性或濒临闭塞，安全性 明显提高 n支架降低再狭窄率，改善患者的长期预 后 n植入支架容易操作 n支架的应用可以减少操作时间 n对于复杂病变，球囊扩张结果往往不理 想，植入支架可以得到满意的结果 支架分类 n根据设计不同，分为网状支架、管状支架、 缠绕型支架、环状支架 。 n根据材料不同，分为316L不锈钢支架、钴支 架、铬支架、镍支架、钽支架。 n根据输送方式的不同，分为球囊膨胀性支架 和自膨胀性支架。 n根据特殊用途而设计不同的支架，如适合分 叉病变的支架和适合分支的支架以及针对冠状 动脉瘤或穿孔的带膜支架 n根据是否带药，分为药物涂层支架和非药物 支架 支架的性能特点 支架的开环和闭环设计 网眼大小 微米支架丝厚度 金属动脉比值 支架可视性 裸金属支架选择原则 n针对不同病变和支架的特性选择不同的 支架 n支架的直径与参照血管的直径比为1.0- 1.1 n长度将病变或夹层全部覆盖 n避免过长支架和一支血管植入多个支架 ，多个支架不可避免时应可能减少支架过 多重叠 Cordis Confidential - Internal Use Only 药物 聚合物 支架 雷帕霉素和紫杉醇 理想药物 聚合物 最理想的释放系统 支架平台 封闭单元式设计 药物洗脱支架 回缩和重塑 内膜增生 结果:安全性, 疗效性,输送性 DES与BMS的比较 n早期的临床试验随访4年结果表明，DES与裸金属支架（ BMS）比，明显降低再次血运重建率，但死亡和心肌梗死 （MI）两者没有差别。 n针对特定亚组患者的随机临床试验，如支架内再狭窄、 慢性完全闭塞、糖尿病、小血管病变，也都证明了DES的 优越性。 n但是由于这些标签外应用“off-label”的临床试验随访时间 较短、样本量较小，对发生率较低的支架内血栓、死亡、 MI这些终点事件无法鉴别，故对于DES应用于这些标签外 指征尚无定论。 DES与BMS的比较 nDES因为有涂层（polymer），所以较硬，顺应性和输送 性较差，故对置入较困难的病变应选择BMS。 nDES较BMS昂贵，对于经济困难的患者应首选BMS。 n对于那些容易发生再狭窄的病变应选择DES。 I I IIaIIa IIbIIb IIIIII 建议的分类 n介入治疗有用、有效 n证据偏向有用、有效 n有效的证据不充分 n介入治疗无效，甚至可能有害 很多大规模随机对照研究的材料证实 较少、小规模随机对照研究的材料或非随机研究和/或 注册登记分析的资料 专家意见 = = Level of Evidence RecommendationRecommendation I I IIaIIa IIbIIb IIIIII 原位病变（De Novo） ACC/AHA 2005 Guideline for PCI Polymer-basedPolymer-based SirolimusSirolimus-eluting-eluting CypherCypher stentsstents RAVELRAVEL SIRIUSSIRIUS E-SIRIUSE-SIRIUS C-SIRIUSC-SIRIUS SES-SMARTSES-SMART DIABETESDIABETES Polymer-basedPolymer-based PaclitaxelPaclitaxel-eluting-eluting TAXUSTAXUS stentsstents TAXUS-ITAXUS-I TAXUS-IITAXUS-II TAXUS-IVTAXUS-IV TAXUS-VTAXUS-V TAXUS-VITAXUS-VI RVD 2.25 3.5 mmRVD 2.25 3.5 mm Length 30 mmLength 30 mm RVD 2.25 4.0 mmRVD 2.25 4.0 mm Length 46 mmLength 46 mm ACC/AHA 2005 Guideline for PCI IIaIIa - -金属支架内再狭窄金属支架内再狭窄 (vs. (vs. brachytherapybrachytherapy) ) - - 分叉病变分叉病变 ( (主支置入药物支架主支置入药物支架, ,分支分支 PTCA PTCA 或或provisional DES)provisional DES) - - 开口病变开口病变 - - 慢性完全闭塞慢性完全闭塞 - - 多支血管病变多支血管病变 ( (合并糖尿病合并糖尿病) ) - -静脉旁路血管病变静脉旁路血管病变 I I - - 金属支架内再狭窄金属支架内再狭窄 (vs. PTCA)(vs. PTCA) ACC/AHA 2005 Guideline for PCI IIbIIb - - 分叉病变分叉病变 V V stentstent - - 药物支架失败后支架内再狭窄药物支架失败后支架内再狭窄 - - 分叉病变分叉病变 T T stentstent or crushing of side branch or crushing of side branch - - 特别弥漫病变特别弥漫病变 (full metal jacket)(full metal jacket) - - 无保护左主干无保护左主干 - -急性心肌梗塞急性心肌梗塞 - - 放射治疗失败后的支架内再狭窄放射治疗失败后的支架内再狭窄 ( (如不外科治疗如不外科治疗!) !) ACC/AHA 2007 guideline update for PCI 预扩张 n如果预计支架植入困难，必须充分预扩张，以防 止药物支架的涂层的损坏和支架的脱载 n如预计支架植入不会太困难，保证最小损伤措施 包括： 选择小一号的球囊（小0.5-1.0mm） 短球囊（重点扩张最狭窄处并保证球囊长 度永远短于拟用的DES支架长度） 使用低压力预扩张（8atm） 也可以选择使用稳定性好的短球囊（cutting balloon 或 safecut） 直接支架 药物支架选择和扩张 n了解所有有关药物支架 的技术规格说明 n支架直径的选择应基于对造影图象中血管的估测 或定量的血管内超声图象的测量 影像标准：支架的球囊:血管直径=1.1:1 IVUS标准：应参考参照血管直径（如是渐细的血 管，取近远段参照血管直径的平均值） 支架选择和展开 n长度选择应强调支架“无病”区到“无病”区（或近段正常 参照血管段到远段参照血管段），即支架应较病变长3-5mm nIVUS和带有标记的引导钢丝对于选择药物支架的长度有帮助 n在裸金属支架时代，“越大越好”获取最大的术后最小管 腔直径以抵消晚期管腔丢失（即显著的内膜增生） n在药物支架时代，“长一些更好”保证病变的全部覆盖 药物支架选择和展开 输送药物支架过程中应避免用手接触支架 过止血阀时，应充分打开，以防止对药物支架涂层 的磨损 如果药物支架难以跨过病变，避免过度用力推送， 最好再次扩张后再次推送 后扩张 并非所有病例中应用的药物支架置入后都需要后扩张 药物支架极低的晚期管腔丢失，没有必要像以往过度追求 的造影效果；但是，应该选用另一个球囊扩张任何支架内 不能被接受的狭窄或支架腰 后扩张的球囊应该总是被定位于药物支架边缘以内（即总 是用短于支架的后扩张球囊) 后扩张球囊大小不应超过两个数量级 IVUS的重要性 支架置入前的应用（预扩张前或后） 评价病变长度和血管渐变程度（包括参照血管内的病变） 评价血管的大小 评价病变与开口或分支血管的位置关系 评价病变的形态学（可能影响预扩张或后扩张的策略） 支架置入后的应用 评价是否所有支架丝与血管壁完全贴附 评价已被支架覆盖的区域（适当的支架大小是否贯穿整个 病变） 评价是否支架已覆盖全部病变 对于多个支架-检查重叠区域以避免空隙 目前常用的药物支架特点 CYPHER Sirolimus-eluting Coronary Stent Stent GeometryClosed-cell FLEXSEGMENT Technology Material316L Stainless Steel Strut Thickness.0055” Crimped Profile.044” Available Sizes Diameters: 2.50, 2.75, 3.00, 3.50 mm Lengths: 8, 13, 18, 23, 28, 33 mm Drug DeliveredSirolimus (rapamycin, Rapamune) Mechanism of Action Inhibits mTOR to block growth factor induced proliferation Cytostatic (blocks cell cycle in late G1phase) Drug delivery Vehicle Controlled-release, nonresorbable, elastomeric polymer coating Drug Release Kinetics 80% of sirolimus released in 30 days Approval Status Approved worldwide TAXUS Express Coronary Stent nA Proven Stent nThe Express2 Stent platform offers excellent deliverability and conformability. nA Reliable Polymer nThe TAXUS Express Stent uses Translute Polymer, a proprietary polymer carrier technology, to control drug release. nAn Effective Drug nThe unique properties of paclitaxel contribute to the efficacy of the TAXUS Express Stent. nPaclitaxels multi-functional effects, stabilize microtubules and inhibit activities that contribute to restenosis.3 nPaclitaxel is highly lipophilic, which may contribute to more uniform drug distribution.4 n316L 不锈钢材料 n支架梁厚度 0.0038” n尖端外廓 0.017” n通过外廓 0.047”* Pictures taken by Boston Scientific. 改善的通过性* *For a 3.0mm stent Pictures taken by Boston Scientific. *Based on internal bench tests of the features of the Libert Stent compared to Express Stent and market research results. Data on file. TAXUS Libert 支架系统 改善的输送性和顺应性 增强的TrakTip尖端 5折球囊技术 增强的TrakTip尖端外廓极小, 提供了更好的 病变通过和改善的跟踪性.* 该设计减少了支架的旋转,增强 了支架的固位. 改善的输送性和顺应性 * Picture taken by Boston Scientific. *Based on internal bench tests of the features of the Libert Stent compared to Express Stent and market research results. Data on file. TAXUS Libert 支架系统 改善的输送性和顺应性 支架平台比较血管覆盖 TAXUS Libert 支架 TAXUS Libert 支架的小的单元面积设计可以保持出色 的血管覆盖和支持,同时减少组织下垂的危险*. Cypher 支架TAXUSExpress2 支架 * Cell area variability based upon stent diameter. Images taken taken by Boston Scientific of 3.0mm diameter stents. Cypher is a trademark of Cordis Corp. Driver is a trademark of Medtronic/AVE. Cypher Select 支架Driver 支架 命名压力 额定爆破压力 命名压力 TAXUS Libert 支架系统 支架顺应性图表 ATM直径 (mm) 2.252.502.753.03.5 82.762.973.43 92.192.442.813.023.49 10 2.242.492.873.083.56 11 2.292.552.933.143.63 12 2.322.592.983.193.68 13 2.362.643.023.233.73 14 2.392.673.063.273.78 15 2.422.703.093.313.81 16 2.442.743.123.343.85 17 2.742.763.143.373.88 18 2.492.793.173.393.92 Nominal pressure for TAXUS Express2 : 9 ATM Caution: This is an investigational device and is not available for sale in the U.S. Copyright 2005 by Boston Scientific Corporation or its affiliates. All rights reserved. Delivery based on disrete, Secure Technology Driver钴钴合金模块块支架 生物相容的PC 技术术 (磷脂酰酰胆碱多聚物) 支架输输送系统统 ABT-5