介入中球囊及支架的应用

1、冠状动脉介入治疗的球囊和支架的应用1 冠状动脉介入治疗球囊的选择2 球囊分类整体交换球囊（OTW- over the wire)快速交换球囊 (monorail)Rapid ExchangeGuidewireInflation lumen& guidewire lumenInflation lumen onlyInflation portOver-the-WireGuidewireInflation lumen& guidewire lumenInflation Port3 球囊的结构球囊尖端球囊 推送杆4 球囊尖端外径：直头圆弧锥形尖端与球囊的连接：胶水黏结热焊接激光焊接5 球囊球囊材料：尼

2、龙、聚乙烯球囊顺应性折叠方式：三层折叠：利于回卷，后撤，低折叠减小通过半径标记方式：中央标记易于通过严重狭窄病变，双标记利于测量病变长度球囊肩部角度：球囊于尖部平滑过渡有利于通过病变球囊与中心杆的连接技术和材料：决定通过扭曲血管的能力6 球囊性能外径（crossing profile)灵活性（flexibility)跟踪性（trackbility)推送性（pushbility)顺应性（compliance)7 球囊操作要领8 预扩张有利于支架的植入有利于病变的测量选择小于血管直径0.5-1mm的球囊进行预扩张，球囊长度应适当预扩张应尽量减少对正常血管的损伤为测量病变长度，使预扩张球囊在冠状动脉

3、内进行造影时，注射造影剂的力度不宜过大，以免加重血管的撕裂对于狭窄程度重、较复杂的病变，预计支架通过较困难的病变应常规充分地预扩张，尤其对初学者9 后扩张防止支架贴壁不良，预防支架内血栓形成，降低再狭窄后扩张球囊可选择大一号的球囊或更高的压力后扩张时一定不能超出支架的边缘，尤其是的DES不可盲目追求所有病例的大球囊高压力的后扩张，以免增加无再流和冠状动脉破裂的风险10 不同类型病变的球囊选择 CTO 病变：常选择单标记、整体交换、小外径（1.5 mm）球囊，如Maverick等长病变：原则上选用较长的球囊，以防两端撕裂并减少扩张次数。分叉病变：可选双导丝球囊、切割球囊。目的：减少斑块移位、降低

4、分支闭塞的概率。 11 不同类型病变的球囊选择 小血管病变：宜选用外形小，推进性好的球囊。还可选用耐高压球囊。扭曲病变：应选择外形较小、推进性好的球囊。OTW球囊推进性较单轨球囊好，还有利于交换导丝钙化病变：应选择外形较小、推进性好的球囊。还可选用双导丝、耐高压乳突或切割球囊。 12 常用的球囊特点13 Maverick PTCA Balloon CathetersProprietary laser bonded technology creates an extraordinary TrakTip Design and precise, smooth bonds throughout the

5、 shaft. Push coil design and improved distal flexibility for enhanced trackability. Our 1.5 and 2.0 mm SoftLEAP Balloons offer enhanced crossability. 14 Apex PTCA Dilatation CatheterSlope Outer Shaft smoothly transitions from stiff to flexible, all in one piece, for more efficient push transmission

6、Bi-Segment Inner Shaft optimizes the balance between push and track Shorter, thinner marker bands increase distal flexibility Redesigned tip with improved flexibility and wire movement; same ultra-low 0.017 profile OptiLEAP Balloon with reduced waist thickness provides great sizing flexibility with

7、lower profiles Nano-composite materials adds structure and pushability to the outer shaft 15 Quantum Maverick BalloonLow profile, full length 1.8F or 2.0F Monorail shaft Low profile 3.2F proximal over-the-wire shaft Bioslide Coating on a PEBAX Distal Shaft Laser bonding technology Quantum LEAP Ballo

8、on Material Tapered TrakTip Design with .017 lesion entry profile* 16 Quantum Maverick Balloon17 18 19 20 NC sprinter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；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；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；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；光滑细小的导丝交换

9、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。21 Sunflex 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.Tapered Tip:The tapered soft tip combined with advanced laser welding technology provides

10、 the most competitive tip profileSlidematrix 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

11、 minimizing watermelon seeding Tight Fold processing results in a slender primary profile for enhanced crossability through tight lesions. Sapphire NCOrbusNeich 22 The IP Transition Zone of the Avita PTCA Dilatation Catheter provides intensified pushability. The new tapered tip design with soft mate

12、rial exhibits a flexible tip for smooth lesion entry and minimal vessel trauma. The 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. Avita HPOrb

13、usNeich 23 RuginCrossTipTM 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。 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。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

14、不等。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。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。 24 VoyagerSuperb Cross Tapered Tip DesignNew tapered tip with .017” tip entry profile designed to cross

15、 tight lesions Improved tip-to-wire conformability1 for confident track and cross Polyurethane tip material is flexible yet durable for tough lesions Flexible tungsten marker technology allows catheter to conform to tortuous anatomy More Options Low Profile Shaft DesignVersatile treatment in a 6F gu

16、ide Excellent track and push in tortuous anatomy with new hypotube design Reinforced mid-shaft design provides flexibility and additional support Flexibility with Visibility Proprietary Tungsten MarkerNew marker material comprised of tungsten polymer Flexible marker design allows the catheter to con

17、form more easily to tortuous anatomy Increased marker flexibility helps to reduce resistance when crossing tight lesions Precise Dilatation Proven Balloon PerformanceShort tapers allow for precise dilatation Improved LOFOLD Balloon Technology processes allows for excellent rewrap and recross1 XCELON

18、 S Balloon Material achieves superb flexibility 25 PowersailPLATEAU Balloon MaterialProvides non-compliance at high pressure without compromising performance Flexibility and conformability for excellent deliverability LOFOLD Balloon TechnologyProvides a low crossing profile for exceptional lesion cr

19、oss LOFOLD balloon technology for improved balloon rewrap Soft Tip DesignTapered tip design creates a low entry profile and excellent tip-to-wire conformability for easy lesion access Soft tip provides flexibility for negotiating tortuosity and crossing stent struts Dual Swaged MarkersProvide lower

20、profiles than conventional markers 26 SafeCut 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. A standard 0.014 guidewire that delivers the catheter to the target lesion also particip

21、ates in the dilatation process. The guidewire exit port is located at the proximal part of the balloon. During 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 ballo

22、on slippage. SafeCuts distal leading tip profile is 0.032 tapered to 0.028 which is smaller than those of other focused force balloons. Balloons with embedded blades for scoring the vessel have high crossing profiles due to the nature of the balloon materials and blades. The integral wire and standa

23、rd guidewire apply evenly distributed force to facilitate controlled plaque at low pressures, reducing trauma to the vessel wall. Other balloons using the same focused force technology use blades which are much more traumatic to the vessel wall. OrbusNeich 27 Cutting BalloonThe Flexibility You Want

24、Nylon balloon material designed to provide flexibility, superb compliance and improved puncture resistance Overall better deliverability to treat more complex lesions. The Deliverability You Need 30% more Deliverable than the Cutting Balloon Ultra2 Device* 50% improvement in re-cross compared to the

25、 Cutting Balloon Ultra2 Device*The Predictability You Rely On Precise dilatation Scoring the plaque by severing the elastic and fibrotic continuity of the vessel wall Dilating the lesion at lower pressures with less recoil Lumen gain through plaque compression instead of vessel wall expansion28 冠状动脉

26、介入治疗支架的选择29 冠状动脉支架广泛应用的原因植入支架后影像好，急性期结果好 支架能够治疗急性或濒临闭塞，安全性明显提高 支架降低再狭窄率，改善患者的长期预后 植入支架容易操作 支架的应用可以减少操作时间 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 30 支架分类 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 。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。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。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根据是否带药，分为药物

27、涂层支架和非药物支架 31 支架的性能特点32 支架的开环和闭环设计33 网眼大小34 35 微米支架丝厚度36 金属动脉比值37 支架可视性38 39 40 41 裸金属支架选择原则 针对不同病变和支架的特性选择不同的支架支架的直径与参照血管的直径比为1.0-1.1 长度将病变或夹层全部覆盖 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 42 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

28、性43 DES与BMS的比较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。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。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。44 DES与BMS的比较DES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。DES较BMS昂贵，对于经济困难

29、的患者应首选BMS。对于那些容易发生再狭窄的病变应选择DES。45 IIIaIIbIII建议的分类介入治疗有用、有效证据偏向有用、有效有效的证据不充分介入治疗无效，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 ofEvidence46 RecommendationIIIaIIbIII原位病变（De Novo）ACC/AHA 2005 Guideline for PCI Polymer-basedSirolimus-elutingCypher stentsRAVELSIRIUSE-SIRIUSC-SIRIUSS

30、ES-SMARTDIABETESPolymer-basedPaclitaxel-elutingTAXUS stentsTAXUS-ITAXUS-IITAXUS-IVTAXUS-VTAXUS-VIRVD 2.25 3.5 mmLength 30 mmRVD 2.25 4.0 mmLength 46 mm47 ACC/AHA 2005 Guideline for PCIIIa-金属支架内再狭窄 (vs. brachytherapy)- 分叉病变 (主支置入药物支架,分支 PTCA 或provisional DES)- 开口病变- 慢性完全闭塞- 多支血管病变 (合并糖尿病)-静脉旁路血管病变I-

31、金属支架内再狭窄 (vs. PTCA)48 ACC/AHA 2005 Guideline for PCIIIb- 分叉病变 V stent- 药物支架失败后支架内再狭窄- 分叉病变 T stent or crushing of side branch- 特别弥漫病变 (full metal jacket)- 无保护左主干-急性心肌梗塞 - 放射治疗失败后的支架内再狭窄 (如不外科治疗!)49 ACC/AHA 2007 guideline update for PCI50 预扩张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如预计支架植入不会太困难，保证最小损伤措施

32、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 51 药物支架选择和扩张了解所有有关药物支架 的技术规格说明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）52 支架选择和展开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

33、支架应较病变长3-5mmIVUS和带有标记的引导钢丝对于选择药物支架的长度有帮助在裸金属支架时代，“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）在药物支架时代，“长一些更好”保证病变的全部覆盖53 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54 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

34、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55 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56 目前常用的药物支架特点57 CYPHER Sirolimus-eluting Coronary Stent Stent GeometryC

35、losed-cell FLEXSEGMENT TechnologyMaterial316L Stainless SteelStrut Thickness.0055”Crimped Profile.044”Available SizesDiameters: 2.50, 2.75, 3.00, 3.50 mmLengths: 8, 13, 18, 23, 28, 33 mmDrug DeliveredSirolimus (rapamycin, Rapamune)Mechanism of ActionInhibits mTOR to block growth factor induced proli

36、ferationCytostatic (blocks cell cycle in late G1phase)Drug delivery VehicleControlled-release, nonresorbable, elastomeric polymer coatingDrug Release Kinetics80% of sirolimus released in 30 daysApproval StatusApproved worldwide58 TAXUS Express Coronary Stent A Proven StentThe Express2 Stent platform

37、 offers excellent deliverability and conformability.A Reliable PolymerThe TAXUS Express Stent uses Translute Polymer, a proprietary polymer carrier technology, to control drug release.An Effective DrugThe unique properties of paclitaxel contribute to the efficacy of the TAXUS Express Stent.Paclitaxe

38、ls multi-functional effects, stabilize microtubules and inhibit activities that contribute to restenosis.3 Paclitaxel is highly lipophilic, which may contribute to more uniform drug distribution.4 59 316L 不锈钢材料支架梁厚度 0.0038”尖端外廓 0.017”通过外廓 0.047”*Pictures taken by Boston Scientific. 改善的通过性*For a 3.0m

39、m stentPictures 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60 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 *Pic

40、ture 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61 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

41、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62 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)2.252.502.753.03.582.762.973

42、.4392.192.442.813.023.49102.242.492.873.083.56112.292.552.933.143.63122.322.592.983.193.68132.362.643.023.233.7314 2.392.673.063.273.78152.422.703.093.313.81162.442.743.123.343.85172.742.763.143.373.882.492.793.173.393.92Nominal pressure for TAXUS Express2 : 9 ATMCaution: This is an investigational device and is not available for sale in the U.S. Copyright 2005 by Boston Scientific