介入中球囊及支架的應(yīng)用.ppt

1、a,1,冠狀動脈介入治療的球囊和支架的應(yīng)用,中國醫(yī)學(xué)科學(xué)院阜外心血管病醫(yī)院 高展,a,2,冠狀動脈介入治療球囊的選擇,3,a,球囊分類,整體交換球囊（OTW- over the wire) 快速交換球囊 (monorail),4,a,球囊的結(jié)構(gòu),球囊尖端 球囊 推送桿,5,a,球囊尖端,外徑：直頭圓弧錐形 尖端與球囊的連接：膠水黏結(jié)熱焊接激光焊接,6,a,球囊,球囊材料：尼龍、聚乙烯球囊順應(yīng)性 折疊方式：三層折疊：利于回卷，后撤，低折疊減小通過半徑 標記方式：中央標記易于通過嚴重狹窄病變，雙標記利于測量病變長度 球囊肩部角度：球囊于尖部平滑過渡有利于通過病變 球囊與中心桿的連接技術(shù)和材料：決定

2、通過扭曲血管的能力,7,a,球囊性能,外徑（crossing profile) 靈活性（flexibility) 跟蹤性（trackbility) 推送性（pushbility) 順應(yīng)性（compliance),a,8,球囊操作要領(lǐng),9,a,預(yù)擴張,有利于支架的植入 有利于病變的測量 選擇小于血管直徑0.5-1mm的球囊進行預(yù)擴張，球囊長度應(yīng)適當(dāng) 預(yù)擴張應(yīng)盡量減少對正常血管的損傷 為測量病變長度，使預(yù)擴張球囊在冠狀動脈內(nèi)進行造影時，注射造影劑的力度不宜過大，以免加重血管的撕裂 對于狹窄程度重、較復(fù)雜的病變，預(yù)計支架通過較困難的病變應(yīng)常規(guī)充分地預(yù)擴張，尤其對初學(xué)者,10,a,后擴張,防止支架貼壁

3、不良，預(yù)防支架內(nèi)血栓形成，降低再狹窄 后擴張球囊可選擇大一號的球囊或更高的壓力 后擴張時一定不能超出支架的邊緣，尤其是的DES 不可盲目追求所有病例的大球囊高壓力的后擴張，以免增加無再流和冠狀動脈破裂的風(fēng)險,11,a,不同類型病變的球囊選擇,CTO 病變：常選擇單標記、整體交換、小外徑（1.5 mm）球囊，如Maverick等 長病變：原則上選用較長的球囊，以防兩端撕裂并減少擴張次數(shù)。 分叉病變：可選雙導(dǎo)絲球囊、切割球囊。目的：減少斑塊移位、降低分支閉塞的概率。,12,a,不同類型病變的球囊選擇,小血管病變：宜選用外形小，推進性好的球囊。還可選用耐高壓球囊。 扭曲病變：應(yīng)選擇外形較小、推進性好

4、的球囊。OTW球囊推進性較單軌球囊好，還有利于交換導(dǎo)絲 鈣化病變：應(yīng)選擇外形較小、推進性好的球囊。還可選用雙導(dǎo)絲、耐高壓乳突或切割球囊。,a,13,常用的球囊特點,14,a,Maverick PTCA Balloon Catheters,Proprietary laser bonded technology creates an extraordinary TrakTip Design and precise, smooth bonds throughout the shaft. Push coil design and improved distal flexibility for enha

5、nced trackability. Our 1.5 and 2.0 mm SoftLEAP Balloons offer enhanced crossability.,15,a,Apex PTCA Dilatation Catheter,Slope Outer Shaft smoothly transitions from stiff to flexible, all in one piece, for more efficient push transmission Bi-Segment Inner Shaft optimizes the balance between push and

6、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 lower profiles Nano-composite materials adds structure and pus

7、hability to the outer shaft,16,a,Quantum Maverick Balloon,Low 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 Balloon Material Tapered TrakTip Design with .017 lesion entry p

8、rofile*,17,a,Quantum Maverick Balloon,18,a,19,a,20,a,21,a,NC sprinter,外形細小的FasTrac頭端技術(shù)-可在遇到 較難通過的病變時提供極佳的通過能力； 柔軟耐用的Fulcrum Plus球囊材料和MiniWrap 折疊技術(shù)提供細小的外徑和出色的再回抱能力； 選擇性的Dura-Trac涂層使球囊在到達和通過 病變的過程中保持持久的潤滑，在球囊擴張 時保持穩(wěn)定； 漸細鋼絲設(shè)計的推送桿增強了球囊的跟蹤能 力和通過遠端病變能力； 光滑細小的導(dǎo)絲交換口使3.5mm以下的任何 兩個球囊可在6F（0.070）的指引導(dǎo)管里對吻。,22,a,

9、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 the most competitive tip profile Slide

10、matrix 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 Tight F

11、old processing results in a slender primary profile for enhanced crossability through tight lesions. Sapphire NC,OrbusNeich,23,a,The IP Transition Zone of the Avita PTCA Dilatation Catheter provides intensified pushability. The new tapered tip design with soft material exhibits a flexible tip for sm

12、ooth 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 HP,OrbusNeich,24,a,Rugin,CrossTipTM 確保Ry

13、ugin通過性可以達到的最高性能。CrossTipTM 是由特殊混合的彈性塑料聚合物制作而成。0.017 英寸(0.043毫米)的入口外徑確保了Ryugin 在完全閉塞的病變的復(fù)雜管腔里的通過性。 CrossTipTM 中等長度的柔韌前端能較易地通過移植支架處的病變并繃緊其鈣化病變。 親水涂層M-Coating，塑料聚合物的復(fù)合層和新一代金屬合金的Hypotube。使用Ryugin通過過度彎曲和大彎曲血管時，它能順滑的到達目標病變部位，并且成功的處理其復(fù)雜閉塞病變。 提供廣泛有效的球囊直徑選擇范圍從超細的1.25毫米直徑到4.0毫米直徑不等。 薄型聚酰胺球囊確保了其卓越的通過性Ryugin C

14、rossTip 是從尖端到薄型聚合物球囊的一段平滑過度部分，平滑柔韌的聯(lián)合體能夠通過各種復(fù)雜病變部位。 泰爾茂新一代FC(Flexible Corrugate) 軸管成為連接高彈性的前端軸管和具備強硬金屬的Hypotube 軸管之間的橋梁。 FC-shaft 是指經(jīng)過加工的柔軟的膠質(zhì)軸，該技術(shù)實現(xiàn)了通過一個平衡軸加強力量的傳輸性和彈性。,25,a,Voyager,Superb Cross Tapered Tip Design New tapered tip with .017” tip entry profile designed to cross tight lesions Improved

15、 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 Design Versatile treatment in a 6F guide Excellent track an

16、d push in tortuous anatomy with new hypotube design Reinforced mid-shaft design provides flexibility and additional support Flexibility with Visibility Proprietary Tungsten Marker New marker material comprised of tungsten polymer Flexible marker design allows the catheter to conform more easily to t

17、ortuous anatomy Increased marker flexibility helps to reduce resistance when crossing tight lesions Precise Dilatation Proven Balloon Performance Short tapers allow for precise dilatation Improved LOFOLD Balloon Technology processes allows for excellent rewrap and recross1 XCELON S Balloon Material

18、achieves superb flexibility,26,a,Powersail,PLATEAU Balloon Material Provides non-compliance at high pressure without compromising performance Flexibility and conformability for excellent deliverability LOFOLD Balloon Technology Provides a low crossing profile for exceptional lesion cross LOFOLD ball

19、oon technology for improved balloon rewrap Soft Tip Design Tapered 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 Markers Provide lower profiles than

20、 conventional markers,27,a,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 participates in the

21、 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 balloon slippage

22、. 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 standard guidewir

23、e 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,28,a,Cutting Balloon,The Flexibility You Want Nylon ba

24、lloon 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 Cutting

25、 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 expansion,a,29,冠狀動脈介入治療

26、支架的選擇,30,a,冠狀動脈支架廣泛應(yīng)用的原因,植入支架后影像好，急性期結(jié)果好 支架能夠治療急性或瀕臨閉塞，安全性明顯提高 支架降低再狹窄率，改善患者的長期預(yù)后 植入支架容易操作 支架的應(yīng)用可以減少操作時間 對于復(fù)雜病變，球囊擴張結(jié)果往往不理想，植入支架可以得到滿意的結(jié)果,31,a,支架分類,根據(jù)設(shè)計不同，分為網(wǎng)狀支架、管狀支架、纏繞型支架、環(huán)狀支架 。 根據(jù)材料不同，分為316L不銹鋼支架、鈷支架、鉻支架、鎳支架、鉭支架。 根據(jù)輸送方式的不同，分為球囊膨脹性支架和自膨脹性支架。 根據(jù)特殊用途而設(shè)計不同的支架，如適合分叉病變的支架和適合分支的支架以及針對冠狀動脈瘤或穿孔的帶膜支架 根據(jù)是否帶

27、藥，分為藥物涂層支架和非藥物支架,a,32,支架的性能特點,33,a,支架的開環(huán)和閉環(huán)設(shè)計,34,a,網(wǎng)眼大小,35,a,36,a,微米,支架絲厚度,37,a,金屬動脈比值,38,a,支架可視性,39,a,40,a,41,a,42,a,裸金屬支架選擇原則,針對不同病變和支架的特性選擇不同的支架 支架的直徑與參照血管的直徑比為1.0-1.1 長度將病變或夾層全部覆蓋 避免過長支架和一支血管植入多個支架，多個支架不可避免時應(yīng)可能減少支架過多重疊,43,a,Cordis Confidential - Internal Use Only,藥物,聚合物,支架,雷帕霉素和紫杉醇 理想藥物,聚合物 最理想的

28、釋放系統(tǒng),支架平臺 封閉單元式設(shè)計,藥物洗脫支架,回縮和重塑,內(nèi)膜增生,結(jié)果:安全性, 療效性,輸送性,44,a,DES與BMS的比較,早期的臨床試驗隨訪4年結(jié)果表明，DES與裸金屬支架（BMS）比，明顯降低再次血運重建率，但死亡和心肌梗死（MI）兩者沒有差別。 針對特定亞組患者的隨機臨床試驗，如支架內(nèi)再狹窄、慢性完全閉塞、糖尿病、小血管病變，也都證明了DES的優(yōu)越性。 但是由于這些標簽外應(yīng)用“off-label”的臨床試驗隨訪時間較短、樣本量較小，對發(fā)生率較低的支架內(nèi)血栓、死亡、MI這些終點事件無法鑒別，故對于DES應(yīng)用于這些標簽外指征尚無定論。,45,a,DES與BMS的比較,DES因為有

29、涂層（polymer），所以較硬，順應(yīng)性和輸送性較差，故對置入較困難的病變應(yīng)選擇BMS。 DES較BMS昂貴，對于經(jīng)濟困難的患者應(yīng)首選BMS。 對于那些容易發(fā)生再狹窄的病變應(yīng)選擇DES。,46,a,建議的分類,介入治療有用、有效 證據(jù)偏向有用、有效 有效的證據(jù)不充分 介入治療無效，甚至可能有害,47,a,Recommendation,原位病變（De Novo）,ACC/AHA 2005 Guideline for PCI,48,a,ACC/AHA 2005 Guideline for PCI,-金屬支架內(nèi)再狹窄 (vs. brachytherapy) - 分叉病變 (主支置入藥物支架,分支 P

30、TCA 或provisional DES) - 開口病變 - 慢性完全閉塞 - 多支血管病變 (合并糖尿病) -靜脈旁路血管病變,49,a,ACC/AHA 2005 Guideline for PCI,50,a,ACC/AHA 2007 guideline update for PCI,51,a,預(yù)擴張,如果預(yù)計支架植入困難，必須充分預(yù)擴張，以防止藥物支架的涂層的損壞和支架的脫載 如預(yù)計支架植入不會太困難，保證最小損傷措施包括： 選擇小一號的球囊（小0.5-1.0mm） 短球囊（重點擴張最狹窄處并保證球囊長 度永遠短于擬用的DES支架長度） 使用低壓力預(yù)擴張（8atm） 也可以選擇使用穩(wěn)定性好

31、的短球囊（cutting balloon 或 safecut） 直接支架,52,a,藥物支架選擇和擴張,了解所有有關(guān)藥物支架 的技術(shù)規(guī)格說明 支架直徑的選擇應(yīng)基于對造影圖象中血管的估測或定量的血管內(nèi)超聲圖象的測量 影像標準：支架的球囊:血管直徑=1.1:1 IVUS標準：應(yīng)參考參照血管直徑（如是漸細的血管，取近遠段參照血管直徑的平均值）,53,a,支架選擇和展開,長度選擇應(yīng)強調(diào)支架“無病”區(qū)到“無病”區(qū)（或近段正常參照血管段到遠段參照血管段），即支架應(yīng)較病變長3-5mm IVUS和帶有標記的引導(dǎo)鋼絲對于選擇藥物支架的長度有幫助 在裸金屬支架時代，“越大越好”獲取最大的術(shù)后最小管腔直徑以抵消晚期

32、管腔丟失（即顯著的內(nèi)膜增生） 在藥物支架時代，“長一些更好”保證病變的全部覆蓋,54,a,藥物支架選擇和展開,輸送藥物支架過程中應(yīng)避免用手接觸支架 過止血閥時，應(yīng)充分打開，以防止對藥物支架涂層的磨損 如果藥物支架難以跨過病變，避免過度用力推送，最好再次擴張后再次推送,55,a,后擴張,并非所有病例中應(yīng)用的藥物支架置入后都需要后擴張 藥物支架極低的晚期管腔丟失，沒有必要像以往過度追求的造影效果；但是，應(yīng)該選用另一個球囊擴張任何支架內(nèi)不能被接受的狹窄或支架腰 后擴張的球囊應(yīng)該總是被定位于藥物支架邊緣以內(nèi)（即總是用短于支架的后擴張球囊) 后擴張球囊大小不應(yīng)超過兩個數(shù)量級,56,a,IVUS的重要性,

33、支架置入前的應(yīng)用（預(yù)擴張前或后） 評價病變長度和血管漸變程度（包括參照血管內(nèi)的病變） 評價血管的大小 評價病變與開口或分支血管的位置關(guān)系 評價病變的形態(tài)學(xué)（可能影響預(yù)擴張或后擴張的策略） 支架置入后的應(yīng)用 評價是否所有支架絲與血管壁完全貼附 評價已被支架覆蓋的區(qū)域（適當(dāng)?shù)闹Ъ艽笮∈欠褙灤┱麄€病變） 評價是否支架已覆蓋全部病變 對于多個支架-檢查重疊區(qū)域以避免空隙,57,a,目前常用的藥物支架特點,58,a,CYPHER Sirolimus-eluting Coronary Stent,59,a,TAXUS Express Coronary Stent,A Proven Stent The Ex

34、press2 Stent platform offers excellent deliverability and conformability. A Reliable Polymer The TAXUS Express Stent uses Translute Polymer, a proprietary polymer carrier technology, to control drug release. An Effective Drug The unique properties of paclitaxel contribute to the efficacy of the TAXU

35、S Express Stent. Paclitaxels 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.4,60,a,316L 不銹鋼材料 支架梁厚度 0.0038” 尖端外廓 0.017” 通過外廓 0.047”*,Pictures taken by Bost

36、on Scientific.,改善的通過性*,*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 支架系統(tǒng) 改善的輸送性和順應(yīng)性,61,a,增強的TrakTip尖端,5折球囊技術(shù),增強的TrakTip尖端外廓極小, 提供了更好的病變通過和改善

37、的跟蹤性.*,該設(shè)計減少了支架的旋轉(zhuǎn),增強了支架的固位.,改善的輸送性和順應(yīng)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 支架系統(tǒng) 改善的輸送性和順應(yīng)性,62,a,支架平臺比較血管覆蓋,TAXUS Libert 支架,TAXUS Libert 支架的小的單元面積設(shè)計可

38、以保持出色的血管覆蓋和支持,同時減少組織下垂的危險*.,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,63,a,命名壓力,額定爆破壓力,命名壓力,T

39、AXUS Libert 支架系統(tǒng) 支架順應(yīng)性圖表,ATM 直徑 (mm) 2.25 2.50 2.75 3.0 3.5 8 2.76 2.97 3.43 9 2.19 2.44 2.81 3.02 3.49 10 2.24 2.49 2.87 3.08 3.56 11 2.29 2.55 2.93 3.14 3.63 12 2.32 2.59 2.98 3.19 3.68 13 2.36 2.64 3.02 3.23 3.73 14 2.39 2.67 3.06 3.27 3.78 15 2.42 2.70 3.09 3.31 3.81 16 2.44 2.74 3.12 3.34 3.85 17 2.74 2.76 3.14 3.37 3.88 2.49 2.79 3.17 3.39 3.92,Nominal pressure for TAXUS Express2 : 9 ATM,Caution