血透導(dǎo)管產(chǎn)品介紹修改

1、Covidien(泰科醫(yī)療血液透析導(dǎo)管產(chǎn)品Aaron LuoVascular TherapiesCovidienWho is Tyco International Ltd.市場(chǎng)領(lǐng)先品牌外科產(chǎn)品呼吸危重癥產(chǎn)品常需醫(yī)用產(chǎn)品影像產(chǎn)品電子元件與附屬系統(tǒng)印刷電路板供電系統(tǒng)工業(yè)處理閥門給排水設(shè)備閥門產(chǎn)品鋼管消防產(chǎn)品消防電子安全產(chǎn)品與服務(wù)工業(yè)用密封膠帶衣架塑料垃圾袋塑料餐具2我們是 2007年6月30日，泰科醫(yī)療更名位Covidien，美國(guó)獨(dú)立上市公司43,000 employees50,000 different medical productsOver $10 billion companyTop 5

2、healthcare company3Tyco healthcare是Tyco International Ltd. 的重要組成局部是為全球衛(wèi)生保健業(yè)提供產(chǎn)品最為廣泛的世界級(jí)供給商全世界有130個(gè)國(guó)家及地區(qū),將近 55,000 家醫(yī)院使用 Tyco 的衛(wèi)生保健產(chǎn)品43,000名員工向全球提供醫(yī)療保健專業(yè)效勞2007年度創(chuàng)造出近100億美元營(yíng)業(yè)額泰科醫(yī)療自2000年進(jìn)入中國(guó)以來(lái)，一直致力于推廣全列先進(jìn)技術(shù)市場(chǎng)領(lǐng)先品牌：Quinton，US Surgical、Nellcor、 Mallinckrodt、Kendall、Valleylab4久負(fù)盛名的一家專注于血透及腹透導(dǎo)管生產(chǎn)廠家Quinton D

3、ialysis Catheters2022/9/155短期急性導(dǎo)管Acute dialysis catheterMahurkar* 短期透析導(dǎo)管系列11.5 Fr 雙腔導(dǎo)管13.5 Fr Qplus 高流量導(dǎo)管12 Fr 三腔導(dǎo)管300-350ml/min450ml/min350-400 ml/min其他：8Fr，10Fr 雙腔導(dǎo)管，適用于兒童及其他特別用途。7Quinton 單腔導(dǎo)管SE & CE8 FrSingles & KitsMahurkar 雙腔導(dǎo)管SE & CE8, 10, 11.5 ,13.5 FrSingles & KitsMahurkar 三腔導(dǎo)管CEKits12 FrCov

4、idien 短期導(dǎo)管管腔設(shè)計(jì)8 三種形狀：直頭、彎頭M形和豫彎型導(dǎo)管。 各種長(zhǎng)度：13.5cm,16cm,19.5cm, 24cm9短期血透導(dǎo)管 臨床應(yīng)用科室主要應(yīng)用科室 腎臟內(nèi)科 ICU 介入科 急診科2022/9/15Mahurkar 11.5 Fr太空耐磨材料接頭硅膠外延管雙“D”管腔，聚氨酯（PU)材料 直頭、彎頭和豫彎形狀，13.5cm, 16cm, 19.5cm & 24cm 長(zhǎng)度可選 300-350ml/min適用于血液透析、血液灌注、血漿置換等。對(duì)應(yīng)腎臟科、激光切槽或側(cè)孔設(shè)計(jì)11Mahurkar* Qplus 高流量13.5Fr 短期導(dǎo)管防損傷“綠色”管尖激光切槽13.5 Fr

5、, 450ml/min流量 高流量，可達(dá)450ml/min 激光切槽，減少血栓形成、減少貼壁，提高血流量12激光切槽自我沖刷能力減少血栓和血栓引起的感染血流在導(dǎo)管外表和導(dǎo)管腔內(nèi)通過(guò)，自我沖刷作用不會(huì)發(fā)送血液湍流或側(cè)孔血流淤滯減少貼壁梗阻更大的開(kāi)口面積不易造成貼壁阻塞切槽的方向最大限度的提供血流通路流速高/動(dòng)脈端抽吸負(fù)壓小血流動(dòng)力學(xué)模型證實(shí)流速更高激光切槽開(kāi)口更易抽吸血液激光切槽工藝優(yōu)于機(jī)械沖鉆側(cè)孔外表和邊緣更光滑，不易形成血栓或細(xì)菌膜Benefits13激光切槽電鏡照片電鏡下：側(cè)孔外表不光滑2022/9/151415Mahurkar 12Fr 三腔管第三腔用于給藥，輸血等激光切槽防損傷“綠色”

6、管尖 增加第三腔用于給藥、采血及輸液等，方便臨床 12 Fr，血流和感染率與雙“D管腔導(dǎo)管無(wú)統(tǒng)計(jì)學(xué)差異 13，16，20，24cm長(zhǎng)度可選 350-400 ml/min16臨床研究A Multi-Center, Prospective, Randomized, Comparative Evaluation of Dual-versus-Triple Lumen Catheters for Hemodialysis & Apheresis in 485 patientsContreras G, MD, et al. A Multicenter, Prospective, Randomized,

7、Comparative Evaluation of Dual-versus Triple Lumen Catheters for Hemodialysis and Apheresis in 485 patients. AJKD, Vol 42, No.2, August 2003 Mahurkar* 12Fr 三腔導(dǎo)管Published, Peer-Reviewed Clinical StudiesContreras, AJKD (August, 2003): Mahurkar 12Fr 三腔導(dǎo)管與雙腔導(dǎo)管相比，導(dǎo)管相關(guān)感染無(wú)增加。Mahurkar 12Fr 三腔導(dǎo)管與雙腔導(dǎo)管相比，理想血流獲

8、得率均為100。18Mahurkar* 12Fr 三腔導(dǎo)管Young, Contreras, Nephrology Nursing Journal (Jan-Feb, 2005)3. Mahurkar 12Fr 三腔導(dǎo)管與雙腔導(dǎo)管相比，插管部位的感染無(wú)差異19血透導(dǎo)管臨床實(shí)踐指南根本原那么CPG 2.4)K/DOQI DIALYSIS ACCESS UPDATE 2006在開(kāi)始透析前置管，短期導(dǎo)管管尖應(yīng)該在上腔靜脈內(nèi)并且在插入時(shí)用透視或胸片確認(rèn)無(wú)滌綸套導(dǎo)管短期導(dǎo)管只能用于住院病人并且留置期不超過(guò)1周。短期股靜脈導(dǎo)管只能用于臥床病人股靜脈導(dǎo)管應(yīng)該有適宜的長(zhǎng)度以輸送高流量血液并將再循環(huán)減到最小。不

9、能到達(dá)下腔靜脈的導(dǎo)管常不能提供300ml/min的血流。更長(zhǎng)的導(dǎo)管(24 to 31 cm)更易到達(dá)理想的位置，盡管這樣會(huì)因?qū)Ч茌^長(zhǎng)而產(chǎn)生更多阻力2022/9/1520長(zhǎng)期慢性透析導(dǎo)管Chronic dialysis catheter長(zhǎng)期血液透析管的開(kāi)展 Staggered TipSplit TipDual CatheterSpiralZ Tip(Tal PALINDROME)2022/9/1522Quinton Permcath (19Fr widest part oval, 15Fr paediatric)硅膠材質(zhì); 血流量可達(dá)300ml/min - 380ml/min13(28cm, 1

10、9(36)cm, 23(40)cmMahurkar 13.5 Fr硅膠材質(zhì); 血流量可達(dá)300ml/min - 380ml/min1936cm，2340cm, 28(45)cm, 33(50)cmMahurkar Maxid 14.5Fr Dual LumenCarbothane材質(zhì); 血流量可達(dá)450ml/min1936cm，2340cm, 28(45)cm, 33(50)cmTal Palindrome 14.5FrCarbothane材質(zhì); 血流量可達(dá)500ml/min1936cm，2340cm, 28(45)cm, 33(50)cm. 局部品種最長(zhǎng)5572cm.Covidien 長(zhǎng)期導(dǎo)

11、管系列23Covidien 長(zhǎng)期導(dǎo)管系列 Tal Palindrome 14.5FrMahurkar Maxid 14.5FrQuinton PermcathMahurkar 13.5Fr24Quinton Permcath階梯形管尖設(shè)計(jì)扁橢圓形；硅膠材質(zhì) 扁橢圓形血流量可達(dá)300ml/min - 380ml/min 硅膠材質(zhì) 階梯形管尖25Mahurkar 13.5 Fr 雙D管腔 硅膠材質(zhì) 血流量300ml/min - 380ml/min 階梯形管尖階梯形管尖雙“D管腔；硅膠材質(zhì)26Mahurkar Maxid 14.5Fr Carbothane材質(zhì)聚碳酸酯基聚氨酯或優(yōu)化聚氨酯材料，抗打折

12、性能優(yōu)異 配套單向閥撕脫鞘：減少出血和預(yù)防氣拴 14.5Fr, 高流量，可達(dá)450ml/min 階梯形管尖 無(wú)側(cè)孔 雙“D管腔14.5Fr 高流量，優(yōu)化聚氨酯材料階梯形管尖；無(wú)側(cè)孔27Mahurkar Maxid 聚碳酸酯基聚氨酯優(yōu)化聚氨酯材料-抗打折圖示MAXIDBard Opti-FlowMedComp Ash-Split Cath*Data on file28單向閥平安撕脫鞘Standard component in Maxid and Palindrome Catheter Kits防止空氣栓塞和過(guò)多出血29FlowGuard 單向閥撕脫鞘技術(shù)預(yù)防空氣栓塞，減少出血 可滑動(dòng)閥門使用方便

13、，不影響手術(shù)操作 PTFE 材料光滑，易撕脫 鎖環(huán)允許擴(kuò)張器在鞘內(nèi)旋轉(zhuǎn)和固定 外表光滑插入阻力小 撕脫鞘柄容易持握和撕脫30Maxid無(wú)側(cè)孔設(shè)計(jì)：應(yīng)該有側(cè)孔或無(wú)側(cè)孔？TWARDOWSKI & MOORE無(wú)證據(jù)支持側(cè)孔可用改善血流和延長(zhǎng)導(dǎo)管壽命側(cè)孔邊緣毛糙側(cè)孔提供血栓形成的拋錨點(diǎn)血栓從導(dǎo)管外面長(zhǎng)入管腔內(nèi)，極難除去遠(yuǎn)端的肝素封管液可以通過(guò)側(cè)孔漏入血液側(cè)孔還可能在血流梗阻部位損傷血管內(nèi)膜Z.J. Twardowski & H.L. Moore. Side Holes at the Tip of Chronic Hemodialysis Catheters are Harmful. Journal o

14、f Vascular Access, Vol 2, 8-10, 2001 31TAL et al. presentation研究提示無(wú)側(cè)孔導(dǎo)管的感染率降低無(wú)側(cè)孔導(dǎo)管的生存率較高平均血流在有側(cè)孔和無(wú)側(cè)孔導(dǎo)管間無(wú)區(qū)別Covidien長(zhǎng)期血透導(dǎo)管 Mahurkar MaxidMichael G. Tal, et al. Comparison of side hole versus non side hole high flow hemodialysis catheters.Hemodialysis International, Vol 10, 63-67, 2006 應(yīng)該有側(cè)孔或無(wú)側(cè)孔？323334

15、Palindrome-現(xiàn)有透析導(dǎo)管技術(shù)的一個(gè)突破性創(chuàng)新Palindrome 是Covidien 公司最新推出的新一代血液透析長(zhǎng)期管，獨(dú)有的“Spiral-Z 尖端2022/9/1535 PalindromeForward Thinking Thinking Forward 長(zhǎng)期導(dǎo)管的進(jìn)化 階梯形管尖分裂形管尖對(duì)稱螺旋“Z形管尖37Tal Palindrome 14.5 Fr 對(duì)稱螺旋“Z形管尖；2004年美國(guó)醫(yī)學(xué)設(shè)計(jì)大獎(jiǎng)：導(dǎo)管正反接時(shí)再循環(huán)率小于5 激光切槽：自我沖刷flash，防血栓，防貼壁，減少感染 Carbothane 材料聚碳酸酯基聚氨酯，抗打折性能優(yōu)異 配套單向閥平安撕脫鞘 改進(jìn)的新

16、型隧道針對(duì)稱螺旋“z”形管尖14.5 Fr, 優(yōu)化聚氨酯材料激光切槽38Tal PALINDROME具有極低的再循環(huán)率2022/9/1539為什么Palindrome反接時(shí)仍有很低再循環(huán)率？flash40MAXID w/o sideholes ArterialASH SPLIT CATH ArterialHemoglide ArterialPALINDROME ArterialTal PALINDROME可保持低的動(dòng)脈壓力14.5Fr CatheterRates of 200-500ml/minPerforms irrespective of placement2022/9/1541特點(diǎn)專利聚

17、氨酯材料雙“D設(shè)計(jì)14.5Fr外徑雙向并對(duì)稱的Z設(shè)計(jì)獨(dú)特的激光切割側(cè)槽設(shè)計(jì)作用易于經(jīng)皮置管，使用中不易破損超級(jí)防打折材料可用PVD 碘酒清潔聚氨酯材料，一定壓力比例下的最有效流量在低動(dòng)靜脈壓下，提供高流量可達(dá)450ml/min解決導(dǎo)管反接問(wèn)題，降低重復(fù)循環(huán)率光滑的邊緣減少血液凝結(jié)血栓， 保證了血流的通暢Tal PALINDROME 長(zhǎng)期留置管特點(diǎn)Ultem接頭硅橡膠連接管耐用內(nèi)聯(lián)夾厚毛氈卡夫FlowGuard單向閥撕脫鞘擴(kuò)張器作用重量輕、耐用、不易損壞增加病人舒適感 - 多種插管位置 - 重復(fù)用夾子夾不會(huì)卷曲確保及時(shí)關(guān)閉體外管固定插管 減少感染促進(jìn)組織生長(zhǎng)防止氣栓、出血Tal PALINDRO

18、ME 長(zhǎng)期留置管特點(diǎn)新的隧道針各種長(zhǎng)度及管尖到卡夫長(zhǎng)度可選擇管體預(yù)彎型不透射線作用可改變形狀/便于使用防止創(chuàng)傷尖端及后部將創(chuàng)傷減到最小適合不同病人需要管體不易打折，流量佳便于在X光/熒光下迅速觀察Tal PALINDROME 長(zhǎng)期留置管Tal PALINDROME雙向并對(duì)稱的雙D型管路和Spiral-Z設(shè)計(jì)，解決了導(dǎo)管反接問(wèn)題，大大降低了重復(fù)循環(huán)率。獨(dú)特的激光切割側(cè)槽設(shè)計(jì)及光滑的邊緣減少血液凝結(jié)血栓，保證了血流的通暢。可配合FlowGuard使用，減少了氣栓和失血的風(fēng)險(xiǎn)。優(yōu)質(zhì)的材料，保證了管路經(jīng)久耐用，平安有效。Ultem外接頭、有銀離子涂層的硅膠外接管、帶卡夫、抗扭結(jié)的CarboThane

19、管材等預(yù)彎型Tal PALINDROME2022/9/1545動(dòng)靜脈端反接研究顯示透析治療是反接率達(dá)27% 57% ，是頻繁發(fā)生的導(dǎo)管功能不良所致 (血栓，纖維蛋白鞘，位置性阻塞，導(dǎo)管移位) 和血流缺乏所致.1反接導(dǎo)管可能恢復(fù)導(dǎo)管功能，但是同時(shí)會(huì)導(dǎo)致再循環(huán)率顯著增加。目前多數(shù)導(dǎo)管設(shè)計(jì)的普遍缺點(diǎn)就是動(dòng)靜脈端反接時(shí)出現(xiàn)很高再循環(huán)率，導(dǎo)致透析 不充分.2,3MJ Oliver et al. Randomized study of temporary hemodialysis catheters. International Journal of Artificial Organs, Vol.25,n

20、o.1,2002Lynne Senecal et al. Blood flow & recirculation rates in tunneled hemodialysis catheters. ASAIO Journal, Vol.50,pp94-97, 2004Twardowski, ZJ et al. All currently used measurement of recirculation in blood access by chemical methods are flawed due to intradialytic disequilibrium or recirculati

21、on at low flow. AJKD, Vol32,no. 6,199846動(dòng)靜脈端反接時(shí)，Palindrome與標(biāo)準(zhǔn)透析導(dǎo)管再循環(huán)率的比較結(jié)果 階梯形管尖 (31%) 分裂形管尖 (16%) Tal Palindrome (2%) K/DOQI 指南建議 (5%)Michael G.Tal. Comparison of recirculation percentage of the Palindrome catheter & standard hemodialysis catheters in a swine model. JVIR, Vol.16, no.9,September 200

22、547PURPOSE: The purpose of this study was to evaluate in vivo recirculation of a new bi-directional dialysis catheterwith a symmetric tip design and compare it to currently marketed staggered and split tip catheters.MATERIALS AND METHODS: Twelve catheters were placed in three 70-kg male swine. The c

23、atheters wereconnected to a roller type peristaltic pump. Blood flow and recirculation rates were measured with ultrasound (US)dilution. Recirculation was measured in blood flow rates of 300 mL/min, 400 mL/min, and 500 mL/min. The dialysislines were then reversed and recirculation was measured in fl

24、ow rate of 400 mL/min. Measurements were conductedwith the catheter tip in the right atrium (RA) and repeated with the catheter tip in the superior vena cava (SVC).RESULTS: Recirculation rates measured with the Palindrome catheter tip (Tyco Healthcare Group LP, Mansfield, MA)in the SVC and in the RA

25、 were 0%. When the dialysis lines were reversed, the Palindrome catheter averagerecirculation was 0% with the tip in the SVC and 1% (0%3%) with the tip in the RA. The average recirculation ratesmeasured with the split tip catheter were 1% (0%10%) in the SVC and 0% when the catheter tip was in the RA

26、. Whenthe dialysis lines were reversed split tip catheter recirculation was 11% (9%16%) with the tip in the SVC and 13%(7%18%) with the tip in the RA. With the staggered tip catheter, 1% (0%5%) recirculation was measured. When thedialysis lines were reversed, the average recirculation in the stagger

27、ed tip catheter measured 23% (18%30%).Recirculation rate with reversal of dialysis lines was significantly lower with the Palindrome catheter when comparedto the split tip and staggered tip designs (P .05).CONCLUSIONS: Preliminary results in vivo indicate that the Palindrome catheter demonstrates mi

28、nimal recirculationwith reversal of the dialysis lines compared to currently marketed split tip and staggered tip catheterComparison of Recirculation Percentage of the Palindrome Catheter and Standard Hemodialysis Catheters in a Swine ModelMichael G. Tal, MD2022/9/1548【在豬模型上對(duì)Palindrome與標(biāo)準(zhǔn)透析導(dǎo)管的再循環(huán)率的比

29、較】 JVIR, Vol.16, no.9,September 2005 Michael G. Tal, MD【目的：在活體內(nèi)評(píng)價(jià)帶對(duì)稱管尖設(shè)計(jì)的新型雙腔導(dǎo)管、階梯形管尖設(shè)計(jì)導(dǎo)管和分裂型管尖設(shè)計(jì)導(dǎo)管的再循環(huán)率。】【材料和方法：12支導(dǎo)管植入3只70公斤重雄性豬。分別在300 mL/min, 400 mL/min, and 500 mL/min血流速度時(shí)測(cè)量再循環(huán)率。然后反接透析血路，管尖在右心房中進(jìn)行測(cè)量，在上腔靜脈中再重復(fù)測(cè)量?！?9結(jié)果：在上腔靜脈和右心房中測(cè)量Palindrome(Tyco Healthcare Group LP, Mansfield, MA) 的再循環(huán)率為0；當(dāng)血路反接

30、時(shí)Palindrome管尖在上腔靜脈中的再循環(huán)率為0，在右心房測(cè)量為1(0-3%)。分裂型管尖導(dǎo)管的再循環(huán)平均在上腔靜脈中為1010，在右心房為0；當(dāng)血路反接時(shí)分裂型管尖導(dǎo)管的再循環(huán)率在上腔靜脈中為11916，在右心房中為13718。階梯形管尖導(dǎo)管，再循環(huán)率為105；當(dāng)血路反接時(shí)，階梯形管尖導(dǎo)管再循環(huán)率平均為231830。在血路反接時(shí)，Palindrome的再循環(huán)率明顯低于分裂型管尖導(dǎo)管和階梯形管尖導(dǎo)管。結(jié)論：在活體實(shí)驗(yàn)的初步結(jié)果顯示，在血路反接時(shí)，Palindrome與目前市場(chǎng)銷售的分裂型管尖和階梯形管尖導(dǎo)管相比， Palindrome的再循環(huán)率最小。5051Tal Palindrome慢性

31、透析導(dǎo)管臨床療效：?jiǎn)沃行难芯坎牧虾头椒ǎ?39個(gè)月觀察期，126支Tal Palindrome插入85例患者。跟蹤調(diào)查了115例患者。記錄了插入并發(fā)癥，通暢率，導(dǎo)管相關(guān)菌血癥，出口感染以及拔管原因等數(shù)據(jù)?；颊邔?dǎo)致終末期腎病的原因，潛在疾病以及插管的位置也進(jìn)行了記錄分析。結(jié)果：患者年齡在3591歲之間平均69歲。50患者有糖尿病。126支導(dǎo)管被插入患者體內(nèi)，總共累計(jì)12,046個(gè)帶管日。插管成功率100。平均導(dǎo)管留置時(shí)間為105天范圍1673天。導(dǎo)管分別從右頸內(nèi)靜脈107例或左頸內(nèi)靜脈19例插入，均無(wú)插管并發(fā)癥。在觀察期間，115例追蹤病人中有16例發(fā)生導(dǎo)管相關(guān)菌血癥發(fā)生率13.9%，血培養(yǎng)證實(shí)

32、的有4例3.5%.發(fā)生7例導(dǎo)管出口感染，10支導(dǎo)管發(fā)生纖維蛋白鞘導(dǎo)致更換導(dǎo)管2022/9/15討論16支13.9導(dǎo)管因?yàn)榕R床感染證據(jù)拔管。拔管率低于類似實(shí)驗(yàn)中的其他導(dǎo)管。在一個(gè)前瞻性研究中118支AshSplit (Medcomp, Harleysville, Pennsylvania) 透析導(dǎo)管，Ewing et al (8)報(bào)道34因?yàn)楦腥景喂堋arr et al (9)報(bào)道102例病人帶管日16,081天，41例40發(fā)生了62次菌血癥。Cheesbrough et al (10)回憶了74支鎖骨下靜脈導(dǎo)管插入53例患者，追蹤的64根導(dǎo)管中16支發(fā)生了導(dǎo)管相關(guān)敗血癥。類似的報(bào)道還有Cap

33、devila et al (11)使用16支Permcath(Sherwood Medical, St Louis, Missouri) 插入36例患者，11例患者發(fā)生了13次導(dǎo)管相關(guān)敗血癥。在本研究中，導(dǎo)管相關(guān)感染發(fā)生率為1.3/1000帶管日。Saad (12)在一個(gè)大型的回憶性研究中報(bào)道為其他導(dǎo)管為帶管日。據(jù)報(bào)道纖維蛋白鞘在中心靜脈導(dǎo)管的發(fā)生率為4210013，本研究Tal Palindrome的發(fā)生率(10/115, 8.7%)顯著低于其他作者關(guān)于其他導(dǎo)管高達(dá)50的報(bào)道。2022/9/15【參考文獻(xiàn)】References8. Ewing F, Patel D, Petherick A,

34、 Winney R, McBride K. Radiological placement of the AshSplit haemodialysis catheter: a prospective analysis of outcome and complications. Nephrol Dial Transplant 2002; 17:614619.9. Marr KA, Sexton DJ, Conlon PJ, Corey GR, Schwab SJ, Kirkland KB. Catheter- related bacteremia and outcome of attempted catheter salvage in patients undergoing hemodialysis. Ann Intern Med 1997; 127:275280.10. Cheesbrough JS, Finch RG, Burden RP. A prospective study of the mechanisms of infection associated with hemodialysis catheters. J Infect Dis 1986; 154: 579589.11. Capdevila JA, Segarra A, Planes AM