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1、施乐辉初次膝关节产品介绍,王建峰Johnny WANG/膝关节产品经理,Headquarters-London,U.K.CEO-Olivier Bouhon,Revenue-$4,100million(2013)Employees-11,000(2013),Thomas James Smith,Smith&Nephew Recon Headquaters in Memphis/USA,1856年 Thomas James Smith 于英国Hull开设药局,1896年 Smith的侄子Horatio Nelson Smith加入成为 Smith&Nephew,1986年,收购了Richards
2、 Medical Company，为医疗行业的引导者,IMS data，2009,骨科领域主流公司发展状况,Future Knee Procedures,*CAGRs based on best estimate scenario,Trends In TKR,TKRs In Younger Patients-60%Males 65-40%Females 65Growth Over Past 10 Years FemalesMales45-54 337%271%55-64 260%213%(CCJR 2009),S&N膝关节产品发展历史,1995 1997 2001 2005 2008 2009
3、 2010,GII,GII Oxinium,Legion PS,Legion Rev,Legion PS&CR,VerilastOxinium&XLPE,Legion Porous,Visionaire,Legion Narrow,Genesis II全膝关节系统,Genesis:创世纪,Genesis II 全膝关节系统,Genesis II 全膝关节系统,1996年上市，累计植入超过75万例全球化的研发团队主要设计者：Dr.Richard Laskin-USADr.Robert Bourne-CANADADr.Mark Snyder-USADr.Steven Haas-USADr.Mich
4、ael Ries-USADr.Ramon Gustilo-USADr.John Hart-AustraliaDr.Lynn Rasmussen-USADr.Jim Rand-USADr.William Smith-USADr.Todd Swanson-USADr.Jan Victor-Belgium,过去20年中8个有关TKA后取出假体的研究表明：3300余个取出膝关节假体中50%以上有显著磨损有10余个超过10年的临床随访研究显示：磨损与TKA术后并发症及最终失败有关,TKA后磨损是一个重要问题吗？,Sharkey et al,Why Are Total Knee Arthroplastie
5、s Failing Today?CORR;Number 404,pp.713 2002,Reasons for revision,GENESIS II 全膝系统的目标,减少磨损优化胫股和髌股关节的活动和功能简单，通用，有效的手术器械全系列产品适应各种病例,股骨髁的内建外旋设计更好的胫股旋转对线、防止股骨前外侧皮质的凹陷 解剖型胫骨平台设计更好的胫股截骨面覆盖 方便实用的手术器械保证了截骨准确、手术迅速 多种假体组合提供临床多样选择 所有关节面高抛光减少关节磨损 多种临床适用后稳定、后叉保留、低要求性、翻修型,Genesis II 设计特点,Genesis II股骨髁,内置外旋设计,mechan
6、ical axis,anatomic axis,3,6,bone cuts,posterior cutexternallyrotated 3relative toposteriorcondyles(perpendicularto AP axis),epicondylar axis,AP axis,常规的外旋截骨,mechanical axis,anatomic axis,6,bone cuts,3,epicondylar axis,AP axis,rectangular extension gap,rectangular flexion gap,常规的外旋截骨,mechanical axis,
7、anatomic axis,6,bone cuts,metal isadded tofill gaps(equalcondylarthickness),epicondylar axis,AP axis,0 joint line created,常规的外旋截骨,mechanical axis,anatomic axis,3,6,bone cuts,posterior cutparallel toposteriorcondyles(3 internalfromepicondylaraxis),epicondylar axis,AP axis,GII 中立位截骨,mechanical axis,an
8、atomic axis,3,6,bone cuts,epicondylar axis,AP axis,rectangular extension gap,trapezoidal flexion gap,GII 中立位截骨,mechanical axis,anatomic axis,6,bone cuts,metal isadded tofill gaps(3 externalrotationbuilt intoposteriorcondyles),epicondylar axis,AP axis,0 joint line created,GII 中立位截骨,TKA中被广为接受的原则之一是股骨髁
9、外旋截骨能截出距形的屈膝间隙，从而平衡屈、伸间隙,股骨髁外旋的处理,GII 股骨髁的主要特点是内侧后髁薄、外侧后髁厚因此股骨截骨仅需中立进行而无需外旋，内建的两侧后髁不等厚匹配了间隙实现了外旋截骨的全部目的又避免了外旋截骨可能带来的问题,内建的股骨髁外旋,股骨前外侧皮质切迹,股骨前外侧可能产生凹陷性缺损,后髁水平截骨假体内建外旋,内建的股骨髁外旋,Open Box 设计,内建的股骨髁外旋,优化的BOX设计,Genesis II高屈曲PS股骨髁,优化的髌骨轨迹,长而深且偏外的股骨滑车槽,Genesis II的滑车沟,正常髌骨轨迹略呈S形当深屈、髌骨所受剪力最大时，防止髌骨内置不允许髌骨轨迹越过中
10、线减少对外侧松解的需要,髌骨轨迹的优化,减少外侧松解率,3！,The Knee 6(1999)87-93Patellar tracking and flexion space balancing using a femoral component with asymmetrical femoral condylesRichard S.Laskin,完美髌股匹配,95髌骨置换后无倾斜和移位,独特的Post与Cam设计使两者之间有更好的形合，特别是在正常步态下两者之间发生旋转时Cam的设计还既增加了形合又减少了对Post的应力,PS股骨髁的设计,最大化的骨保留,稍稍后置的Post，有利于增加屈膝O
11、pen Box 设计保留骨量，维持了前方骨质的连续,Genesis II 的PS设计,Insall-Burstein II PFC Sigma PS Genesis II PS Nex-Gen Legacy Optitrak PS.,高屈曲设计,Genesis II高屈曲PS,小半径股骨后髁,Genesis II高屈曲PS股骨髁,后髁屈度较小利于后滚和屈曲,前方斜切,后方减薄,Genesis II高屈曲PS胫骨垫,柱前方斜切,7后倾,Genesis II高屈曲PS胫骨垫,高屈曲前端斜切 减少前端的撞击 允许2度的过伸降低后缘高度 减小深屈时的压力前缘的改进 增加了与股骨髁的匹配,标准型前部边缘
12、的斜面 避免髌骨撞击柱的宽度 内外径增加0.8mm，以增加柱的强度,高屈垫与标准垫,小半径J沟设计，更抱合股骨髁，便于高屈曲,OK,better,柱前方斜切,7后倾,Genesis II高屈曲PS胫骨垫,多种股骨髁选择,Genesis II股骨髁的种类,Genesis II胫骨托,胫骨托仅2.5mm厚，为钛质嵴有后倾末端以锥度与髓腔柄连接胫骨平台髓腔柄的向内侧偏移可使其更好地中置于髓腔中。符合正常解剖。,胫骨托的设计,柄后倾 3 并稍偏内侧,锥度连接杆偏心设计,最大化胫骨覆盖,非对称性的胫骨托设计能够增加对胫骨截面的覆盖，特别是胫骨的后内侧。,胫骨托的设计,降低磨损,施乐辉公司所特有能减少聚乙
13、烯磨损85%-89%,强调减少摩擦磨损和粘附磨损：OXINIUM材料,所有Genesis II的胫骨托表面都是高抛光的，以减少胫骨垫的底面磨损,强调减少底面磨损,假体图示,Genesis II胫骨垫,Genesis II髌骨,膝关节屈曲角度,可使膝关节屈曲角度达到155。由于这一设计改变仅仅局限在胫骨垫上，故无需增加截骨量。,GII 植入物型号,GII 设计理念的临床优势黑晶股骨髁-降低磨损中立位截骨-避免Notching，减少松解股骨截骨量少-更安全更利于翻修解剖型胫骨平台-更加符合解剖髌股关节-髌骨轨迹友好,Oxinium 黑晶股骨髁,施乐辉公司所专利特有 截至2011年，超过300,00
14、0例黑晶膝关节置换 Robert Bourne教授于1997年开展第1台膝关节手术，15年的长期随访，效果优良,What is Oxinium Material?,Made from two of the most biocompatible metals,97.5%Zirconium+2.5%Niobium+Oxygen+Heat,=OXINIUM,OXINIUM is Oxidized Zirconium,Zirconium alloy is heated in air.Oxygen diffuses into alloy and transforms surface into ceram
15、ic.Not coated!Oxidized surface reaches 5 m,with oxygen-enriched transition zone below.,能减少聚乙烯磨损85%-89%,OXINIUM材料：强调减少摩擦磨损和粘附磨损,OX&Ciremic承重压力实验,陶瓷头承重试验不断增加重量，当达到8060磅时，陶瓷头破碎,承重两万磅时完好无损,可以压弯,从来不碎,Oxinium承重压力,20,000 lbs of load placed on the femoral,OXINIUM Will Not Break,20,000 lbs of load placed on
16、the head,20,000 lbs,可以压弯从来不碎,VERILAST Technology demonstrates lower wear rates than other XLPE formulations using similar test conditions,LEGION,黑晶膝关节,低磨损陶瓷界面坚硬不碎金属内核低金属过敏不含镍无金属过敏,OXINIUM&XLPE,VERILAST Technology with LEGION Primary Knee System,Exclusive30yearwearperformance*claim,初次及翻修的转换,组合式的膝关节,与
17、LEGION膝关节翻修系统的截骨一致，由此Genesis II SPC股骨髁可以很方便地迁移到LEGION翻修系统，从而使医生在同一个系统中有多种不同限制性的人工膝关节可供选择。与高限制性聚乙烯垫亦可通用，可使医生在较复杂的初次置换病例中使用更稳定的胫骨垫。,Confidential Do Not Distribute,The Power of Simplicity精于心 简于形,S&N膝关节产品发展历史,1995 1997 2001 2005 2008 2009 2010,GII,GII Oxinium,Legion PS,Legion Rev,Legion PS&CR,VerilastOx
18、inium&XLPE,Legion Porous,Visionaire,Legion Narrow,1.Bourne RB,McCalden RW,MacDonald SJ,Mokete L,Guerin J.Influence of patient factors on TKA outcomes at 5 to 11 years followup.Clin Orthop Relat Res.2007;464:2731.2.FDA Clearance,April,2010.(Use the reference created around the new clearance)Confident
19、ial For internal use only by Smith&Nephew employees and sales force.Do not publicly distribute.,the power of simplicity,Built-in Femoral Rotation,Surgeon-directed Femoral Rotation,Compatible Base Plates,Inserts,Patellas,Augments,Stems and Offset Couplers,GENESIS II CR GENESIS II PS LEGION CR LEGION
20、PS LEGION CKCruciate Retaining Knee Posterior Stablized Knee Cruciate Retaining Knee Posterior Stabilized Knee Constrained Knee,EnduranceBuilt on a legacy of success:98%10-yr survivorship1No one else has an industry-exclusive 30 year wear claim for LEGION CR and PS because no one else has VERILAST T
21、echnology2VersatilitySeamless options for diverse surgical challengesProven designs allow natural anatomic reconstruction and offer patient-appropriate materialsEaseEasy,intuitive instrumentationOR Efficiencies of VISIONAIRE Patient-matched Technology+LEGION CR Porous Knees,claim,Trademark of Smith&
22、Nephew.Certain marks Reg.US Pat.&TM Off.,对比GII,XLPE-高交联垫片更少磨损股骨髁新设计-更宽泛适应症股骨工具独特设计-使用更加方便节省手术时间外旋截骨-更多假体类型适用更多术式-,-优良的髌骨轨迹-最大155高屈曲-解剖型胫骨托设计-相同的胫骨垫片设计,产品特点,外旋截骨器,Guide set 2-6 for Legion,Guide set 0 for GII,Drill holes for DCF block,L,M,L,M,四合一截骨板,12mm,9.5mm,9.5mm,截骨后,假体植入后,9.5mm,9.5mm,7mm,LEGION 的含
23、义,“强大的古罗马军团；众多的”,LEGION可交换性,符合人体的解剖,假体几何结构J 曲线，多中心半径设计符合大多数股骨部件的尺寸,符合人体的解剖,关节活动中髌骨滑动槽逐渐靠近中线,0,中线,60,90,外侧需要松解的几率：相比竞争对手的8-15%，LEGION只有3%,施乐辉是唯一一家公司提供不对称解剖型胫骨假体的公司,对称型胫骨平台过大,对称型胫骨平台过小,解剖型胫骨平台正好,符合人体的解剖,高屈曲设计,最大155高屈曲设计,Trademark of Smith&Nephew.Reg.US Pat.&TM Off.,LEGION股骨部件,LEGION Revision&CR、PSOXIN
24、IUM及CoCr材料尺寸 2-6号SPC设计AP box截骨相等,LEGION CRLEGION PSLEGION Rev,LEGION胫骨部件,GII&LEGION相同处材料=钛合金尺寸 1-8号不对称设计相同锁定机制高抛光表面GII2.3 mm厚度3后倾LEGION5.5 mm厚度0后倾,GII（male taper）,LEGION（Female taper）,LEGION胫骨衬垫,GII-CPE尺寸：1-8号厚度：Standard 9,11,13,15,18 mm PS High Flex 9,11,13,15,18,21,25 mm Constrained 11,13,15,18,21
25、,25 mmLEGION-XLPE尺寸：1-6号厚度：STD：High Flex 9,11,13 and 15mm Constrained：11,13,15,18mm,Based on in-vitro wear simulation testing,the LEGION Primary Knee System with VERILAST technology is expected to provide wear performance sufficient for 30 years of actual use under typical conditions.The results of
26、in-vitro wear simulation testing have not been proven to quantitatively predict clinical wear performance.Also,a reduction in total polyethylene wear volume or wear rate alone may not result in an improved clinical outcome as wear particle size and morphology are also critical factors in the evaluat
27、ion of the potential for wear mediated osteolysis and associated aseptic implant loosening.Particle size and morphology were not evaluated as part of the testing.Trademark of Smith&Nephew.,VERILAST Technology with LEGION Primary Knee System,Exclusive30yearwearperformance*claim,LEGION Total Knee SystemVERILAST Technology the power of simplicity,Trademark of Smith&Nephew.Reg.US Pat.&TM Off.,Legion/Genesis II系统人工全膝关节置换的明智选择,Confidential For internal use only by Smith&Nephew employees.Do not disclose or distribute to third parties.,GII/Legion,TC-Plus,S B,Dynamic,
