1、Codman Valves for HydrocephalusThe Hakim Valve mechanismTechnology developed to provide long-term accuracy and reliability in valve performance.Hakim阀能保持长期的精确性和稳定性Original Valve最初的阀门Long valve sometimes a“pain in the neck”MicroValve显微阀门MicroValve+RickhamHakim shunt housing developmentHakim ValvesHak
2、im ValveIs available as Valve only单一阀门 System(with separate catheters)系统(带单独的导管)Unitised system合成系统 Valve with pre-attached distal catheter and separate ventricular catheter带预置装置的远端导管与阀门,以及独立的脑室导管Hakim Valve Lets talk about the valve mechanism 让我们讨论阀门机械装置MicroValve显微阀门MicroValve显微阀门 Ruby ball and co
3、llar红宝石球 Flat spring弹簧片 Spring pillar弹簧柱 Micro adjustable fulcrum显微调节支点Hakim precisionFlow through designAnti reflux valve防逆流阀Pre-chamber前腔To stop reverse flow防止倒流Injection inSampling outPumping注射取样泵Hakim valve constructionAnti reflux mechanism防逆流装置No longer required不再需要Reflux pressure presses the b
4、all down onto the collar closing the valve逆流压力将球压入轴环关闭阀门逆流压力将球压入轴环关闭阀门MicroValve微型阀门 Accurate to+/-1mm H2O 精确度+/-1mm水柱 Quoted and independently verified to+/-10mm H2O Flat pressure/flow curve水平压力/流量曲线Pressure definition压力定义areaatmospheric pressure大气压力hydrostatic pressure流体静压weightarea=area g h h Flo
5、w definition流量定义Flow流量流量 p压力差Resistance阻力=pFlow in a shunt is controlled by the pressure differential分流管内的流量是由压力差控制的pOpening pressures (mm H20)050100150200250HAKIMPrecisionValveCORDISHAKIMP-SMEDICALP-SMEDICALP-SMEDICALOpening pressures开放压力Opening pressures开放压力 Means what it says So a wide band means
6、 you are not sure at what pressure that valve will open给定的是一压力范围意味着你不能确定阀门究竟在哪个压力下开放 Customers feel it is an operating band顾客感觉是一压力带 But there is no top and bottom没有上下限 Only a bottom只有基线 This helps customers know what they are implanting-if performance is reliable Opening pressures Maybe But the thr
7、ust of our argument is that they should think about it more争论的焦点将是医生必须考虑更多 Their decisions affect the quality of the whole of a childs life医生的决定影响一个孩子一生的生命质量 Is a 50%revision rate good enough?50的翻修率够好吗?Next logical step in this argument is Programmability下一个讨论焦点是阀门的可调性Opening pressures (mm H20)05010
8、0150200250HAKIMPrecisionValveCORDISHAKIMP-SMEDICALP-SMEDICALP-SMEDICALHOLTEROpening pressuresPressure responsive or Flow responsive?Some of our competitors confuse the doctors by suggesting one mechanism is superior to the other.我们的竞争对手常误导医生,为了证明其阀门优于其它“Ah but yours is not a flow responsive system”“
9、他们不是流量响应系统”The truth is a little more simplePressure responsive or Flow responsive?Flow occurs when there is a pressure differential当有压力差时才会产生液体流动 It is the case that flow can add to that pressure but a pressure responsive valve responds to that pressure how ever it is generated事实上流速会增加压力但压力响应系统只对应产
10、生时的压力Pressure responsive or Flow responsive?There is only one valve that can claim to be a flow responsive mechanism只有一种阀门称得上是流量响应阀门BUT但是 Clinical studies have shown it makes no difference临床试验证明并无多大区别 Does that stop doctors pontificatingNot a chance!Flow Hakim designed to react to pressure not flow
11、Hakim设计反映的是压力而非流量 He wanted a pressure/flow curve that was a straight line他希望的压力/流量曲线是一条直线 This was an idea behind his original design这是设计者的初衷 Improved upon with the Precision随着精确性而不断提高 The achievement of his goal is confirmed by the UK MDA report这一结果得到了英国MDA的认证Artefact Metal in the valve will show
12、on a scan MRI or CT 阀门的金属会在CT或MRI有伪影 The artefact is not usually in the area to be studied但通常并不影响研究“But it has metal in it!”Yes,thats because we find it gives better and more predictable performance in the long term金属能保证长期的稳定性和可预见性 Silicone can calcify-52%underdrainage?!硅橡胶会钙化导致52引流不够Programmability
13、可调性 Shunt registry tells us 55%revisions are pressure related注册证上显示的是55的翻修率 Patients needs change患者需要调整压力 Shunt misbehaves Hakim Programmable has 18 pressure Hakim可调压阀共有18级调压范围 From 30mm to 200mm H2O 从30mm水柱到200mm水柱ProgrammingCombining high quality bio-compatible materials with expertise in micro-ma
14、chining and micro-assembly.高质量的生物相容性材料与专业的显微 制造技术的完美结合Hakim programmableProgramming the valveThe programmer head emits a series of magnetic pulses that control the angular position of the valve rotor调压器发出的一系列磁脉冲控制转轴的角度This allows the valve opening pressure to be adjusted non-invasively保证无侵袭地调整开放压力12
15、How does it work?Rotor转子Magnet磁铁valve base plateStator固定片rotor axis转轴 10 magnets are integrated in the rotor转子中共有10个磁极 a cross shaped stator is integrated in the base plate十字形固定片固定在底座上 this system constitutes a stepping motor,that can be activated by an external magnetic field系统还包含一个步进马达,可被外部磁场激活Val
16、ve positioning for easy programmingValve programmingProgrammingProgrammingProgrammingProgramming steps Taking the radiological pictureCheck X-RayProgrammabilityCatheters Ventricular catheter脑室导管Catheters Distal catheters远端导管Shunts-components Ventricular catheter脑室导管 Valve阀门 Peritoneal cathete腹膜导管 Ac
17、cessories附件Shunt implantationVentricular catheter connection脑室导管连接Introducing distal catheter引导远端导管Ventricular catheters:Standard标准 Dotted点列式Right angle右角型Right angle with reservoir带储液囊右角型with spring带弹簧型“flanged”凸缘式Shunt reservoirsRickham reservoirSalomon reservoirOther ACCU-FLO reservoirsPre-chambe
18、r functions1.Aspirate and sample of CSF脑脊液取样2.Flushing obstructed ventricular catheter冲洗堵塞的脑室导管3.Flushing obstructed valve冲洗堵塞的阀门Shunt implantationValves accessories-distal catheters passers附件远端导管引导器Reusable DisposableSystem componentsAtrialCatheters心室导管System components系统组成A system is complete Vent
19、ricular catheter with connector and stylet带连接器和穿刺针的脑室导管 Valve阀门 Distal catheter远端导管 Introducer导引器 Instructions说明书Systems Standard valve标准阀门 Unitised standard valve合成标准阀门 Unitised MicroValve合成微型阀门 Unitised MicroValve with Rickham 带Rickham储液囊的合成微型阀门 Standard valve only单独的标准阀门 MicroValve valve only单独的微
20、型阀门 MicroValve with Rickham valve only单独的带Rickham储液囊的微型阀门Pressures available Very Low 10mm Low40mm Medium70mm Medium high100mm High130mm Programmable 30mm to 200mmAll measured in mm H2O所有压力都以水柱表示Thats the Original valveand the MicroValve那就是初始阀门和显微阀门New Hakim Product shapes新的Hakim产品形式New Valve Housin
21、gs新的阀门构架新的阀门构架 New housing design新颖的结构设计 -In line -Burr hole Self sealing reservoir自封性储液囊 Pumping Chamber泵 Swiss technology瑞士技术2 New ShapesRight angle/Burr holeIn-Line2 New FormatsRight angle/Burr holewith integratedSiphonGuardIn-LineRight Angle/Burr HolePrecision/ProgrammableNew Marketing Support P
22、ackageNew Detail Aid in 3 LanguagesClinical ProofPaperPatientsAgesDatePublicationRomner583Prem 891999NeurofocusYamashita1793 days 881999J.NeurosurgeryRohde605 days141998Acta NeurochurgicaCarmel3771999NeurofocusBlack131994NeurosurgeryReinprecht907 weeks851995Acta NeurochurgicaBelliard501996Neurochiru
23、rgieClinical Proof For the best patient management of hydrocephalus,the ability to re-programme the valve pressure has been found to significantly benefit patientsClinical Proof The Codman Hakim Programmable valve is suitable for all age groups of patients with hydrocephalus.Codman Hakim可调压式分流管适用于所有
24、年龄范围的脑积水患者Clinical Proof临床验证 The Codman Hakim Programmable valve is particularly effective in the management of Hydrocephalus in cases of:Codman Hakim 分流管能有效治疗下列各类型脑积水Idiopathic NPH 先天性先天性NPHSlit ventricle syndrome 脑室狭小综合症脑室狭小综合症Aqueductal stenosis 中导水管狭窄症中导水管狭窄症Myelomeningocele 脊髓脊膜突出症脊髓脊膜突出症DandyW
25、alker cysts DandyWalker囊肿囊肿 Meningitis 脑膜炎脑膜炎Clinical Proof Published clinical studies have demonstrated that incremental pressure changes as fine as 10 mm H2O are essential for best patient outcome有临床研究报道精确至10mm 水柱的压力调整最适宜患者康复Clinical ProofThe Codman Hakim Programmable valve saves time and money,compared to fixed pressure valve systems.Codman Hakim的可调式分流管相比那些固定压力的阀门系统要更节省精力和费用