1、Codman Valves for Hydrocephalus,The Hakim Valve mechanism,Technology 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 + Rickham,Hakim shunt housing development,Haki
2、m Valves,Hakim Valve,Is available asValve 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,R
3、uby ball and collar红宝石球Flat spring弹簧片Spring pillar弹簧柱Micro adjustable fulcrum显微调节支点,Hakim precision,Flow through design,MicroValve,Anti 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 construction,Anti reflux mechanism防逆流装置,No longer required不
4、再需要,Reflux pressure presses the ball down onto the collar closing the valve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 H2OFlat pressure / flow curve水平压力/流量曲线,Pressure definition压力定义,area,atmospheric pressure大气压力,h,Flow definition流量定义,
5、 p,Flow in a shunt is controlled by the pressure differential分流管内的流量是由压力差控制的,p,Opening pressures (mm H20),0,50,100,150,200,250,HAKIMPrecisionValve,CORDISHAKIM,P-SMEDICAL,P-SMEDICAL,P-SMEDICAL,Opening pressures开放压力,Opening pressures开放压力,Means what it saysSo a wide band means you are not sure at what
6、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,MaybeBut the thrust of our argument is that t
7、hey 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),0,50,100,150,200,250,HAKIMPrecis
8、ionValve,CORDISHAKIM,P-SMEDICAL,P-SMEDICAL,P-SMEDICAL,HOLTER,Opening pressures,Pressure 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” “他们不是流量响应系统”T
9、he truth is a little more simple,Pressure 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生时的压力,Press
10、ure 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 Hakim设计反映的
11、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 on a scanM
12、RI 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可调性,Shun
13、t 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 misbehavesHakim 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,Programming,Combining high quality bio-compatible materials with expertise in micro-machining a
14、nd 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 programmable,Programming the valve,The 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,1,2,How
15、 does it work ?,Rotor转子,Magnet磁铁,valve base plate,Stator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
16、,Valve positioning for easy programming,Valve programming,Programming,Programming,Programming,Programming steps,Taking the radiological picture,Check X-Ray,Programmability,Catheters,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
17、cathete腹膜导管Accessories附件,Shunt implantation,Ventricular 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 reservoirs,Rickham reservoirSalomon reservoir,Other ACCU-
18、FLO reservoirs,Pre-chamber functions,1. 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 implantation,Valves accessories - distal catheters passers附件远端导管引导器,Reusable,Disposable,System components,AtrialCatheters心室导管,System
19、components系统组成,A system is completeVentricular 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
20、独的标准阀门MicroValve valve only单独的微型阀门MicroValve with Rickham valve only单独的带Rickham储液囊的微型阀门,Pressures available,Very Low 10mmLow40mmMedium70mmMedium high100mmHigh130mmProgrammable30mm 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
21、新的Hakim产品形式,New Valve Housings新的阀门构架,New housing design新颖的结构设计 - In line - Burr holeSelf sealing reservoir自封性储液囊Pumping Chamber泵Swiss technology瑞士技术,2 New Shapes,Right angle / Burr hole,In-Line,2 New Formats,Right angle / Burr holewith integratedSiphonGuard,In-Line,Right Angle / Burr Hole,Precision
22、/ Programmable,New Marketing Support Package,New Detail Aid in 3 Languages,Clinical Proof,PaperPatientsAgesDatePublicationRomner583Prem 891999NeurofocusYamashita1793 days 881999J. NeurosurgeryRohde605 days141998Acta NeurochurgicaCarmel3771999NeurofocusBlack131994NeurosurgeryReinprecht907 weeks851995
23、Acta NeurochurgicaBelliard501996Neurochirurgie,Clinical Proof,For the best patient management of hydrocephalus, the ability to re-programme the valve pressure has been found to significantly benefit patients,Clinical Proof,The Codman Hakim Programmable valve is suitable for all age groups of patient
24、s with hydrocephalus.Codman Hakim可调压式分流管适用于所有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NPHSlit ventricle syndrome 脑室狭小综合症Aqueductal stenosis 中导水管狭窄症Myelom
25、eningocele 脊髓脊膜突出症DandyWalker cysts DandyWalker囊肿 Meningitis 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 Proof,The 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,
