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1、Codman Valves for Hydrocephalus,The Hakim Valve mechanism,Technology developed to provide long-term accuracy and reliability in valve performance.Hakim閥能保持長期的精確性和穩(wěn)定性,Original Valve最初的閥門,Long valve sometimes a “pain i
2、n the neck”,MicroValve顯微閥門,MicroValve + Rickham,Hakim shunt housing development,Hakim Valves,Hakim Valve,Is available asValve only單一閥門System (with separate catheters) 系統(tǒng)(帶單獨(dú)的導(dǎo)管)Unitised system合成系統(tǒng)Valve with p
3、re-attached distal catheter and separate ventricular catheter帶預(yù)置裝置的遠(yuǎn)端導(dǎo)管與閥門,以及獨(dú)立的腦室導(dǎo)管,Hakim Valve,Lets talk about the valve mechanism 讓我們討論閥門機(jī)械裝置,MicroValve顯微閥門,MicroValve顯微閥門,Ruby ball and collar紅寶石球Flat spring彈簧片
4、Spring pillar彈簧柱Micro adjustable fulcrum顯微調(diào)節(jié)支點(diǎn),Hakim precision,Flow through design,MicroValve,Anti reflux valve防逆流閥,Pre-chamber前腔,To stop reverse flow防止倒流,Injection inSampling outPumping注射取樣泵,Hakim valve construc
5、tion,Anti reflux mechanism防逆流裝置,No longer required不再需要,Reflux pressure presses the ball down onto the collar – closing the valve逆流壓力將球壓入軸環(huán)-關(guān)閉閥門,,,MicroValve微型閥門,Accurate to +/- 1mm H2O 精確度+/-1mm水柱Quoted and indep
6、endently verified to +/-10mm H2OFlat pressure / flow curve水平壓力/流量曲線,Pressure definition壓力定義,,,,,,,,,,,,,,,,area,atmospheric pressure大氣壓力,,,h,,,Flow definition流量定義,? p,,Flow in a shunt is controlled by the pressure di
7、fferential分流管內(nèi)的流量是由壓力差控制的,,,,,,,,?p,Opening pressures (mm H20),,,,,,,,,,,,,,,0,50,100,150,200,250,HAKIMPrecisionValve,CORDISHAKIM,P-SMEDICAL,P-SMEDICAL,P-SMEDICAL,Opening pressures開放壓力,Opening pressures開放壓力,Mean
8、s what it saysSo a wide band means you are not sure at what pressure that valve will open給定的是一壓力范圍意味著你不能確定閥門究竟在哪個壓力下開放Customers feel it is an operating band顧客感覺是一壓力帶But there is no top and bottom沒有上下限Only a bottom只有基
9、線This helps customers know what they are implanting - if performance is reliable,Opening pressures,MaybeBut the thrust of our argument is that they should think about it more爭論的焦點(diǎn)將是醫(yī)生必須考慮更多Their decisions affect the q
10、uality of the whole of a child’s life醫(yī)生的決定影響一個孩子一生的生命質(zhì)量Is a 50% revision rate good enough? 50%的翻修率夠好嗎?Next logical step in this argument is Programmability下一個討論焦點(diǎn)是閥門的可調(diào)性,Opening pressures (mm H20),,,,,,,,,,,,,,,0,50
11、,100,150,200,250,HAKIMPrecisionValve,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 mech
12、anism is superior to the other.我們的競爭對手常誤導(dǎo)醫(yī)生,為了證明其閥門優(yōu)于其它“Ah but yours is not a flow responsive system” “他們不是流量響應(yīng)系統(tǒng)”The truth is a little more simple,Pressure responsive or Flow responsive?,Flow occurs when there
13、is a pressure differential當(dāng)有壓力差時才會產(chǎn)生液體流動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事實(shí)上流速會增加壓力-但壓力響應(yīng)系統(tǒng)只對應(yīng)產(chǎn)生時的壓力,Pressure responsi
14、ve or Flow responsive?,There is only one valve that can claim to be a flow responsive mechanism只有一種閥門稱得上是流量響應(yīng)閥門BUT但是Clinical studies have shown it makes no difference臨床試驗(yàn)證明并無多大區(qū)別Does that stop doctors pontificatingN
15、ot a chance!,Flow,Hakim designed to react to pressure not flow Hakim設(shè)計反映的是壓力而非流量He wanted a pressure / flow curve that was a straight line他希望的壓力/流量曲線是一條直線This was an idea behind his original design這是設(shè)計者的初衷 Improved
16、upon with the Precision隨著精確性而不斷提高The achievement of his goal is confirmed by the UK MDA report這一結(jié)果得到了英國MDA的認(rèn)證,Artefact,Metal in the valve will show on a scanMRI or CT 閥門的金屬會在CT或MRI有偽影The artefact is not usually
17、in the area to be studied但通常并不影響研究“But it has metal in it!”Yes, that’s because we find it gives better and more predictable performance in the long term金屬能保證長期的穩(wěn)定性和可預(yù)見性Silicone can calcify - 52% underdrainage?!硅橡膠會鈣化-
18、導(dǎo)致52%引流不夠,Programmability可調(diào)性,Shunt registry tells us 55% revisions are pressure related注冊證上顯示的是55%的翻修率Patients needs change患者需要調(diào)整壓力Shunt misbehavesHakim Programmable has 18 pressure Hakim可調(diào)壓閥共有18級調(diào)壓范圍From 30mm to 2
19、00mm H2O 從30mm水柱到200mm水柱,Programming,Combining high quality bio-compatible materials with expertise in micro-machining and micro-assembly.高質(zhì)量的生物相容性材料與專業(yè)的顯微 制造技術(shù)的完美結(jié)合,Hakim programmable,Programming the valve,The pr
20、ogrammer head emits a series of magnetic pulses that control the angular position of the valve rotor調(diào)壓器發(fā)出的一系列磁脈沖控制轉(zhuǎn)軸的角度This allows the valve opening pressure to be adjusted non-invasively保證無侵襲地調(diào)整開放壓力,1,2,How does it wor
21、k ?,Rotor轉(zhuǎn)子,Magnet磁鐵,valve base plate,Stator固定片,rotor axis轉(zhuǎn)軸,10 magnets are integrated in the rotor轉(zhuǎn)子中共有10個磁極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, t
22、hat can be activated by an external magnetic field系統(tǒng)還包含一個步進(jìn)馬達(dá),可被外部磁場激活,,,,Valve positioning for easy programming,Valve programming,Programming,Programming,Programming,Programming steps,Taking the radiological picture,,,C
23、heck X-Ray,Programmability,Catheters,Ventricular catheter腦室導(dǎo)管,Catheters,Distal catheters遠(yuǎn)端導(dǎo)管,Shunts - components,Ventricular catheter腦室導(dǎo)管Valve閥門Peritoneal cathete腹膜導(dǎo)管Accessories附件,Shunt implantation,Ventricular cathet
24、er connection腦室導(dǎo)管連接Introducing distal catheter引導(dǎo)遠(yuǎn)端導(dǎo)管,Ventricular catheters:,Standard標(biāo)準(zhǔn),Dotted點(diǎn)列式,Right angle右角型,Right angle with reservoir帶儲液囊右角型,with spring帶彈簧型,“flanged”凸緣式,Shunt reservoirs,Rickham reservoirSalomo
25、n reservoir,Other ACCU-FLO reservoirs,Pre-chamber functions,1. Aspirate and sample of CSF腦脊液取樣,2. Flushing obstructed ventricular catheter沖洗堵塞的腦室導(dǎo)管,3. Flushing obstructed valve沖洗堵塞的閥門,Shunt implantation,Valves accessor
26、ies - distal catheters passers附件-遠(yuǎn)端導(dǎo)管引導(dǎo)器,Reusable,Disposable,System components,AtrialCatheters心室導(dǎo)管,System components系統(tǒng)組成,A system is completeVentricular catheter with connector and stylet帶連接器和穿刺針的腦室導(dǎo)管Valve閥門Distal
27、 catheter遠(yuǎn)端導(dǎo)管Introducer導(dǎo)引器Instructions說明書,Systems,Standard valve標(biāo)準(zhǔn)閥門Unitised standard valve合成標(biāo)準(zhǔn)閥門Unitised MicroValve合成微型閥門Unitised MicroValve with Rickham 帶Rickham儲液囊的合成微型閥門Standard valve only單獨(dú)的標(biāo)準(zhǔn)閥門MicroValve val
28、ve only單獨(dú)的微型閥門MicroValve with Rickham valve only單獨(dú)的帶Rickham儲液囊的微型閥門,Pressures available,Very Low 10mmLow40mmMedium70mmMedium high100mmHigh130mmProgrammable30mm to 200mmAll measured in mm
29、 H2O所有壓力都以水柱表示,That’s the Original valveand the MicroValve那就是初始閥門和顯微閥門,New Hakim Product shapes新的Hakim產(chǎn)品形式,New Valve Housings新的閥門構(gòu)架,New housing design新穎的結(jié)構(gòu)設(shè)計 - In line -
30、 Burr holeSelf sealing reservoir自封性儲液囊Pumping Chamber泵Swiss technology瑞士技術(shù),,2 New Shapes,Right angle / Burr hole,In-Line,,2 New Formats,Right angle / Burr holewith integratedSiphonGuard,In-Line,Right Angle / Burr H
31、ole,Precision / Programmable,New Marketing Support Package,New Detail Aid in 3 Languages,Clinical Proof,PaperPatientsAgesDatePublicationRomner583Prem – 891999NeurofocusYamashita1793 days – 881999J. Neu
32、rosurgeryRohde605 days–141998Acta NeurochurgicaCarmel3771999NeurofocusBlack131994NeurosurgeryReinprecht907 weeks–851995Acta NeurochurgicaBelliard501996Neurochirurgie,Clinical Proof,Fo
33、r 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 g
34、roups of patients with hydrocephalus.Codman Hakim可調(diào)壓式分流管適用于所有年齡范圍的腦積水患者,Clinical Proof臨床驗(yàn)證,The Codman Hakim Programmable valve is particularly effective in the management of Hydrocephalus in cases of: Codman Hak
35、im 分流管能有效治療下列各類型腦積水,Idiopathic NPH 先天性NPHSlit ventricle syndrome 腦室狹小綜合癥Aqueductal stenosis 中導(dǎo)水管狹窄癥Myelomeningocele 脊髓脊膜突出癥Dandy–Walker cysts Dandy–Walker囊腫 Meningitis 腦膜炎,Clinical Proof,Published cli
36、nical studies have demonstrated that incremental pressure changes as fine as 10 mm H2O are essential for best patient outcome有臨床研究報道精確至10mm 水柱的壓力調(diào)整最適宜患者康復(fù),Clinical Proof,The Codman Hakim Programmable valve saves time a
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