Neurosurgery Image of valves Strata™ Valve The Adjustable Delta ® Valve.

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Neurosurgery Image of valves Strata™ Valve The Adjustable Delta ® Valve

Transcript of Neurosurgery Image of valves Strata™ Valve The Adjustable Delta ® Valve.

Page 1: Neurosurgery Image of valves Strata™ Valve The Adjustable Delta ® Valve.

Neurosurgery

Image of valves

Strata™ ValveThe Adjustable Delta® Valve

Page 2: Neurosurgery Image of valves Strata™ Valve The Adjustable Delta ® Valve.

Neurosurgery

RegularSmall

• 體外調節控制閥的壓力

• 無需反覆更換閥門,減少手術費用

• 避免二次手術創傷

• 抗虹吸閥一體化設計,同時解決虹吸現象和壓力分級

Strata Valve

42866 42856

Page 3: Neurosurgery Image of valves Strata™ Valve The Adjustable Delta ® Valve.

Neurosurgery

Strata ValveCutaway of Regular Valve

Delta Chamber

Reservoir

Valve Mechanism

Proximal Occluder

Inlet Connector

Outlet Connector

Distal Occluder

Polypropylene Base

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Neurosurgery

紅寶石圓錐

流體壓力彈簧

磁性轉軸

性能级别

轉軸定位彈簧

轉軸鎖定彈簧設計,

降低閥門受外界磁場干擾機會

不對稱齒和特殊底盤設計將外磁場影響減小到最小程度

Strata Valve MechanismHow it works...

Page 5: Neurosurgery Image of valves Strata™ Valve The Adjustable Delta ® Valve.

Neurosurgery

Strata Valve Performance CharacteristicsFive Performance Levels

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Neurosurgery

Strata ValveAdjustment Tools

Locator Tool Adjustment ToolIndicator Tool

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Neurosurgery

輕鬆四步體外調壓 :

1. Locator Tool 底座定位2. Indicator Tool 指示盤讀數3. Adjustment Tool 磁性轉盤調壓4. Indicator Tool 指示盤確認結果

體外調壓工具,多重確認壓力,確保安全

Strata ValveAdjustment Tools

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Neurosurgery

Strata ValveValve Adjustment Reliability

X-ray Hand tool

0.5 1.0

1.0 0.5

1.5 0.5

2.0 2.5

•All initial valve settings were confirmed by X-ray

•All post-operative adjustments were confirmed by X-ray

•238 valve adjustments

•4 instances where the x-ray did not match patient chart

98% ACCURACY RATE

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Neurosurgery

Codman Programmable Hakim Valve FDA Study

•377 Patients

–235 First Insertion

–142 Revisions

•540 total valve adjustments.

•118 discrepancies between x-rays and patient charts.

Error Rate of 22%

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Neurosurgery

Image of X-Ray

0.5 1.0 1.5 2.0 2.5

Dot Code

Magnet

根據磁性轉軸相對於編碼的方向用 X-Ray確認壓力級別

Strata ValveX-Ray

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Neurosurgery

Strata NSC ValvePressure/Flow Ranges

Performance Level Old Description

Performance Level 0.5 Low-Low Pressure

Performance Level 1.0 Low Pressure

Performance Level 1.5 Medium Pressure

Performance Level 2.0 High Pressure

Performance Level 2.5 New higher pressure to match the upper Hakim valve range.

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Neurosurgery

競爭對手

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Neurosurgery

Integra NeuroCareNovus Valve

Hydrodynamic Leverage 8:1 槓桿14 cm H20 > 10 cm H20 Under drainage 引流不足

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Neurosurgery

Impact of Hydrodynamic Leverage

• The hydrodynamic leverage ratio determines the amount of added resistance the anti-siphon mechanism will contribute in the upright position.

• To determine this added resistance, the negative hydrostatic column is divided by the leverage ratio to determine the added resistance.

Example: Hydrodynamic Leverage: 8:1

Negative Hydrostatic Column: 48cm H2O

Additional Shunt Resistance: 48/8 = 6 cm H2O

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Neurosurgery

Codman SiphonGuard DeviceSiphonGuard(Flow Restrictor)

Secondary Flow

Primary Flow

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Neurosurgery

Codman SiphonGuardFacts

• The siphon guard is merely a flow restrictor. A ball in the center of the device diverts fluid through a tortuous circumferential flow path, when the patient is upright.

• 當病人站立時其圓球會阻塞住主通道 ,CSF由側細支流流通 ,其機械原理是限制其流速。

• The small flow path is highly susceptible to occlusion.• 因其側細支流通道極小 ,阻塞機率極高。• The product was recalled in 2001, reportedly due to

performance issues.• 產品曾於 2001年被原廠招回 ,主要是因 CSF引流問題。