NebShair Final Presentation

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    NebShair

    D-Lab Health Spring 2010 Presents

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    Problem Statement Design Focus Background

    Design SpecificationsExisting Technologies

    NebShairDesign OverviewPatient InterfaceDosage MonitoringGas Regulation

    Initial ValidationVapor SensorPressure Regulation

    EvaluationDesign issuesCost/ManufacturingImpactRegulatory PathwayMoving Forward

    Presentation Overview

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    Current problemsSingle userNo way of monitoring amount of drug deliveredPatient interface leads to high drug waste

    Problem Statement

    High incidence of respiratoryinfections in developing world

    -Asthma is the most chronic diseaseaffecting children (WHO)

    In Nicaragua, there is a largedemand for jet nebulizers amongst

    children-Long lines and waits for use of machine

    (30-40 people) for one machine

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    Multi-patient

    Dosage Monitoring

    Design Focus

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    Minimum pressure for correct size particles15 psi to 50 psi (better the more expensive)

    Ensures Standard Dosage0.5 mL albuterol + 3 mL salean

    Easily cleaned ModularAffordable Efficient

    Background

    Design Specifications/Parameters

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    Existing Technologies Jet Nebulizers

    Preferred method, especially for infantsand children

    Vaporizes medicine using compressed air

    Not breath-actuated

    drug loss andpoor dosage monitoring

    Vibrating Mesh 2 sieves vibrating at high frequencies to

    vaporize and deposit medicine Breath-actuated State-of-the-art technology, difficult to

    duplicate, and expensive

    Ultrasound Ultrasonic waves break the medicine into

    smaller vapors Shown to physically disintegrate the

    medicine

    Background

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    NebShair

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    Patient Interface Dosage Monitor Pressure

    Regulation

    NebShair Design Overview

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    Multiuser system Reservoir

    With multiple tubes leading to each patient Tube with its own one way valve and dosage sensor

    attachment

    Idea initially considering the Ultrasoundnebulizer

    Created too much vapors Wanted to capture those vapors

    Breath-Actuated Spring loaded one-way valve

    Pressure adjusted right above threshold of thereservoir Benefits

    Patient directed Better regulation of dosage No waste when children are not actively using the

    machine

    NebShair Patient Interface

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    Vapor Sensor

    Instrumentation: LED light, photodetector,Arduino

    How it works: LED light sends signals to the photodetector, whichdetectsp the light. The photodetector measures voltage

    drop and that is directly correlated to the amount of light

    falling on its surface.

    More light lower resistance lower voltage Larger drug particles more light scattered less light

    falls on photodetector lower resistance lowervoltage

    Arduino threshold voltage- correlates to passing medicine

    vapors

    Summing of signal over time to alert patient withDosage LED

    NebShair Dosage Monitor

    Dosage light

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    One-way ValveJust below 1.5 psi for

    breath-actuation

    Gas Pressure SensorSenses and triggers

    Solenoid ValveRedirects compressedair when triggered to

    regulate pressure

    NebShair Pressure Regulation

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    Vapor Sensor

    Initial tests Sensitivity of photodetector to

    presence of vapors

    Saturation of tubing withvapors and condensation effectson the LED and photodetector

    Accuracy of the dosagesummation

    NebShair Initial Validation

    Future tests Similar tests, but mimic vapor flows by methods of

    inhalations (instead of using the jet compressor to push

    vapors through)

    Run tests with the one-way valve (condensation)

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    NebShair Initial ValidationPressure Regulation System

    Initial tests Control system calibrated to keep pressure

    steady (~1 psi gauge)

    Tested with standardized one way valves Hardware limitations on pressure

    Future tests Improve hardware to achieve higher pressure Calibrate with many 1-way valves Design custom valve

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    Our two components merging into one systemSimple dimension problem

    Coagulation Sterilization

    Design IssuesEvaluation

    Dosage light

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    Evaluation

    CostPrototype Cost Analysis

    Price Amount Cost

    Tupperware $10/part 1 part $10

    LED $1/part 8 parts $8

    Photoresistor $1.5/part 4 parts $6

    Wire $0.39/ft 6 ft $2.34

    Arduino $29/part 1 part $29

    Breadboard $19.95/ 2 parts 2 parts $19.95

    Gas pressure $34.25/part 1 part $34.25Solenoidvalve $8/part 1 part $8

    Tubing $19.99/100ft 10 ft $2.00

    Spring valve $4.00/part 4 parts $16.00

    Total $136

    Final- Mass ManufacturedPrice Amount Cost

    Tupperware $1/part 1 part $1

    LED $.50/part 8 parts $4

    Photoresistor $1/part 4 parts $4

    Wire $0.39/ft 6 ft $2.34

    Gas pressure $10/part 1 part $10.00

    Solenoid

    valve $5/part 1 part $5Tubing $19.99/100ft 10 ft $2.00

    Spring valve $3.00/part 4 parts $12.00

    Total $40

    For cost-efficiency, individual components would be manufacturedin existing infrastructure (outsourced)

    Assembly would be local in-house manufacturing site

    Manufacturing

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    Respiratory disease rampantAsthma- 300 million people worldwide suffer

    The most common chronic disease amongstchildren can be medicated!

    26.20/100,000 Child death rate from respiratorydiseases

    Under-dosed and long waits

    ImpactEvaluation

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    Nebulizer Direct PatientInterface, DeVilBiss

    Compressor/Nebulizer,CAF K970289(4/15/1997)

    DeVilbiss Model 5650K923888

    Jet-nebulizer

    Healthdyne, Inc. 323K922623 (12/1/1992)

    one-way valve and filter

    Regulatory Pathway- 510K and Predicate Devices

    Evaluation

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    Pan American Health Organization (PAHO) international public health agency recognized by the UN serves as regional office for the WHO

    Duties: Medical Device Regulation Program:

    Defines medical device Pre & post market approval Audit manufacturer and distributor Apply pre-market assessment controls Harmonize regulatory requirements

    Regulatory Pathway- Local RegulationEvaluation

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    DesignImprovements

    Low-cost vibratingmesh??

    Evaluation

    Moving Forward