D-Lab Health Spring 2010 Presents…

NebShair  
Ensuring adequate nebulization dosage for
children in Nicaragua  
 Presentation Overview  

•  Problem Statement •  Initial Validation

•  Design Focus –  Vapor Sensor
•  Background –  Pressure Regulation
–  Design Specifications •  Evaluation
–  Existing Technologies –  Design issues
•  NebShair –  Cost/Manufacturing
–  Design Overview –  Impact
–  Patient Interface –  Regulatory Pathway
–  Dosage Monitoring –  Moving Forward
–  Gas Regulation
 Problem Statement  
Current problems
–  Single user
–  No way of monitoring amount of drug delivered
–  Patient interface leads to high drug waste
•  High incidence of respiratory
infections in developing world
-Asthma is the most chronic disease
affecting children (WHO)
•  In Nicaragua, there is a large
demand for jet nebulizers amongst
children
-Long lines and waits for use of machine
(30-40 people) for one machine
 Design Focus  

Multi-patient

Dosage Monitoring
 Background  
Design Specifications/Parameters
•  Minimum pressure for correct size particles
–  15 psi to 50 psi (better the more expensive)
•  Ensures Standard Dosage
–  0.5 mL albuterol + 3 mL salean
•  Easily cleaned
•  Modular
•  Affordable
•  Efficient
 Background
Existing Technologies
•  Jet Nebulizers
–  Preferred method, especially for infants
and children
–  Vaporizes medicine using compressed air
–  Not breath-actuated drug loss and
poor 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
NebShair  
NebShair Design Overview  

•  Patient Interface

•  Dosage Monitor

•  Pressure
Regulation
 NebShair Patient Interface  
•  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 Ultrasound
nebulizer
•  Created too much vapors
•  Wanted to capture those vapors
•  Breath-Actuated
–  Spring loaded one-way valve
•  Pressure adjusted right above threshold of the
reservoir
–  Benefits
•  Patient directed
•  Better regulation of dosage
•  No waste when children are not actively using the
machine
NebShair Dosage Monitor  

Vapor Sensor
•  Instrumentation: LED light, photodetector,
Arduino Dosage light

•  How it works:
–  LED light sends signals to the photodetector, which
detectsp 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  lower
voltage
–  Arduino
•  threshold voltage- correlates to passing medicine
vapors
•  Summing of signal over time to alert patient with
Dosage LED
NebShair Pressure Regulation  

•  One-way Valve
–  Just below 1.5 psi for
breath-actuation
•  Gas Pressure Sensor
–  Senses and triggers
•  Solenoid Valve
–  Redirects compressed
air when triggered to
regulate pressure
NebShair Initial Validation

Vapor Sensor
•  Initial tests
–  Sensitivity of photodetector to
presence of vapors
–  Saturation of tubing with
vapors and condensation effects
on the LED and photodetector
–  Accuracy of the dosage
summation

•  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)
NebShair Initial Validation

Pressure 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
 Evaluation

Design Issues  
•  Our two components merging into one system
–  Simple dimension problem
•  Coagulation
•  Sterilization
Dosage light
 Evaluation
Cost
Prototype Cost Analysis Final- Mass Manufactured
Price Amount Cost Price Amount Cost
Tupperware $10/part 1 part $10 Tupperware $1/part 1 part $1
LED $1/part 8 parts $8 LED $.50/part 8 parts $4
Photoresistor $1.5/part 4 parts $6 Photoresistor $1/part 4 parts $4
Wire $0.39/ft 6 ft $2.34 Wire $0.39/ft 6 ft $2.34
Arduino $29/part 1 part $29 Gas pressure $10/part 1 part $10.00
Breadboard $19.95/ 2 parts 2 parts $19.95 Solenoid
Gas pressure $34.25/part 1 part $34.25 valve $5/part 1 part $5
Solenoid Tubing $19.99/100ft 10 ft $2.00
valve $8/part 1 part $8 Spring valve $3.00/part 4 parts $12.00
Tubing $19.99/100ft 10 ft $2.00 Total $40
Spring valve $4.00/part 4 parts $16.00
Total $136

Manufacturing
• For cost-efficiency, individual components would be manufactured
in existing infrastructure (outsourced)
•  Assembly would be local in-house manufacturing site
 Evaluation

Impact  
•  Respiratory disease rampant
–  Asthma- 300 million people worldwide suffer
–  The most common chronic disease amongst
children– can be medicated!
–  26.20/100,000 Child death rate from respiratory
diseases
•  Under-dosed and long waits
 Evaluation
Regulatory Pathway- 510K and Predicate Devices

Nebulizer Direct Patient

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

DeVilbiss Model 5650 Healthdyne, Inc. 323

K923888 K922623 (12/1/1992)
Jet-nebulizer one-way valve and filter
 Evaluation

Regulatory Pathway- Local Regulation  

•  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
 Evaluation  
Moving Forward

•  Design
Improvements
•  Low-cost vibrating
mesh??