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Lung Model for Inhaler Efficiency Testing

The document describes developing physical models of the human lung to test the delivery efficiency of inhaled pharmaceutical aerosols. It outlines existing lung models and their limitations. The authors designed and built flexible and rigid 3D printed lung models based on geometric properties of real human lungs. They used various visualization techniques to observe particle deposition during inhaler testing and evaluated the new models' ability to better simulate human lung function and airflow compared to existing methods.

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k_vivek07
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335 views43 pages

Lung Model for Inhaler Efficiency Testing

The document describes developing physical models of the human lung to test the delivery efficiency of inhaled pharmaceutical aerosols. It outlines existing lung models and their limitations. The authors designed and built flexible and rigid 3D printed lung models based on geometric properties of real human lungs. They used various visualization techniques to observe particle deposition during inhaler testing and evaluated the new models' ability to better simulate human lung function and airflow compared to existing methods.

Uploaded by

k_vivek07
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd

A Device to Model a Human Lung to

Determine the Delivery Efficiency of Inhaled


Pharmaceutical Aerosols

2004 Mechanical & Industrial Engineering, University of Toronto


 Overview
 Background
 Existing Models
 Developed Models
Flexible Lung Model
Rigid Lung Model
 Testing Methodology
 Model Assessment and Conclusion

2004 Mechanical & Industrial Engineering, University of Toronto


Medication Administration
Medications are administrated by:
 Oral ingestion
 Intravenous Injections
 Respiratory system (Pharmaceutical Inhalers)

2004 Mechanical & Industrial Engineering, University of Toronto


Pharmaceutical Inhalers
Advantages  Quick absorption into the blood stream
 Less medicine for similar therapeutic result
Projection  50% of medication through inhalers
Problem  Less than 20% of inhaled dosage reaches the
lower respiratory system
Need  More efficient pharmaceutical inhalers
 Means of testing pharmaceutical inhalers

2004 Mechanical & Industrial Engineering, University of Toronto


 Inhalers
Pressurized
Metered Breath
Dose Inhaler Activated
(pMDI) Inhaler

Pressurized
Aerosol
Inhaler with
Spacer Nebulizer

Dry Powder
Inhaler (DPI)
 Test Inhaler
 ADVAIR pMDI 120 dose (125 mcg)
 Treats the two main components of asthma, airway constriction
and inflammation
 Each dose contains 25 mcg salmeterol xinafoate and 125 mcg
fluticasone propionate
 Inhalers doped with Rose Bengal Dye for visualization
purposes
 Spectrophotometer
Allows for precise measurements of flow concentration in
all regions of the lung model
Consists of:
 A source that generates electromagnetic radiation
 A dispersion device that selects a particular
wavelength from the broad band radiation of the
source
 A sample area
 A detector to measure the intensity of radiation

2004 Mechanical & Industrial Engineering, University of Toronto


Available Solutions
 Computer / Mathematical Models
 Physical Models
 Twin Impinger
 Cascade Impactor
 Limitations
 Our Goal:
Devise a physical lung model, superior to the existing
models, to test pharmaceutical inhalers

2004 Mechanical & Industrial Engineering, University of Toronto


Lung Properties
Human Respiratory System
Mouth/Nose  Trachea  Bronchioles  Alveoli

Alveoli

2004 Mechanical & Industrial Engineering, University of Toronto


Lung Geometry

• Weibel Model A

– Number of generations, z
– Branch diameter
z
 1
d ( z )  d 0 3  , where  d 0  d trachea
 2

– Branch length
Lung Geometry

 Weibels Model
Z (Branching generation)

N (z) (Number of branches) = 2 Z

d (z) (Branch diameter) = do x 2 –z/3

 23 generations of bronchiole branching

 Average Trachea diameter is 1.8 cm

2004 Mechanical & Industrial Engineering, University of Toronto


Particle Deposition

• Methods and Areas of Particle Deposition

– Impaction
– Sedimentation
– Diffusion
Weibels Model

2004 Mechanical & Industrial Engineering, University of Toronto


Physical Lung Properties
 Average volume of inhaled air is 500cc
 Average pressure difference is 2mm Hg
 Approximation of airflow within the human lung:
 Quiet breathing = 0.4 litres/s
 Mild Exercise = 1.25 – 1.5 litres/s

2004 Mechanical & Industrial Engineering, University of Toronto


 Existing Models
Computer / Mathematical Models
 Not very accurate, based only on mathematical
equations
 No physical data to support the models
 Do not account for the randomness of particle flow and
deposition inside a complex organ like the human lung

Physical Models
 Twin Impinger
 Cascade Impactor

2004 Mechanical & Industrial Engineering, University of Toronto


 Twin Impinger
 Tests the lung penetration
capability of a pressurized
metered dose inhaler
(pMDI)

2004 Mechanical & Industrial Engineering, University of Toronto


 Twin Impinger Apparatus
 Cascade Impactor
 Measures the aerodynamic size distribution and mass
concentration levels of solid particulates and liquid
aerosols
 Cascade Impactor Apparatus
Other Design Concepts

• Medical Tubing Concept


– Positive displacement pump
– Standard medical tubing
– Standard connectors

• Advantage: Ease of separation


• Concern: Flow obstruction at junctions
Existing Solutions
• Computer/Mathematical Models
– Limited to the accuracy of the governing equations
– Requires experimental verification
 Limitations
Twin Impinger
 Only 2 compartments
 Simplified particle flow path
 No flow visualization

Cascade Impactor
 No set path to follow
 No flow visualization

2004 Mechanical & Industrial Engineering, University of Toronto


MUSSL Lung Model Based on
Direct Flow Visualization
• A transparent lung model
• Use particle deposition tracing
– Ink Visualization
– X-ray Scintigraphy using Radiolabeled particles
– Planar Laser Imaging
Design Concepts
• Expanding-Contracting Lung Design
– Machined representation of lung covered with
silicon membrane
– Expanded by external breathing bag
– Difficult to control expansion and contraction
Detailed Design Description

• Drawing of lung
• Machining of lung
• Mouth-trachea induction port
• Ventilator/breathing apparatus
• Tracer dye labeled aerosol
• Filtration and resistance devices
• Testing and Apparatus Setup
Drawing of the Lung

• AutoCAD Representation
– 2-D
– 8 to 9 generations
– Approx. 750 branches
Drawing of Lung
• SolidWorks 2003 Drawing
Drawing Procedure

a) The sketch is projected to offset plane. b) The inter-planes are created.

c) Circles are drawn on the midlines. d) Circles are extruded to planes.


Machining of Lung
• MasterCAM file conversion
Machining of Lung
• Machining of Bronchial Tree
– Completed by Excentrotech Precision Ltd.
– G-code
    generation: MasterCAM
– High-speed 5-axis CNC mill
Machining of Lung
• Machining of Exit Channels
– Completed by MIE Machine Shop
– G-code
    generation: MasterCAM
– 3-axis CNC mill
Final Design
• Machined representation of human lung in
aluminum
Mouth-Trachea Induction Port
• Simulates the filtering effects and geometric
properties of the mouth and throat
• Schematics provided by Nuclear Medicine
Department at McMaster University
Mouth and trachea induction port
development and assembly
 Counter bored for the insertion of the adapter
 Adapter to provide un obstructed/continuous flow
 Not a permanent fit allows switch to the clear mouth/trachea

port

2004 Mechanical & Industrial Engineering, University of Toronto


 Creating the 3-D Model

2004 Mechanical & Industrial Engineering, University of Toronto


 Design Requirements
• Model must transparent to allow for easy flow
visualization to take place

• Model must be able to mimic basic mechanical


proprieties of an average human lung

» Air Volume ( 500 cc )


» Pressure ( 750 mmHg )

2004 Mechanical & Industrial Engineering, University of Toronto


 Construction Overview
3-D Model Creation Stages

1. Construction of the wax model


2. Coating of the model with the flexible
elastomer shell
3. Separation of the model from the cured
flexible shell

2004 Mechanical & Industrial Engineering, University of Toronto


Stage 1

Creating the Wax Model

2004 Mechanical & Industrial Engineering, University of Toronto


Second Attempt:

Heating of the Mold

Plate was heated


above melting Allowed for uniform
temperature of the cooling of wax
wax

2004 Mechanical & Industrial Engineering, University of Toronto


Completed Wax Model

2004 Mechanical & Industrial Engineering, University of Toronto


Mouth/trachea
induction port

Lung model

Outlet port

Stand

2004 Mechanical & Industrial Engineering, University of Toronto


Hollow, flexible cast of a
human lung
According to a procedure developed at North
Carolina State University

– Silicon or latex hollow cast could be used as a


breathing model
Hollow Cast Model

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