This is the final presentation for the PEI AI four-year design project.

1. Detailed Design
PEI Anesthesia Innovations
K. Abrey, V. Keefe, E. O’Rielly, K. Waugh
April 5th, 2024

2. Table of Contents
01
04
02
03
05
Introduction
Project Execution
Detailed Design
Prototyping & Testing
Implementation
06
07
Recommendations
Conclusion

3. Introduction
01
➔ Project Background
➔ Project Status
➔ Project Management Update

4. Project Background
Project Goal:
Design an ETT cuff that measures the
pressure applied to the trachea during
intubation to verify proper sealing.
Purpose:
Measuring the pressure applied to the
trachea by the cuff will prevent injuries
and illness caused by under/over
inflation of the cuff including sores in the
trachea, pneumonia, and sepsis.

5. Project Status
● Implementation of a piezoelectric sensor that
measured the resulting voltage that changes with the
applied interface pressure
● The replica trachea held force sensing resistors (FSRs)
which measured the resistance caused by the cuff’s
inflation and contact.
● With correlation of the intracuff pressure to the applied
force, this data can be used to ensure airway
management and reducing the risk of complications.
Overview

6. Justification
Project Status
Meeting Requirements
● Testing using a 9mm tube
inflated to between 20-30
cmH2O
● Multiple tests conducted
to ensure inflation and
deflation within 30
seconds
● Responses observed
using Arduino &
corresponding acquired
data analyzed & displayed
● Future recommendations
will result in full
compliance
Req
ID
Requirement Description
Verification
Method
Status
1
Seal must be created between trachea wall & cuff
surface.
Test
Future
Recommendations
2 Improve measurement efficiency by at least 30%
Test Future
Recommendations
Analysis
3 Cuff can be inflated within 30 seconds by a single user
Test
Compliant
4 Cuff can be deflated within 30 seconds by a single user Compliant
5 Maintain intracuff pressure between 20-30 cmH2O
Test Future
Recommendations
Analysis
6 Sampling time for data acquisition of 2 seconds
Test Future
Recommendations
Analysis
7 Consider ETTs of 6-9mm internal diameter Inspection Compliant
8 Adhere to applicable standards and regulations.
Inspection
In Progress
Analysis
9
The cuff material must not be thicker than 50um
(0.05mm)
Test In Progress
Current Status: 33% Compliance

7. Project Management Update
Schedule
Estimated Hours of Work: 1305 hours
HR Budget with Buffer: $158,000
Prototyping Budget: Functional prototype max. $1,000
Development budget max. $5,000
Total spent: $2,423.35
Budget
Name Count Cost
1.5" PVC Tubing (Artificial Trachea) 1 $0.00
9mm Shiley Circular Cuffed ETT 1 $0.00
Silicone RTV 4500 Sealant 1 $22.57
Element Piezo Film Sensor (DT2-
028K) 1 $35.66
Force-Sensing Resistor 400 Short 4 $65.50
Breadboard Solderless PCB Board 3 $15.63
Arduino Mega 2560 1 $93.38
USB Data Sync Cable for Arduino 1 $11.49
Total 13 $244.23

8. Risks & Management
Risks
6
17
Risks
Occurred
& Have
Been
Mitigated
12
17
* Low Risks
Specifics of these occurrences and
mitigation tactics will be found in
the Detailed Design Report
Technical Risks Compliance Risks
Connection errors (i.e. data inconsistencies or
corruption).
Failure to meet industry standards (i.e. research & medical
devices).
Measurements are not acquired from the components. Safety Risks
Acquired data is incomplete, insufficient, or noisy. * Failure to comply with safety regulations and prevent hazards.
* Calibration errors. * Electrocution while using components.
* Component failure or material deficiency. * Fume inhalation while soldering components.
* Misinterpretation of results. Schedule Risks
* Failure to meet evaluation criteria. * Readiness of all components.
Environment Risks * Required phases are incomplete or insufficient.
* Effect of ambient room conditions on measured values. * Process/procedure deviations.
* Environment availability. Cost Risks
* Procurement cost for development exceeds budget.

9. Project Execution
02
➔ Requirements Definition
➔ Conceptual Design
➔ Preliminary Design
➔ Detailed Design

10. Requirements Definition
Req
ID
Requirement Description
Verificatio
n Method
Statu
s
1
Seal must be created between artificial trachea wall & cuff
surface.
2 Improve pressure measurement efficiency by at least 30%
3 Cuff can be inflated within 30 seconds by a single user
4 Cuff can be deflated within 30 seconds by a single user
5 Maintain intracuff pressure between 1.96-2.94 kPa
6 Sampling time for data acquisition of 2 seconds
7 Consider ETTs of 6-9mm internal diameter
8
Adhere to standards & regulations associated with FSDE
Design Clinic Projects.
9
Cuff material must not exceed 50um (0.05mm) thick when
ready for market.
Colour Legend
Verification
Method
Status
Analysis In Progress
Inspection Compliant
Demonstration Non-Compliant
Test

11. Conceptual Design - Overview
Select the most feasible &
effective conceptual design(s)
for the ETT prototype.
Practical & technical
requirements, including safety,
inflation accuracy, seal
creation, data resolution, cost-
effectiveness, convenience, &
durability.
Mechanical, Bioimpendance,
Piezoresistive & Piezoelectric
approaches.
Piezoresistive & Piezoelectric.
Objective(s)
Criteria
Methodology
Utilized a House of Quality to
bridge requirements & solution
functions, & decision matrix to
compare the feasibility &
quality of each design.
Utilize FSRs for high sensitivity,
precision, biocompatibility, &
ease of integration. Employ
PVDF film known for flexibility,
biocompatibility, chemical
inertness, & high sensitivity to
applied force.
Investigated Concepts
Chosen Concepts
Summary
FSR
Air input
Power
line
Ground
line
Air supply
line
Applied
force
PVDF

12. Preliminary Design - Overview
Exclusions: Biodegradable
plastics, animal size variations,
location detection, & operating
room display interface. This
project will not conduct live
testing.
Procurement has been
submitted, totalling $605.60.
Prototype Budget: up to
$1,000.00. Development Budget:
up to $5,000.00
Class IIa medical device
compliance. Incorporate ISO
standards & regulations.
Emphasis on scalability,
budget, time, compliance, and
environmental considerations.
Project Updates
Financial Status
Risk Management
Risks: Tracheal injury,
scheduling, compliance
assurance, & design cost.
Mitigations: Effective
communication, cost-effective
procurement, and strict
adherence to medical
regulations.
Piezoelectric concept utilizing
PVDF for the ETT cuff with FSRs
measuring force applied to the
artificial tracheas.
Design Guidelines
Summary
FSR
Air input
Power
line
Ground
line
Air supply
line
Applied
force
PVDF
Regulatory Compliance

13. Detailed Design - Overview
Execution of calibration, build, &
test plans. Valuable insights
gained.
Successful verification of short
FSR accuracy. Limitations
identified with long FSR &
piezoelectric film sensor.
Further refinement required for
optimal performance.
Inconsistencies observed in
sensor readings. Limitations in
detecting intracuff pressure
identified. Need for more
sensitive sensors & realistic
testing scenarios emphasized.
Focus on manufacturing &
refining design. Aim to ensure
compliance with all
commercial medical
requirements.
Project Update Calibration Phase Build Phase
Adhesive failure encountered
during assembly.
Reassessment of assembly
procedures & adhesive
selection criteria undertaken.
Short FSR demonstrated
satisfactory performance. Long
FSR & piezoelectric film sensors
showed limitations requiring
refinement. Silicone glue failure
during the build phase
highlighted the importance of
material selection.
Testing Phase
Future Work
Summary

14. Detailed Design
03
➔ Overview of Design
➔ Subsystems
➔ Analyses
➔ Manufacturing & Assembly
➔ Sustainability

15. Overview of Design
Consists of two subsystems: Intubation
system & data collection system
System - Prototype
Requirements
Req ID Description Status
1 Seal Creation Future Work
2 Improve measurement efficiency by at least 30% Future Work
3 Can be inflated within 30 seconds Compliant
4 Can be deflated within 30 seconds Compliant
5 Maintain 20-30 cmH2O intracuff pressure Future Work
6 Sampling time of 2 seconds Future Work
7 Consider ETTs of 6-9mm internal diameter Compliant
8 Adhere to applicable standards and regulations In Progress
9 The cuff material must not be thicker than 50um In Progress

16. Intubation Subsystem
The two issues encountered during the testing of this subsystem were:
● The silicone glue was not strong enough to keep the piezoelectric film
sensor attached to the cuff for all trials
● The voltage of the piezoelectric film sensor was inverting from reading 5V
as maximum pressure and 0V as maximum pressure.
○ We were unsure of the cause or meaning of this until yesterday
○ Ellen will expand upon this later
Requirements & Validation
Test Performance Overview
Req ID Description Status
1 Seal Creation Future Work
3 Can be inflated within 30 seconds Compliant
4 Can be deflated within 30 seconds Compliant
5 Maintain 20-30 cmH2O intracuff pressure Future Work
7 Consider ETTs of 6-9mm internal diameter Compliant
9 The cuff material must not be thicker than 50um In Progress

17. Data Collection Subsystem
There were no issues with this subsystem throughout testing.
Test Performance Overview
Requirements & Validation
Req ID Description Status Validation
2
Improve measurement efficiency by at least
30%
Future Work N/A
6 Sampling time of 2 seconds Future Work N/A
8 Adhere to applicable standards and regulations In Progress N/A

18. Analyses
● Failure Modes & Effects Analysis (FMEA)
● Design for Manufacturing and Assembly (DFMA)
● Calibration analysis
● Build analysis
● Testing analysis
● Post-report testing analysis
These will be further discussed later in
the presentation.

19. Reliability
Item/ Function
Potential Failure
Model(s)
Potential
Effect(s) of
Failure
Severity
Potential Cause(s)/
Mechanism(s) of Failure
Probability
Current Design
Controls
Detectability
Risk
Priority
Number
Recommended Action(s)
Responsibility &
Target Completion
Date
One-Way Valve: Allow air
to be injected into the ETT
cuff & preventing the air
from leaving the cuff until
purposefully removed
using a syringe for
deflation
Failure of the
one-way valve to
prevent the air
unintentionally
leaving the ETT
cuff
Unintentional
deflation of the
ETT cuff
7
Material degradation, fatigue,
& manufacturing defects
2
Quality
monitoring, air
volume &
pressure
monitoring, visual
inspection
5 70
Requires the cause of the
inaccurate voltage
readings to be
discovered and remedied
April 2025
ETT: Keep the airway
open to facilitate
mechanical ventilation
Failure of the ETT
to maintain its
rigid structure
Lack of open
airway to
facilitate
mechanical
ventilation
9
Material degradation, fatigue,
manufacturing defects,
kinking, & environmental
conditions in transport/
storage
2
Quality
monitoring,
maintenance of
original tube
materials &
qualities
10 180
This system is not
required to detect
structural failure of the
ETT. This is detected by
the mechanical
ventilation equipment
N/A
ETT Cuff: Create a seal
against the trachea wall
to prevent aspiration
Failure of the cuff
to maintain the
seal & contain the
injected air
Inhalation of
bodily fluids
(vomit, saliva,
etc)
9
Material degradation, fatigue,
manufacturing defects,
improper tube sizing, trauma,
stress, & environmental
conditions in transport/
storage
4 Yet to be tested 5 180
Once this concept
becomes a fully
functional, market-ready
product, conduct trials in
animal & human subjects
April 2027
Piezoelectric Film
Sensor: Measure the
voltage produced by the
force exerted by the ETT
cuff onto the trachea wall
Failure of the film
sensor to
accurately and
consistently
measure the
voltage produced
by the force
exertion
Inability to
measure the
force exerted on
the trachea wall,
potentially
causing sores
7
Excitation of the sensor, faulty
ground connection, faulty
power connection, faulty
integration with the existing
ETT cuff, fatigue,
environmental factors,
resonance, & electromagnetic
interference
10
Yet to discover
the exact cause
1 70
Investigate the cause of
the inaccurate, but
consistent,
measurements
April 2025
Failure Modes & Effects Analysis - Intubation Subsystem

20. Reliability
Failure Modes & Effects Analysis - Data Collection Subsystem
Item/ Function Potential Failure Model(s)
Potential Effect(s) of
Failure
Severity
Potential
Cause(s)/
Mechanism(s) of
Failure
Probability
Current
Design
Controls
Detectability
Risk
Priority
Number
Recommended
Action(s)
Responsibility &
Target
Completion
Date
USB B Cable:
Connect the
Arduino Mega 2560
to a laptop for
power supply and
program execution
Failure to supply power to the
Arduino Mega 2560 & failure to
transfer the data from the Arduino
to the laptop
Inability to supply power to
the entire system &
inability to read the
voltage data, therefore
inability to determine the
exerted force
7
Loose connection,
broken wires
within the cable
due to bending
2
Quality
monitoring
1 14 None N/A
Arduino Mega 2560:
Process the Arduino
code & collect the
voltage from the
connective wiring
Failure to process and execute the
code, failure to receive data from
the connective wiring, & failure to
send data through the USB B cable
Inability to transfer voltage
data to the laptop,
therefore inability to
determine the exerted
force
7
Burning of the
Arduino Mega
processor/
microcontroller,
loose connections
2
Quality
monitoring
1 14 None N/A
Connective Wiring:
Connect the
piezoelectric film
sensor to the
Arduino Mega 2560
Failure to provide power to the
piezoelectric film sensor, failure to
receive data from the piezoelectric
film sensor, & failure to deliver data
to the Arduino Mega 2560
Inability to read voltage
data from the piezoelectric
film sensor, therefore
inability to determine the
exerted force
7
Loose wires,
frayed wires
3
Quality
monitoring
1 21 None N/A

21. Manufacturing & Assembly
Process
● Choosing the most simple & cost effect manufacturing & assembly processes
● In the final design, 3D printing or molding the entire cuff made of piezoelectric material will still be
feasible with the correct equipment
Design
● Ensuring that the design specifications are suitable for the chosen manufacturing & assembly
processes
● We chose to maintain the original cuff profile
Material
● Selecting the appropriate material for the design based on the material properties (strength,
appearance, thermal & electrical properties)
● We researched & verified the material function within applicable force ranges & repeated inflation/
deflation
Environment
● Ensuring that the design will function properly within the required environmental conditions
(temperature & humidity)
● We researched & verified the material function within application temperature & humidity ranges
Compliance
● Ensuring that the design is compliant with applicable standards & regulations
● We aim to consider the Quality System Requirements for Medical Devices

22. Sustainability
ETTs in human medical care are single use, but
can be sterilized and reused in veterinary
medicine.
This creates a large amount of plastic waste, as
is a common issue in medical care.
This ETT modification of the cuff material will not
increase or decrease the amount of plastic
medical waste.

23. Prototyping & Testing
04
➔ Modifications to Testing & Prototype
➔ Results of Final Verification Testing
➔ Final Prototype

24. Design of Experiments (DoE)
Critical Variables:
Cuff pressure, sensor sensitivity, & external forces applied to the ETT.
● When these factors interact, they may have a combined effect on the accuracy of
force measurement.
Experimental Runs:
Testing every possible combination of these factors was impractical. Instead of testing
all possible combinations of cuff pressure, sensor sensitivity, external forces, several
combinations were tested while still capturing the main effects & key interactions.
Reduction of Runs:
By testing fewer combinations, the team saved time & resources while still obtaining
valuable insights into how different factors interact & affect pressure measurement.
Uncontrollable or Nuisance Factors:
Variations in patient anatomy, tissue elasticity, & the positioning of the ETT.
● They may influence measurements & introduce bias into the experimental results.

25. Modifications to Testing & Prototype
Sensor Placement Optimization:
Adjusted sensor placement on ETT to ensure optimal positioning for accurate pressure
readings. Conducted calibration tests to validate the effectiveness of the sensor placement.
FSR Wiring Improvements:
The FSR sensors leads were too delicate and broke during initial testing. New FSRs were
soldered and heat shrink was used on the leads to prevent the wires from being pulled apart.
Original Prototype Build Moved Sensor to Anterior Secured Lead Wires

26. Modifications to Testing & Prototype
Cuff Material Enhancement:
The Piezo sensor needed a greater amount of silicone glue to increase prototype strength &
reduce the risk of failure. Cured for 24 hours while being taped to the cuff.
User Interface:
Improved the ease of operation by Incorporated arduino code for both the FSR and Piezo
Sensor readings and displayed them with serial plotting.
Strain Gauge testing:
Due to a time constraint , we omitted a test that was originally outlined, that involved a strain
gauge & aluminum piping. The goal was to correlate the pipe deflection to the applied
pressure.

27. Results of Verification
Testing

28. Results of Verification
Testing

29. Final Prototype - Test Setup
Arduino Mega 20mL Syringe
Air Supply Line
9mm Cuffed ETT
1.5” PVC Tube
FSRs (4)
Piezoelectric film sensor
Connection Colour
Ground Black
Power Red
FSR 1 Blue
FSR 2 Green
FSR 3 Orange
FSR 4 Yellow
USB-B Cable

30. Demonstration & New Discovery
● Voltage switches at 0V,
signifying the end of
inflation & the start of
deflation
● 0V is read when the cuff
is fully inflated (20mL) &
when the seal is formed.
● The piezoelectric film
sensor was glued on
when the cuff was fully
inflated, thus 0V paired
with the voltage
represents the cuff being
fully inflated
● Phenomenon will exist in
the final product when
the cuff is entirely made
of piezoelectric material

31. Implementation
05
➔ Implementation Process
➔ Relevant Instructions (step-by-step)
➔ Manufacturing & Assembly

32. Ideal Product Manufacturing
● The cuff would be formed/molded entirely from PVDF material giving
it piezoelectric properties
● Wire leads would be embedded into the ETT just like the air supply
tube
● Wire leads would be fixed to the inside of the PVDF cuff to read
voltage change during inflation and prevent contact with saliva
● A quick connect on the opposite end of the wire leads to allow quick
connection to the current patient monitoring system

33. Instructions for Use
This device will be used in the same manner as a regular ETT with only
minor differences.
● Before intubation, the device will need to be plugged into the
microcontroller that runs the required code
● The microcontroller will need to be powered and connected to a
display monitor
● Regular intubation then occurs, but instead of waiting for an audible
signal to stop inflation, a visual spike in contact pressure will be
displayed by the monitor.

34. Recommendations
06
➔ Future Improvements
➔ Design Modifications

35. Future Recommendations
Start
Manufacturing
Future Projects Clinical Trials
1 2 3
A. Consider the concept of
viscoelasticity
B. Ensure implementation of
a method to shield from
EMI & other noise
C. Visual display of results
that is compatible with
patient monitors &
ensure a sampling time
of 2 seconds or less
D. Establish correlation
between voltage &
applied force
A. 3D print or mold the ETT
cuff out of piezoelectric
material
B. Ensure a cuff profile of
less than 50um
C. Wires and connections
will be integrated into the
walls of the ETT
A. Ensure established
airtight seal in live
models
B. Potential for monitoring
breathing patterns
C. Test to ensure 30%
increased efficiency
D. Consider scaling the
operations and testing
E. Ensure adherence to
applicable regulations

36. Conclusion
07
➔ Feasibility
➔ Future work

37. Conclusion
● Successful creation of an ETT with pressure measurement capability
● Validated test results from project duration
● Voltage switch occurs when the ETT cuff is fully inflated & when the
seal is formed
● Provided recommendations for future work
● On schedule & under development budget
● Final prototype cost of $244.23

38. CREDITS: This presentation template was created by
Slidesgo, and includes icons by Flaticon and
infographics & images by Freepik
Thank You!
Arduino Mega 20mL Syringe
Air Supply Line
9mm Cuffed ETT
1.5” PVC Tube
FSRs (4)
Piezoelectric film sensor
Connection Colour
Ground Black
Power Red
FSR 1 Blue
FSR 2 Green
FSR 3 Orange
FSR 4 Yellow
USB-B Cable