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Pre-term Infant Ventilator Support

Mayah Carlton, Reuven Reyman, Jeffrey Keppler, Parissa Teli, Mike Zhang

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Problem Definition

10% of Pregnancies – result in preterm births
Skin to Skin Contact – Proven to benefit preterm infants
Challenge – Jet Ventilator cable is extremely short and can easily be pulled out from baby

Mayah

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Project Sponsor

Dr Henry Lee

Neonatologist / Medical Director
Family Centered Care Task Force
Researches Family Interactions in NICU

Mayah

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Objective

Mayah

Prevent unintended removal of ventilator cable from infant during parental skin-to-skin time

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Fundamental Requirements and Constraints

Reuven

Fundamental Requirements	Constraints
Enhancement of Safety Ergonomics Size & Integration	Existing Ventilator Cables Sterilization capabilities Medical Device Standards and Regulations

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Fundamental Requirements:

Fundamental requirements for this device are

Safety Enhancement: The device shall improve safety during skin-to-skin treatment by providing consistent and reliable support for the infant's endotracheal tube positioning.
Ergonomics: The design must be ergonomic and user-friendly, supporting the comfort and ease of use for parents, nurses, and infants..
Size & Integration: the device will need to rest somewhere around the ventilator and integrate with the other components in that area

Constraints

Constraints for this design include

Existing Ventilator Cables as the device must integrate with the existing cables of the ventilator
Since portions of the device are attached to and near sterile areas, it must be sanitizable
If sold on the market, the device will need to comply with applicable standards and regulations

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Ventilation Cable Tension Sensor

Pros:

Prevent excessive tension on baby’s ventilator cable

Cons:

Possibility of failure
Additional device and cabling added to complex ventilator system

Reuven

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Ventilation Cable Tension Sensor

High Risk Area:

Alarm Accuracy

Planned Risk Reduction Test:

Determine Threshold Tension Value Empirically
Sensor Testing

Reuven

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Pros:

Conforms with Existing Procedure
Size

Cons:

Existing Products
Failure Possibility
Comfortability

Parissa

Support Vest

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High Risk Areas:

Infant / Parent Comfort
Securing box

Planned Risk Reduction Test:

Material Durability

Parissa

Support Vest

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Design Description：

Secure Tube Management
Safe Transfer
Skin-to-skin Care

Pros:

Reduce Manpower Needs
Similar existing structures
Integrated Design

Cons:

Large footprint
Complex Structure
Requires large factor of safety
High initial cost

Mike

Integrated Infant Transfer System

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High Risk Areas:

Infant Overall Safety
Effect on Efficiency
Tube Connection Safety

Planned Risk Reduction Test:

Hardware Testing

Simulated User Operation

Load Capacity Tests

Tube Tension Monitoring

Analytical Prediction

Stress Data Analysis & Safety Assessment

Mike

Integrated Infant Transfer System

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Alarm Box

Pros:

Battery operated
Low Battery indicator
Auditory and visual alert methods

Cons:

Complex ventilator system
Requires batteries

Additional regulatory constraints

Jeffrey

MAE 156A | Team 7 | Page 12

Moving to the next component, the pros that we have is we want to explore the idea of using battery power to minimize the amounts of tubes and cables that pass to and from the infant. In addition, we will be including a low battery indicator to ensure that nurses are warned in case the battery looses charge. In addition, we plan to include both Auditory and visual alerts to have redundant safety measures to warn the nurses that the sensor detects something.�With this new alarm box, it will add a new level of complexity to the overall procedure. Furthermore, as the alarm box requires batteries it will require additional safety regulations to consider.��Feedback:

- Soft shell for box? Sharp corners?�- Tactile Sensor as an option, address it

Draw block diagram to illustrate the process
Identify the threshold values
Identify safety factors
Make sure to clearly say why we need the alarm

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Alarm Box

High Risk Areas:

Loud Noises (45db max)
Alarm Fatigue

Planned Risk Reduction Test:

Response Time
Alarm Testing
Connectivity Testing
Redundancy Testing

Jeffrey

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Remaining Questions and Unresolved Issues

Balancing Patient Comfort and Safety

Streamlining Transfer Process

Safety Regulations and Protocol

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Mayah

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Next Quarter – Milestones

1

Vest/Box Design

Material Selection

Vest Box Interface Prototype

Customer Feedback

Early Warning Design

Sensor Design Prototype

Sensitivity and Consistency Testing

Customer Feedback

Mayah

Transfer Stand

Design Prototype

Durability and Safety Testing

Customer Feedback

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Next Quarter – Individual Component Analysis

Research Medical Related Device Implementation

Sensor Implementation

Support Vest

Transfer Stand

Alarm Box

Mayah

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Gantt Chart

Jeffrey

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Thank You

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Problem Definition Notes

10% of pregnancies result in a preterm birth
As part of caring for preterm babies, skin to skin contact has been proven to be an extremely beneficial treatment for preterm infants and mothers.
However, some preterm infants required respitory assistance with the use of jet ventilators. This equipment increases the risk associated with parental skin to skin contact due to the risk of dislodging the endotracheal tube

Our sponsor is interested in helping solve this problem

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NOTES Sponsor

Neonatologist and Medical Director of the NICU at the Jacobs Medical Center
As a part of Family centered care task force, Dr Lee is interested in researching family interactions within the NICU. Dr Lee is dedicated to promoting family connections with the baby in the NICU setting because of the clinical and psychological benefits

1

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NOTES Objective

Build, test, and document a device that allows for a safer experience of skin-to-skin treatment with preterm infants while attached to the ventilator by endotracheal tube and respiratory tubing.

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NOTES Fundamental Requirements and Constraints

Safety Enhancement: The device shall improve safety during skin-to-skin treatment by providing consistent and reliable support for the infant's endotracheal tube positioning.

Ergonomics: The design must be ergonomic and user-friendly, supporting the comfort and ease of use for parents, nurses, and infants.

Early Warning System: The device shall incorporate an early warning system that detects and alerts for potential dislodgment of the endotracheal tube.

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NOTES Design Solutions

Discuss :

List pros and Cons

High Risk Areas

Planned risk reduction test

Risk Reduction Achievements Completed

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Design Solutions Under Consideration

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Pros and Cons

Transportation Design:
The tray design provides stability and simplifies operation.
Sliding may cause device displacement or cable tension.

Adjustable Support System:
Enhances safety and flexibility.
Increases cost.

Soft Wrap:
Soft and skin-friendly, reduces parental burden.
Precise length management for tube fixation.

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List pros and Cons

All-in-One Infant Transfer Care Station:

Multifunctional design reduces manpower needs.

Complex structure and large footprint.

Ventilator Tension Sensor:

Effectively reduces tube load, prevents blockage, and ensures easy operation.

Prone to false triggers, with difficult sensitivity adjustment.

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High Risk Areas

Operational issues:

Complex equipment prone to misuse, affecting efficiency and infant safety.

Tube detachment risk:

Loosening or pulling threatens respiratory support.

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Planned risk reduction test

Operational issues:

Hardware Tests:

1.Simulated User Operation. 2.Durability and Usability Tests

Analytical Predictions:

Break down steps, optimize design. Simulate interactions, enhance intuitiveness.

Tube detachment risk:

Hardware Tests:

1.Tensile Strength Test. 2.Alarm System Test.

Analytical Predictions:

Conduct force analysis. Conduct force analysis.

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NOTES Questions

How do we balance creating a device with robust safety features without sacrificing patient comfort

How do we ensure that we don’t interrupt the existing workflow of the hospital by introducing a new device

What are the safety regulations and protocols that our device must adhere to

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NOTES Project Management for Next Quarter

Milestones

Material selection for vest

Customer feedback (safety / comfort of the baby and parent)

Vest/ Box interface prototype
Sensor design prototype

Create sensitivity and consistency testing setup

Early warning device prototype

Customer feedback (effectiveness of warning system)

Topics for each member's individual component analysis (IDEAS)

Sensor implementation – Reuven? (sensor and sensor/tube interface)
Box – baby interface vest - Parissa (sling or stand)
Stand / tray idea - Mike (transfer tray/ actuating arms)
Early warning device - Jeffrey (light/ speaker)
Study of skin-to-skin treatment workflow from incubator to parent (IE type)
Study of Bluetooth/ lowray (idk this word) device use in hospital
Study of tension impact on intubated infants/ tension testing devices
Study of medical related device implementation/ procedures/ sanitary and safety regulations - Mayah

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