Endotracheal Tube Cuff Valve Client: Dr. Lester Proctor Advisor: Paul D. Thompson, Ph.D. Team V-Tec Michael Alexander - Team Leader Claire Edlebeck - BWIG Samantha Bergh - BSAC Jack Ho - Communications

Outline Problem Statement Background Current Devices Design Constraints Design Ideas Design Matrix Future Work

Problem Statement Endotreacheal Tubes Use in pediatrics Cuff Pressure Systematic failure @ 25cm H2O Use in pediatrics

Background Information 20,000 Operations Annually 25% Children 75% Require Endotracheal Tube Inflatable Cuff for Adults Advantages Tight Seal Prevents Aspiration Disadvantages Ischemia due to excess pressure Risk Increased in Children http://connection.lww.com

With Lanz® Pressure Regulating Valve Current Devices Hi-Lo® Tracheal Tube With Lanz® Pressure Regulating Valve Pressure maintenance Monitoring High-volume, low-pressure Specialization Current Devices: Lanz® valve automatically maintains intracuff pressure to approximately 30cm H2O Lanz® valve reduces the need for manual cuff pressure monitoring High-volume low-pressure cuff Reduces risk of tracheal damage during long-term intubations, especially in children

Design Constraints Requirements Performance Safety Shelf Life Life in Service Materials Appearance Design Constraints: Cuff cannot fail before reaching 25 cm h2o, must fail at 25 cm h2o Cuff failure can be bypassed to accommodate unforeseen situations Must perform at level of current tubes Must be FDA approved for humans Must be disposable, but last for duration of patient intubation Should be able to be stored for one year Should not increase MRI visibility of tube Clean, with white finish for high visibility

T-Valve Simple design adding another valve allowing for pressure release. The added valve will simply be used as a safety valve, releasing excess pressure Modifications such as a readable gauge can also be applied to this design. One-way release Original intake

T-Valve: Pros & Cons Pros Cons Extremely simple design Basic design can be modified in many ways Modifications Balloon vs. pressure release valve Readable gauge Cons Not as easy to override compared to other designs Not easy to manually cause valve to fail if valve sticks

T-Valve Modifications Balloon Pressure inside balloon = pressure in cuff Allows for over inflation Gauge Readable gauge with pressure readings Digital or analog

Clip Valve Basic one-piece lever system. System encloses the pilot balloon Opens the release valve when the pilot balloon inflates to a certain pressure Closes when the balloon deflates to normal pressure Open Closed Balloon inflated

Clip Valve: Pros & Cons Pros Cons Can easily be manually overridden both ways Consistently fails and re-fails Cons Relies on pilot balloon System is not enclosed Clip could malfunction at 2 different places

Clamp Y Additional valve and tube attached to pilot balloon Standard pressure release valve Predictably fails at 25cm H2O pressure Clamp to override One-way outtake Y One-way release http://greatcare.ec51.com/images/bank/1098801555.jpg - -0 greatcare.ec51.com/ product/

Clamp: Pros & Cons Pros Cons Consistently fails Ability to override Relatively inexpensive to manufacture Can add pressure sensor Works with any clamp Cons Size Possible clamp failure Previously mentioned pitfalls

Design Matrix Safety (10) Simplicity (5) Ease of Use (5) Effectiveness (10) Price (5) Total (35) T-Valve 9 5 4 6 29 Clip 7 2 1 21 Clamp 10 3 32

Future Plan Discuss design with client Decide on best design for client requirements Develop viable manufacturing plan & prototype Pressure sensor Pressure release outtake valve Calibration Find Manufacturer Begin prototype testing and refining

Any Questions?