Team 19

Improvement of Balloon Atrial Septostomy for Patients Born with Transposition of the Great Arteries

Team Members:
Lauren Baker
Kayla Charles
Ronin Komarnisky
Haley Strauss
Brycelyn Whitman

Team Mentors:

Sara Belko - Thomas Jefferson University Medical College

Dr. Mehdi Nikkah - Arizona State University


YouTube Link:
View the video link below before joining the zoom meeting

Zoom Link:
https://asu.zoom.us/j/89513662820

Abstract

Balloon atrial septostomy is a life-saving device for infants born with transposition of the great arteries in which deoxygenated blood returns to the heart and oxygenated blood returns to the lungs. This congenital birth defect is a condition affecting 4.7 children in every 10,000 born. Using a catheter with an inflatable balloon, the doctor pushes the deflated balloon through the small hole, inflates it, and pulls it through to create a larger hole. They repeat this process until the hole is large enough allowing for sufficient oxygen levels. Current devices pediatric cardiologists use include a 6 Fr catheter with an unmarked tip and a 13.5 mm balloon that becomes misshapen when deflated. After interviewing lead users, we narrowed down the key problems: too large of a catheter size, balloon is too non-compliant, and the tip needs to have a marker to determine where it is in the body. Due to lead users' input, the key product to design would be a typically used balloon catheter system with a smaller outer diameter of 4 or 5 Fr, a radiopaque tip, and a non-compliant balloon that could deflate to its initial shape. While this smaller catheter does exist, it can only use a 9.5 mm balloon which is insufficient to create this larger hole. Another possible problem; however, it is not seen this way by physicians, is that the force and angle to pull the balloon out is due to the doctor’s method and determined through practice. Thus, a product we are further interested in is a device that would tear the hole larger from the inside without the need to forcefully pull the balloon catheter through repeatedly. However, due to the customer interviews that have occurred, we are following through with the improvements to the current system on the problems they identified. With these changes, we have estimated that our proposed device should cost end users around $500-1,000. Through completion of mathematical modeling, we can determine that these end goal specifications can be met.