Challenge
This project is part of the partnership with GSE Biomedical that seeks to develop cardiovascular devices within our country. One of the most common cardiac complications is related with the formation of an aortic aneurysm which can quickly become a serious medical emergency because of the risk of developing an aortic dissection. The aneurysm occurs when part of the artery becomes weakened and a bulge is created in the aortic wall. The formation of this abnormality can go unnoticed and continue its growth until the rupture without presenting any symptom being a life-threatening condition. The aneurysms are treated with stent grafts which are meshed devices placed within the aortic wall to provide structural support and avoiding the blood pressure to reach the wall limiting its growth. Similar to some other cardiac devices, these implants are normally placed at a high cost in the market leaving them out of reach for many people who need treatment for their cardiac conditions.
Solution
The designs were proposed by the GSE Biomedical team with the purpose of finding a stent configuration that would allow the implant to expand and acquire the configuration of the body and the legs of the stent in a single device instead of overlapping different parts to create the whole device as it is commonly done. This proposal would reduce the manufacturing processes needed to create the implant and thus reducing the final price of the stent graft.
Results
Understanding the functional parameters of the stent graft allowed us to participate in the finite element analysis of the different proposed geometries to find the most suitable for the needed configuration. Bioana designed the simulation models for analyzing all of the geometries using different materials characterized in the software for the evaluation of the plasticity behavior of the stent once it was expanded to its final diameter dimension. In addition, Bioana created models of simulation for the mechanical testing necessary to validate the correct performance of the implant.
“Bioana team, you guys are simply amazing. Thanks so much for all your team’s hard work on this. We remain impressed beyond measure.”
Mark Lee
CEO, Ocumetics
"Our experience with Bioana had been outstanding. Their commitment, eye for detail, punctuality, proactivity and understanding manufacturing principles, workflow, quality and resourcefulness has been beyond our expectations."
Frank Harder
CRO , Bolb Inc.