Redesigning Carotid Angioplasty Protection Device Filters through In Vitro Experiments

1. In Vitro Experiments and Redesign of Protection Device Filters Used in Carotid AngioplastyErdrin AzemiHeather GrayEmily MinerAGM Inc. Project Advisor: Ender A. Finol, Ph.D.Project Director: Mark H. Wholey, M.D.Senior DesignBioE1160

2. Overview • Objective: • To perform flow motion analysis on several Stroke Reduction Filters currently available in the market • Protection device filters are used during angioplasty procedures to reduce the risk of thromboembolism • Redesign the components of these filters, as we see necessary, following flow motion analysis

3. Atherosclerotic Plaque • Stroke is the 3rd • leading cause of • death in the U.S. • Atherosclerotic • plaque can cause • stroke Schematic of Plaque in the Carotid Artery2

4. 3 2 1 Angioplasty Procedure

5. Project Goals • To test four current endovascular filters on the market: (Angioguard TM, Acunet TM, EPI Filter WireTM, and Neuroshield TM) • To redesign a more effective and efficient endovascular filter protection device • To accomplish all the testing experiments by the end of January

6. Current Filters EPI Filter Wire TM Neuroshield TM Angioguard TM

7. Features & Benefits of the Filter Features • Efficiently catches clots • Provide more reinforcements around Nitinol ring • Better labeling of delivery and retrieval sheaths Benefits • Lowers the risk of thromboembolism • Easier to guide through different size arteries and lasts duration of surgery • Reduces user confusion

8. Description Guide Wires AGMshield EPI Filter Wire TM Angioguard TM

9. Design Alternatives • We are currently addressing problems with the size and stability of the NitinolTM ring, clot catching efficiency, and the labeling of the delivery and retrieval sheaths • After the appropriate testing, we plan to redesign the above components, hopefully maximizing efficiency and reaching our goals

10. Competitive Analysis Competitors • There are several protection device filters on the market. In our study, we will be dealing with the 4 that we have previously mentioned. We will consider these to be our direct competitors Strengths • Relative to other competitors, our design approach will piece together all of the most effective parts of each filter tested Weaknesses • Because of our limited resources, there are surely several problems that we will be unable to address at this moment

11. Technology Experimentation • We will be using a in-vitro flow loop provided by Carnegie Mellon University • Existing filters Engineering Modeling • SolidWorksTM Modeling will be used to develop our design

12. Team/Resources Advisors • Dr. Endor Finol • Dr. Mark Wholey Equipment/Support • Flow pump and lab provided by CMU • Filters provided to Dr. Wholey by various suppliers: AngioguardTM, AcunetTM, EPI Filter WireTM, and NeuroshieldTM Location • Carnegie Mellon University Laboratory Manufacturing • Will be limited by funds and advisor needs

13. Schedule Fall 2003 • Design History File • Meeting with advisors • Literature Research • Prepare for Presentation • Flow Loop Set Up • Perform Preliminary Tests

14. Schedule Spring 2004 • Perform experiments and achieve data • Meet with advisors • Filter Redesign • Design Implementation • Final Paper and Presentation

15. Team Chores

16. Current Status We have completed the following tasks: • Meeting with advisors • Completed an initial design history file • Prepare for Presentation • Flow Loop Set Up (to be completed 12/5-pm)

17. Acknowledgements Thank You: • Mark Wholey, MD • Ender Finol, PhD • Mark Gartner • Bioengineering Department, University of Pittsburgh • Elena DiMartino • Carnegie Mellon University

18. THANK YOU! ?