In Vitro Experiments and Redesign of Protection Device Filters Used in Carotid Angioplasty Erdrin Azemi Heather Gray Emily Miner AGM Inc. Project Advisor: Ender A. Finol, Ph.D. Project Director: Mark H. Wholey, M.D. Senior Design BioE1160

Overview Objective:Objective: To perform flow motion analysis on several Stroke Reduction Filters currently available in the marketTo 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 thromboembolismProtection 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 analysisRedesign the components of these filters, as we see necessary, following flow motion analysis

Atherosclerotic Plaque Stroke is the 3rdStroke is the 3rd leading cause of death in the U.S. AtheroscleroticAtherosclerotic plaque can cause stroke Schematic of Plaque in the Carotid Artery 2

1 3 2 Angioplasty Procedure

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

Current Filters Angioguard TM EPI Filter Wire TM Neuroshield TM

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

Description EPI Filter Wire TM Angioguard TM AGMshield Guide Wires

Design Alternatives We are currently addressing problems with the size and stability of the Nitinol TM ring, clot catching efficiency, and the labeling of the delivery and retrieval sheathsWe are currently addressing problems with the size and stability of the Nitinol TM 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 goalsAfter the appropriate testing, we plan to redesign the above components, hopefully maximizing efficiency and reaching our goals

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 competitorsThere 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 competitorsStrengths Relative to other competitors, our design approach will piece together all of the most effective parts of each filter testedRelative to other competitors, our design approach will piece together all of the most effective parts of each filter testedWeaknesses Because of our limited resources, there are surely several problems that we will be unable to address at this momentBecause of our limited resources, there are surely several problems that we will be unable to address at this moment

Technology Experimentation We will be using a in-vitro flow loop provided by Carnegie Mellon UniversityWe will be using a in-vitro flow loop provided by Carnegie Mellon University Existing filtersExisting filters Engineering Modeling SolidWorks TM Modeling will be used to develop our designSolidWorks TM Modeling will be used to develop our design

Team/Resources Advisors Dr. Endor FinolDr. Endor Finol Dr. Mark WholeyDr. Mark WholeyEquipment/Support Flow pump and lab provided by CMUFlow pump and lab provided by CMU Filters provided to Dr. Wholey by various suppliers: Angioguard TM, Acunet TM, EPI Filter Wire TM, and Neuroshield TMFilters provided to Dr. Wholey by various suppliers: Angioguard TM, Acunet TM, EPI Filter Wire TM, and Neuroshield TMLocation Carnegie Mellon University LaboratoryCarnegie Mellon University LaboratoryManufacturing Will be limited by funds and advisor needsWill be limited by funds and advisor needs

Schedule Fall 2003 Design History FileDesign History File Meeting with advisorsMeeting with advisors Literature ResearchLiterature Research Prepare for PresentationPrepare for Presentation Flow Loop Set UpFlow Loop Set Up Perform Preliminary TestsPerform Preliminary Tests

Schedule Spring 2004 Perform experiments and achieve dataPerform experiments and achieve data Meet with advisorsMeet with advisors Filter RedesignFilter Redesign Design ImplementationDesign Implementation Final Paper and PresentationFinal Paper and Presentation

Team Chores Erdrin A. Heather G. Emily M. Further Literature Research Set up group meetings Contact advisors Monitor experiment Take pictures during experiments Collect data during experiments Solid Works Modeling Write FMEA for redesign Write HFE for redesign Fax questionnaire to physicians Write-up questionnaire Sort and tally questionnaire results Put together final presentation Put together final paper

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

Acknowledgements Thank You: Mark Wholey, MDMark Wholey, MD Ender Finol, PhDEnder Finol, PhD Mark GartnerMark Gartner Bioengineering Department, University of PittsburghBioengineering Department, University of Pittsburgh Elena DiMartinoElena DiMartino Carnegie Mellon UniversityCarnegie Mellon University