In Vitro Experiments and Redesign In Vitro Experiments and Redesign of Protection Device Filters Used in of Protection Device Filters Used in

Carotid AngioplastyCarotid Angioplasty

Erdrin AzemiErdrin AzemiHeather GrayHeather GrayEmily MinerEmily MinerAGM Inc. AGM Inc.

Project Advisor:Project Advisor: Ender A. Finol, Ph.D. Ender A. Finol, Ph.D.Project Director:Project Director: Mark H. Wholey, M.D. Mark H. Wholey, M.D.

Senior DesignSenior DesignBioE1160BioE1160

OverviewOverview

• Objective:Objective: • To perform flow motion analysis To perform flow motion analysis

on several Stroke Reduction Filters on several Stroke Reduction Filters currently available in the market currently available in the market

• Protection device filters are used Protection device filters are used during angioplasty procedures to during angioplasty procedures to reduce the risk of thromboembolismreduce the risk of thromboembolism

• Redesign the components of these Redesign the components of these filters, as we see necessary, filters, as we see necessary, following flow motion analysisfollowing flow motion analysis

Atherosclerotic PlaqueAtherosclerotic Plaque

•Stroke Stroke is the 3rd is the 3rd leading cause ofleading cause ofdeath in the U.S.death in the U.S.

•Atherosclerotic Atherosclerotic plaqueplaque can cause can causestrokestroke

Schematic of Plaque in the Carotid Schematic of Plaque in the Carotid ArteryArtery22

1133

22

Angioplasty ProcedureAngioplasty Procedure

Project GoalsProject Goals

• To test four current endovascular filters To test four current endovascular filters on the market: (Angioguard on the market: (Angioguard TMTM, Acunet , Acunet TMTM, , EPI Filter WireEPI Filter WireTMTM, and Neuroshield , and Neuroshield TMTM) )

• To redesign a more effective and efficient To redesign a more effective and efficient endovascular filter protection deviceendovascular filter protection device

• To accomplish all the testing To accomplish all the testing experiments by the end of Januaryexperiments by the end of January

Current FiltersCurrent Filters

Angioguard Angioguard TMTM

EPI Filter Wire EPI Filter Wire TMTMNeuroshield Neuroshield TMTM

Features & Benefits of the Filter

FeaturesFeatures

• Efficiently catches Efficiently catches clotsclots

• Provide more Provide more reinforcements reinforcements around Nitinol ringaround Nitinol ring

• Better labeling of Better labeling of delivery and retrieval delivery and retrieval sheathssheaths

BenefitsBenefits

• Lowers the risk of Lowers the risk of thromboembolismthromboembolism

• Easier to guide through Easier to guide through different size arteries different size arteries and lasts duration of and lasts duration of surgerysurgery

• Reduces user confusionReduces user confusion

DescriptionDescription

EPI Filter Wire EPI Filter Wire TMTM

Angioguard Angioguard TMTM

AGMshieldAGMshield

Guide WiresGuide Wires

Design AlternativesDesign Alternatives

• We are currently addressing problems with We are currently addressing problems with the size and stability of the Nitinolthe size and stability of the NitinolTMTM ring, clot ring, clot catching efficiency, and the labeling of the catching efficiency, and the labeling of the delivery and retrieval sheathsdelivery and retrieval sheaths

• After the appropriate testing, we plan to After the appropriate testing, we plan to redesign the above components, hopefully redesign the above components, hopefully maximizing efficiency and reaching our goalsmaximizing efficiency and reaching our goals

Competitive AnalysisCompetitive AnalysisCompetitors Competitors • There are several protection device filters on the market. In our There are several protection device filters on the market. In our

study, we will be dealing with the 4 that we have previously study, we will be dealing with the 4 that we have previously mentioned. We will consider these to be our direct competitorsmentioned. We will consider these to be our direct competitors

StrengthsStrengths• Relative to other competitors, our design approach will piece Relative to other competitors, our design approach will piece

together all of the most effective parts of each filter testedtogether all of the most effective parts of each filter tested

WeaknessesWeaknesses• Because of our limited resources, there are surely several Because of our limited resources, there are surely several

problems that we will be unable to address at this momentproblems that we will be unable to address at this moment

TechnologyTechnology

ExperimentationExperimentation

• We will be using a in-vitro flow loop provided by We will be using a in-vitro flow loop provided by Carnegie Mellon UniversityCarnegie Mellon University

• Existing filtersExisting filters

Engineering Modeling Engineering Modeling

• SolidWorksSolidWorksTMTM Modeling will be used to develop our Modeling will be used to develop our designdesign

Team/ResourcesTeam/Resources

AdvisorsAdvisors

• Dr. Endor FinolDr. Endor Finol

• Dr. Mark WholeyDr. Mark Wholey

Equipment/SupportEquipment/Support

• Flow pump and lab provided by CMUFlow pump and lab provided by CMU

• Filters provided to Dr. Wholey by various suppliers: Filters provided to Dr. Wholey by various suppliers: AngioguardAngioguardTMTM, , AcunetAcunetTMTM, EPI Filter Wire, EPI Filter WireTMTM, and Neuroshield, and NeuroshieldTMTM

LocationLocation

• Carnegie Mellon University LaboratoryCarnegie Mellon University Laboratory

ManufacturingManufacturing

• Will be limited by funds and advisor needsWill be limited by funds and advisor needs

ScheduleScheduleFall 2003Fall 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

ScheduleScheduleSpring 2004Spring 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 ChoresTeam Chores

Erdrin A.Erdrin A. Heather G.Heather G. Emily M.Emily M.Further Literature Further Literature ResearchResearch

Set up group Set up group meetingsmeetings

Contact advisorsContact advisors

Monitor experimentMonitor experiment Take pictures Take pictures during experimentsduring experiments

Collect data during Collect data during experiments experiments

Solid Works Solid Works ModelingModeling

Write FMEA for Write FMEA for redesignredesign

Write HFE for Write HFE for redesignredesign

Fax questionnaire Fax questionnaire to physiciansto physicians

Write-up questionnaire

Sort and tally Sort and tally questionnaire questionnaire resultsresults

Put together final Put together final presentationpresentation

Put together final paper

Put together final Put together final paperpaper

Current StatusCurrent StatusWe have completed the following We have completed the following

tasks:tasks:

• Meeting with advisorsMeeting with advisors

• Completed an initial design history Completed an initial design history filefile

• Prepare for PresentationPrepare for Presentation

• Flow Loop Set Up (to be completed Flow Loop Set Up (to be completed 12/5-pm)12/5-pm)

AcknowledgementsAcknowledgements

Thank You:Thank You:• Mark Wholey, MDMark Wholey, MD

• Ender Finol, PhDEnder Finol, PhD

• Mark GartnerMark Gartner

• Bioengineering Department, University Bioengineering Department, University of Pittsburgh of Pittsburgh

• Elena DiMartinoElena DiMartino

• Carnegie Mellon UniversityCarnegie Mellon University