patent ductus and vascular occlusion devices

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Patent Ductus and Vascular Occlusion Devices. Michelle Carlsen Elaine Isom Brad Klosterman Ornob Roy Advisor: Dr. Thomas Doyle. Project Definition. Objective : Design, build, and market an occlusion device which can be used to close the Patent Ductus and cylindrical vasculature - PowerPoint PPT Presentation

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  • Patent Ductus and Vascular Occlusion DevicesMichelle Carlsen Elaine IsomBrad KlostermanOrnob RoyAdvisor: Dr. Thomas Doyle

  • Project DefinitionObjective: Design, build, and market an occlusion device which can be used to close the Patent Ductus and cylindrical vasculaturePresentation topics: Backgroundsolutionaccomplishmentscurrent status future plans

  • Background:Patent DuctusCondition affecting Infants/Children~ 10-12% of congenital defects40 cases/yr at Vanderbilt> 20,000 nationwideConnection btw pulmonary artery and aorta

  • Background:General VasculatureLess common than PDACylindrical shapeReroute blood flowIsolate defective vasculatureImpede significant flow

  • PDA/ Vascular ConditionsDiagnosis:Heart murmurExtreme weight lossStunted growthIrregular blood flow*

    * General vasculatureConsequences:Irreversible pulmonary-vascular diseaseCongestive heart failureHemorrhaging (e.g. diabetics, post-surgical patients)*

  • RequirementsBiocompatibleQuick endothelialization (1-2months) Delivered through a catheter < 2mm diameter Simple, Retrievable Inexpensive Various size (2 to 10mm) Form-fittingMaximum effectiveness

    Internal deviceComplete closure

    Standard catheter size

    Minimum trainingCost effective - comparativelyUniversal DeviceImmovable and closureNo leakage

  • Current SolutionsEndomethiasininitial form of treatmentsteroid medicine (vasoconstrictor)restricted to premature infantsSuturingeffectiveinvasive, long recovery

    Coilsinexpensivenot form fittingTitanium devicesform fittingvery expensiveUltrasonic Devicesnon-invasivehigh-intensitynot human tested

  • AccomplishmentsIdentification of associated diseasesAnalysis of previous device designsStudies in biocompatible materials (Prof. Kinser, Material Sciences)Fluoroscopy viewingSDRC I-DEAS CAD/CAM modeling Began mock circulation system

  • I-DEAS ModelingGoalallow for quick and accurate prototypingmarketing and visualization

  • Current Status3D modeling using SDRC I-DEASMaterial search4 design conceptsLarge scale simulation: drawings, materials, construction

  • Design 1Advantages:adjust on contactexpandable polymerform-fitting (PDA & general)Disadvantages:FDAexpensive (polymer & wireretrievable??

  • Design 2Advantages:form-fitting (PDA & general)collapsible (>500%)endothelialize quicklyinexpensiveDisadvantages:complexpossible limited retrieval

  • Design 3Advantagesvery rigideasily retrievableadjustable

    Disadvantagesdifficult to maneuverexpensive

  • Design 4Advantages:form-fitting (PDA & general)retrievablesimple inexpensiveDisadvantages:expansion limitations??Two materials

  • Material SearchZotefoamsplastazote foam (polyethylene)Medicellmedical spongesTitanium/wire materialThrombosing fibersPolyurethane foam (earplugs)Polyurethane that is modified with lower alkyl Sulfonate and L(L-glutamic acid co L-leucine)biocompatible, used in surgical implantations and blood contacting procedures

  • Suitable MaterialsHydromerMedicell Hydrophilic Open Cell Medical Foamconsists of polyurethane and polyvinylpyrrolidone polymersFoamexFunctional FlexibilityTitanium Feet

  • SimulationEchigo, S et al. Development of New Transvenous Patent Ductus Arteriosis Occlusion Technique Using a Shape Memory Polymer. ASAIO Transactions: 1990 pg M197.

  • Simulation ProtocolLarge scaleFluid:water glucose mixturepigs bloodPulsatile PumpLatex Tubing (18 flexitube)Plastic PDA (conical 2mm opening)

  • Division of LaborElaine/Michelle:PDA designmaterial searchliterature analysis/searchOrnob/Brad:Vascular Occluder Designmodeling using I-DEASsimulation design idea, construction

    Group:device design ideaslarge scale prototypesdesignsafe analysis

  • Future PlansDecide on final designAcquire materials for designContinue meeting with Dr. DoyleDesignsafe analysis Large scale replicationPatent