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Patent Ductus and Vascular Occlusion Devices Michelle Carlsen Elaine Isom Brad Klosterman Ornob Roy Advisor: Dr. Thomas Doyle
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Project Definition Objective: Design, build, and market an occlusion device which can be used for Patent Ductus and cylindrical vasculature Presentation topics: –Background –solution –accomplishments –current status –future plans
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Background:Patent Ductus Infants/Children ~ 10-12% of congenital defects 40 cases/yr at Vanderbilt > 20,000 nationwide Connection btw pulmonary artery and aorta
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Background: General Vasculature Less common than PDA Cylindrical shape Reroute blood flow Isolate defective vasculature Impede significant flow
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PDA/ Vascular Conditions Diagnosis: –Heart murmur –Extreme weight loss –Stunted growth –Irregular blood flow * * General vasculature Consequences: –Irreversible pulmonary- vascular disease –Congestive heart failure –Hemorrhaging (e.g. diabetics, post-surgical patients) *
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Requirements Biocompatible Quick endothelialization (1-2months) Delivered through a catheter < 2mm diameter Simple, Retrievable Inexpensive Various size (2 to 10mm) Form-fitting Maximum effectiveness
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Solutions Endomethiasin –steroid medicine (vasoconstrictor) –restricted to premature infants Suturing –effective –invasive, long recovery Coils –inexpensive –not form fitting Titanium devices –form fitting –very expensive Ultrasonic Devices –non-invasive –high-intensity –not human tested
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Accomplishments Identification of associated diseases Analysis of previous device designs Studies in biocompatible materials (Prof. Kinser, Material Sciences) Fluoroscopy viewing SDRC I-DEAS CAD/CAM modeling
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I-DEAS Modeling
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Current Status 3D modeling using SDRC I-DEAS Material search 3 design concepts Large scale simulation: drawings, materials
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Design 1 Advantages: adjust on contact expandable polymer form-fitting (PDA & general) Disadvantages: FDA expensive (polymer & wire retrievable??
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Design 2 Advantages: form-fitting (PDA & general) collapsible (>500%) endothelialize quickly inexpensive Disadvantages: complex possible limited retrieval
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Design 3 Advantages: form-fitting (PDA & general) retrievable simple inexpensive Disadvantages: expansion limitations?? Two materials
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Material Search Zotefoams –plastazote foam (polyethylene) Medicell –medical sponges Titanium/wire material Thrombosing fibers Polyurethane 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
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Division of Labor Elaine/Michelle: –PDA design –material search –literature analysis/search Ornob/Brad: –Vascular Occluder Design –modeling using I-DEAS –simulation design idea Group: –device design ideas –large scale prototypes –designsafe analysis
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Future Plans Decide on final design Acquire materials for design Continue meeting with Dr. Doyle Designsafe analysis Large scale replication Patent
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Simulation Echigo, S et al. “ Development of New Transvenous Patent Ductus Arteriosis Occlusion Technique Using a Shape Memory Polymer.” ASAIO Transactions: 1990 pg M197.
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