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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 for Patent Ductus and cylindrical vasculature
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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 for Patent Ductus and cylindrical vasculature • Presentation topics: • Background • solution • accomplishments • current status • future plans
Background:Patent Ductus • Infants/Children • ~ 10-12% of congenital defects • 40 cases/yr at Vanderbilt • > 20,000 nationwide • Connection btw pulmonary artery and aorta
Background:General Vasculature • Less common than PDA • Cylindrical shape • Reroute blood flow • Isolate defective vasculature • Impede significant flow
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)* PDA/ Vascular Conditions
Requirements • Biocompatible • Quick endothelialization (1-2months) • Delivered through a catheter < 2mm diameter • Simple, Retrievable • Inexpensive • Various size (2 to 10mm) • Form-fitting • Maximum effectiveness
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 Solutions
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
Current Status • 3D modeling using SDRC I-DEAS • Material search • 3 design concepts • Large scale simulation: drawings, materials
Design 1 • Advantages: • adjust on contact • expandable polymer • form-fitting (PDA & general) • Disadvantages: • FDA • expensive (polymer & wire • retrievable??
Design 2 • Advantages: • form-fitting (PDA & general) • collapsible (>500%) • endothelialize quickly • inexpensive • Disadvantages: • complex • possible limited retrieval
Design 3 • Advantages: • form-fitting (PDA & general) • retrievable • simple • inexpensive • Disadvantages: • expansion limitations?? • Two materials
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
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 Division of Labor
Future Plans • Decide on final design • Acquire materials for design • Continue meeting with Dr. Doyle • Designsafe analysis • Large scale replication • Patent
Simulation Echigo, S et al. “ Development of New Transvenous Patent Ductus Arteriosis Occlusion Technique Using a Shape Memory Polymer.” ASAIO Transactions: 1990 pg M197.