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Patent Ductus and Vascular Occlusion Devices

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

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Patent Ductus and Vascular Occlusion Devices

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  1. Patent Ductus and Vascular Occlusion Devices Michelle Carlsen Elaine Isom Brad Klosterman Ornob Roy Advisor: Dr. Thomas Doyle

  2. Project Definition • Objective: Design, build, and market an occlusion device which can be used to close the Patent Ductus and cylindrical vasculature • Presentation topics: • Background • solution • accomplishments • current status • future plans

  3. Background:Patent Ductus • Condition affecting Infants/Children • ~ 10-12% of congenital defects • 40 cases/yr at Vanderbilt • > 20,000 nationwide • Connection btw pulmonary artery and aorta

  4. Background:General Vasculature • Less common than PDA • Cylindrical shape • Reroute blood flow • Isolate defective vasculature • Impede significant flow

  5. 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

  6. Biocompatible Quick endothelialization (1-2months) Delivered through a catheter < 2mm diameter Simple, Retrievable Inexpensive Various size (2 to 10mm) Form-fitting Maximum effectiveness Internal device Complete closure Standard catheter size Minimum training Cost effective - comparatively Universal Device Immovable and closure No leakage Requirements

  7. Endomethiasin initial form of treatment 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 Current Solutions

  8. 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 • Began mock circulation system

  9. Goal allow for quick and accurate prototyping marketing and visualization I-DEAS Modeling

  10. Current Status • 3D modeling using SDRC I-DEAS • Material search • 4 design concepts • Large scale simulation: drawings, materials, construction

  11. Design 1 • Advantages: • adjust on contact • expandable polymer • form-fitting (PDA & general) • Disadvantages: • FDA • expensive (polymer & wire • retrievable??

  12. Design 2 • Advantages: • form-fitting (PDA & general) • collapsible (>500%) • endothelialize quickly • inexpensive • Disadvantages: • complex • possible limited retrieval

  13. Design 3 • Advantages • very rigid • easily retrievable • adjustable • Disadvantages • difficult to maneuver • expensive

  14. Design 4 • Advantages: • form-fitting (PDA & general) • retrievable • simple • inexpensive • Disadvantages: • expansion limitations?? • Two materials

  15. 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

  16. Suitable Materials • Hydromer • Medicell Hydrophilic Open Cell Medical Foam • consists of polyurethane and polyvinylpyrrolidone polymers • Foamex • Functional Flexibility • Titanium Feet

  17. Simulation Echigo, S et al. “ Development of New Transvenous Patent Ductus Arteriosis Occlusion Technique Using a Shape Memory Polymer.” ASAIO Transactions: 1990 pg M197.

  18. Simulation Protocol • Large scale • Fluid: • water glucose mixture • pig’s blood • Pulsatile Pump • Latex Tubing (18 flexitube) • Plastic PDA (conical 2mm opening)

  19. Elaine/Michelle: PDA design material search literature analysis/search Ornob/Brad: Vascular Occluder Design modeling using I-DEAS simulation design idea, construction Group: device design ideas large scale prototypes designsafe analysis Division of Labor

  20. 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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