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 for Patent Ductus and cylindrical vasculature Presentation topics: –Background –solution –accomplishments –current status –future plans

3. Background:Patent Ductus 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. 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) *

6. Requirements Biocompatible Quick endothelialization (1-2months) Delivered through a catheter < 2mm diameter Simple, Retrievable Inexpensive Various size (2 to 10mm) Form-fitting Maximum effectiveness

7. 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

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

9. I-DEAS Modeling

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

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: form-fitting (PDA & general) retrievable simple inexpensive Disadvantages: expansion limitations?? Two materials

14. 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

15. 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

16. Future Plans Decide on final design Acquire materials for design Continue meeting with Dr. Doyle Designsafe analysis Large scale replication Patent

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.