1. 3/10/2003 Patent Ductus Arteriosus Occlusion Device Oral Presentation #3 Group 6 David Brogan, Darci Phillips & Daniel Schultz Advisor: Dr. Thomas Doyle

2. 3/10/2003 Patent Ductus Arteriosus (PDA)  Ductus arteriosus (DA) allows blood to bypass pulmonary and enter systemic  DA normally closes within 10-18 hrs of delivery (if not deemed abnormal/patent)  PDA affects 1800 babies/year in USA alone  Many adverse effects  growth retardation, breathlessness or lack of appetite  Most common problem is congestive heart failure

3. 3/10/2003 Current Treatments  Drug therapy (indomethacin)  Implantable devices (most common are coils)  Usually need 3-4 coils  Difficult to remove and reposition  Invasive surgery (ligate the PDA to inhibit blood flow)

4. 3/10/2003 Project Goals  To design, develop and patent a PDA occlusion device that can…  Be delivered via a catheter  Conform to the shape of the PDA and cause occlusion  Can be repositioned easily  Be cost effective (<$200)  Provide an initial success rate of 100%  More patient friendly procedure

5. 3/10/2003 Current Best Competitor  Amplatzer Duct Occluder  Most effective, has highest success rate of current devices  Drawback - Not pliable  PDA must conform to shape of ADO

6. 3/10/2003 Effect of Occlusion Device

7. 3/10/2003 Our Design

8. 3/10/2003 Delivery Path of Device

9. 3/10/2003 Foam Issues  We can make a polyurethane foam with methylene bisphenyl diisocyanate (MDI), polytetramethylene glycol (PTMEG), 1,4- butanediol and water.  Have ordered MDI and 1,4-butanediol, but have not found a vendor yet to supply the PTMEG.  Contacted DuPont but was unable to secure a sample due to company restrictions.

10. 3/10/2003 Work Completed  Conducted extensive research on other treatment methods (to avoid short comings on our design)  Met with Dr. Doyle to discuss our progress and future goals  Have placed order for foam chemicals (will arrive by Wednesday)  Have ordered and received Nitinol memory wire in two different diameter thicknesses  Have secured an In-Vitro PDA Simulation device for testing

11. 3/10/2003 Foam Molds

12. 3/10/2003 Current Status  Making final design refinements to device  Developing life-size PDA device prototype  Developing equations to model PDA testing apparatus  Making arrangements with Mechanical Engineering professor to have Nitinol wire machined here at Vanderbilt  Completing Design Safe and Innovation Work Bench assignments  Making necessary modifications to website

13. 3/10/2003 In-Vitro Modeling Specs.  Pressure Drop : 100 mm Hg  Calculate flow inside PA using Hagen- Poiseuille Eqn.  Q = -ΔP *  *r 4 /(8*μ*L)  All variables are known, thus Q can be calculated easily

14. 3/10/2003 Needs  Obtain missing foam ingredient (PTMEG)  Make arrangements to machine Nitinol wire  Meet with Dr. Doyle to discuss further progress

15. 3/10/2003 Future Direction  Build scaled prototype with correct biomaterials  Figure out best way to secure Nitinol within device  Begin conducting pressure and durability tests in PDA simulated environment  Refine design based on testing  Talk with Dr. Doyle/Office of Technology Transfer about patenting this PDA Occlusion Device

16. 3/10/2003 Contact Information  David Brogan  david.m.brogan@vanderbilt.edu david.m.brogan@vanderbilt.edu  1-210-364-4546  Darci Phillips  darci.j.phillips@vanderbilt.edu darci.j.phillips@vanderbilt.edu  1-615-386-9015  Daniel Schultz  daniel.j.schultz@vanderbilt.edu daniel.j.schultz@vanderbilt.edu  1-615-421-6067