1. 2/14/2003 Patent Ductus Arteriosus Occlusion Device Oral Presentation #2 Group 6 David Brogan, Darci Phillips & Daniel Schultz Advisor: Dr. Thomas Doyle

2. 2/14/2003 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. 2/14/2003 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. 2/14/2003 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. 2/14/2003 Effect of Occlusion Device

6. 2/14/2003 Our Design

7. 2/14/2003 Delivery Path of Device

8. 2/14/2003 Foam Issues  We can make a polyurethane foam with methylene bisphenyl diisocyanate (MDI), polytetramethylene glycol (PTMEG), 1,4-butanediol and water.  In touch with chemical engineering professors at Vanderbilt.  Also looking to make corporate contacts.

9. 2/14/2003 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  Locating a company from which to purchase chemicals.  Have ordered Nitinol memory wire in two different diameter thicknesses  Have secured an In-Vitro PDA Simulation device for testing

10. 2/14/2003 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

11. 2/14/2003 Needs  Obtain missing foam ingredient (PTMEG)  Make arrangements to machine Nitinol wire  Meet with Dr. Doyle to discuss further progress

12. 2/14/2003 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

13. 2/14/2003 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