1. 4/11/2003 Patent Ductus Arteriosus Occlusion Device Oral Presentation #4 Group 6 David Brogan, Darci Phillips & Daniel Schultz Advisor: Dr. Thomas Doyle

2. 4/11/2003 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 20,000 babies/year in USA alone  Many adverse effects  growth retardation, breathlessness or lack of appetite  Most common problem is congestive heart failure

3. 4/11/2003 Current Treatments  Drug therapy (indomethacin)  Implantable devices (most common are coils)  Usually need 3-4 coils  Difficult to remove and reposition  $65 a coil  Invasive surgery (ligate the PDA to inhibit blood flow)

4. 4/11/2003 Current Best Competitor  Amplatzer Duct Occluder  Most effective  Highest success rate of current devices  In final stage of FDA approval  Drawbacks:  Not pliable  PDA must conform to shape of ADO  $2500

5. 4/11/2003 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

6. 4/11/2003 Effect of Occlusion Device

7. 4/11/2003 Our Current Prototype

8. 4/11/2003 Delivery Path of Device Location of Occlusion Device

9. 4/11/2003 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 Lyonell and are awaiting shipment on the PTMEG.  Contacted PTG about prototyping and building the polyurethane foam.

10. 4/11/2003 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. 4/11/2003 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

12. 4/11/2003 In-Vitro Modeling Specs.  Pressure Drop : 100 mm Hg  Calculate flow inside PA using Hagen- Poiseuille Eqn.  Q = -ΔP *  *r 4 /(8*μ*L)  r = 2-10 mm  All variables are known, thus Q can be calculated easily

13. 4/11/2003 Needs  Obtain missing foam ingredient (PTMEG)  Meet with Dr. Doyle to discuss further progress of device past this semester  Confirm a partnership with PTG to have working/actual prototype manufactured

14. 4/11/2003 Future Direction  Build scaled prototype with correct biomaterials  Figure out best way to secure Nitinol within device  Finish conducting pressure and durability tests in PDA simulated environment  Refine design based on testing

15. 4/11/2003 Recommendations  Much depending on the outcome of the next two weeks  If we were to conclude at this exact moment in time, we would recommend…  Follow-up on patent  We have discussed applying for a preliminary patent with Brian Cox and Dr. Doyle  Preliminary Patent needs to be filed by April 22, 2003  Continue with PTG arrangements  Non-Disclosure agreement in the works with PTG  Further strength and pressure tests  Refine design one final time

16. 4/11/2003 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