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Patent Ductus Arteriosus Occlusion Device Oral Presentation #4

Patent Ductus Arteriosus Occlusion Device Oral Presentation #4. Group 6 David Brogan, Darci Phillips & Daniel Schultz Advisor: Dr. Thomas Doyle. Patent Ductus Arteriosus (PDA). Ductus arteriosus (DA) allows blood to bypass pulmonary and enter systemic

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Patent Ductus Arteriosus Occlusion Device Oral Presentation #4

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

  2. 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 4/11/2003

  3. 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) 4/11/2003

  4. 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 4/11/2003

  5. 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 4/11/2003

  6. Effect of Occlusion Device 4/11/2003

  7. Our Current Prototype 4/11/2003

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

  9. 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. 4/11/2003

  10. 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 4/11/2003

  11. 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 4/11/2003

  12. In-Vitro Modeling Specs. • Pressure Drop : 100 mm Hg • Calculate flow inside PA using Hagen-Poiseuille Eqn. • Q = -ΔP * p*r4/(8*μ*L) • r = 2-10 mm • All variables are known, thus Q can be calculated easily 4/11/2003

  13. 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 4/11/2003

  14. 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 4/11/2003

  15. 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 4/11/2003

  16. Contact Information • David Brogan • david.m.brogan@vanderbilt.edu • 1-210-364-4546 • Darci Phillips • darci.j.phillips@vanderbilt.edu • 1-615-386-9015 • Daniel Schultz • daniel.j.schultz@vanderbilt.edu • 1-615-421-6067 4/11/2003

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