3/10/2003

Patent Ductus Arteriosus Occlusion DeviceOral Presentation #3

Group 6David Brogan, Darci Phillips & Daniel Schultz

Advisor: Dr. Thomas Doyle

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

3/10/2003

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)

3/10/2003

Project GoalsTo 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

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

3/10/2003

Effect of Occlusion Device

3/10/2003

Our Design

3/10/2003

Delivery Path of Device

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.

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

3/10/2003

Foam Molds

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

3/10/2003

In-Vitro Modeling Specs.Pressure Drop : 100 mm HgCalculate flow inside PA using Hagen-

Poiseuille Eqn. Q = -ΔP * *r4/(8*μ*L)

All variables are known, thus Q can be calculated easily

3/10/2003

Needs

Obtain missing foam ingredient (PTMEG)

Make arrangements to machine Nitinol wire

Meet with Dr. Doyle to discuss further progress

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

3/10/2003

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