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Practical and Engineering Considerations in Catheter-based Aortic Valve Development Robert F. Wilson, M.D. University of Minnesota Percutaneous Valve Design Requirements Deliverability Delivering the valve to the valve orifice Deployability Accurately deploying the valve in the valve orifice Stickability Designing the valve to adhere to the valve orifice Functionality Valve functions as a one-way valve for the orifice Durability Valve retains function and position for the desired lifetime Delivery Size (!) Delivery system diameter determines delivery options Normal adult human vascular dimensions: Femoral artery averages 4.5-7.6 mm in diameter (14-24 Fr) Femoral vein averages 10 mm in diameter (31 F) 5-7% of patients with a 9.5 Fr IABP develop limb ischemia Packing size:“putting 5 gm in a 2 gm bag” A 21 mm cuff has a circumference of 66 mm A 19 mm valve diameter as a circumference of 60 mm Available Internal CSA Based on Guide Catheter Outer Diameter Delivery catheter internal CSA (assuming wall thickness = 0.28 mm) 10 F 6.60 12 F 9.73 14 F 13.59 16 F 18.09 18 F 23.24 20 F 29.03 22 F 35.43 24 F 42.31 Available valve material Stent thicknesses range from: 0.002 to 0.010” Pericardial thicknesses range from: Bovine 0.012-0.014” Porcine 0.007-0.008” Equine 0.006-0.007” SIS 0.002-0.003” Packed CSA for Valve Tissue Packed CSA for Valve Cuff or Stent Packed valve CSA v. Delivery Catheter CSA Big Delivery Catheters = Big Problems Many percutaneous aortic valves under development require delivery catheters 20 Fr. This necessitates: a transvenous-trans-septal approach or a high level of peripheral vascular complications Approaches to reducing delivery size Find thinner valve leaflet material Equine pericardium SIS (intestinal mucosa) Nano skeleton with “seeded” valve tissue “Extrude” the valve HLT Valve: 15.5 Fr Delivery System Percutaneous Valve Design Requirements Deliverability Delivering the valve through the valve orifice Deployability Accurately deploying the valv
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