Pulmonary Embolism Extraction Catheter Development Trip Cothren Lauren Nichols Dustin Temple Advised by: Dr. Michael Barnett, VUMC Cardiology
Problem There are over 600,000 cases of pulmonary embolisms annually in the United States, which result in nearly 60,000 fatalities. Systemic thrombolytics can be dangerous Is there a catheter solution that can quickly remove PE in the hospital setting?
Thrombolytics Medicine used to dissolve blood clots Risk of bleeding in other organs Vascular injury at injection site Great risk of stroke in the elderly Elderly is our target population
Goals The goal of this project is to design a catheter that can efficiently remove an embolism from the pulmonary artery. The main goals of the project are: To research and evaluate current technology in pulmonary embolism extraction To design a catheter that can successfully remove embolisms percutaneously and completely without damage to the patient To produce a feasible prototype of our design
Our Design Combined ideas from multiple existing medical products Inferior vena cava filter Absorbable hemostat Local clot busting drug administration Security from multiple backups
Filter Based off inferior vena cava filter Umbrella-like device Expandable to various sizes Combined to reduce stress on vessel wall
Surgicel or Gelita Material that attracts clots Coat prongs of filter Oxidized cellulose polymer Used clinically for over 50 years Coat prongs of filter Prevent clots pieces from going downstream Made by Ethicon
Trellis Catheter Device Inflatable back-end “clot-catching” device Local drug delivery Use of guide wire
Preliminary CAD
Design Length of 2m Stainless steel guidewire diameter of 0.75mm Silicone sheath Outermost diameter of 6F (2mm) Titanium basket Surgicel coated on basket prongs
Procedure Clot localized with x-ray angiography Catheter inserted through femoral vein Procedure time less than 1 hour Basket device pushed through clot, then sheath removed and basket expanded tPA locally administered and catheter pulled back out with clot pieces attached
Cost of Comparison Devices Trellis Device $2095 for complete device AngioJet $38,000 for drive unit $650 - $2050 for disposables (catheters)
Price Item Description Amount Needed Price Price/Instrument Surgicel Matrix for platelet adhesion 1 - 0.5''x2'' piece 273.4/piece 22.78 Guidewire Stainless Steel Wire 2 m, 0.75mm diameter 13.99/300in 3.73 Catheter Sheath Silicon Tube 2 m, 2mm diameter 0.2/ft 1.3 Drug Eluting Sheath 2 m, 1mm diameter Basket Titanium 150 mm, 0.1mm 27/25ft 0.54 Raw Material Cost 29.65
Potential Problems Hemolysis causes release of adenosine when cells lyse Bradycardia or heart failure Renal failure Unpredictable thrombolytic tolerance Mechanical damage to vessel wall
Future Work Refine model using Pro Engineer or AutoCAD Further work with prototype DesignSafe
References http://www.medgadget.com/archives/img/sidcath.jpg http://www.socalcardiology.com/media/angiojet.jpg http://www.lexmed.com/images/cathphoto2.jpg