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Team Members: Team Leader- Adam Goon BSAC- Mike Conrardy BWIG- Andrew Bertram Communicator- Joel Webb Advisor- Professor John Webster Client- Tim Hacker, PhD Background Information Problem statement Design Requirements Stem cell injections Design Alternatives ◦ Balloon ◦ Multiple Needle ◦ Guided Design Matrix Proposed Design Future Work • Current research is being conducted injecting stem cells into dead heart tissue. • Research is done using pigs. • The catheter being used currently has a single needle on the tip and must be moved for every injection site. •2.7 mm diam, 27 gauge needle, 4 to 6 mm depth of needle • Current Devices • Myostar by Biosense-Webster •Stiletto by Boston Scientific Left Ventricle http://www.thefinalsprint.com/2007/02/hearthealth-and-marathon-running-preparation-is-key/ Time consuming Needle depth is inconsistent Flexibility ◦ Reposition the catheter ◦ Single injection ◦ Heart is beating ◦ Difficult to position http://www.med.upenn.edu/mcrc/patel_lab/ documents/LVCatheterUsingEtOHinSwineJICE. pdf Multiple, quick injection Small enough for arteries ◦ >1 injection per catheter location ◦ < 14 French diameter (4.66 mm) Flexible to get through aorta Consistent depth of needle Accurately position the device Inject contrast agent Take still image and mark contrast agent Insert injection catheter Determine placement and protrude needle Observe electrical activity of heart on ECG Insertion of needle causes increase in activity Wait for activity to stabilize Stop ventilator for injection Inject stem cells #1 Two layers Fills most of ventricle Simultaneously injects stem cells to large area ◦ Polyethylene Terephthalate ◦ Rubber tubing ◦ Needles attached to rubber exterior #2 Multiple needle catheter ◦ Preformed needle shape ◦ Single location ◦ Simultaneous injection Similar to an ablation catheter http://www.angiodynamics.com/pages/p roducts/starburst_talon.asp #3, 3 components Slotted outer component Track for guidance Inner needle injection catheter Outer component rests against apex of heart Use holes for multi-level injections using preformed curved catheter Cost (0.05) Time Reduction (0.30) Accuracy of Injection (0.30) Flexibility (0.05) Ease of Manufacturing (0.30) Total #1 Balloon 1 (0.05) 9 (2.7) 4 (1.2) 8 (0.4) 1 (0.3) 4.65 #2 Guided 5 (.25) 7 (2.1) 8 (2.4) 5 (.25) 4 (1.2) 6.2 #3 Multiple Needle 7 (.35) 4 (1.2) 6 (1.8) 6 (.3) 8 (2.4) 6.05 360o movement of exterior component Predetermined angle of injection Track moveable to different holes through handle ◦ Screw mechanism ◦ Full turn causes track to move to next hole Contact companies for guidance on development Finalize design of handle Improve consistency of depth of needle Create prototype and conduct testing http://www.madehow.com/Volume-6/Angioplasty-Balloon.html http://www.angiodynamics.com/pages/products/starburst_talon.asp Callans, D.J., Ren, J.F., Narula, N., Patel, V., Michele, J., Gelzer, A., Dillon, S.M. Left Ventricular Catheter Ablation using Direct, Intramural Ethanol Injection in Swine. Journal of Interventional Cardiac Electrophysiology, 6, 225–231. http://www.thefinalsprint.com/2007/02/heart-health-and-marathon-running-preparation-is-key/