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

Left Ventricle health-and-marathon-running-preparation-is-key/ 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

 Time consuming ◦ Reposition the catheter ◦ Single injection ◦ Heart is beating ◦ Difficult to position  Needle depth is inconsistent  Flexibility documents/LVCatheterUsingEtOHinSwineJICE. pdf

 Multiple, quick injection ◦ >1 injection per catheter location  Small enough for arteries ◦ < 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 ◦ Polyethylene Terephthalate ◦ Rubber tubing ◦ Needles attached to rubber exterior  Fills most of ventricle  Simultaneously injects stem cells to large area

 #2 Multiple needle catheter ◦ Preformed needle shape ◦ Single location ◦ Simultaneous injection  Similar to an ablation catheter 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

 360 o 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

   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. 