Team Members:Team Leader- Adam GoonBSAC- Mike ConrardyBWIG- Andrew BertramCommunicator- Joel Webb

Advisor- Professor John WebsterClient- 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

http://www.thefinalsprint.com/2007/02/heart-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

http://www.med.upenn.edu/mcrc/patel_lab/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

http://www.angiodynamics.com/pages/products/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

#2Guided

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/