1. LEC DEVICE Group Members: Kevin Mihelc Amine Hallab Jen Bacior Hiroki Meguro Advisors: Kelly Dympna, MD John Patzer, PhD 1 February 2005

2. Project Overview Intended Use: Open Liver Biopsy Combines 3 Functions 1.Removal of Tissue 2.Cauterization 3.Biopsy Tissue Protection

3. LEC DEVICE 17 cm Blades 2 cm

4. Individual Responsibilities Blade Redesign Testing Protocol Design History File Update

5. Secondary Blade Design Remove Closed Faces 1.Facilitate Easy Removal of Tissue Sample 2.Simplify Fabrication Process Round Triangular Edges 1.Wedge Point is difficult to cauterize 2.Simplify Fabrication by removing joints

6. Testing Protocol Preliminary Testing Using CosmosWorks - Examine stresses subjected on device Discarded Livers from Animal Research Study 1.Cutting Ability 2.Cauterization Effectiveness 3.Cauterization Time 4.Heat and Current Protection

7. Testing Protocol (Cont.) Sterilization Test - Multiple Autoclave Cleansings User Survey 1.Ease of Operation 2.Comfortableness 3.Comparison to Previous Biopsy Technique

8. Design History File - Revise and Update DHF to ensure proper representation of the LEC tool

9. Upcoming Milestones Functional Computer Prototype – 2 weeks Submit for Fabrication – 2 weeks Full Testing Completed – 4/7/05 Revised Design History File – 4/7/05

10. Mark Gartner Department of BioEngineering LEC Group Members John Patzer, PhD Kelly Dympna, MD Stephan Safta and Richard Miller Acknowledgements