LEC DEVICEGroup Members:

Kevin MihelcAmine Hallab

Jen BaciorHiroki Meguro

Advisors:Kelly Dympna, MD John Patzer, PhD

1 February 2005

Project Overview

• Intended Use: Open Liver Biopsy

• Combines 3 Functions1. Removal of Tissue

2. Cauterization

3. Biopsy Tissue Protection

LEC DEVICE

17 cm

Blades

2 cm

Individual Responsibilities

• Blade Redesign

• Testing Protocol

• Design History File Update

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

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

Testing Protocol (Cont.)

• Sterilization Test

-Multiple Autoclave Cleansings

• User Survey

1. Ease of Operation

2. Comfortableness

3. Comparison to Previous Biopsy Technique

Design History File

- Revise and Update DHF to ensure proper

representation of the LEC tool

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

•Mark Gartner

• Department of BioEngineering

•LEC Group Members

•John Patzer, PhD

• Kelly Dympna, MD

•Stephan Safta and Richard Miller

Acknowledgements