PHIL MATTA, DAVE GOLDMAN, MEGAN PETERSON, HUY NGUYEN, NATE CHAMBERLAIN, KWAKU OPOKU

Department of Biomedical Engineering, Institute of Technology

ABSTRACTThe Ablatech Tumor Ablation Delivery System (TADSystem) is a device that uses Direct Current (DC) Ablation (or elecrochemical therapy) to cause tissue necrosis of fibroadenomas and lipomas. DC Ablation technology employs the basic principles of electrolysis, which causes creation of hydrogen ions and hydroxyl ions at an anode and cathode, respectively.The TADSystem consists of a delivery device made out of two steel halves insulated from each other using cyanoacrylate . A conical tip is attached to make a needle. The needle was then insulated using polyolefin shrink wrap material leaving regions which act as electrodes. The needle is connected to a treatment generator. A dosing algorithm coded into the generator logic circuit determines the charge required to destroy the volume of tissue entered by the physician. The resulting algorithm provides equal treatment times for tumors of the same volume regardless of their type.

   INTRODUCTION

FIBROADENOMA•Fibroadenomas are the most common benign breast tumors & are made of glandular and fibrous tissue. •Fibroadenomas range in size from 1cm to 5cm.•There are 700,000 tumors annually.

LIPOMA•Lipomas are benign tumors found underneath the skin or in the muscle.•Can occur anywhere on the body but most common on the torso, neck, upper thighs, upper arms and armpits.•Lipomas range in size from 1 cm to 3 cm.•There are 3 million lipoma tumors annually.

DC ABLATION•Electrolysis of water. •Generates H+ ions at the cathode & OH- ions at the anode.•Tumor cells die from pH extremes.•Dead cells are removed by body’s defense system.

Cathode: H20 - 2e- ½ O2(g) + 2H+

Anode: H20 +e- ½ H2 + OH-

MATERIALS & METHODSDELIVERY DEVICE

SURGERY CRYOABLATION

DC ABLATION

Apprehensions Large Size Small Size

Scarring Poor Ergonomics Minimal Scarring

Vasculature Issues Better Ergonomics

Ease of Use

Low Cost

Lipoma

EBA

DC

A. Stainless steel needle milled to halfB. Steel halves coated epoxy insulationC. Two needle halves glued together using epoxy resinD. Tip machined and needle insulated revealing electrodesE. Needle with handle attached

NEEDLE/MILLING PIC

Confirm/Cancel

Prompt for Tissue Selection

Fibroadenoma SelectedLipoma Selected

Display Treatment Time and Prompt To Start

Confirm/Cancel

Prompt for Volume Input

Initialize and Start Treatment

Cancelled

Cancelled

GENERATOR

TREATMENT ALGORITHM

INSERTION FORCE “KILL ZONE”TESTING

Lipoma-Control Porcine

Fibroadenoma-Control Porcine

Lipoma-Experimental Porcine

“Kill-Zone”

Fibroadenoma-Experimental Porcine

“Kill-Zone”

CONCLUSION•Controlled treatment was achieved using algorithm•Diffusion patterns are fairly well-defined •Needle insertion force is enough to pierce tissue without causing any damage to the needle•Epoxy resin glue bonded needle halves: Lap Shear test•Well insulated regions provide electrodes

FUTURE•Reduce needle size: Could eliminate incision•Use platinum as needle material•More reproducible machining •More testing with algorithm•Testing in actual tumor tissue•Polymer coating for insulation

ACKNOWLEDGEMENTS•Advisors: Kai Kroll and Tom Nelson, Oncostim Inc.•Dillon and Stephan, MDC•Dr. Steven Saliterman: Pure genius•Rob: Coerced us into doing testing•Megan’s mom and little brother Josh•Huy’s girlfriend: Palatable logo•Nate’s Molly•Phil’s Dad and wife: She gave me rides home•Dave’s…well Dave’s awesomeness and use of his lab

NEEDLE BUCKLING TEST

LAP-SHEAR ADHESIVE TEST

Picture/Schematic of entireDevice/possibly in use