Device to Improve Yield of Fine Needle Aspiration TEAM MEMBERS: Kristen Seashore Tu Hoang Anh Mai Chris Goplen Jason Tham CLIENT: Frederick Kelcz, M.D. Department of Radiology ADVISOR: Professor Mitch Tyler

Outline Background (Fine Needle Aspiration) Problem Statement Current Devices Competition Alternate Designs Design Matrix Future Work

Fine Needle Aspiration (FNA) Biopsy to remove tissue cells for testing Fine needle procedure (21 to 25 gauge) Performed on the following tissue types: –Neck lymph nodes –Neck cysts –Thyroid gland –Breast tissue –Any lump that can be felt 70-80% success rate Categories of results: –Benign –Malignant –Non-definitive

FNA Procedure Small needle inserted into suspected mass Needle moved in and out of tissue Pressure difference draws cells into needle Sample examined for abnormal cells Sample of about 100 cells average

Problem Statement Improve current FNA procedure –Single procedure –Reduce operating time and cost –Maximize tissue sample size –Minimize patient discomfort Create automated device –Precise needle oscillation –Suction cell removal Testing –Phantom tissues –Human testing

Current Devices Manual aspiration biopsy technique –Handheld needle with syringe for suction –Manually inserted needle –Multiple attempts to collect sample Current Biopsy Fine Needle

Competition Cameco Syringe Gun –Applies constant suction with specimen filter –Difficult to use and more expensive Vacuum Needle –Partial withdrawal creates suction Patented FNA Gun –Vibratory needle motion –No testing or marketing No device had advantage over manual method Cameco Syringe Gun

Design Constraints Performance Requirements Safety Standards and Reliability Accuracy and Repeatability Dimensions and Weight Ergonomics Shelf and Service Life

Design 1: Manual Mechanical Plunger manually drives needle shaft Linear spring causes plunger recoil and suction Hexagonal plunger rotation adjusts needle depth

Design 1: Pros and Cons Pros –Simple design –All motion is linear –Easy depth adjustment –Small size Cons –Manual –Not ergonomic

Design 2: Solenoid Two AC solenoids with DC solenoid in between DC solenoid movement drives shaft Electrical cord powers AC solenoids Rechargeable battery powers DC solenoid AC solenoid distance adjusts needle depth

Design 2: Pros and Cons Pros –All motion is linear –Adjustable needle depth Cons –Electrical safety –AC power cord required

Design 3: Wheel and Motor Motor turns wheel Wheel drives needle shaft Rechargeable battery powers motor Wheel radius adjusts needle depth

Design 3: Pros and Cons Pros –Easy to build –Common parts –Internal power source Cons –Oscillation not entirely linear –Depth difficult to adjust

Design Matrix Feature (possible points) Solenoid Manual Mechanical Wheel & Motor Ergonomics (10)867 Durability (6)364 Oscillation Adjustability (12) Repeatability (15)128 Accuracy (12)117 Patient Comfort (15) Cost (4)143 Safety (20)12816 Interface (6)525 TOTAL (100)766278

Future Work Finalize detailed design Order project materials Construct prototype Test prototype Re-evaluate design and modify Final presentation and delivery

References Damadian et al. “Method of Conducting a Needle Biopsy Procedure”. United States Patent No. US 7,008,383 B1: March 7, “Fine Needle Aspiration”. Medax Medical Devices: “Fine Needle Aspiration”. American Academy of Otolaryngology: “Fine Needle Aspiration Biopsy (FNA)”. Virtual Cancer Centre: Hopper MD, K. et al. “Fine-Needle Aspiration Biopsy for Cytopathologic Analysis: Utility of Syringe Handles, Automated Guns, and the Nonsuction Method”. Radiology: December 1992, ( ). Kelcz MD, Frederick. Department of Radiology. Mladinich DVM, MS, C. et al. “Evaluation and Comparison of Automated Biopsy Devices”. Radiology: September 1992, ( ). Suen, K. “Fine-Needle Aspiration Biopsy of the Thyroid”. Canadian Medical Association Journal: September 2002, ( ).