1. Team Members: Joe Bothwell BWIG IT Ryan Fischer Communicator Brant Kochsiek Team Leader Brian Schwartz BWIG David Ugai BSAC Dan Carlson BSAC

2. Client: Venkat K. Rao, M.D., MBA Division of Plastic Surgery UW Medical School Advisor: Naomi C. Chesler, Ph. D Biomedical Engineering

3. A device to fill silicone breast implant bags with 300-500 mL saline without exposing the saline to the environment is desired. Currently, 60 mL syringes are used to fill 300-500 mL breast implant bags. Syringes are filled from a bowl. The proposed solution is to utilize a peristaltic pump attached to a syringe to dispense saline into the bag. ABSTRACT

4. PROBLEM STATEMENT The goal of this project is to develop a breast implant device for filling implants with saline solution after they are inserted into the patient. This device should dispense saline accurately (+/- 3 mL) and quickly (less than five minutes).

5. Background Insert silicone implant bag in patient Fill implant bag with saline solution Currently use 60 mL syringes to fill Must refill syringes several times to fill implant bag Syringes refilled with saline from large bowl Slow process and open to atmosphere

6. MOTIVATION The current technique is slow and tedious due to the refilling of the syringes. The filling of the syringes from a bowl of saline is open to the environment Prone to human error

7. Product Design Specification Dispense 300-600 mL of saline in 2-3 minutes Closed system Easy use / small to fit next to surgeon Dial in volume of saline to be dispensed Precise dispensing (+/- 3 mL) Dispense with pressures greater than 500mmHg

8. Design Alternatives Klein Pump Masterflex Pump Pressurized IV Bag with Flow Meter

9. Masterflex Pump 2 channel, hi-flow pump by Cole Parmer Cost of $1,325.00 Maximum flow of 3400 mL/min Automatic shut off after designated volume is dispensed Fully reversible User friendly interface

10. Klein Pump Available through Dr. Rao and the UW hospital (Cost $0) Variable flow rates Must reverse tubing through pump to change flow direction

11. Pressurized IV Bag with Flow Meter Depends on mechanical force of pressure Direct Reading Series DR DR100212 flow meter Cost approximately $400.00

12. Design Matrix Klein PumpMasterflex Pump Pressurized IV Bag with Flow Meter Simplicity 7103 Time Needed 8106 Size of Device 779 Precision of Filling Bag 5108 Price 1024 Reversible 7100 Total444930

13. Chosen Design Masterflex L/S Drive EW-07523-60 pump Automated system to deliver exact volumes at precise flow rates, as specified by our client

14. Current Design Our client feels it is best to go with the UW-Hospital’s Klein peristaltic pump, because of funding complications with the Masterflex pump The Klein pump is not automated, and without further funding this requirement cannot be satisfied

15. Future Work Purchase Masterflex Pump Adapt pump to tubing, implant, and syringe Perform experiments to ensure quality results Train staff on use of the pump Test on human subjects Compose an easy-to-use manual

16. References Venkat K. Rao, MD, MBA, Professor of surgery, UW Medical School Naomi C. Chesler, Ph. D, Biomedical Engineering, UW Madison Juan Ayala, Technical Support, Cole Parmer Instruments, www.coleparmer.comwww.coleparmer.com Scott Kephart, local sales representative, Gilson, www.gilson.com www.gilson.com Traci Bretl, RN, Outpatient Surgery Materials Management Supervisor, UW Hospital