Advisors: Gary Byram, Ph.D. MedTG Needle Design Steve Harris Adam Travis Brett Byram Group #15 Advisors: Gary Byram, Ph.D. Paul King, Ph.D., P.E.

Problem Patient IV injection and blood sampling => multiple needle sticks Excessive waste, biohazard Psychological damage, trauma Time spent acquiring, lab time – for each stick Many needle sticks, increased infection risk

Solution? Combined needle design, multi-lumen Multifunctional: venous sensors, blood drawing, and injection Valves & Ports Multi-lumen catheter Blood draw lumen IV administration lumen X Sensor access orifices

Why not just turn off the IV fluid draw blood and turn the IV fluid back on? Most RNs will not allow an IV to be shut off without direct consent from the doctor In order to get clean draws with a syringe the blood must be drawn on the opposite side or in a more peripheral location Using a vacutainer on an IV needle sucks up IV fluid as well as blood.

Device Function Sensor-IV catheter placed into peripheral vein (brachial veins) Sensor-IV allows IV fluid administration or blood drawing WITHOUT re-sticking a new needle

Device Function Proximal end: micro-valve and pump system allows continual injection while drawing blood 4 lumen: Lateral sensors allow real-time blood monitoring Blood draw lumen can also function as IV administration lumen

Device Attributes Disposable after 4-7 days of use (based on existing catheter lifetime) No added safety concerns in comparison to traditional catheters Reusable pump unit Device physical properties are similar to standard needle/catheter Movement effects are unresearched

Patent Search Double lumen catheter for dialysis (6,666,842) Constant inflow and outflow Inserted in a peritoneal cavity Triple lumen catheter (5,195,962) Lumens for extraction and return Third lumen may be used for drug delivery

Market Size According to a recent study completed in 2001 the disposable medical device industry is about 48.6 billion dollars a year. Catheters and other infusion devices make up approximately 39.1% of this market. Information obtained from a study done by Freedonia

Needle Costs The target price for the needle is 20$ The controller would be leased on a monthly basis target lease price would be 40$/month (the controller is reusable). The estimated manufacture price is 8$ per needle and 150$ per controller

Plan of Attack Computational Model: CFD software Physical Model: testing, rough design

Parameters for CFD Model Venous pressure (1.5 kPa) IV pressure (to be defined) Venous inner diameter (2.4 mm) Catheter inner diameter (1.3 mm) Research other parameters as needed

Initial CFD Work

Proposed Schedule February- Begin computational model and begin to obtain materials for physical model February – March: refine design parameters, continue testing April: finish design, prepare presentation

Up Coming Work Refine Computational Model now that we have developed fundamental skills Obtain information from Dr. D. Quinn regarding specific catheter safety concerns Possibly make a trip down to Huntsville to visit CFDRC for a product demo Obtain catheter for physical model