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 Information 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 The Sensor IV device is patent pending, but has made it past the examiner and is just waiting on a number (Application No. 10/137,186) (Status can be seen by searching patent website for the above application number)

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 estimated manufacture price is 8$ These are just costs for the needle there will be a control until as well that will be leased

Parameters for Modeling Venous blood velocity (48 mm/sec) IV drip rate (20 cc/hour) Blood draw rate (7ml/180sec) Viscosity (3.75 cP) Venous inner diameter (2.4 mm) Catheter inner diameter (1.3 mm)

Current CFD Work

Physical Model Materials

Physical Model Setup

Up Coming Work Complete Design Safe work Obtain quantitative information from Dr. Quinn Work with computational model to find a numerical solution for the x-distance and work to change the actual lumen geometry Now that we have the physical modeling working we’ll use the catheter and a dual needle setup to start collecting data