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

lumenXSensor 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)

Skin

Vein

Blood sample withdrawal

Catheter

Fluid delivery

• 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: Blood draw lumen

Channel for Embedding Optical Sensors

Sensor access dimple

Channel for embedding electrical sensors

Sensor access dimple

IV administration

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