Design of a Dual Port, Single Lumen Peripheral IV Catheter

1. University of Pittsburgh Senior Design – BioE 1160/1161 Design of a Dual Port, Single Lumen Peripheral IV Catheter Kelly Baron Erik Frazier Riley Smith April 18, 2005 Mentors: Sandra Gartner, RN Vorp Laboratories

2. Background • 90% of all patients admitted to hospitals for care are in need of some type of IV therapy • Two types of peripheral IV catheters are available on the market today • Single port, single lumen • Dual port, dual lumen (peripheral midline) • Single port, single lumen IV catheters are more commonly used • Cheaper • Easier to insert

3. Background • Single port, single lumen IV catheters only allow for either fluid delivery or collection • Blood is normally drawn from the patient’s arm opposite the IV line by sticking the vein with a needle each time • Patient discomfort from blood draw needle sticks is the most common complaint on Venipuncture Press Ganey Scores Better or Worse?

4. Project Goals • The key goal of our design is to decrease patient discomfort by eliminating the need for a new needle stick every time blood is drawn • This is not intended as new technology but rather a device to make the average hospital recovery experience less painful • Clearly, such a device must be comparable in cost to current IV catheters and must not require specialization for insertion

5. Design Specifications • Class II Device • Dual port design for fluid delivery and collection through the same lumen • Line flushing • May not be suitable for situations where interruption of drip is unacceptable • Cost-efficient • As easy to insert as single port, single lumen catheters on the market • Any nurse or technician on duty should be capable of using this improved design

6. Market and Economics • No significant change in price from single port IV catheters • Market size • $1.37B worldwide for IV infusion catheters • 10.2% growth last 5 yrs • U.S. Manufacturers dominate catheter industry producing 70% - 80% of catheters used worldwide Business Communications Co., Inc.

7. Quality System Considerations • Manufacturability • Simple Design • Rapid prototype • Manual fabrication using standard components Medex ® Optiva ® 18G, 1 ¼ in. • Luer locks identical to current single port, single lumen models • Human factors • Biocompatibility assurance • Ease of use

8. Initial Design Considerations • Originally a dual-lumen design was proposed • Allowed for simultaneous fluid delivery and blood draw through separate lumens • Too difficult to insert – sheath would be needed to ensure proper entrance into vein

9. Proposed Solution • Two ports, single lumen • One port for blood draw and one for delivery of IV fluids, or both for fluid delivery • IV fluid must be temporarily stopped for blood draw

10. 1.25 in 1.25 in Design Development Design 2.1 Design 1 Design 2.2 Design 2.3 2.25 in 2.5 in Design 3

11. Prototype Fabrication • Stereolithography and manual fabrication • Luer locks and hub • SLA silicone material - Accura SI 20 • ~10% more rigid than high-density polyurethane used in current IV catheters on the market • Acceptable for prototype testing • Material change to polyurethane for human testing/use • Lumen incorporated directly from product currently on market • Components “glued” together using UV epoxy

12. Experimental Methods • Functionality Testing • Prototype inserted into the “vein” of a medical training arm • “Blood” solution ran through tubes in the arm to simulate blood flowing through a vessel • “Blood” solution exhibits similar properties to those of human blood • Viscosity • Deep red color • “Blood” drawn with syringe through straight port of device for six trials

13. Experimental Methods (cont’d) • Pressure/Flow Rates • Prototype connected to Compact Infusion Pump, Pressure Transducer and Pressure Monitor • Flow rates at various infusion speeds determined by observing time needed to pump 5 mL solution through device • Peak pressure measured for three trials at each flow rate • Straight port • Curved port • Medex ® Optiva ® 18G, 1 ¼ in. Catheter • Compared data to that of current catheter on the market

14. Experimental Methods (cont’d) • Contamination of Collected Fluids • 10 mL 5% stock solution Coomassie Blue in H2O • Serial dilutions performed from 5% to 0% • Triplicate optical density (OD) measured for each dilution using a BioRad Microplate Reader (570 nm l) • 2.4 x 10-3 % determined maximum concentration capable of measurement • Two syringes connected to prototype leur locks • 2 mL max detectable concentration injected through curved port • 2 mL fresh H2O drawn through straight port • Flushed with 2 mL H2O • No flush • OD of drawn fluid determined and compared to 0% solution

15. Training Arm Results Successes • Insertion • Fluid Delivery • Blood Draw • Limitations • Prototype fabrication was not completely air tight, allowing air bubbles in blood draw sample • We have had no prior IV experience • Prototypes designed for single use, and were damaged after multiple insertions • Blood analog developed some aggregations in it, possibly due to improper mixing

16. Pressure/Flow Results Projected maximum fluid flow rate ~125 mL/hr = ~2.08 mL/min

17. Contamination Results With Line Flushing: 1.25 x 10-6 g/mL in “blood” sample No Line Flushing: 2.64 x 10-6 g/mL in “blood” sample

18. Competitive Analysis • Strengths • Cost-efficient • Equivalent to current single port, single lumen models (~$2) • Much less expensive than dual port, dual lumen catheters (~$8 + personnel cost) • Will not need to pay extra costs for insertion by specialized individuals • Easy to Insert • As compared with dual lumen designs inserted peripherally • Decreases patient discomfort experienced from numerous blood draws • Weaknesses • Medical staff resistant to change

19. Conclusions • Functionality testing yielded positive results • Easy to insert for experienced individuals • Medical grade production will decrease limitations • Air Tight • Smoother Surfaces • Standard Peripheral Components • Pressure/Flow – device capable of delivering necessary fluids • Line flushing will eliminate most contamination of fluids • Capable of fluid delivery and collection • If used properly, will decrease patient discomfort typically experienced from frequent blood draws

20. Future Work • Develop prototypes made of standard materials • Polyurethane luer locks • Additional experimental methods using blood or blood models • Animal testing • Make the device available in different gauge sizes

21. Work Breakdown • All group members participated in researching current devices in writing an SBIR Phase I Grant • Kelly and Erik: Mentor Correspondence, Material Ordering, Market Analysis, Powerpoint, Updated DHF and Gantt Chart • Riley: SolidWorks File and Prototype Fabrication/Correspondence

22. Acknowledgements Sandra Gartner, RN, MSN Tim Maul, BS Alejandro Nieponice, MD David Vorp, PhD The Swanson Institute Mark Gartner, ME Jeff Graybill, BS Generous gift of Drs. Hal Wrigley and Linda Baker that made this work possible University of Pittsburgh Department of Bioengineering

23. Questions?

24. Reynolds Number Re= r*D*v /m v= Q/A=125mL/hr*(1 hr/ 3600s) /((0.048cm)2*p) = 4.797 cm/s r= 1g/cm3 D= 0.096 cm m= 1 cp= 1/100 *g /cm-s Re= 4.797 cm/s * 1 g/cm3 * 0.096 cm / (1/100 g/cm-s) = 46.1 Laminar Flow