Jon KleinISEProject Manager Nguyen VuMETechnical Lead (MSD1) Kyle MengesMETechnical Lead Christine LowryMEDesign Engineer Chris SteinMEDesign Engineer Priya NarasimhanEEElectrical Engineer Julie CoggshallISESystems Engineer

Customer Needs Top 10 Specifications Static Subsystem Concept Hemolysis Design and Testing Automated Pressure Curves Design and Testing Physiological Sub-System Concept Physiological Design and Test Results Project Evaluation

Design and build a test loop to help in LVAD development by characterizing the pressures and flows associated with the device as well as its impact on blood. 1.Generate pressure and flow curves for static system (automatically adjusted) 2.Extracting fluids while running to determine damage to blood 3.Process data to generate pressure and flow for dynamic system (scaled model of the physiological circulatory system working with a PVS)

Engr Spec #MetricUnitsIdeal Value Lower Limit Upper Limit ES1System Leakage# leak locations002 ES6Portabilityminutes45160 ES9Cost * Renegotiated from MSD1 U.S. Dollars ES13Pressuremm Hg ES14Pressure Accuracymm Hg ES15Flow Rateliters/minute6010 ES16Flow Rate Accuracyliters/minute ES17Temperaturedegrees C (F)37 (98.6)21 (70)49 (120) ES18Temperature Accuracydegrees F ES22System LxWxHinches48x36x3036x12x1260x48x36

Concept Summary LVAD (A) Reservoir (B) Flow Sensor (C) Automated/Manual Resistance (D) Quick-Connect Drainage (E) Differential Pressure Sensor (F) Water Bath (G) Thermocouple (H) Extraction Needle (I) Circulation Pump (J) Heating Element (K) D C A B J H E G I K F Direction of Flow

Automatically generated performance curves

Less modular design than intended – but still meets specs

The test loop does not cause significant hemolysis

Arterial Air Pressure (G) Reservoir Temperature (H) Arterial Compliance tank (I) Arterial Pressure Sensor (J) A B D G E F Flow Sensor – Full Loop (A) Resistance (B) PVS (C) Flow Sensor – LVAD Bypass (D) Differential Pressure Sensor (E) LVAD (F) H J I C Direction of Flow

Arterial tank pressure decay = 0.8 mmHg/sec Sufficient pressure is supplied by pressurizing the tank to prevent the ventricle of the PVS from collapsing Initial Compliance value = 50 mmHg/mL (based on 2550 mL of air and 30 mmHg air pressure) To achieve a Compliance value = 2 mmHg/mL the arterial tank should be filled with 3700 mL of fluid and pressurized to 100 mmHg.

Successfully Fulfilled all Customer Needs Met 15 out of 20 Specifications including Budget - Did not verify arterial compliance and Temperature – behind Schedule - Did not obtain performance using Glycerin mixture – behind Schedule - Accuracy of Temperature and Flow rate were not well defined in initial development of specifications – meets customers needs Investigate the need for automated temperature control when performing tests Verify Compliance using PVS and LVAD ~ 2 mmHg/mL Automate Compliance tank pressurization Verify program compatibility with multiple pressure sensors and flow meters Verify the effect of pressure drop using a quick-connect during LVAD performance characterization Increase the range of the automated test curves Reduce test loop footprint Improve fill/drain system to reduce set-up and take- down time

The P09021 Team would like to express its appreciation and gratitude to those who contributed to the progress of this project including: Dr. Steven Day Mr. John Wellin Dr. Richard Doolittle Dr. Daniel Phillips Mr. Robert Kraynik Dr. Olles, Dr. Cheng, Dave, Jim, Steve, Jess and the LVAD Research Team