Team Members: Jon Klein Nguyen Vu Kyle Menges Christine Lowry Chris Stein Priya Narasimhan Julie Coggshall Pg.1 Meeting Timeline Start Time Topic of Review 10:00 Introductions, Review Agenda 10:02 Design Review 1 Action Items 10:03 System Design and BOM 10:15 Fluids Analysis – Electrical Simulation, Results 10:35 Blood Tank – Bubble Rise Time, Fluid Extraction 10:40 Water Bath – Heat Transfer 10:45 Tubing – Heat Transfer Automated Resistance - Linear motor’s force 10:50 approximation Compliance Tank – Arterial Tank Dimensioning, 11:00 Electrical Equivalent Model 11:15 Custom LVAD Connection 11:20 System Drain – Saline Flush 11:25 Pressure, Flow, and Temperature Sensors and DAQ 11:50 LabView Front Panel Concept 11:55 Wrap-up Pg.1 To review the detailed design proposal to ensure design adequacy. Pg.2 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 curve for dynamic system (scaled model of the physiological circulatory system working with a PVS) Pg.5 Item # Description Responsible Comments Valve and non-valve connections Calculated bubble rise time A001 Create Quick Connect Design IE-Jon A002 Reservoir Calculations – Air Bubbles ME-Nguyen A003 Temperature Control – Heating Tank, find out what changes are in the human body with regards to temperature? ME-Chris Heating element, water bath A004 Should we use the flow sensors Dr. Day has? EE-Priya Yes EE-Priya Use Bleed port ME - Kyle Automate clamp EE-Priya Do not need Ideal value ~2 mL/mm Hg, range varies for different diseases Disposable syringe, A005 A006 A007 A008 A009 Pressure Sensor Selection – are resolution, output format and frequency response appropriate? Will sensor trap blood? Select Resistance Generation Method – research automated clamp valve Compliance Tank Analysis – Do we need two tanks? Compliance Tanks – What are the clinical comparisons for the compliance values, what about different disease states. Blood removal - Look into self healing membrane. ME-Christine, Nguyen ME - Chris Pg.4 Engr Spec # Metric ES1 ES2 ES3 System Leakage Systemic Vascular Resistance Arterial Compliance ES5 ES6 ES7 ES8 ES9 Blood damage Portability Drain Time Fill Time Cost ES10 Blood System Volume ES11 ES12 ES13 ES14 ES15 ES16 ES17 ES18 ES19 ES20 ES21 ES22 ES23 ES24 Units Importance System Properties # leak locations 5 MPa·s/m3 5 mL/mm Hg 5 g Hgb/100 ml minutes minutes minutes U.S. Dollars 3 3 3 3 3 liters 3 Fluid Properties Viscosity N·s/m2 5 3 Density kg/m 5 Data Management Pressure mm Hg 5 Pressure Accuracy mm Hg 5 Flow Rate liters/minute 5 Flow Rate Accuracy liters/minute 5 Temperature degrees C (F) 5 Temperature Accuracy degrees F 5 Data Processing/Output seconds 3 Sample Extraction Sample Extraction Time seconds 3 Sample Extraction Size milliliters 3 Test Rig Physical Dimensions Height inches 1 Length inches 1 Width inches 1 Ideal Value Lower Limit Upper Limit 0 100 2 0 90 1 2 120 2.2 16 45 15 20 2000 12 1 5 5 1000 20 60 30 30 3000 1 0.5 3 For blood testing - Approximately $100/liter of blood 0.0027 1060 0.0005 800 0.0035 1500 Water at 37 C (.000653), Blood at 37 C (0.0027) Water at 37 C (992), Blood at 37 C (1060) 100 0.2 6 0.05 37 (98.6) 0.1 10 0 0.001 0 0.001 21 (70) 0.01 0 200 Current loop pressure sensors measure ±15 psi 0.5 10 Adult flow rate approximately 6 lpm 0.1 49 (120) 0.5 60 Time to process data into graphical representation 30 4 15 2 60 5 48 36 30 36 12 12 60 48 36 Notes Reflects the average range for human body at approximately 100 mm Hg fluid pressure Must be biocompatible to use and not damage blood How long it takes to prepare and actually move Somewhere between 2-5 ml "Cart size" Summary Number of 3's Risk Area Cost Risk Item Likelihood Severity (1-3) (1-3) 2 RPN Total 3 Severity Risk Priority Level Number Description/Comment Likelihood Pressure Sensors Desired sensor accuracy not within budget 1 2 3 Find suitable DAQ to achieve accuracy DAQ Dedicated DAQ system not within budget 3 2 6 Investigate costs, potential for sharing existing DAQ system Compliance Tank Desired compliance value not achieved 2 3 6 Early milestone in test plan to ensure enough time to fix the problem 2 Monitor fluid and VAD temperature, implement temperature control system 4 Research and verify the proper mixture of water/glycerin is used, control/maintain temperature Physiological Temperature Simulation Viscosity System temperature is not maintained Viscosity variation does not simulate human blood properties 1 2 2 2 Mitigation Activity Risk Area Risk Item Description/Comment Inaccurate Pressure and flow measurements are measurements inaccurate Likelihood 2 Severity Risk Priority Level Number 2 Mitigation Activity 4 Use proper instrumentation and verify proper placement. Discuss with experts prior to purchasing. 6 Debug software, document procedure for DAQ operation and troubleshooting. Discuss with experts prior to purchasing. 4 Early milestone in test plan to ensure enough time to fix the problem 2 Early milestone in test plan to ensure enough time to fix the problem. Use alternative fill method to reduce bubble formation Measurement Design DAQ Error Instrumentation and DAQ not communicating properly, DAQ does not collect or output data properly Leak System or components leak causing error in measurement and/or contamination Air bubbles Air bubbles cannot be removed from system – tank sizes do not allow for bubbles to escape, or there are low points in the system Valves, sensors, connectors damage Blood Damage blood Resistance Flow restriction does not function properly 2 2 1 3 2 2 3 3 9 Early milestone in test plan to ensure enough time to fix the problem. Put in separate, simplified loop 1 2 2 Design for the implementation of a back-up, manually controlled resistance method Severity (choose most severe) Risk Ranking Likelihood 3 Highly Likely > 50% 2 1 Product Complete product failure, does not function Meets some customer needs and Somewhat Likely specifications, product performs with less 20% - 50% functionality than desired Rare 0 - 20% Performance of product is not impacted Project Injury Complete project failure Severe injury, potential death Moderate impact to budget schedule Treatment required No impact to project budget or schedule Minor or no injury Likelihood Severity RPN Red 3 3 6 Yellow 2 2 3 Green 1 1 1 Score level to Change Color: Pg. 6-7 EW-30623-79 BOM 3/4" to 1/2" Polypro reducing coupling (PVS inlet) [McMaster] 3/8" NPT x 1/2" Barbed threaded tank fitting [Eldon James] Glycerin Tank - Barbed Tconnector (HDPE 1/2" x 1/2") [Cole-Parmer] 1" NPT x 1/2" Barbed threaded fitting for PVS (Nylon) [McMaster] Y connector [Eldon James] BOM Reducer 1 to 1/2 plastic (HDPE) into PVS/Reducer 3/4 to 1/2 plastic (HDPE) Out of PVS [Cole-Parmer] Glycerine Tank - Shut-off Valve (1/2" to 1/2" barb)[Eldon James] BOM Biocompatible Valve [Cole-Parmer] Biocompatible Non-valved [Cole-Parmer] BOM 10Qt [McMaster] BOM Dimensions: 43.9”L x 25.6” x 33.3”H Weight: 42.55 lbs. Sam’s Club Pg.8 Blood Loop Pg.9 Glycerin Loop Pg.10 -12 Voltage (pres s ure) at the arterial capacitor. (V) With venous capacitor Without venous capacitor Voltage (pres s ure ) at Current(flow the venous rate) in the capacitor (V) loop(A) Ris e time of the arterial capacitor (s ) Ris e time of the venous capacitor (s ) 96.61 3.41 6.64 0.0403 0.0727 96.36 0 7.13 0.0403 0.0000 Pg. 13-14 Properties & Equations: Assumptions: The assumptions that were chosen for the fluids analysis include: •Laminar Flow •Incompressible Flow •Steady State Summary: • Using the assumptions listed above, the head losses associated with diameter changes, connections and sections of tubing were analyzed •The steady-state assumption at the desired flow rate (6 L/min) for the Physiological Loop is assumed to be “worst-case” in regards to the head losses. The analysis proves that there is adequate flow and pressure within the system to allow for adjustments to be made through testing to compensate for the non-steady characteristics Pg. 15-17 Blood Loop Fluids Analysis Results (Q= 6L/min) hlT = 12893.8 in2/s2 P VAD Out = 100 mmHg (1.93 psi) P VAD In = 33.86 mmHg (0.65 psi) ∆P VAD = 66.14 mmHg (1.28 psi) Pg. 18-21 Physiological Loop Fluids Analysis Results (Q= 6L/min) hlT = 12893.8 in2/s2 P VAD Out = 100 mmHg (1.93 psi) P VAD In = 34.12 mmHg (0.65 psi) ∆P VAD = 65.88 mmHg (1.28 psi) Pg. 22-25 Fb Analysis: 2R The bubble will reach its maximum velocity when the acceleration is zero: mg Fd We calculated for a bubble of 0.5mm in radius. All the bubble with smaller size will take more time to rise. After calculation in Maple, we found that the time and distance for that the bubble reach its maximum velocity are negligible. So we can assume that the velocity of the bubble is constant with the value V=Vmax=0.213m/s. As a result, the traveled distance is represented as below: The distance is in meters, and the time is in seconds. BOM Stainless Steel [Mopec] Stainless Steel Lid [Mopec] BOM B-D Disposable Luer-Lock 5mL Syringe[Cole Parmer] Stainless steel cannula (13 gauge luer-lock) [Cole Parmer] BOM 10 Qt: [McMaster] Pg. 26-27 Screw-Plug Immersion Heater 304 SS, W/Temp Control, 120 Volt, 1000 Watts, 1" NPT Parts From: McMaster-Carr Submersible Pump for Water PET Plastic Housing, 1/40 hp, 115 VAC, 6' Cord Pg. 26-27 Tank Dimensions: Ø = 4.875” x 5.5” Ti T∞ q” Tw Tb r2 98oF Tw = = 310.15K Tb = 70oF (room temperature) = 294.26K Attempt w/ LCM (Lumped Capacitance Method) r1 Ti Pg. 26-27 Tank Dimensions: Ø = 4.875” x 5.5” Tw Tb Tw = 98oF = 310.15K Tb = 70oF (room temperature) = 294.26K Attempt w/ LCM (Lumped Capacitance Method) Results: •Time for the blood loop to heat less than 2 hours. •Show temperature rise will be less likely to damage the blood. BOM Tygon 1/2" ID tubing (S-50-HL Medical Grade) AAX00037 Tygon 7/8" ID tubing (S-50-HL Medical Grade BOM Stepless ear clamps [Oetiker] Double Snap-Grip Nylon Hose and Tube Clamp[McMaster] Pg.28-29 T∞=70oF Ti=98oF Tm=? y x Pg. 498 equation 8.37 Properties and Equation from Fundamentals of Heat and Mass Transfer 6th editions |<------L=50in------>| Particular Solution Assume Solution: Solution Homogenous: Now: Assume solution: Pg. 28-29 Temperature drop v.s distance 295 294.8 Temperture(K) 294.6 294.4 6 (L/min) 3( L/min) 294.2 Total Distance 294 293.8 293.6 293.4 0 1 2 3 4 Distance (m) 5 6 7 Pg. 30 Automated - linear actuator & stepper motor combination (Anaheim Automation) Back Up Manual Resistance Competitively priced, high resolution digital captive linear acutuators • Linear force up to 22.5 lbs (100N) • Linear step resolution of .001”, .002” and .004” • Unipolar and bipolar coil constructions • Fast, powerful and precise positioning • Precision radial ball bearing design • Industry standard frame size • Customized designs available Parallax BASIC Stamp 2 microcontroller (to control stepper motor) http://www.anaheimautomation.com/manuals/L010451%20%20TSMCA42%20Spec%20Sheet.pdf http://www.parallax.com/Store/Microcontrollers/BASICStampProgrammin gKits/tabid/136/CategoryID/11/List/0/SortField/0/Level/a/ProductID/294/De fault.aspx Pg.31 Arterial Tank: Acrylic 7.2in tall 8in OD 7.75in ID Bottom & Top: Acrylic 9in OD 0.236 thickness Bolts: Steel Hex Nut (1/4"-20, 7/16” width, 5/32" height) x8 Washer: Stainless Steel x8 Silicon O-Ring x2 Barbed Hose Fitting (Stainless - pressure regulator hookup) (53505K72) Quick-connect Air Hose fitting (3/8" NPT threaded) Low-Pressure SS CaseGauge +/-1% Accuracy 4" Dial, 1/4" NPT (McMaster) Cole-Parmer Pressure Regulator Resistance Calculations MeanArterial Pr essure MeanVenousPr essure L Pr essure m m Hg R Flow CariacOutput L min Source: Berne R. etal Physiology 4th edition Mosby, St Louis 1998 Tank size Calculations Complance C Vair=Volume of air in tank dVfluid dPfluid Vtank Atank h fluid Pfluid ghfluid Vair Pair = density of fluid Atank= Cross sectional area of tank g=Acceleration due to gravity Vtank=Volume of tank C= Compliance Pfluid=absolute pressure of fluid Pair=absolute pressure of air Source: University of Virginia Article, Design Initial testing of a mock human circulatory loop to test LVAD performance Pg. 32 Pg. 33 • Saline Flush Pg. 34 Sensitivity - 0.156V/liter Resolution – 7.8mV Flow sensor (Transducer+board digiflow-ext1 ) Specs Resolution Output format Max measurement Model's specs 1ml/min -5V to 5V Frequency 15kHz to 18MHz (transmitter frequency) Price Don’t need to purchase Pg.34 Sensitivity – 10mV/psi Resolution – 36.1µV Pressure Sensor (Omega PX26-005DV ) Specs Model's specs Output format (@10V) 50mV Price $36.00 Pg. 35 Thermocouple. (Omega - KMQSS-020G-12) Specs Model's specs Type Ungrounded Price $28.65 S 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Pg.35-36 Thermocouple DAQ (NI 9211A) Specs Resolution Number input pins Voltage range Sampling rate Price DAQ (OMB-DAQ-54) Specs Resolution Number input pins Voltage range Sampling rate Price Model's specs 22 bits (4.761µV/code) 10 single ended Per Channel 31mV to 20V 80 S/sec $649 Model's specs 24bit (9.54nV/code) 4 -80mV to 80mV 15 S/s (samples per secs) $521 Pg.11 N ?More needed ? 1 2 3 4 5 6 7 8 9 10 11 12 RISK Dedicated DAQ system not within budget Instrumentation and DAQ not communicating properly, DAQ does not collect or output data properly 6 6 13 14 15 16