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Developing a Cardiovascular Model. James Clear Chase Houghton Meghan Murphy. Problem Statement. No all-purpose cardiovascular model is currently commercially available. Models are made for testing of a particular device exclusively
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Developing a Cardiovascular Model James Clear Chase Houghton Meghan Murphy
Problem Statement • No all-purpose cardiovascular model is currently commercially available. • Models are made for testing of a particular device exclusively • No in vitro model exists for physicians to learn and visualize cardiac procedures • Current model exists from last semester but has design flaws and performance shortcomings
Problem Statement: Current Devices • Patented model for fatigue testing of prosthetic tricuspid valve replacements. Model applies pressure on valve to mimic in vivo forward and backflow gradients. • Agar gel model with characteristics of biological tissue used to model left ventricular and aortic chambers. Ultrasound imaged flow dynamics through bicuspid valve. • Model testing ventricle assist devices pumping performance and quantifying flow dynamics. Resistance comparable to native heart present. • Patented teaching model for complex cardiac surgery including repair of congenital heart defects. Clay open system model with detachable colored tubes.
Previous Design Emptied by lifting model Leaking joints Anatomically incorrect heart Size and weight of base- not portable Design flaws to be addressed: Not easily drained, model leaks, heart itself is not anatomically correct, not portable, no flow gradient
Performance Criteria • Cardiovascular Model Specifications • Water tight • Portable • Anatomically representative • Pulsatile flow • Aesthetically pleasing
Primary Objective It is the purpose of this team to use the previously established model as a foundation for developing a heart model of the inferior venous flow for testing intracardiac procedures including stent and catheter delivery.
Specific Device Objectives • Our device has been designed to: • Demonstrate catheters used as optical scopes in the heart • Proof of concept for this scope device for potential investors • Demonstrate Swan-Ganz catheters used to measure blood pressure in the heart • Perform right heart catheterization- measure pressures in the heart • Demonstrate catheter delivery to intended site using sail on catheter tip • Illustrated in model by water flow under pump generated pressure gradient
Solution Description: Adaptations to Current Design • Remove upper half – decrease size, increase portability • Connect metering bellows pump to simulate blood flow through veins • Flow rate: 1.6 L/min • Pressure gradient: .2 psi • Acrylic tubing – can withstand high impact stress, high clarity • Acrylic dichloroethyleneglue – welding joints • Catheter access point– for entry of catheter and prevent back flow, collecting basin for any water loss
Goals • This model will: • Be a useful, anatomically accurate tool for physicians and medical device companies • Preliminary tests for devices • Instructional use for physicians • Be portable in order to transport
Factors • Cost • Materials • Pipes, connectors, valves, heart casing • Labor/Machining • Quality • Design of the new model • Size, portability, water tight, aesthetically pleasing • Benefits • Layout and modularity/size of model
Performance Metrics • Outcome measurements • Ability of devices to be effectively used on the model • Catheter manipulation, stent delivery, intrarticular device mobility • Ability to transport easily and set up quickly • Water retention • Anatomical accuracy
Portable and quickly assembled Easily Viewable Aesthetic Experiment Block Diagram Test Model Functionality Refine Design features to implement functions Closed Circuit FINAL DESIGN Hinge Heart Pump No Leaks Determine heart functions to mimic
Design • Dimensions • Inferior Vena Cava – 1 in interior Diameter (avg. diameter 20 mm) • Femoral Vein- .5 in interior Diameter (avg. diameter 10 mm) • Solid acrylic tubing welded at joints with dicholoethylene glue • Metering bellows pump • Approximate geometry of the heart • Self healing polymer for model septum • Fit inside carry on luggage • 22” x 14” x 9”
Synthesis—System and Environment www.cvcu.com.au/images/cv_torso.jpg
Model Heart http://medical-dictionary.thefreedictionary.com/bioprosthetic+valve
Device Functions and Specs • Visualize catheter movement through device • high clarity acrylic tubing • Water tight venous system • acrylic dicholoethylene glue • Anatomically correct venous flow • Metering bellows pump- .2 psi, 1.6 l/min • Anatomically correct heart • Casted with clear flexible urethane
Design Specs • Acrylic Tubing • Ober-Read SP80-30 bellows metering pump • Max 2.1 L/min flow rate • Dichloroethylene glue • Trocar– for inserting devices into pressurized model
Progress & Future Direction • Experiment with tubing to determine joints, especially 180 turn • Acrylic Tubing shows potential for welding joints • Dicholoroethylene glue shows potential for sealing joints • Form negative of heart cast using heart model; determine geometry
Validation • Performance will be assessed by how physicians interface with device and how realistically the device models cardiac procedures • Conclusions will be drawn on how the design implements intended design features • Portable, Transparent, Pump, Water-tight • Physician input will be considered for future design improvements and used to identify drawbacks
Physician Specific Validation • Does the model visibly demonstrate optical scope catheter use into the heart? • Does the model demonstrate Swan-Ganz catheter use in the heart? • Is it possible to measure pressures in the heart (perform right heart catheterization)? • When catheter delivery is demonstrated, is it clear to observers what structures the model replicates?
References • Appartus for Testing Prosthetic Heart Valve Hinge Mechanism. More RB et al., inventors. United States Patent US5531094. http://www.freepatentsonline.com/5531094.pdf accessed 12 Nov 2009. • Durand LG, Garcia D, Sakr F, et al. A New Flow Model for Doppler Ultrasound Study of Prosthetic Heart Valves. Journal of Heart Valve Disease. [Internet] 2006 Nov 4 [cited 12 November 2009]; 17. Available from: http://www.icr-heart.com/journal/. • Hertzberg BS, Kliewer Ma, Delong DM et al. Sonographic Assessment of Lower Limb Vein Diameters: Implications for the Diagnosis and Characterization of Deep Venous Thrombosis. AJR. May 1997; 168:1253-1257. • Pantalos GM, Koenig SC, Gillar KJ, Giridharan GA, Ewert DL. Characterization of an adult mock circulation for testing cardiac support devices. ASAIO. Feb 2004; 50(1):37-46. • Pediatric congenital heart defect model. United States Patent US7083418. http://www.patentstorm.us/patents/7083418/description.html accessed 12 Nov 2009. • Replogle RL, Meiselman HJ, Merrill EW et al. Clinical Implications of Blood Rheology Studies. Circulation 1967; 36:148-160.