P07021: Instrument to Detect Thromboemboli Evelyn Adames Project Manager Carlos Cheek Lead Mechanical Engineer Thomas Fountain Mechanical Engineer Robert Mahar Lead Electrical Engineer Gabriela Noriega Electrical Engineer Adam Wagner Electrical Engineer Trevor Hyde Electrical Engineer Eric Shyu Computer Engineer KGCOE Multidisciplinary Sr. Design R•I•T

Outline Project Background Key Customer Needs & Specifications Selected Concept Risk Assessment System Design KGCOE Multidisciplinary Sr. Design R•I•T

Project Background Background & Motivation: Mission Statement: Cardiovascular devices provide a bridge to transplant or long term viable solution for Congestive Heart Failure (CHF) Patients. Surgery and medicine can not provide a solution Limited amount of donor hearts Current Cardiovascular devices are thought to produce emboli There is currently no model for predicting emboli formation in cardiovascular devices. Mission Statement: To develop a thromboemboli detector Will be used to evaluate blood damage induced by artificial heart. KGCOE Multidisciplinary Sr. Design R•I•T

Key Needs & Specifications Key Customer Needs Detection of emboli Provides count of emboli detected Determines size of embolus Corresponding Specifications Laminar Flow in Test Section Velocity in test section greater than 2.5cm/s No stagnation regions in flow system Test section tube diameter of 1/16” (Due to optical design) KGCOE Multidisciplinary Sr. Design R•I•T

Selected Concept: Light Scattering A beam of light is directed at a tubular test section Particles absorb and scatter light Scattered light is collected by photo detector Detected signal is used to characterized particles Fluid Flow Light Source Embolus Detector Source: Solen et. Al Instrument to Detect Emboli, 1995 KGCOE Multidisciplinary Sr. Design R•I•T

System Design U-Jig/Test Section Pump Reservoir Reservoir Overflow Tubing KGCOE Multidisciplinary Sr. Design R•I•T

System Design KGCOE Multidisciplinary Sr. Design R•I•T

Technical Risk Assessment Risk: Acquiring a detectable signal Several iterations will be needed to optimize experimental set-up and attain a signal Proposed Mitigation: Develop mathematical model to anticipate voltage signal Simulate testing conditions in LabVIEW KGCOE Multidisciplinary Sr. Design R•I•T

Technical Risk Assessment Safety Risks: Exposure to Lasers Laser light is hazardous to the human eye and skin when exposed for prolonged periods Proposed Mitigation: Research industry and RIT standards Training will be provided to all team members KGCOE Multidisciplinary Sr. Design R•I•T

Product Development Process Phase Phase 0: Planning Phase 1: Concept Development Phase 2: System Level Design Phase 3: Detailed Design Phase 4: Testing and Refinement MSD I MSD II Alpha Prototype 1 2 3 4 Current Phase of Development KGCOE Multidisciplinary Sr. Design R•I•T

Current State of Design Design meets all customer needs Design meets engineering specifications for full system and subsystems On target to meet project budget of $5000 Working on incorporating feedback from TDR Minor redesign work to fluids rig and amplification circuit KGCOE Multidisciplinary Sr. Design R•I•T

Budget KGCOE Multidisciplinary Sr. Design R•I•T

SD II Milestones Week 2 - Design finalized and all parts on order Week 3,4 - Machining & Building Week 5 - Functional alpha prototype/ Experimental Week 7 - Design Verification Testing complete, Initiate any design revisions Week 9 - Documentation Finalized: User Manual, Conference Paper, Poster Week 10 - Project review – Phase 4 Completion KGCOE Multidisciplinary Sr. Design R•I•T

Questions? KGCOE Multidisciplinary Sr. Design R•I•T

Supplementary Slides KGCOE Multidisciplinary Sr. Design R•I•T

Applicable Standards American National Standards Institute Standard for the safe use of lasers. ANSI Z136.1: This standard describes criteria for evaluating the overall hazard potential of a laser system. It consists of a series of classifications based on hazard potential, and specific control measures for minimizing laser hazards. The International Electro-technical Commission Safety of Laser Products IEC 825-1: Part 1: Equipment classification, requirements, and user's guide concentrates on the hazards presented by laser radiation to the eye and the skin. This standard specifies the minimum safety requirements for laser products. KGCOE Multidisciplinary Sr. Design R•I•T

Surrogate Fluid Design Hollow 10micron glass spheres will represent erythrocytes Polystyrene spheres will represent emboli Can be sturdily suspended in water Fluid 1: consists of water and a monodisperse dilute solution (concentration to be determined later). Fluid 2: will be designed experimentally based on the TED’s response to whole blood. A sample of blood will be placed through the TED at optimal conditions and the response (voltage signal) will be recorded. Spheres and dye will be added to water so that the TED responds to the surrogate fluid as it would to blood. KGCOE Multidisciplinary Sr. Design R•I•T

Current Amplification Circuit Design KGCOE Multidisciplinary Sr. Design R•I•T

Intended Use Short Term Long Term Develop a method for emboli detection Long Term Device to be used in the design and pre-clinical approval of various cardiac assist devices. KGCOE Multidisciplinary Sr. Design R•I•T

Bill of Materials KGCOE Multidisciplinary Sr. Design R•I•T

KGCOE Multidisciplinary Sr. Design R•I•T