1. 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
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2. Outline Project Background Key Customer Needs & Specifications
Selected Concept
Risk Assessment
System Design
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3. 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
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4. 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
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5. 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
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6. System Design U-Jig/Test Section Pump Reservoir Reservoir
Overflow Tubing
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7. System Design
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8. 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
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9. 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
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10. 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
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11. 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
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12. Budget
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13. 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
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14. Questions?
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15. Supplementary Slides
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16. 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.
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17. 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.
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18. Current Amplification Circuit Design
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19. 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.
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20. Bill of Materials
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21. KGCOE Multidisciplinary Sr. Design
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