Production Documentation For An Artificial Heart Valve
1. Overview of Project
1.1 The Objective
The objective of the study will be the design, simulation, prototyping, and testing of an artificial heart valve that can mimic a natural heart valve by being non-toxic, capable of withstanding the task, and assuring smooth flow of blood.
1.2 Scope
The subsequent discussion will cover design methodology, simulation techniques, prototyping methods, testing processes, and data analysis for the artificial heart valve.
2. Design and Modeling
2.1 CAD Design
Software Used: SolidWorks
Design Specifications: the detailed three-dimensional model of the heart valve, leaflets, annulus, and supporting structure.
Material Selection: Biocompatible materials like medical-grade silicone to be used for the model, and titanium
Documents:
Working Drawings: Drawings that are detailed for each component.
Assembly Drawings: Exploded views showing how components fit together.
2.2 Finite Element Analysis (FEA)
Software Used: ANSYS
- Meshing: High-quality mesh with refined elements in critical areas.
- Material Properties: Elastic modulus, Poisson's ratio, and density assigned based on the selected materials.
- Boundary Conditions: Simulated physiological pressures and flow rates.
- Documents:
- FEA Reports: The detailed reports of the analysis will be done on the results of the distribution of stress and deformation.
3. Prototyping
3.1 3D Printing
- Materials: Biocompatible plastics and silicone.
- Process: The printing of a physical prototype, layer by layer.
- Documents:
- STL Files: 3D printable files of each component.
- Material Safety Data Sheets (MSDS): For the materials used in printing.
4. Simulation
4.1 Computational Fluid Dynamics (CFD)
- Software Used: ANSYS Fluent
- Simulation Setup: Simulation of blood flow through the valve at different cardiac cycle conditions.
- Measurements Made: Flow rate, pressure drop, and velocity profiles.
- Documents:
- CFD Reports: Detailed results of the simulation and analysis.
5. Testing
5.1 Bench Testing
- Setup of Rig: Simulates the human cardiovascular system with blood-mimicking fluid.
- Sensors Used: Pressure transducers, flow meters, and high-speed cameras.
- Test Procedures:The valve is loaded in a cyclical manner to simulate heartbeat over a period, with multiple measurements of valve performance.
- Documents:
- Test Protocols: Detailed step-by-step procedures for tests.
Data Sheets: Data collected from sensors during the test.
5.2 Data Collection
Parameter Measured: Time of operation-open/closings, pressure drop, flow rate.
Data Logging: LabVIEW for automatic data logging.
Documents:
LabVIEW Code: List of the scripts used for logging and analyzing the data.
6. Data Analysis
6.1 Software Tools
MATLAB: For statistical processing and visualization of test data.
Python: Additional data processing and analysis.
Documents:
- Analysis Scripts: MATLAB and Python scripts used for the analysis of data.
- Analysis Reports: In-depth reports of findings from the analysis of data.
6.2 Analysis Procedures
- Stress Analysis: Calculation of stress distribution across the components of the valve.
- Deformation Analysis: Ascertainment of the magnitude of deformation under load that remains within operational limits.
- Fatigue Analysis: Making the necessary predictions on the lifespan of valves when subjected to repeated cycles.
7. Iterative Design and Testing
7.1 Design Refinement
- Feedback Loop: Refine the design using the test data.
- Re-simulation: More FEA and CFD simulations are done on an improved design.
- Documents:
- Updated CAD Models: The improved 3D models based on feedback.
- Updated FEA and CFD Reports: New reports for the analysis made from changes to the design.
7.2 Re-testing
- Prototype Updates: Prototypes are updated in light of improved designs.
- Repeat Testing: New prototypes are bench-tested to verify improvements have been made.
- Documents:
-New Test Protocols: Procedures for the testing of updated prototypes.
New Data Sheets: Collected data from re-testing.
8. Firmware and Software
8.1 Firmware Development
- Microcontroller Used: Arduino or similar used in the test rig.
-Firmware Code: Code that controls sensors and actuators.
- Documents:
- Firmware Source Code: All code, commented.
- Compilation Instructions: Step-by-step compilation and uploading of firmware.
8.2 Software Developed
Data Logging Software: LabVIEW scripts to automatically gather data.
Analysis Software: MATLAB and Python scripts to analyze the data.
-Documents:
Software Source Code: The full commented code.
User Manuals: How to use these developed software tools.
9. Conclusion
9.1 Summary
This project successfully executed the design, simulation, prototyping, and testing of an artificial heart valve. The iterative processes ensure that the performance of the valve is continuously improved and optimized.
9.2 Future Work
- In Vivo Testing: The next step will include planning animal trials to validate the performance of the valve.
- Regulatory Approval: Documentation to be prepared for regulatory submissions.