Project number
26027
Organization
SynCardia Systems
Offering
ENGR498-F2025-S2026
SynCardia is developing the “Emperor” Total Artificial Heart (ETAH), a next-generation total artificial heart (TAH). The Emperor TAH is based off of the existing, clinically proven design of the SynCardia Total Artificial Heart (STAH), utilizing the same materials, geometry, and components for all blood-contacting portions of the device. The Emperor TAH, while incorporating these attributes, upgrades the drive mechanism from a pneumatic design to a mechanically actuated one, which results in significant improvements in portability, efficiency, noise, heat, and reliability.
This new device, while similar to the current STAH system, will require new verification activity to demonstrate system reliability for durable implantation. While the current mock circulatory loop used to verify the function of the STAH is effective at simulating a wide variety of physiological conditions, it is complex, relatively large, and limited to just one artificial heart. SynCardia is tasking the capstone team with the design, construction, and qualification of a new test apparatus that will be able to simulate patient physiology for a number of ETAH test units that allow the new system to demonstrate reliability and functional equivalence with the on-market STAH.
The test apparatus shall:
• accurately simulate normotensive patient physiology (including pressures, resistances, flow rates, temperatures, and fluid exposure/submersion) for the duration of testing
• allow for the successful attachment and function of enough test units to demonstrate reliability equivalence (mean time between failure) to the STAH with sufficient statistical confidence to support a regulatory submission
• allow for the tracking of device performance over time (pressures, flow rates, temperatures, power consumption, etc)
A successful test apparatus should:
• allow for the successful attachment and function of enough test units to demonstrate reliability equivalence (mean time between failure) to the STAH with sufficient statistical confidence with 1 year or less of testing
• allow for the simulation of patient pathophysiology, such as systemic and/or pulmonary hypertension, hypotension, and non-hypertensive hypervolemia
This test apparatus will need to be subjected to installation qualification, operational qualification, and performance qualification (IQ/OQ/PQ), and the verification protocols must be written and tested by the student team. This qualification and documentation will allow SynCardia engineers and technicians to conduct full verification testing of the new artificial heart design.
This new device, while similar to the current STAH system, will require new verification activity to demonstrate system reliability for durable implantation. While the current mock circulatory loop used to verify the function of the STAH is effective at simulating a wide variety of physiological conditions, it is complex, relatively large, and limited to just one artificial heart. SynCardia is tasking the capstone team with the design, construction, and qualification of a new test apparatus that will be able to simulate patient physiology for a number of ETAH test units that allow the new system to demonstrate reliability and functional equivalence with the on-market STAH.
The test apparatus shall:
• accurately simulate normotensive patient physiology (including pressures, resistances, flow rates, temperatures, and fluid exposure/submersion) for the duration of testing
• allow for the successful attachment and function of enough test units to demonstrate reliability equivalence (mean time between failure) to the STAH with sufficient statistical confidence to support a regulatory submission
• allow for the tracking of device performance over time (pressures, flow rates, temperatures, power consumption, etc)
A successful test apparatus should:
• allow for the successful attachment and function of enough test units to demonstrate reliability equivalence (mean time between failure) to the STAH with sufficient statistical confidence with 1 year or less of testing
• allow for the simulation of patient pathophysiology, such as systemic and/or pulmonary hypertension, hypotension, and non-hypertensive hypervolemia
This test apparatus will need to be subjected to installation qualification, operational qualification, and performance qualification (IQ/OQ/PQ), and the verification protocols must be written and tested by the student team. This qualification and documentation will allow SynCardia engineers and technicians to conduct full verification testing of the new artificial heart design.