Project number
25027
Organization
SynCardia Systems
Offering
ENGR498-F2024-S2025
Background:
SynCardia is the manufacturer of the only FDA-approved Total Artificial Heart (SynCardia TAH or STAH), used as a therapeutic bridge to stabilize and sustain patients until heart transplantation. The STAH system is composed of a surgically implanted, pneumatically driven replacement heart, that is connected to an external driver that provides the pulsatile pneumatic pressure required to pump the patient’s blood. There are two models of external driver: one for hospital use only, and one for home use following patient discharge.
Project Scope:
The current Companion 2 (C2) Hospital Driver that is used intraoperatively and throughout much of a TAH recipient's hospital stay is in need of design updates. Specifically, the wheeled cart that the driver unit is docked into for power, transport, and intraoperative use suffers from component obsolescence issues and a difficult supply chain. Of particular note is the obsolescence of the connector that is used to enable power and input/output communication between the cart and driver.
In order to address these issues, a significant enough set of modifications are needed such that a total redesign of this cart and connector are in scope. This means a full redesign of the mechanical and electrical systems that connect the driver to power, enable it to move through the operating room and hospital, and display detailed information during the implant procedure and throughout the patient’s hospital stay. Because half of the connector is integrated into the C2 driver unit, this means minor changes will be needed to the driver unit itself.
SynCardia is tasking the team with initial design and prototyping of this integrated cart and driver system. The team will:
(1) Work with SynCardia engineers to design an updated C2 hospital driver system that addresses component obsolescence and improves upon the existing design.
(2) Produce a prototype of the new C2 hospital driver system and hospital cart.
(3) Work with SynCardia’s quality and regulatory compliance processes in order to document the updated C2 driver system for future design iteration, verification and validation testing, regulatory submission, and integration into the TAH system.
This is a one-of-a-kind opportunity. A successful design will undergo additional iterations before verification and validation and, if demonstrated to be a viable update to the hospital driver, could be incorporated into a clinical device that would be used as a critical part of the process of every future SynCardia TAH implant. Depending on the quality of your work and the demonstration of its effectiveness to regulatory authorities, your design or a future iteration of it could be included in future STAH systems and used to sustain and improve patient lives.
SynCardia is the manufacturer of the only FDA-approved Total Artificial Heart (SynCardia TAH or STAH), used as a therapeutic bridge to stabilize and sustain patients until heart transplantation. The STAH system is composed of a surgically implanted, pneumatically driven replacement heart, that is connected to an external driver that provides the pulsatile pneumatic pressure required to pump the patient’s blood. There are two models of external driver: one for hospital use only, and one for home use following patient discharge.
Project Scope:
The current Companion 2 (C2) Hospital Driver that is used intraoperatively and throughout much of a TAH recipient's hospital stay is in need of design updates. Specifically, the wheeled cart that the driver unit is docked into for power, transport, and intraoperative use suffers from component obsolescence issues and a difficult supply chain. Of particular note is the obsolescence of the connector that is used to enable power and input/output communication between the cart and driver.
In order to address these issues, a significant enough set of modifications are needed such that a total redesign of this cart and connector are in scope. This means a full redesign of the mechanical and electrical systems that connect the driver to power, enable it to move through the operating room and hospital, and display detailed information during the implant procedure and throughout the patient’s hospital stay. Because half of the connector is integrated into the C2 driver unit, this means minor changes will be needed to the driver unit itself.
SynCardia is tasking the team with initial design and prototyping of this integrated cart and driver system. The team will:
(1) Work with SynCardia engineers to design an updated C2 hospital driver system that addresses component obsolescence and improves upon the existing design.
(2) Produce a prototype of the new C2 hospital driver system and hospital cart.
(3) Work with SynCardia’s quality and regulatory compliance processes in order to document the updated C2 driver system for future design iteration, verification and validation testing, regulatory submission, and integration into the TAH system.
This is a one-of-a-kind opportunity. A successful design will undergo additional iterations before verification and validation and, if demonstrated to be a viable update to the hospital driver, could be incorporated into a clinical device that would be used as a critical part of the process of every future SynCardia TAH implant. Depending on the quality of your work and the demonstration of its effectiveness to regulatory authorities, your design or a future iteration of it could be included in future STAH systems and used to sustain and improve patient lives.