Problem Background:

Heart transplantation is the best solution for patients with end stage heart disease. Currently, there are far more patients waiting to receive hearts than there are suitable heart donations. As a result, many patients do not receive this lifesaving therapy and die on the waitlist. Two current routes of organ donation exist: donation after brain death (DBD) and donation after cardiac death (DCD). Unfortunately, donation after cardiac death is not widely used. This is because current technology does not allow enough time for DCD heart function to be accurately evaluated, so they are discarded. It is estimated that over two thousand marginal but usable hearts are allocated for donation but are discarded via this DCD method.

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Solution:

A device capable of reconditioning donor hearts is estimated to increase by up to 30% the number of heart transplants able to be performed in the United States alone. The THeRMoS is one such device. Donor hearts would be explanted and placed on the device which would rewarm and recondition the heart by perfusing the coronary arteries with oxygenated blood. The device could then be switched to working heart mode, and the heart could be analysed as if it were still “in vivo”. The THeRMoS device would give physicians accurate information about the heart’s condition and performance. Physicians would make informed decisions about the heart’s suitability for transplant outside of the dying donor. The device would be a positive step in closing the gap on the heart transplant waitlist and could potentially save lives.

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Project Tasks:

The project included systems engineering block diagramming, human factors/risk analyses, competitive analyses and associated market studies, financial outlook, regulatory strategies, clinical strategies for testing, mass manufacturing plans and a product launch strategy. 

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** No CAD or product images can be shown due to preliminary IP protection **