Primary Investigators: Dr. C Fox
Institution: Drexel University
Funding began in 2018.
What is the major problem being addressed by this study?
Thousands of children suffer from heart failure and other heart-related complications, which costs the healthcare industry countless dollars each year. These children could benefit from medical devices for the heart since there are limited donor organs and finite devices. Current medical devices or heart pumps have significant design limitations, and pediatric patients with heart failure will remain vulnerable to this restricted set of treatment options until new medical device technology is developed. To address this unmet therapeutic need, we are designing a new artificial heart pump for children and adolescent patients with heart failure.
What specific questions are you asking and how will you attempt to answer them?
The proposed training project in engineering and medicine will enable me to further develop my technical abilities, understanding of strategies for the treatment of cardiovascular diseases, new methods for teaching, mentoring, and communication skills, and ability to perform bench-to-bedside medical device development for people with heart failure and stroke-related illnesses. The professional development and training will be performed while advancing the technology-driven design and development of a new medical device or artificial heart pump for pediatric patients. The project will also investigate the broad benefits of this new device for these kids.
What is the long-term biomedical significance of your work, particularly as it pertains to the cardiovascular area? What major therapeutic advance(s) do you anticipate that it will lead to? For instance, new drug(s), a surgical technique/procedure, a diagnostic tool/test, a previously undetected risk factor, etc:
The proposed technology-driven research will contribute toward our long-term goal of developing a uniquely designed, implantable, magnetically levitated, artificial heart pump, thereby creating a new class of blood pumps unlike any on the market today. This project is situated at the intersection of medicine, entrepreneurship, engineering, innovation, product commercialization, and education in the design and development of new cardiovascular therapeutics. I expect to gain significant new knowledge about hybrid blood pump technology and its clinical relevance to treat pediatric patients. This research will enable us to investigate a paradigm-shifting intervention that addresses a significant human health problem.
Clinical studies using total artificial hearts (TAHs) have demonstrated that pediatric and adult patients derive quality of life benefits from this form of therapy. Two clinically approved TAHs and other pumps under development, however, have design challenges and limitations, including thromboembolic events, neurologic impairment, infection risk due to large size and percutaneous drivelines, and lack of ambulation, to name a few. To address these limitations, we are developing a hybrid‐design, continuous‐flow, implantable or extracorporeal, magnetically levitated TAH for pediatric and adult patients with heart failure. This TAH has only 2 moving parts: an axial impeller for the pulmonary circulation and a centrifugal impeller for the systemic circulation. This device will utilize the latest generation of magnetic bearing technology. Initial geometries were established using pump design equations, and computational modeling provided insight into pump performance. The designs were the basis for prototype manufacturing and hydraulic testing. The study results demonstrate that the TAH is capable of delivering target blood flow rates of 1‐6.5 L/min with pressure rises of 1‐92 mmHg for the pulmonary circulation and 24‐150 mmHg for the systemic circulation at 1,500‐10,000 RPM. This initial design of the TAH was successful and serves as the foundation to continue its development as a novel, more compact, non‐thrombogenic, and effective therapeutic alternative for infants, children, adolescents, and adults with heart failure.
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