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Continuing development of the Cleveland Clinic-Nimbus total artificial heart
T C Rintoul1, K C Butler, D C Thomas
1Nimbus, Inc., Rancho Cordova, CA 95670.
ASAIO Journal (American Society for Artificial Internal Organs : 1992)
|July 1, 1993
Summary
Nimbus, Inc. and the Cleveland Clinic Foundation are developing a fully implantable total artificial heart (TAH) with an automatic control system. Human fitting studies show satisfactory TAH pump fit within the pericardium.
Area of Science:
- Biomedical Engineering
- Cardiovascular Research
- Medical Device Development
Background:
- Development of a completely implanted total artificial heart (TAH) by Nimbus, Inc. and the Cleveland Clinic Foundation.
- Focus on key features: electrohydraulic energy converter, automatic Frank-Starling response control, and dual ventricles with specific material compositions.
- Advancements in TAH control systems, including hybridized microcircuit fabrication and testing.
Purpose of the Study:
- To detail the development and key features of a novel, completely implanted total artificial heart (TAH).
- To report on the testing and in vivo performance of the TAH system, including its control mechanisms.
- To assess the anatomical fit of the TAH in human patients undergoing heart transplantation.
Main Methods:
- Fabrication and testing of the TAH control hybrid microcircuit, emphasizing simplicity, reliability, efficiency, and thermal management.
- Conducting eight in vivo experiments with externally controlled TAH systems, including variable volume devices in later trials.
- Performing human fitting studies with adult heart transplant patients, utilizing chest circumference measurements, chest films, and transesophageal echocardiograms for fit prediction.
Main Results:
- Successful fabrication and initiation of testing for the TAH control hybrid.
- Demonstrated Frank-Starling pump response in vivo, though maximum output was limited by bovine model capacity.
- Satisfactory anatomical fit of the TAH within the pericardium in human subjects, without compromising vascular or chest wall structures.
Conclusions:
- The developed total artificial heart (TAH) system exhibits promising features for implantable cardiac support.
- In vivo and human fitting studies indicate the potential for successful clinical application, with reliable methods for predicting pump fit.
- Further research may focus on overcoming output limitations observed in animal models and refining the device for broader patient use.