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Development of a completely implantable total artificial heart
L K Fujimoto1, G Jacobs, J F Chen
1Department of Artificial Organs, Cleveland Clinic Foundation, Ohio 44106.
Summary
Designing an implantable total artificial heart requires precise anatomic fit. This study developed a 3D model and a novel E4T system, demonstrating excellent fit and no compression of vital structures in cadaver models.
Area of Science:
- Biomedical Engineering
- Cardiovascular Surgery
- Medical Imaging
Background:
- Anatomic fit is crucial for implantable total circulatory support systems.
- Previous designs faced challenges in achieving optimal spatial integration within the thorax.
- Engineering and physiological requirements necessitate a well-defined anatomical interface.
Purpose of the Study:
- To develop a three-dimensional anatomic model of the adult thorax for implantable device design.
- To conceptualize and define the configuration of a one-piece, implantable total artificial heart (E4T system).
- To validate the anatomic fit and assess potential compression of cardiovascular structures by the E4T system.
Main Methods:
- Construction of a 3D anatomic model using data from cadavers, radiographs, CT, NMR, and cineangiograms.
- Definition and sizing of the E4T system, including actuator placement and port design.
- Implantation of the E4T model in three human cadavers, followed by NMR imaging for validation.
Main Results:
- Identification of critical anatomical information including valve, chamber, and vessel locations.
- Definition of the E4T system with a hydraulic actuator between ventricles, designed for 8 L/min output at 120 beats/min.
- Excellent anatomic fit observed in all cadaver models, with NMR imaging showing no compression of natural internal structures.
Conclusions:
- The developed 3D anatomic model facilitated the design of the E4T total artificial heart.
- The E4T system demonstrates excellent implantability and fit within the thoracic cavity.
- The design effectively avoids compression of critical cardiovascular structures, validating its feasibility.