Design and Embodiment of a Novel Adjustable Active Cardiac Support Device System

Abstract

The American Heart Association estimates that congestive heart failure (CHF) affects over 5 million people in the United States. Recent research indicates that current pharmacological therapies have limitations in their ability to treat end-stage heart failure patients. Device based therapies that provide passive support and active assist through altering the stress environment to reduce end diastolic volume and increase stroke work may be beneficial in overcoming the limitations of simply just increasing the use of pharmacological therapies; however, current devices are inadequate in their design to restore natural heart mechanics. Dr. John C. Criscione of Texas A&M has proposed a minimally invasive adjustable active cardiac support device (AACSD) that promotes natural heart mechanics using passive support and active assist. Design research, using FDA Design Controls, is necessary to supplement prototyping to develop and embody a design for manufacture for continued proof-of-concept studies in ovines. The design research consists of identifying user needs and functionality of the AACSD for the development of design specifications that drive the design process for the selection of a suitable concept for the AACSD. With a concept selected, geometry and materials of the device are selected to embody a design for manufacture. A parts list, engineering drawings, and assembly instructions allow for the manufacture of the device. Finally, a failure modes and effects analysis allows for evaluation of the design and recommendations for future design research. The design research successfully identified an embodied design for manufacture that will aid in further development of the AACSD as a future therapy for CHF.