Heart valve disease is more prevalent among older individuals because heart valves can deteriorate and incur damage over time. With approximately 2.5% struggling with valvular heart diseases, these conditions are a growing concern, impacting cardiovascular health and requiring advanced solutions. Among these conditions, aortic valve disease accounts for 61%, Mitral disease for 15%, and other valve diseases for 24%, as per CDC.
Heart valves allow the blood to flow in one direction. Proper functioning of heart valves is essential for maintaining overall cardiovascular health as improper functioning allows for the blood to leak back. Any abnormalities in heart valve function can lead to serious cardiac issues.
Rajesh Kandula, serving as the Principal R&D Engineer-FEA at Jenavalve Technologies, is at the forefront of cutting-edge research and development in the field of cardiovascular health. With a dedicated focus on FEA (Finite Element Analysis), Mr. Kandula is instrumental in the company's pursuit to develop a groundbreaking Trilogy transcatheter heart valve system (THV) used for transcatheter aortic valve replacement (TAVR) to treat severe aortic regurgitation and aortic stenosis.
As the Principal R&D Engineer-FEA, Kandula is leveraging the power of Finite Element Analysis to design and thoroughly analyze the behavior of components in in-vivo/in-vitro loading, assess material characteristics, and predict the life expectancy of heart valve structures. This meticulous approach ensures that the Trilogy valve not only meets but exceeds the rigorous mechanical demands of the cardiovascular system.
Finite Element Analysis (FEA) is a computational technique widely used in various engineering fields to simulate the behavior of complex structures and systems under different conditions. In the heart valve design process, FEA will be utilized at every stage to significantly minimize design uncertainties, optimize performance, and enhance overall design quality.Rajesh Kandula shed light on the transformative potential of FEA.
Rajesh shared that Nitinol is being widely used in stent frame design, for material characterization, due to its shape memory and super elastic properties. This material displays a complex set of mechanical characteristics. Additionally, bio-prosthetic tissue used in valves is characterized by hyper-elastic material properties. Both of these materials exhibit highly non-linear behavior. “It would be incredibly challenging to understand and predict the behavior of these materials without the aid of Finite Element analysis”, he said.
Finite Element Analysis (FEA) is also a valuable tool for design engineers in understanding the behavior of components under different stress and strain conditions. It allows for quick iterations in the design process, leading to reduced research and development (R&D) time and cost which ultimately benefits patients through savings.
Rajesh highlighted that the bio-prosthetic heart valve experiences repetitive physiological loading during the cardiac cycle, and so, “it becomes crucial to design the valve in a way that it can withstand the hundreds of millions of cycles that the human heart undergoes in a lifetime” he noted. Finite Element Analysis can help predict the life of the stent frame.
Talking about optimization, Rajesh shared how the Trilogy catheter is essential for deploying THV (transcatheter heart valve) to the heart. FEA was used to optimize the shafts, improving their ability to withstand bending, tension, and torque.
The expert lastly added that analyzing patient-specific anatomy using Finite Element Analysis (FEA) allows for a detailed examination of the unique characteristics and mechanical behavior of the individual's heart valve. This approach enables healthcare professionals and researchers to gain insights into how the valve responds to various physiological conditions, helping to tailor treatment and intervention strategies to the specific needs of the patient.
Finite Element Analysis serves as a powerful predictive tool that helps designers and researchers develop heart valves capable of withstanding the rigorous mechanical demands of the cardiovascular system. It is contributing to the creation of reliable and long-lasting solutions for patients in need of heart valve replacements.
