Heart valve disease affects millions, disrupting lives and requiring complex interventions. Current treatments, such as valve replacement and repair, often fall short, especially in the long term and for pediatric patients. However, groundbreaking advancements in medical technology are emerging, offering hope for more effective and sustainable solutions. Researchers at Georgia Tech are pioneering a revolutionary approach using Georgia Tech Printing expertise to create personalized, bioresorbable heart valves. This innovative technology promises to transform the landscape of cardiac care by leveraging 3D printing to develop heart valves that not only function flawlessly but also encourage the body’s natural healing processes.
The Challenge of Heart Valve Disease
Heart valve disease is a significant health concern, diagnosed in over 5 million Americans annually. This condition, arising from birth defects, lifestyle factors, or aging, impairs blood flow, leading to potentially fatal complications if left unaddressed. While valve replacement and repair exist, they are often temporary fixes. Traditional replacement valves, frequently made from animal tissue, typically last only 10 to 15 years, necessitating repeated surgeries. For children, the situation is even more challenging, as their growth necessitates multiple re-interventions, making current options far from ideal.
Georgia Tech’s Breakthrough: 3D-Printed Bioresorbable Heart Valves
To overcome these limitations, researchers at Georgia Tech have developed a groundbreaking solution: 3D-printed heart valves crafted from bioresorbable materials. Utilizing advanced Georgia Tech printing techniques, these valves are designed to precisely match each patient’s unique anatomical requirements. The ingenuity of this approach lies in the valve’s bioresorbable nature. Once implanted, the valve serves its purpose and then is gradually absorbed by the body. Simultaneously, it facilitates the regeneration of new, natural tissue that seamlessly takes over the valve’s function. This eliminates the need for permanent artificial implants and the associated risks of long-term complications and repeat surgeries.
This pioneering work stems from the collaborative efforts of faculty members Lakshmi Prasad Dasi and Scott Hollister within the Wallace H. Coulter Department of Biomedical Engineering (BME) at Georgia Tech and Emory University. Their combined expertise has paved the way for this paradigm-shifting technology.
“This technology is very different from most existing heart valves, and we believe it represents a paradigm shift,” states Dasi, the Rozelle Vanda Wesley Professor in BME. “We are moving away from using animal tissue devices that don’t last and aren’t sustainable, and into a new era where a heart valve can regenerate inside the patient.”
Dasi’s profound expertise in heart valve mechanics and Hollister’s leadership in tissue engineering and 3D printing for pediatric devices have been instrumental in bringing this innovative concept to fruition.
“In pediatrics, one of the biggest challenges is that kids grow, and their heart valves change size over time,” explains Hollister, Professor and Patsy and Alan Dorris Chair in Pediatric Technology. “Because of this, children must undergo multiple surgeries to repair their valves as they grow. With this new technology, the patient can potentially grow new valve tissue and not have to worry about multiple valve replacements in the future.”
How the 3D-Printed Heart Valve Works
While 3D-printed heart valves and bioresorbable materials have existed separately, Georgia Tech’s innovation lies in their synergistic combination. This marks the first instance of merging these technologies to create a resorbable device with shape memory capabilities.
“From the start, the vision for the project was to move away from the one-size-fits-most approach…and toward a patient-specific implant that can outlast current devices,” explains Sanchita Bhat, a research scientist in Dasi’s lab. This personalized approach, enabled by Georgia Tech printing, is central to the technology’s potential.
The heart valve is 3D-printed using poly(glycerol dodecanedioate), a biocompatible material meticulously chosen for its properties. Crucially, the valve possesses shape memory. This allows it to be folded and delivered via a minimally invasive catheter procedure, eliminating the need for open-heart surgery. Upon reaching body temperature after implantation, the valve reverts to its intended shape. The bioresorbable material then actively signals the body to generate new tissue, effectively replacing the device. Within months, the original 3D-printed valve is completely absorbed, leaving behind a regenerated, fully functional heart valve.
Srujana Joshi, a Ph.D. student in Dasi’s lab, plays a vital role in the rigorous testing and refinement of the heart valve design. This iterative process is essential to ensure optimal performance and safety.
“Once you have an idea for an implant, it takes a lot of fine-tuning and optimization to arrive at the right design, material, and manufacturing parameters that work,” Joshi elaborates. “It is an iterative process, and we’ve been testing these aspects in our systems to make sure the valves are doing what they’re supposed to do.”
The durability of the heart valve is meticulously evaluated through computational models and benchtop studies in Dasi’s lab. Their specialized heart simulation setup replicates the physiological conditions of a real heart, precisely mimicking the pressure and flow dynamics of individual patients. Furthermore, dedicated machinery subjects the valve to millions of heart cycles in an accelerated timeframe, ensuring its mechanical robustness.
A Paradigm-Shifting Technology for the Future of Cardiac Care
Developing a material that can both perform the demanding function of a heart valve and simultaneously promote tissue regeneration is a formidable challenge. The journey from laboratory bench to clinical application for new medical devices is lengthy and requires meeting stringent milestones.
The Georgia Tech researchers are optimistic that their Georgia Tech printing innovation will revolutionize treatment for heart valve patients, ushering in a new era of tissue-engineered medical devices. They emphasize the particular need for improved pediatric implants, a population often underserved due to the rarity of childhood diseases and the high costs associated with specialized manufacturing. The combination of bioresorbable materials and 3D printing offers a promising pathway to create more effective and accessible pediatric devices.
“The hope is that we will start with the pediatric patients who can benefit from this technology when there is no other treatment available to them,” Dasi envisions. “Then we hope to show, over time, that there’s no reason why all valves shouldn’t be made this way.”
Note: Harsha Ramaraju, Ryan Akman, Adam Verga, David Rozen, Satheesh Kumar Harikrishnan, and Hieu Bui also contributed significantly to the development of this technology.
Funding for the bioresorbable material was provided by the National Institutes of Health (NIH/NHLBI R21-126004). Early financial support was received from the Georgia Research Alliance.
