
Existing Technology:
Over 5 million people in America receive a heart valve disease diagnosis each year, but there is currently no proven long-term cure for this problem. Blood flow is disturbed when a person's heart valve is seriously compromised due to ageing, lifestyle choices, or birth defects. Complications may be lethal if treatment is not received.
Valve replacement and repair are the only methods of managing severe valvular heart disease, but both often require repeated surgeries that are expensive, disruptive, and life-threatening. Most replacement valves are made of animal tissue and last up to 10 or 15 years before they must be replaced. For pediatric patients, solutions are extremely limited and can require multiple reinterventions.
3D Printed Bioresorbable Heart Valve- New Technology:
Georgia Tech researchers have created a 3D-printed heart valve made of bioresorbable materials and designed to fit an individual patient’s unique anatomy. Once implanted, the valves will be absorbed by the body and replaced by new tissue that will perform the function that the device once served.
The invention comes out of the labs of faculty members Lakshmi Prasad Dasi and Scott Hollister in the Wallace H. Coulter Department of Biomedical Engineering (BME) at Georgia Tech and Emory.
Dasi is a leading researcher in heart valve function and mechanics, while Hollister is a top expert in tissue engineering and 3D printing for pediatric medical devices. They brought their teams together to create a first-of-its-kind technology.
Growing into the Heart
Although 3D-printed heart valves currently exist and bioresorbable materials have been used for implants before, this is the first time the two technologies have been combined to create one device with a resorbable, shape memory material.
The initial research involved finding the right material and testing different prototypes. The team’s heart valve is 3D-printed using a biocompatible material called poly(glycerol dodecanedioate).
From the start, the vision for the project was to move away from the one-size-fits-most approach that has been the status quo for heart valve design and manufacturing, and toward a patient-specific implant that can outlast current devices.
Sanchita Bhat, PhD student and Research Scientist, GIT
The valve has shape memory, so it can be folded and delivered via a catheter, rather than open heart surgery. Once it is implanted and reaches body temperature, the device will refold into its original shape. The material will then signal to the body to make its own new tissue to replace the device. The original device will absorb completely in a few months.
Bhat and Joshi are currently testing the heart valve’s physical durability with both computational models and benchtop studies. Dasi’s lab has a heart simulation setup that matches a real heart’s physiological conditions and can mimic the pressure and flow conditions of an individual patient's heart. An additional machine tests the valve’s mechanical durability by putting it through millions of heart cycles in a short time.
A Paradigm Shifting Technology
According to the researchers, it is an enormous challenge to create a material that can carry out a heart valve’s rigorous function, while also encouraging new tissue to develop and take over. Also, new medical devices undergo a long journey from bench to bedside, and several key milestones must be met.
The researchers hope their technology can revolutionize treatment for heart valve patients — and that it will usher in a new era of more tissue-engineered 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. Then we hope to show, over time, that there’s no reason why all valves shouldn’t be made this way.
Dasi, Professor, Rozelle Vanda Wesley, Wallace H. Coulter Department of Biomedical Engineering (BME)
Note: Harsha Ramaraju (research scientist), Ryan Akman (research scientist), Adam Verga (Ph.D. candidate), David Rozen (undergraduate student), Satheesh Kumar Harikrishnan (former research engineer), and Hieu Bui (former postdoctoral fellow) also played a major role in developing this technology.
Funding: Development of the bioresorbable material was supported by the National Institutes of Health grant number NIH/NHLBI R21-126004.
Reference:
https://research.gatech.edu/feature/heart-valves
(Newswise/SD)