PFI-TT: Three-Dimensional Printing and Magnetic Assembly for Minimally Invasive Cardiac Surgery

North Carolina State University, Raleigh NC

Investigators

Abstract

The broader impact/commercial potential of this Partnerships for Innovation - Technology Translation (PFI-TT) project is a minimally invasive, catheter-based approach for repairing heart valves. Currently, the standard surgery for valve repairs is an open-heart surgery, which is only available to patients who are acceptable surgical candidates. Open-heart surgery has significant risk and recovery requirements. The proposed prototype integrates three-dimensional printing and magnetic assembly to make possible deployment of implants through thin tubes known as catheters that can place the replacement valve in the heart, addressing the need for open-heart surgery and potentially providing more effective treatment of blood back flow into the heart. This new approach will expand access to heart valve repairs, specifically the mitral valve, to patients for whom the risk of open-heart surgery is too high. The need for heart valve replacement is growing, and this new approach will further increase the market by addressing unmet needs. Three-dimensional printing can provide implants with different sizes for custom fits to individual patients, and magnetic assembly inside patients is an under-explored concept that has potential for wider surgical and interventional applications. The proposed project will result in a prototype for a novel annuloplasty ring that is fabricated through three-dimensional printing and includes magnets, allowing for magnetically guided assembly within the mitral valve. The annuloplasty ring is designed for percutaneous delivery through a catheter and manipulation with catheter-based tools. Following assembly, the ring will be anchored to the annulus of the mitral valve, and an internal mechanism will be engaged to reduce the diameter of the ring, thus improving coaptation of the leaflets and treating mitral valve regurgitation. The capability for tunable diameter reduction, while the heart is beating, is a unique advantage over the standard open-heart surgery. Mechanisms for magnetic assembly and diameter reduction will be investigated by designing, fabricating, and testing structures on tissue phantoms and pig hearts. The interdisciplinary team of materials researchers, clinicians, and entrepreneurs conducting this project will choose designs that simultaneously meet requirements for manufacturing and material properties, have a compact design for delivery through catheters, and are straightforward to translate. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.