Invention:
This technology is a novel heart valve and deployment system that maintains eccentric geometries while optimizing valve function and hemodynamics, reducing adverse events. The asymmetrical leaflet design features two identical mirrored larger leaflets and one shorter leaflet. Traditional symmetric leaflet design features three equal leaflets that rely on diastolic closure with all leaflets meeting in the center and small bending forces needed in systole to open all leaflets. The larger leaflets preferentially open along the long axis of the ellipse and asymmetrical leaflets coopt off the center of the ellipse, shifting the cooption point along the long axis to increase the opening area. Increasing the angle of the commissural attachment further reduces the diastolic stresses. The leaflet configuration relies on alignment of the long axis of the valve between the commissures of the BAV, which no delivery system can control/image at this time.
Background:
Heart valve disease, such as Bicuspid Aortic stenosis, often results in eccentric valve geometry and orifices. The aortic valve separates the left lower heart chamber (left ventricle) and the body’s main artery (aorta). Flaps of tissue (cusps) on the valve open and close with each heartbeat and make sure blood flows in the right direction. Usually, the aortic valve has three cusps. A bicuspid valve has only two cusps. Rarely, some people are born with an aortic valve that has one cusp (unicuspid) or four cusps (quadricuspid). Current prosthetic heart valves physically force valve orifices and surrounding structures to assume a circular geometry resulting in tissue strain and adverse events.
Applications:
- Heart valve replacement
- Transcatheter aortic valve replacement (TAVR)
Advantages:
- Highly durable
- Reduced structural stress
- Limits leaking
- Improved biocompatibility
