SYSTEMS AND METHODS FOR ASSEMBLING COMPONENTS OF A FABRIC-COVERED PROSTHETIC HEART VALVE

摘要

A system and method for assembling a prosthetic heart valve, including a procedure for tightly wrapping fabric around a heart valve support stent having a highly contoured undulating outflow edge. A mandrel retains tension without manual assistance in a tubular length of fabric wrapped over the support stent, and includes relatively axially movable inner and outer clamping mechanisms and a pedestal tube on which the support stent rests. The clamping mechanisms include clamps that pull the fabric only in the support stent cusps. The mandrel assembly may be placed in a chuck of a sewing machine system for automatically forming the seam. A small shuttle with bobbin thread reciprocates within a channel inside of the support stent and cooperates with the sewing machine needle to form a lock-stitch in the fabric tube. The mechanization of the fabric covering procedure greatly enhances manufacturing throughput and reduces ergonomic strain on workers.