Abstract: A system and method for assembling a prosthetic heart valve, including a procedure for sewing fabric around a heart valve support stent. The system includes a support stent handling component that works in conjunction with a sewing machine component. The sewing machine has a bobbin, and the system includes a non-contact sensor to monitor the passage of a needle thread loop over the bobbin. The sensor may be a monitoring laser, and a controlling processor receives information therefrom for 100% real-time inspection of each stitch. The occurrence of an unsuccessful stitch may prompt the processor to repeat the stitch at a slower speed. The automation of the fabric sewing procedure greatly enhances manufacturing throughput and reduces ergonomic strain on workers.

Abstract: A simulated heart valve root used for training physicians in techniques of implantation of prosthetic heart valves as well as for more realistically testing the efficacy of prosthetic heart valves. The simulated heart valve root is made of the flexible, tubular body having an inner wall defining an annular ledge within which the prosthetic heart valve is implanted. Discrete nodes or areas of simulated calcification may be provided on the annular ledge. A simulated aortic root includes alternating cusps and commissures with calcification simulated at least at one of the commissures. A tear in the annular ledge may also be provided which simulates a tear that might occur from a valvuloplasty procedure. A reinforcing sleeve may surround the flexible tubular body to provide rigidity or hoop strength thereto. A method of testing includes mounting the simulated heart valve root in a flow conduit, implanting a prosthetic heart valve in the root, applying pulsatile flow to the assembly, and monitoring for leaks.

Abstract: A remodeling mitral annuloplasty ring with a reduced anterior-to-posterior dimension to restore coaptation between the mitral leaflets in mitral valve insufficiency (IMVI). The ring has a generally oval shaped body with a major axis perpendicular to a minor axis, both perpendicular to a blood flow axis. An anterior section lies between anteriolateral and posteriomedial trigones, while a posterior section defines the remaining ring body and is divided into P1, P2, and P3 segments corresponding to the three scallops of the same nomenclature in the posterior leaflet of the mitral valve. The anterior-to-posterior dimension of the ring body is reduced from conventional rings; such as by providing, in atrial plan view, a pulled-in P3 segment. Viewed another way, the convexity of the P3 segment is less pronounced than the convexity of the P1 segment. In addition, the ring body may have a downwardly deflected portion in the posterior section, preferably within the P2 and P3 segments.

Abstract: An annuloplasty repair segment and template for heart valve annulus repair. The elongate flexible template may form a distal part of a holder that also has a proximal handle. Alternatively, the template may be releasably attached to a mandrel that slides within a delivery sheath, the template being released from the end of the sheath to enable manipulation by a surgeon. A tether connecting the template and mandrel may also be provided. The template may be elastic, temperature responsive, or multiple linked segments. The template may be aligned with the handle and form a two- or three-dimensional curve out of alignment with the handle such that the annuloplasty repair segment attached thereto conforms to the curve. The template may be actively or passively converted between its straight and curved positions.