Sulzer Carbomedics Inc.

Edward J Sarnowski

Riyad E Moe

Louis A Campbell

Xiao-Yan Gong

Xiao Yan Gong

Donald W James

A method for manufacturing a prosthetic heart valve. An elastic valve body and at least one leaflet are formed on a mold. The leaflet has a free edge which is formed by the mold without cutting the leaflet at the free edge.

Method for making polymer heart valves with leaflets having uncut free edges

A method and apparatus for pre-stressing devices incorporating materials subject to stress softening is disclosed, as well as the resulting device. The method includes fabricating a heart valve with an inflow side and an outflow side. At least a portion of the heart valve includes a material subject to stress softening. The material experiences stress when a pressure differential occurs between the inflow side and the outflow side of the valve. The method includes creating a stress in the material prior to implantation in order to stabilize the stress/strain response of the material prior to implantation.

Pre-stressing devices incorporating materials subject to stress softening

A heart valve is disclosed which includes a valve body and a plurality of flexible leaflets coupled to the valve body. The plurality of leaflets has an open position and a closed position. Each of the plurality of leaflets comprises a belly when the plurality of leaflets are in their respective closed positions. The belly of one or more of the plurality of leaflets has a continuous curvature except for a non-continuous portion.

Heart valve leaflet

A heart valve prosthesis includes a molded body and a plurality of leaflets. Each leaflet includes a free margin having opposite ends and a mid-point. The opposite ends are attached to a peripheral portion of the valve. Each free margin is adjacent each other free margin to form a natural-state non-uniform gap therebetween. The gap has a maximized width adjacent the mid-point of each leaflet. Each free margin is scalloped to form a peak at the opposite ends and a mid-point peak between the opposite ends. Each peak is substantially the same height above the base.

Heart valve leaflet with scalloped free margin

A flexible leaflet heart valve includes a base, a peripheral portion and a plurality of leaflets. Each leaflet includes a scalloped free margin having opposite ends and a mid-portion between the opposite ends. The opposite ends are attached to the peripheral portion of the valve at a first height above the base. The mid-portion of each free margin is positioned at a second height above the base, less than the first height. Each free margin is adjacent each other free margin to form a gap therebetween. Each leaflet is of a first thickness and at least a portion of each free margin is of a second thickness, greater than the first thickness. This may include extending the second thickness along the entire free margin between the opposite ends or extending the second thickness only along the mid-portion of the free margin.

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Austin, TX, United States of America

Edward J Sarnowski