St. Jude Medical, Inc.

James L Kurk

Chad Qingshen Cai

Steven D Kruse

Yi-Ren Woo

Stephen D Kruse

Improved dip coating methods and mandrels for forming polymer leaflets and valve prostheses generally involve one or more features on the mandrel that facilitate the processing. The mandrel has a top surface and an outer surface comprising a plurality of ridges and contoured surfaces extending to the ridges. An edge on the mandrel separates the top surface and the contoured surfaces, with the mandrel edge corresponding to the free edge of the leaflet. In preferred embodiments, the edge separating the top surface from the contoured surfaces is sharp. The polymer formed on the top surface can be efficiently separated from the remaining portions of the polymer structure to form the free edges of the leaflets.

Mandrel for use in forming valved prostheses having polymer leaflets by dip coating

Valved prostheses include a support structure and a plurality of flexible polymer leaflets connected to the support structure, in which the leaflets have an improved structural design. The support structure has a plurality of commissure supports and scallops between the commissure supports. Generally, the flexible polymer leaflets project away from the support structure at an attachment edge where the leaflets connect to the support structure. In particular embodiments, the leaflets at the attachment edge are at an angle from about 5 degrees to about 85 degrees relative to a plane normal to the valve axis. In some embodiments, the flexible polymer leaflets having a coaptation depth from about 0.3 times the valve radius to about 0.8 times the valve radius. In further embodiments, the flexible polymer leaflets form a valve with a valve height from about one times the valve radius to about 2 times the valve radius and have leaflet lengths at least about 1 millimeter greater than the valve radius.

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Lino Lakes, MN, United States of America

James L Kurk