ARTIFICIAL VALVED CONDUITS FOR CARDIAC RECONSTRUCTIVE PROCEDURES AND METHODS FOR THEIR PRODUCTION

摘要

Artificial heart valve structures and methods of their fabrication are disclosed. The heart valve structures may be fabricated from a biocompatible polymer and include one or more heart valve leaflet structures incorporated within a conduit. The valve structures may incorporate one or more conduit sinuses, as well as a gap between the lower margin of the valve leaflets and the interior of the conduit. In addition, the valve structures may include one or more valve sinuses created in a space between the valve leaflets and the conduit inner surface. Computational fluid dynamics and mechanical modeling may be used to design the valve leaflets with optimal characteristics. A heart valve structure may also incorporate a biodegradable component to which cells may adhere The incorporated cells may arise from patient cells migrating to the biodegradable component, or the component may be pre-seeded with cells prior to implantation in a patient.

主权项

1. A heart valve structure comprising:
a conduit comprising an inner conduit surface, an outer conduit surface, and a diameter; and a heart valve multi-leaflet structure having an open state and a closed state comprising
a first heart valve leaflet, comprising a first sinus edge and a first fan edge; anda second heart valve leaflet, comprising a second sinus edge and a second fan edge;wherein the first fan edge intersects the second fan edge at an outer commissure point, and the first sinus edge intersects the second sinus edge at an inner commissure point, thereby forming a commissure extending from the outer commissure point to the inner commissure point,wherein the first fan edge intersects the first sinus edge at a first outer leaflet point, thereby forming a first baseline extending from the first outer leaflet point to the commissure, the first baseline further having a first width as measured from the first outer leaflet point to the commissure,wherein the second fan edge intersects the second sinus edge at a second outer leaflet point, thereby forming a second baseline extending from the second outer leaflet point to the commissure, the second baseline further having a second width as measured from the second outer leaflet point to the commissure,wherein the second baseline is essentially collinear with the first baseline,wherein the first sinus edge extends from and is not coextensive with the first baseline, thereby forming a first sinus structure bounded by the first sinus edge, the commissure, and the first baseline,wherein the second sinus edge extends from and is not coextensive with the second baseline, thereby forming a second sinus structure bounded by the second sinus edge, the commissure, and the second baseline,wherein the first fan edge extends from and is not coextensive with the first baseline, thereby forming a first fan structure bounded by the first fan edge, the commissure, and the first baseline, andwherein the second fan edge extends from and is not coextensive with the second baseline, thereby forming a second fan structure bounded by the second fan edge, the commissure, and the second baseline, wherein at least a portion of the first fan edge, at least a portion of the second fan edge, and at least a portion of the inner conduit surface are mutually disposed to form a valve gap in the closed state, wherein at least a portion of the first sinus structure and a portion of the inner conduit surface are nonadjacent, thereby forming a first valve sinus bounded at least in part by at least a portion of the inner conduit surface and at least a portion of the first sinus structure, and wherein at least a portion of the second sinus structure and a portion of the inner conduit surface are nonadjacent, thereby forming a second valve sinus bounded at least in part by at least a portion of the inner conduit surface and at least a portion of the second sinus structure.