Aortic bioprosthesis and systems for delivery thereof

A system for replacing a valve within a human body, the system comprising:

• a delivery device comprising:
• an inner member comprising a guide wire lumen and a stent holder, and
• an outer member comprising a sheath;
• and
• a replacement valve for use within a human body, the replacement valve comprising:
• a valve component, and
• a stent component configured to house at least a portion of the valve, wherein the stent component is configured to shift between a collapsed configuration and an expanded configuration, the stent component comprising:
• a central, longitudinal stent axis;
• an inflow end and an outflow end;
• a lower anchoring crown defining an at least partly conical body, wherein the lower anchoring crown defines the inflow end of the stent component;
• an upper anchoring crown in communication with the lower anchoring crown and defining an at least partly conical body, wherein:
• the at least partly conical body of the lower anchoring crown slopes outwardly in a direction of the inflow end, and
• the at least partly conical body of the upper anchoring crown slopes outwardly in a direction of the outflow end;
• and
• an outflow stent section defining an at least partly conical body and comprising a commissural post section and a stabilization arch section,
• wherein:
• the commissural post section is in communication with the upper anchoring crown;
• the stabilization arch section comprises a plurality of stabilization arches in communication with the commissural post section and defines an at least partly conical body,
• each stabilization arch comprises a divergent portion that diverges away from the stent axis in a direction towards the outflow end in the expanded configuration and an arch apex inclined at an angle α5 measured from the divergent portion in a direction towards the stent axis in the expanded configuration, and
• each stabilization arch includes a first base portion having a first thickness adjacent a first commissural post section and a second base portion having a second thickness adjacent to an adjacent second commissural post section,
• wherein the arch apex of the stabilization arch has a third thickness which is greater than the first thickness and is greater than the second thickness, and
• at least one attachment element for removable attachment to the delivery device, wherein:
• the at least one attachment element is located at the inflow end of the stent component,
• the inflow end is defined as an end toward a left ventricle when delivered from a transapical approach,
• the at least one attachment element comprising an opening configured to enlarge when the stent component expands, and
• the stent holder comprises at least one groove for receiving the at least one attachment element of the stent component.

A replacement valve for use within a human body, the replacement valve comprising:

• a valve component;
• and
• a stent component configured to house at least a portion of the valve component, wherein the stent component is configured to shift between a collapsed configuration and an expanded configuration, the stent component comprising:
• a central, longitudinal stent axis;
• an inflow end and an outflow end;
• an outflow stent section defining the outflow end and comprising a stabilization arch section and a commissural post section communicating with the stabilization arch section,
• wherein:
• the commissural post section defines supports for the valve component, and
• the stabilization arch section comprises a plurality of stabilization arches and has an outer profile defined by a divergent portion that diverges away from the stent axis in a direction towards the outflow end in the expanded configuration and an arch apex inclined at an angle of divergence measured from the divergent portion in a direction towards the stent axis in the expanded configuration, and
• each stabilization arch includes a first base portion having a first thickness adjacent a first commissural post section, the arch apex having a second thickness, and a second base portion having a third thickness adjacent a second commissural post section,
• wherein the first thickness and the third thickness are equal and the second thickness is greater than the first thickness and is greater than the third thickness;
• an anchoring section defining the inflow end;
• and
• a first crown section communicating with the outflow stent section and with the anchoring section, wherein the first crown section comprises a first divergent portion that diverges outwardly in a direction towards the outflow end, the first crown section having a free end.