Methods for creating sinus-matched aortic valves
Methods for generating aortic heart valve leaflets are disclosed wherein the aortic sinus surfaces (the inner surfaces of the sinuses of Valsalva) are used as a template to generate geometric representations of replacement aortic heart valve leaflets. As such, sinus-matched replacement leaflets can be sized and shaped according to the patient-specific geometry of the aortic root. Patient-specific aortic valve assemblies based on aortic root and sinus geometry are also described. Methods for estimating the coaptation area of a sinus-matched valve and assessing whether the valve is functionally competent for implantation are described.
1. A stentless aortic valve prosthesis tailored to the native sinus anatomy of a subject's aortic root prepared by the steps of:
receiving a three-dimensional anatomical imaging data set spanning and corresponding to at least a portion of the patient-specific geometry of the aortic root of the subject;
segmenting from the three-dimensional anatomical imaging data set a geometric surface data set that includes an inner aortic root surface and three aortic sinus surfaces;
identifying a first, second, and third ceiling point on the inner aortic root surface of the geometric surface data set;
truncating the geometric surface data set at the level of a plane passing through the first, second, and third ceiling points, thereby generating a truncated geometric surface data set;
for each of the three aortic sinus surfaces within the truncated geometric surface data set:
identifying two of the ceiling points and a base point for the aortic sinus surface;
calculating a construction plane passing through the two ceiling points and the base point of the truncated geometric surface data set;
calculating an intersection of the construction plane and the truncated geometric surface data set to define a concave leaflet surface;
extracting from the concave leaflet surface a leaflet wall curve where the concave leaflet surface is in contact with the construction plane;
constructing an anchoring flange surface based on the leaflet wall curves from each of the three aortic sinus surfaces from the truncated geometric surface data set; and
joining the three concave leaflet surfaces with the anchoring flange to form a stentless aortic valve prosthesis.
2. The stentless aortic valve prosthesis of claim 1 , wherein the inner aortic root surface of the geometric surface data set includes a proximal end and a distal end, and further comprising an anatomically shaped suture ring affixed to the anchoring flange, wherein the shape of the suture ring is defined by the intersection of a plane with the inner aortic root surface of the geometric surface data set at a specified distance between the proximal end and the distal end.
3. The aortic valve prosthesis of any of claims 1 and 2 wherein the aortic valve leaflet is a bioprosthetic aortic valve leaflet.
4. The aortic valve prosthesis of claim 3 wherein the bioprosthetic aortic valve leaflet comprises porcine tissue.
5. The aortic valve prosthesis of claim 3 wherein the bioprosthetic aortic valve leaflet comprises bovine tissue.
6. The aortic valve prosthesis of claim 3 wherein the bioprosthetic aortic valve leaflet comprises human tissue.
7. The aortic valve prosthesis of any of claims 1 and 2 wherein the aortic valve leaflet comprises a synthetic material.
8. The aortic valve prosthesis of claim 7 wherein the synthetic material is selected from the group of a polymer or woven fabric.
9. The aortic valve prosthesis of claim 7 wherein the synthetic material is selected from the group of silicone, polyurethane, polycarbonate urethane, and polytetrafluoroethylene.
10. The stentless aortic valve prosthesis of claim 1 , wherein the anchoring flange has a width of from 0.5 mm to 8 mm.