Artificial vascular valves
AssigneePurdue Research Foundation
InventorsStephen F. Badylak, Arthur C. Coffey, Leslie A. Geddes, Michael C. Hiles, James Hong, Rebecca Roeder
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Abstract
A method for preparing vascular valves from submucosal tissue is described. Both bicuspid and tricuspid valve constructs are described. The bicuspid constructs can be formed with or without a supporting stent. The tricuspid constructs are formed by fixing submucosal tissue to a supporting stent, folding the submucosal tissue, and forming the valve commissures from the folded submucosal tissue by cutting along the folds. The artificial vascular valves are useful for replacing damaged or diseased valves of a warm-blooded vertebrate.
Claims18
A tissue graft in the form of a bicuspid valve for replacement of a defective vascular valve, said tissue graft comprising submucosal tissue, delaminated from both the tunica muscularis and at least the lumenal portion of the tunica mucosa, in the form of a continuous tube having a diameter (D) approximating that of the defective valve said tube having first and second opposite ends and a triple walled intermediate portion having length (L) about 1.5 D to about 3.5 D;
- said triple walled portion of the tissue graft being formed by everting the first end of the tube to form a tubular construct having a double walled end and a double walled portion proximal to and extending from said double walled end and reverting said first end over the double walled portion and the double walled end of the tubular construct;
- wherein the two walls of the double-walled portion are sutured together to form a sutured portion having a length S and the end of the sutured portion proximal to the double walled end is located at least a distance 1/2 D from the double walled end, and the ratio of L to S is about 2.5 to about 3.5.
A method of forming a synthetic tissue valve, said method comprising
- overlaying a sheet of submucosal tissue onto a stent having a plurality of stent posts an annular base, and a central axis, wherein the submucosal tissue contacts the posts of the stent;
- fixing the submucosal tissue to the tips of the stent posts;
- folding the sheet of submucosal tissue to form folds that extend from the top of each stent post to a point along the central axis;
- conditioning the tissue to retain the shape of the tissue;
- fixing the submucosal tissue to the sides of the stent posts and the base of the stent;
- and
- cutting the fold in the submucosal tissue to form the commissures of the valve.
A synthetic tissue valve comprising
- a stent, comprising an annular base and three stent posts that extend vertically from said annular base, wherein the annular base and the three stent posts define a central axis that extends through the center of the annular base equidistant from each of the stent posts;
- and
- a layer of submucosa overlaid onto the stent posts and fixed onto the stent along the perimeter of each of the stent posts, said submucosa being folded back upon itself along three radial axes that extend from a point along the central axis to the top of each of the three stent posts to form the submucosa layer into three concave semi-hemispheres of submucosa, said submucosa having a slit cut along the folds formed at the three radial axes to allow unidirectional flow from the convex side of the submucosal tissue to the concave side.
Dependencies are inferred from the claim text.