METHOD OF MAKING VALVE BIOPROTESIS OF HEART VALVE ON FLEXIBLE BASE FRAMEWORK WITH LOW PROFILE Russian patent published in 2019 - IPC A61F2/00 

FIELD: medicine.

SUBSTANCE: invention refers to medical equipment, namely to bioprosthesis of heart valves. Valve framework is made from high-strength titanium alloy BT 1–0 or from alloy containing 35 % of cobalt, 35 % of nickel, 20 % of chrome and 10 % of molybdenum. Valve framework has three flexible struts and elastically deformable base and is covered with synthetic fabric. Primary skin of the frame with synthetic fabric is made so that all fixing sutures are located outside the prosthesis. On top of the rack, a wrapping knitting element is made to increase the reliability of fastening the locking element to the frame posts. Inner lining of the frame is completely made of biological tissue representing pericardium of calf or pericardium of pig, so that the through hole of the bioprosthesis is completely covered with biological tissue and has no sutures in the lumen of the valve. Shutter flaps are cut out of xenopericardium after 12–48 hours in neutral 0.3–0.8 % aqueous solution of glutaric aldehyde or in neutral 0.5–5 % water solution of diglycidyl ether of ethylene glycol. Flaps are attached to the frame posts by a double symmetrical mattress suture, wherein the flaps are butt-jointed, and wherein the bioprosthesis closure element is formed after the stabilization process of the xenopericardium biotissue is completed with the cross-linking agent after the bioprosthesis closure element is fixed to the posts and to the base of the frame. Position of the flaps of the bioprosthesis closure element is changed with 6–12-hour periodicity, thereby alternately reproducing the phases of complete opening and complete closure of the flaps of the bioprothesis closure element. Elastic collar of polyester jersey is anchored outside the base of the frame before completion of its internal lining with a biological tissue, but after formation of its closing element.

EFFECT: method allows enlarging indications for using this bioprosthesis, implanting into an aortic, mitral and tricuspid positions without any anatomical restrictions, besides providing optimum coaptation of valve flaps and minimizing reverse blood leakage, increase the area of the through hole at the preset fitting diameter of the prosthesis and reduce the transplastic gradient, and also reduce load on the valve caps and reduce wear of the bioprosthesis during operation.

8 cl, 7 dwg, 1 tbl