Method of forming prefabricated units used in production of systems of prosthetic aortic valve transcatheter implantation and prosthetic aortic valve prefabricated unit

A method of forming prefabricated units used in production of systems of prosthetic aortic valve transcatheter implantation with a non-thrombogenic smooth surface layer or with a porous fibrous layer constituting a scaffold for epithelium cell culture, intended for manufacturing TAVI system in form of a material made of nanofiber integrated with a stent, comprising:

• preparing between 1 and 133 stents made of a cobalt-nickel alloy with a wall thickness of 150-500 μm
• providing solutions of polycarbonate silicones and/or polycarbonate urethanes and/or polyurethane with average molecular weight in range from 5000 g/mol to 200 000 g/mol in a solvent DMAC,
• providing an electrospinning machine operating with humidity conditions in range of 40-60% and in temperature in the range of 16-22° C.
• electrospraying a smooth layer of polycarbonate silicone is applied with use of the solution in DMAC with a concentration of 2-11% w/w. and/or by electrospinning polycarbonate urethane fiber is applied with use of the solution in DMAC with concentration of 8-20% w/w. onto a roller to obtain a first surface layer,
• applying specified speed, number of heads, thickness of capillaries, rotation speed, voltage and distance between each capillary and the roller, whereas flow on a pump administering the solution on the heads is set for 0.2 to 5 ml/h and after a period of 30 min to 40 ml/h forming a layer covering the roller with thickness of approximately 1-100 μm and a length of 50-6000 mm, thereafter
• forming an inner intermediate layer by electrospraying the layer of polycarbonate silicone with use of the solution in DMAC with a concentration of 2-8%/w. and/or by electrospinning the polycarbonate urethane silicone with use of the solution in DMAC with the concentration of 8-20%/w. applying specified speed, number of heads, thickness of capillaries, rotation speed, voltage and distance between each capillary and the roller, and after the period of 30 min to 40 h, when the thickness of the layer is approximately 5 to 100 μm, the forming is stopped, and
• placing the stents onto the formed layer, positioning their location so that the distance between each of them was 30 mm, and similarly to applying the inner intermediate layer,
• applying the inner intermediate layer on entire length of the roller, obtaining the thickness of approximately 5 to 100 μm after 30 min to 40 h, thereafter a final surface layer is applied similarly to the first surface layer until prefabricated units of a polymer material thickness of 50 to 250 μm is obtained.