FIELD: medical equipment.
SUBSTANCE: inventions group relates to medical equipment, namely to an implantable hollow prosthesis made of a polymeric material, the structure of which is made in the form of elements of knots connected by fibrils, and elements of the void space with the elements connected into a three-dimensional network, and a method for forming the internal frame of an implantable hollow prosthesis. The prosthesis includes a prosthesis body formed from an inner frame and a layer formed by winding a tape on the frame, made of a material selected from the group including a material having a void space volume fraction of 25-94%, a void space specific surface area of 0.1-9, 0 mcm2/ mcm3, the average distance between voids in the volume is 1.5-50 µm, the average volumetric chord is 0.4-30 µm, and the material having a volume fraction of the void space is 1-35%, the specific surface area of the void space is 0.5-20 mcm2/ mcm3, the average distance between voids in the volume is 0.5-15 mcm, the average volumetric chord is 0.1-10 mcm2. The inner porous frame is made with a wall thickness of 0.2-2.0 mm, made of a polymeric material, the structure of which is made in the form of node elements connected by elongated fibrils, and elements of the void space with the elements connected into a three-dimensional network, having a volume fraction of the void space of 45 -94%, the specific surface of the space of voids is 0.2-0.9 mcm2/ mcm3, and also having an average distance between voids in the volume of 0.5-20 mcm, an average volumetric chord of 3-60 mcm. Winding on the frame is made in 2-6 layers of a layer of polymeric material tape. In the method, the inner frame is formed by extrusion of a polymeric material selected from the group including polytetrafluoroethylene and copolymers of tetrafluoroethylene with hexafluoropropylene and tetrafluoroethylene with perfluorovinylpropyl ether with a comonomer content of not more than 2 wt.% into a cylindrical billet, followed by its compaction in the longitudinal direction by 10-20% at temperature from 290 to 320°C, uniaxial stretching by 250-1200% of the initial length of the workpiece and subsequent sintering at a temperature of 340-370°C until a structure is formed from elements of knots connected by elongated fibrils, and elements of the void space with the connection of elements into a three-dimensional network, having a volume fraction of the void space of 45-94%, a specific surface of the void space of 0.2-0.9 mcm2/ mcm3, an average distance between voids in the volume of 0.5-20 mcm, an average volume chord 3-60 mcm.
EFFECT: increasing the elastic and strength properties of the prosthesis, while ensuring an increase in the permeability of the internal porous framework for body tissues and high bonding strength to the shell of the implantable prosthesis formed by winding the tape, which provides greater resistance to cutting through the prosthesis wall during anastomoses and will allow a greater degree of approximation properties of the prosthesis to the properties of the native artery.
14 cl, 1 tbl, 12 dwg
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Authors
Dates
2022-06-21—Published
2021-10-12—Filed