Cutting balloon assembly and method of manufacturing thereof

A method for fabrication of a cutting balloon assembly for incision of hard stenosed regions of a blood vessel, comprising:

• (a) providing a predetermined number of filaments having predetermined properties, diameter and length;
• (b) fabricating a scoring mesh from said filaments, comprising:
• providing a weaving jig having a cylindrical structure including a plurality of pins disposed circumferentially about the surface of the structure in rows and extending outwardly therefrom;
• placing the filaments between the pins and interlacing the filaments to form a scoring mesh having a mesh proximal end and a mesh distal end;
• said interlacing the filaments comprising interweaving the filaments between the mesh proximal end and the mesh distal end, and intertwining at least a part of said interlacing filaments to form at least one permanent link with neighboring filaments defining a scoring element formed by turns of the intertwined filaments in a longitudinal direction between the mesh proximal end and the mesh distal end;
• forming at least distal filament loops comprising filaments that protrude from the mesh distal end, bend and arrive back at the distal end of the scoring mesh, said at least distal filament loops being configured for tying said distal filament loops of the scoring mesh at the mesh distal end;
• annealing the scoring mesh, wherein the annealing of the scoring mesh comprises:
• preliminary heating the scoring mesh on the jig;
• cooling the scoring mesh on the jig after preliminary heating;
• taking the scoring mesh off from the jig and stretching the scoring mesh up to a diameter less than the diameter of an expandable balloon in the deflated state;
• putting the scoring mesh on a mandrel having a diameter less than that of the diameter of the expandable balloon in the deflated state;
• fastening the scoring mesh to the mandrel;
• final heating the scoring mesh placed on the mandrel;
• and
• cooling the scoring mesh after said final heating to a room temperature;
• (c) providing a delivery catheter having a catheter proximal end, a catheter distal end, and at least one catheter lumen extending between the catheter proximal and distal ends;
• (d) providing the expandable balloon of (b) having a balloon proximal end and a balloon distal end, and mounting said expandable balloon on the catheter distal end;
• and
• (e) mounting said scoring mesh on said expandable balloon.