Ready to use biodegradable and biocompatible device and a method of preparation thereof

A method for making a hemostat device, the method comprising:

• preparing a homogenous solution of gelatin and chitosan by at least
• adding gelatin to water to form a gelatin solution,
• adding an acid to the gelatin solution to provide an acidified gelatin solution, and
• adding chitosan to the acidified gelatin solution to form the homogenous solution of gelatin and chitosan;
• air drying and freeze drying the homogenous solution of gelatin and chitosan to provide an air dried scaffold;
• processing the air dried scaffold to provide a porous sponge defining a porous gelatin-chitosan polyelectrolyte matrix structure having opposing first and second porous faces, and a plurality of vesicular voids between the first and second porous faces, the first porous face having pores greater in size than pores in the second porous face;
• the porous gelatin-chitosan polyelectrolyte matrix structure configured to provide, between the opposing first and second porous faces, a differential and regulated porosity on a same platform in a molecularly integrated matrix;
• the pores of the second porous face configured to prevent loss of blood components, and the pores of the first porous face configured to permit blood to enter the hemostat device;
• loading the porous sponge with a clotting agent, a bioactive material, and an anti-fibrinlytic agent, by exposing the porous sponge to the clotting agent, the bioactive material, and the anti-fibrinlytic agent in an aqueous solution so that the clotting agent, the bioactive material, and the anti-fibrinlytic agent are carried internally by the plurality of vesicular voids in the porous gelatin-chitosan polyelectrolyte matrix structure and configured to clot blood entering the porous gelatin-chitosan polyelectrolyte matrix structure from the first porous face, to entrap platelets and blood cells, and to stabilize clotted blood in the porous gelatin-chitosan polyelectrolyte matrix structure;
• and
• drying the loaded porous sponge.

A method for making a hemostat device, the method comprising:

• forming a porous gelatin-chitosan polyelectrolyte matrix structure having opposing first and second porous faces, and a plurality of vesicular voids between the first and second porous faces, the first porous face having pores greater in size than pores in the second porous face;
• positioning a clotting agent material carried internally by the plurality of vesicular voids in the porous gelatin-chitosan polyelectrolyte matrix structure and configured to clot blood entering the porous gelatin-chitosan polyelectrolyte matrix structure from the first porous face, the clotting agent material comprising calcium chloride and thrombin;
• positioning an anti-fibrinlytic agent carried internally by the plurality of vesicular voids in the porous gelatin-chitosan polyelectrolyte matrix structure and configured to stabilize clotted blood in the porous gelatin-chitosan polyelectrolyte matrix structure without using a cross-linker, the anti-fibrinlytic agent comprising tranexamic acid;
• the porous gelatin-chitosan polyelectrolyte matrix structure configured to provide, between the opposing first and second porous faces, a differential and regulated porosity on a same platform in a molecularly integrated matrix;
• the pores of the second porous face being configured to prevent loss of blood components, and the pores of the first porous face configured to permit blood to enter the hemostat device;
• and
• positioning a bioactive material carried by the plurality of vesicular voids in the porous gelatin-chitosan polyelectrolyte matrix structure, the bioactive material comprising D+Glucosamine to entrap platelets and blood cells.