Coating for bioprosthetic device and method of making same

A process for treating heart valves prior to implantation into a human comprising the steps of:

• harvesting a fresh heart valve from a donor organism;
• initiating cross-links in the valve by treating with glutaraldehyde;
• incubating the valve in a solution containing a diamine;
• reacting the valve with a water soluble carbodiimide;
• soaking the valve in a solution containing a sulphated polysaccharide;
• reacting the valve with a water soluble carbodiimide in the presence of a diamine;
• soaking the valve in a solution containing heparin;
• reacting the valve with glutaraldehyde;
• storing the valve in a sterilizing solution.

A process for improving the biophysical stability of bioprotheses for heterograft or allograft implantation, which comprises:

• harvesting tissue from an organism;
• initiating covalent cross-links in the protein structure of the tissue to protect the tissue from excessive swelling or other losses of structural integrity;
• soaking the tissue in an aqueous solution of a diphosphonate.
• covalently binding the diphosphonate to the tissue thereby forming a three-dimensional matrix;
• and
• sterilizing the matrix;
• wherein the modified tissue produced is substantially water insoluble;
• and, after implantation in a host organism, the matrix is less likely to elicit an antigenic response or to be subject to calcification than natural tissue or tanned tissue.

A process for improving the biophysical stability of bioprostheses for heterograft or allograft implantation, which comprises:

• harvesting tissue from an organism;
• initiating covalent cross-links in the protein structure of the tissue to protect the tissue from excessive swelling or other losses of structural integrity;
• soaking the tissue in an aqueous solution of a dye;
• covalently binding the dye to the tissue thereby forming a three-dimensional matrix;
• and
• sterilizing the matrix;
• wherein the modified tissue produced is substantially water insoluble;
• and, after implantation in a host organism, the matrix is less likely to elicit an antigenic response or to be subject to calcification than natural tissue or tanned tissue.

A process for improving the biophysical stability of bioprostheses for heterograft or allograft implantation, which comprises:

• harvesting tissue from an organism;
• initiating covalent cross-links in the protein structure of the tissue to protect the tissue from excessive swelling or other losses of structural integrity;
• soaking the tissue in an aqueous solution of a phosphoprotein;
• covalently binding the phosphoprotein to the tissue thereby forming a three-dimensional matrix;
• and
• sterilizing the matrix;
• wherein the modified tissue produced is substantially water insoluble;
• and, after implantation in a host organism, the matrix is less likely to elicit an antigenic response or to be subject to calcification than natural tissue or tanned tissue.

A process for improving the biophysical stability of bioprostheses for heterograft or allograft implantation, which comprises:

• harvesting tissue from an organism;
• initiating covalent cross-links in the protein structure of the tissue to protect the tissue from excessive swelling or other losses of structural integrity;
• soaking the tissue in an aqueous solution of a chelating agent;
• covalently binding the chelating agent to the tissue thereby forming a three-dimensional matrix;
• and
• sterilizing the matrix;
• wherein the modified tissue produced is substantially water insoluble;
• and, after implantation in a host organism, the matrix is less likely to elicit an antigenic response or to be subject to calcification than natural tissue or tanned tissue.

A process for improving the biophysical stability of bioprostheses for heterograft or allograft implantation, which comprises:

• harvesting tissue from an organism;
• initiating covalent cross-links in the protein structure of the tissue to protect the tissue from excessive swelling or other losses of structural integrity;
• soaking the tissue in an aqueous solution of chondroitin sulfate;
• and
• soaking the tissue in an aqueous solution of a water-soluble carbodiimide;
• wherein chondroitin sulfate is covalently bonded to the tissue and the tissue produced is substantially water insoluble;
• and, after implantation in a host organism, the matrix is less likely to elicit an antigenic response or to be subject to calcification than natural tissue or tanned tissue.