Graft prosthesis, materials and methods
AssigneesCook Biotech Incorporated, Cook Medical Technologies LLC
InventorsWilliam A. Cook, Michael C. Hiles, Thomas G. Kozma, Umesh H. Patel
Life of this patent
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Abstract
A graft prostheses (11), materials and method for implanting, transplanting, replacing, or repairing a part of a patient. The graft prosthesis includes a purified, collagen-based matrix structure removed from a submucosa tissue source. The submucosa tissue source is purified by disinfection and removal steps to deactivate and remove contaminants, thereby making the purified structure biocompatible and suitable for grafting on and/or in a patient.
Claims64
A graft prosthesis comprising:
- a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having a contaminant level making said purified structure biocompatible.
The graft prosthesis of claim, wherein said purified structure has a processing agent level of less than 100,000 parts per million per kilogram.
A graft prosthesis comprising:
- a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having an endotoxin level of less than 12 endotoxin units per gram.
A graft prosthesis comprising:
- a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having a nucleic acid content level of less than 2 micrograms per milligram.
A graft prosthesis comprising:
- a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having a virus level of less than 500 plaque forming units per gram.
A graft prosthesis comprising:
- a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having a processing agent level of less than 100,000 parts per million per kilogram.
A method for obtaining a collagen-based matrix from a submucosa tissue source, comprising:
- treating the submucosa tissue source with a disinfecting agent to provide a disinfected submucosa tissue source;
- and
- removing the collagen-based matrix from the disinfected submucosa tissue source.
A method for obtaining a collagen-based matrix from a submucosa tissue source, comprising:
- providing a submucosa tissue source which has been treated with a disinfecting agent;
- and
- removing the collagen-based matrix from said submucosa tissue source.
A composition comprising:
- a collagen-containing structure removed from a tissue source initially containing said structure and other tissue, said collagen-containing structure having an endotoxin level of no greater than 12 endotoxin units per gram.
A purified collagen-containing matrix obtained from a mammalian tissue source, said matrix comprising mammalian tela submucosa and residual contaminants from said mammalian tissue source, said structure obtainable by a process which comprises disinfecting said mammalian tissue and then removing said structure from the disinfected mammalian tissue.
Dependencies are inferred from the claim text.