Process for improving the biostability of tissue implant devices

Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Heart valve – Having rigid or semirigid pivoting occluder

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623 66, A61F 224

Patent

active

051044056

ABSTRACT:
Processes are disclosed for improving the biostability of tissue implant devices. The processes comprise methods for treating harvested tissue with calcification inhibitor, tissue crosslinking reagent, and reagents capable of forming additional tissue reaction sites providing bioprosthetic devices having enhanced amounts of tissue bound calcification inhibitor. After long-term implantation, the treated tissue remains calcification free and exhibits a high degree of physical stability which minimizes the risk of mechanical failure.

REFERENCES:
patent: 5002566 (1991-03-01), Carpentier et al.
"Inhibition of Ectopic Calcification of Glutaraldehyde Cross-linked Collagen and Collagenous Tissues by a Covalently Bound Diphosphonate (APD)"; Marcel E. Nimni, et al.
"Covalent Binding of Aminopropanehydroxydiphosphonate to Glutaraldehyde Residues in Pericardial Bioprosthetic Tissue: Stablity and Calcification Inhibition Studies", C. L. Webb, et al, Experimental and Molecular Pathology 50, 291-302 (1989).
"Inhibition of Bioprosthetic Heart Valve Calcification with Aminodiphosphonate Covalently Bound to Residual Aldehyde Groups", C. L. Webb, et al; Ann. Thorac Surg. 46: 309-316, Sep. 1988.
"Controlled-Release Drug Delivery of Diphosphonates to Inhibit Bioprosthetic Heart Valve Calcification: Release Rate Modulation with Silicone Matrices via Drug Solubility and Membrane Coating" (Apr. 1987) G. Golomb, et al; Journal of Pharmaceutical Sciences, vol. 76, No. 4.
"Inhibition of Bioprosthetic Heart Valve Calcification by Sustained Local Delivery of Ca and Na Diphosphonate via Controlled Release Matrices"; Gershon Golomb, et al; vol. XXXII Trans. Am. Soc. Artif Intern Organs 1986; pp. 587-590.
"The Role of Glutaraldehyde-Induced Cross-links in Calcification of Bovine Pericardium Used in Cardiac Valve Bioprostheses"; Gershon Golomb, et al; Nov. 1986.
Information from the Claims/U.S. Patents Database Nimni Patents.
"Prevention of Calcification of Bioprosthetic Heart Valve Leaflets by Ca.sup.2+ Diphosphonate Pretreatment"; T. P. Johnson, et al; Journal of Pharmaceutical Sciences vol. 77, No. 9, Sep. 1988 pp. 740-744.
"The Cross-Linking and Structure Modification of the Collagen Matrix in the Design of Cardiovascular Prosthesis"; Marcel E. Nimni; Journal of Cardiac Surgery 3:523-533; Dec. 1988.
"Biochemical Differences Between Dystrophic Calcification of Cross-linked Collagen Implants and Mineralization During Bone Induction" Calcif Tissue Int (1988) 42: 313-320.

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