Calcification-resistant materials and methods of making same through use of trivalent aluminum

• US 5,094,661 A
• Filed: 04/01/1988
• Issued: 03/10/1992
• Est. Priority Date: 04/01/1988
• Status: Expired due to Term

• Current Assignee: University of Michigan
• Original Assignee: University of Michigan
• Inventors: Levy, Robert J., Sintov, Amnon
• Primary Examiner(s): Willis, Jr., Prince
• Assistant Examiner(s): McNally, John F.
• Application Number:
  US07/176,789
• Time in Patent Office: 1,439 Days
• Field of Search: 8/94.11, 8/404, 8/94.29, 623/1, 623/2, 623/11, 623/22
• US Class Current: 8/94.11
• CPC Class Codes: A61L 2300/102 Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
• CPC Class Codes: A61L 2400/02 Treatment of implants to prevent calcification or mineralisation in vivo
• CPC Class Codes: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• CPC Class Codes: A61L 27/3687 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: Y10S 623/92 Method or apparatus for preparing or treating prosthetic

Abstract

Bioprosthetic materials, either natural or synthetic, are treated with trivalent aluminum cations to prevent in vivo calcification. Such bioprosthetic materials include porcine aortic valve leaflets, bovine pericardium, aortic homografts, biocompatible elastomers, and the like which are intended for invasive, or in-dwelling use in a human or animal body. Simple incubation of the natural bioprosthetic materials in an aluminum ion-containing solution, such as aqueous AlCl₃, prior to implantation has been found to inhibit calcification of the biomaterial over a prolonged period and to do so without adverse side effects. Incorporation of an aluminum-containing compound into the formulation for polymers, such as polyurethane, has also been found to inhibit calcification with no adverse side effects.

Claims

1. A method of treating glutaraldehyde pre-treated bioprosthetic tissue comprising incubating the bioprosthetic tissue in an aqueous solution of AlCl₃ ranging from 0.1M to 0.001M for a period of time ranging from 1 hour to 24 hours at about 4°

C. to 25°

C.