Calcification-resistant materials and methods of making same through use of multivalent cations
First Claim
1. An implant formed of a biocompatible biomaterial which is a tissue which occurs naturally in a donor living being and is insoluble in the interior of the body of a host living being, said biomaterial having incorporated therein an effective amount of trivalent iron cations and at least one anticalcification agent selected from the group consisting of citrates and diphosphonates to render said biomaterial resistant to in vivo pathologic calcification.
2 Assignments
0 Petitions
Accused Products
Abstract
Bioprosthetic materials, either natural or synthetic, are treated with trivalent iron cations, or salts, 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 iron ion-containing solution, such as aqueous FeCl3, particularly with the addition of an anticalcification agent, such as a diphosphonate, 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 iron-containing compound, with or without an additional anticalcification agent, into the formulation for polymers, such as polyurethane, has also been found to inhibit calcification with no adverse side effects.
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Citations
24 Claims
- 1. An implant formed of a biocompatible biomaterial which is a tissue which occurs naturally in a donor living being and is insoluble in the interior of the body of a host living being, said biomaterial having incorporated therein an effective amount of trivalent iron cations and at least one anticalcification agent selected from the group consisting of citrates and diphosphonates to render said biomaterial resistant to in vivo pathologic calcification.
- 3. An implant formed of a biocompatible biomaterial which is a biocompatible synthetic polymer and is insoluble in the interior of the body of a host living being, said biomaterial having incorporated therein an effective amount of trivalent iron cations to render said biomaterial resistant to in vivo pathologic calcification.
- 6. A material suitable for implantation in the interior of the body of a living being, the material being a tissue which occurs naturally in a donor living being having incorporated therein an effective amount of trivalent iron cations and at least one anticalcification agent selected from the group consisting of citrates and diphosphonates to render the tissue resistant to pathologic calcification in an in vivo environment.
- 8. A material suitable for implantation the interior of the body of a living being, the material being a biocompatible biomaterial which is a biocompatible synthetic polymer having incorporated therein an effective amount of trivalent iron cations to render the biomaterial resistant to pathologic calcification in an in vivo environment.
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10. A material for implanting in the interior of a human or animal living body, the material being prepared by the process of:
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(a) dissolving a biocompatible synthetic polymeric material in an organic solvent; (b) adding a soluble salt of trivalent iron cations to the dissolved biocompatible synthetic polymeric material to form a mixture; and (c) forming said mixture into a desired configuration. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18)
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23. A material for implanting in the interior of a human or animal living body prepared by the process of:
incubating a glutaraldehyde pre-treated bioprosthetic tissue in an aqueous solution of soluble salt of trivalent iron and an anticalcification agent selected from the group consisting of citrates and diphosphonates, the soluble salt of trivalent iron and the anticalcification agent selected from the group consisting of citrates and diphosphonates having concentrations in the range of from about 0.1M to 0.00001M for a period of time ranging from approximately between 1 hour to 24 hours at a temperature of approximately between 4°
C. to 25°
C.- View Dependent Claims (24)
Specification