Calcification-resistant medical articles

• US 6,254,635 B1
• Filed: 02/02/1998
• Issued: 07/03/2001
• Est. Priority Date: 02/02/1998
• Status: Expired due to Term

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Ogle, Matthew F., Schroeder, Richard F.
• Primary Examiner(s): MILANO, MICHAEL J
• Application Number:
  US09/017,185
• Time in Patent Office: 1,247 Days
• Field of Search: 623/2, 623/3, 623/11, 623/16, 623/66, 623/2.1, 623/2.12, 623/2.13, 623/2.42, 623/23.72, 623/23.73, 427/2.1, 427/2.24
• US Class Current: 623/2.13
• CPC Class Codes: A61L 2400/02 Treatment of implants to prevent calcification or mineralisation in vivo
• CPC Class Codes: A61L 27/042 Iron or iron alloys
• CPC Class Codes: A61L 27/047 Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
• 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

Abstract

Medical articles can include biocompatible material with a deposit of anticalcific elemental metal. The biocompatible material can be tissue, fabric or the like. The biocompatible material can be configured on the medical article such that when the medical article is positioned for its intended use, the biocompatible material is substantially removed from blood flow or is in a low blood flow area effectively removed from vascular blood flow. Gas phase or solution phase methods can be used to deposit the anticalcific elemental metal.

Claims

1. A medical article comprising tissue, said tissue comprising a deposit of anticalcific, elemental metal.

2. The medical article of claim 1 wherein said anticalcific elemental metal is selected from the group consisting of aluminum, iron, magnesium and combinations thereof.

3. The medical article of claim 1 wherein said medical article is a heart valve prosthesis.

4. The medical article of claim 1 wherein said tissue comprises crosslinked tissue.

5. The medical article of claim 1 wherein said tissue comprises a deposit of at least about 0.01 mg of elemental metal per gram of tissue.

6. The medical article of claim 1 wherein said elemental metal is selected from the group consisting of zinc, gallium, lanthanum and beryllium.

7. The medical article of claim 1 wherein said tissue comprises uncrosslinked tissue.

8. The medical article of claim 1 wherein said tissue is crosslinked with glutaraldehyde.

9. The medical article of claim 1 wherein said tissue comprises a deposit of about 0.1 mg to about 20 mg of elemental metal per gram of tissue.

10. The medical article of claim 1 wherein said tissue is porcine tissue or bovine tissue.

11. The medical article of claim 1 wherein calcification of said medical article is reduced at least about 30 percent following about one month of implantation within a patient, said reduction being determined in comparison with a comparable medical article lacking said elemental metal.

12. The medical article of claim 1 wherein calcification of said medical article is reduced at least about 75 percent following about one month of implantation within a patient, said reduction being determined in comparison with a comparable medical article lacking said elemental metal.

13. The medical article of claim 1 wherein said tissue further comprises a second anticalcific elemental metal.

14. The medical article of claim 1 wherein said tissue further comprises an anticalcific metal compound.

15. A heart valve prosthesis comprising leaflets, said leaflets comprising a synthetic polymer and a deposit of anticalcific, elemental metal.

16. The heart valve prosthesis of claim 15 wherein said elemental metal is selected from the group consisting of aluminum, iron, magnesium and combinations thereof.

17. The heart valve prosthesis of claim 15 wherein said polymer is selected from the group consisting of polyamides, polyesters, polystyrenes, polyacrylates, vinyl polymers, polycarbonates, polyurethanes, poly dimethyl siloxanes, cellulose acetates, poly methyl methacrylates, ethylene vinyl acetates, polysulfones, nitrocelluloses and similar copolymers.

18. The heart valve prosthesis of claim 15 wherein calcification of said prosthesis is reduced at least about 75 percent following about one month of implantation within a patient, said reduction being determined in comparison with a comparable prosthesis lacking said elemental metal.

19. The heart valve prosthesis of claim 15 wherein said polymer comprises a deposit of about 0.1 mg to about 20 mg of elemental metal per gram of polymer.

20. The heart valve prosthesis of claim 15 wherein said polymer further comprises an anticalcific metal compound.