Annuloplasty ring for regeneration of diseased or damaged heart valve annulus

• US 20020123803A1
• Filed: 12/28/2000
• Published: 09/05/2002
• Est. Priority Date: 12/28/2000
• Status: Active Grant

• Current Assignee: Zimmer Orthobiologics, Inc. (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Orthobiologics, Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Scott, Timothy L.
• Granted Patent: US 6,669,725 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

An improved, non-resorbable annuloplasty ring that will provide support for the valve annulus while also promoting healing and/or regeneration of the annulus tissue is disclosed. Healing and/or regeneration of valvular tissue is promoted using a growth factor mixture that has been shown to be capable of promoting growth of a wide range of tissues, including heart valve tissue, and which promotes tissue growth based upon the local tissue environment (i.e., specific cell recruitment and proliferation). Thus, an annuloplasty ring that provides an actual healing response in addition to mechanical support to a dilated heart valve annulus is provided.

Claims

1. An annuloplasty prosthesis comprising:

a non-resorbable ring and

a growth factor associated with said ring and having activity for inducing growth of heart valve annulus tissue.

2. The prosthesis of claim 1 wherein said growth factor is disassociable from said ring under physiological conditions.

3. The prosthesis of claim 1 wherein said growth factor comprises a mixture of proteins having activity for inducing the growth of heart valve annulus tissue.

4. The prosthesis of claim 1 wherein said growth factor comprises at least one bone morphogenetic protein chosen from the group consisting of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 and BMP-7.

5. The prosthesis of claim 4 wherein said growth factor comprises BMP-3, BMP-2, BMP-4, BMP-5, BMP-6, and BMP-7.

6. The prosthesis of claim 1 wherein said growth factor comprises TGFβ

-1 or TGFβ

-b 2.

7. The prosthesis of claim 1 wherein said ring comprises a cloth exterior.

8. The prosthesis of claim 1 wherein said ring comprises a foam filler material.

9. The prosthesis of claim 1 wherein said ring comprises a resorbable polymer.

10. The prosthesis of claim 1 further comprising a bioresorbable polymer mixed with said growth factor.

11. The prosthesis of claim 10 wherein said bioresorbable polymer comprises a polymer chosen from the group consisting of polyglycolic acid, polylactic acid and mixtures and derivatives thereof.

12. The prosthesis of claim 1 further comprising a disassociable therapeutic agent, other than said growth factor, associated with said ring.

13. The prosthesis of claim 12 wherein said other therapeutic agent is an antibiotic.

14. The prosthesis of claim 13 wherein said antibiotic is chosen from the group consisting of minocycline and rifampin.

15. The prosthesis of claim 1 wherein said ring comprises at least one flexible portion.

16. The prosthesis of claim 1 wherein said ring comprises at least one rigid portion.

17. The prosthesis of claim 1 wherein said ring comprises at least one semi-rigid portion.

18. A method of treating a patient having a diseased or defective heart valve, the method comprising:

surgically implanting the annuloplasty prosthesis of claim 1 at the annulus of said diseased or defective heart valve.

19. The method of claim 18 further comprising gradually delivering said growth factor to tissue adjacent said annulus.

20. The method of claim 18 further comprising rapidly delivering said growth factor to tissue adjacent said annulus.

21. The method of claim 20 wherein said prosthesis further comprises a porous cloth exterior and said method further comprises diffusing said growth factor from the pores of said cloth.

22. The method of claim 18 wherein said prosthesis further comprises a porous foam filler material and said method further comprises diffusing said growth factor from the pores of said foam.

23. The method of claim 18 wherein said prosthesis further comprises a porous foam filler material and a porous cloth exterior and said method further comprises both rapidly and gradually delivering said growth factor adjacent said annulus.