Annuloplasty ring for regeneration of diseased or damaged heart valve annulus

• US 6,669,725 B2
• Filed: 12/28/2000
• Issued: 12/30/2003
• Est. Priority Date: 12/28/2000
• Status: Expired due to Fees

• Current Assignee: Zimmer Orthobiologics, Inc. (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Centerpulse Biologics Incorporated
• Inventors: Scott, Timothy L.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): Blanco, Javier G.
• Application Number:
  US09/750,588
• Publication Number:
  US 20020123803A1
• Time in Patent Office: 1,097 Days
• Field of Search: 623/2.36, 623/2.37
• 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 for inducing growth of heart valve annulus tissue, said growth factor comprising at least one bone morphogenetic protein selected from the group consisting of;

BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, and BMP-7.

2. The prosthesis of claim 1 wherein said growth factor comprises BMP-2.

3. The prosthesis of claim 1 wherein said growth factor comprises BMP-3, BMP-2, BMP-4, BMP-5, BMP-6, and BMP-7.

4. The prosthesis of claim 1 wherein said growth factor comprises a bone morphogenetic protein selected from the group consisting of:

BMP-2, BMP-7, and mixtures of BMP-2 and BMP-7.

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

6. The prosthesis of claim 1 further comprising at least one antibiotic selected from the group consisting of minocycline and rifampin.

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

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

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

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

surgically implanting an annuloplasty prosthesis comprising a non-resorbable ring and a growth factor associated with said ring, said growth factor comprising at least one bone morphogenetic protein selected from the group consisting of;

BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, and BMP-7 in the annulus of said diseased or defective heart valve; and

rapidly delivering said growth factor to tissue adjacent said annulus.

11. The method of claim 10 further comprising gradually delivering said growth factor to tissue adjacent said annulus.

12. The method of claim 10 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.

13. The method of claim 10 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.