Stentless bioprosthetic valve having chordae for replacing a mitral valve

• US 7,591,847 B2
• Filed: 10/10/2003
• Issued: 09/22/2009
• Est. Priority Date: 10/10/2002
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Jordana, Jorge L., Navia, Jose' Luis, Navia, Jose' A.
• Primary Examiner(s): Pellegrino; Brian E.
• Application Number:
  US10/683,341
• Publication Number:
  US 20040122513A1
• Time in Patent Office: 2,174 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.1, 623/2.12, 623/2.13, 623/2.38, 623/2.42, 623/904, 623/2.36, 623/2.37, 623/2.41
• US Class Current: 623/2.1
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A stentless bioprosthetic valve includes at least one piece of biocompatible material comprising a bi-leaflet conduit having a proximal end and a distal end. The proximal end defines a first annulus for suturing to the valve annulus. The conduit includes first and second leaflets that mimic the native leaflets and extend between the conduit ends. The distal end defines a second annulus at which the first and second leaflets terminate. The conduit further includes first and second pairs of prosthetic chordae projecting from the leaflets at the second annulus. One of the first pair of prosthetic chordae extends from the first leaflet and has a distal end for suturing to a papillary muscle and the other of the first pair of prosthetic chordae extends from the first leaflet and has a distal end for suturing to another papillary muscles.

Claims

1. A stentless bioprosthetic valve for replacing a native mitral valve resected from a valve annulus in a heart, the native mitral valve haying anterior and posterior leaflets and associated native chordae tendinea, said bioprosthetic valve comprising:

at least one piece of biocompatible material comprising a bi-leaflet conduit having dimensions that correspond to the dimensions of the native mitral valve, said conduit having a proximal end and a distal end, said proximal end of said conduit defining a first annulus for suturing to the valve annulus in the heart;

said conduit including first and second leaflets that mimic the three-dimensional anatomical shape of the anterior and posterior leaflets of the native mitral valve, said first and second leaflets extending between said proximal end and said distal end of said conduit, said distal end of said conduit defining a second annulus at which said first and second leaflets terminate;

said conduit further including first and second pairs of prosthetic chordae projecting from said first and second leaflets at said second annulus, each of said prosthetic chordae comprising a solid uninterrupted extension of said at least one piece of biocompatible material, said first and second pairs of prosthetic chordae providing prolapse prevention for the bioprosthetic valve and supporting the left ventricular muscle throughout the cardiac cycle;

one of said first pair of prosthetic chordae extending from said first leaflet and having a terminal end for suturing to one of the two papillary muscles and the other of said first pair of prosthetic chordae extending from said first leaflet and having a terminal end for suturing to the other of the two papillary muscles;

one of said second pair of prosthetic chordae extending from said second leaflet and having a distal end for suturing to one of the two papillary muscles and the other of said second pair of prosthetic chordae extending from said second leaflet and having a distal end for suturing to the other of the two papillary muscles;

each of said prosthetic chordae having a proximal end extending from said second annulus, each of said prosthetic chordae having a substantially constant cross-sectional shape along an entire length of said prosthetic chordae from said proximal end to said terminal end that is sutured to the respective papillary muscle.

2. The bioprosthetic valve of claim 1 wherein said at least one piece of biocompatible material comprises harvested biological tissue.

3. The bioprosthetic valve of claim 2 wherein said harvested biological tissue comprises pericardial tissue.

4. The bioprosthetic valve of claim 1 wherein said at least one piece of biocompatible material comprises an artificial tissue.

5. The bioprosthetic valve of claim 1 further comprising a biocompatible, unstented ring connected to said first annulus for supporting said first annulus and for suturing to the valve annulus in the heart, said ring, when sutured to the valve annulus, impeding dilatation of the valve annulus and preserving motion of the valve annulus.

6. The bioprosthetic valve of claim 5 wherein said ring is formed from said at least one piece of biocompatible material that has been folded over itself and sutured at the proximal end of said conduit.

7. The bioprosthetic valve of claim 5 wherein said ring is a separate piece of biocompatible material that is sutured about said first annulus.

8. The bioprosthetic valve of claim 7 wherein said ring comprises a synthetic material.

9. The bioprosthetic valve of claim 7 wherein said ring comprises harvested biological tissue.

10. The bioprosthetic valve of claim 7 wherein said ring extends radially outwardly of a peripheral edge of said first annulus.

11. The bioprosthetic valve of claim 7 wherein said ring is wrapped around a peripheral edge of said first annulus.