Method and apparatus for replacing a mitral valve with a stentless bioprosthetic valve

• US 20040122512A1
• Filed: 10/10/2003
• Published: 06/24/2004
• 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?apos; Luis, Navia, Jose?apos; A.
• Granted Patent: US 7,087,079 B2
• Time in Patent Office: Days
• US Class Current: 623/2.12
• 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. The conduit has a distal end and a proximal end that defines a first annulus for suturing to the valve annulus of a heart. The conduit further includes first and second leaflets that mimic the anterior and posterior leaflets of the native mitral valve. The first and second leaflets extend between the proximal and distal ends. The distal end defines a second annulus at which the first and second leaflets terminate. The second annulus is for suturing to free edges of the anterior and posterior leaflets of the native mitral valve that remain intact following resection of the native mitral valve so that the native chordae tendinae continue to provide prolapse prevention and left ventricular muscle support functions in addition to maintaining the continuity between the valve annulus and the papillary muscles. A method for replacing the native mitral valve with a stentless bioprosthetic valve is also provided.

Claims

1. A stentless bioprosthetic valve for replacing a native mitral valve resected from a valve annulus in a heart, the native mitral valve having anterior and posterior leaflets and associated chordae tendinae, 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 further 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 second annulus for suturing to free edges of the anterior and posterior leaflets of the native mitral valve that remain intact following resection of the native mitral valve so that the native chordae tendinae, which are attached to the papillary muscles, continue to provide prolapse prevention and left ventricular muscle support functions in addition to maintaining the continuity between the valve annulus and the papillary muscles.

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 2 wherein said harvested biological tissue comprises a porcine mitral valve.

5. The bioprosthetic valve of claim 2 wherein said harvested biological tissue comprises a homograft mitral valve.

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

7. 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.

8. The bioprosthetic valve of claim 7 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.

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

10. The bioprosthetic valve of claim 9 wherein said ring comprises a synthetic material.

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

12. A stentless bioprosthetic valve for replacing a native mitral valve resected from a valve annulus in a heart, the native mitral valve having anterior and posterior leaflets and associated chordae tendinae, 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;

said conduit further 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 second annulus for suturing to free edges of the anterior and posterior leaflets of the native mitral-valve that remain intact following resection of the native mitral valve so that the native chordae tendinae, which are attached to the papillary muscles, continue to provide prolapse prevention and left ventricular muscle support functions in addition to maintaining the continuity between the valve annulus and the papillary muscles; and

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.

13. The bioprosthetic valve of claim 12 wherein said at least one piece of biocompatible material comprises harvested biological tissue.

14. The bioprosthetic valve of claim 13 wherein said harvested biological tissue comprises pericardial tissue.

15. The bioprosthetic valve of claim 13 wherein said harvested biological tissue comprises a porcine mitral valve.

16. The bioprosthetic valve of claim 13 wherein said harvested biological tissue comprises a homograft mitral valve.

17. The bioprosthetic valve of claim 12 wherein said at least one piece of biocompatible material comprises an artificial tissue.

18. A method for replacing a native mitral valve having anterior and posterior leaflets with a stentless bioprosthetic valve, said method comprising the steps of:

providing at least one piece of biocompatible material that comprises a bi-leaflet conduit having dimensions that correspond to the dimensions of the native mitral valve being replaced, the conduit having a proximal end and a distal end, the proximal end defining a first annulus and the distal end defining a second annulus, the conduit further including first and second leaflets that mimic the three-dimensional shape of the anterior and posterior leaflets of the native mitral valve, the first and second leaflets extending from the proximal end and terminating at the distal end of the conduit;

resecting the majority of the anterior and posterior leaflets of the native mitral valve from the valve annulus but leaving the free edges of the anterior and posterior leaflets intact along with the native chordae tendinae, which are attached to the papillary muscles, so that the native chordae tendinae can provide prolapse prevention and left ventricular muscle support functions for the bioprosthetic valve in addition to maintaining the continuity between the valve annulus and the papillary muscles;

suturing the first and second leaflets at the second annulus of the conduit to the free edges of the anterior and posterior leaflets of the native mitral valve that remain following resection of the native mitral valve; and

suturing the first annulus of the conduit to the valve annulus of the native mitral valve to secure the bioprosthetic valve to the valve annulus.

19. The method of claim 18 further comprising the steps of:

providing a biocompatible, unstented support ring that encircles the first annulus; and

suturing the support ring to the valve annulus of the heart to secure the bioprosthetic valve to the valve annulus and to impede dilatation of the valve annulus and preserve motion of the native mitral valve annulus.

20. The method of claim 19 wherein said step of providing a support ring includes the steps of:

folding a portion of the biocompatible material at the proximal end of the conduit over onto itself; and

suturing the folded portion to the conduit about the first annulus.

21. The method of claim 19 wherein said step of providing a support ring includes the steps of:

providing a separate ring-shaped piece of biocompatible material; and

suturing the ring-shaped piece about said first annulus.