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

• US 7,087,079 B2
• Filed: 10/10/2003
• Issued: 08/08/2006
• Est. Priority Date: 10/10/2002
• Status: Expired due to Term

• 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:
  US10/683,105
• Publication Number:
  US 20040122512A1
• Time in Patent Office: 1,033 Days
• Field of Search: 606/159, 606/167, 623/2.1, 623/2.12, 623/2.13, 623/904, 623/2.16, 623/1.24, 623/1.26, 623/1.3, 623/1.31, 128/898
• US Class Current: 623/2.16
• 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 tendineae 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 that extend from the valve annulus at a proximal end to free edges at a distal end, the native mitral valve being resected so that the free edges and associated native chordae tendineae remain intact, the free edges forming a ring from which the native chordae tendineae extend to native papillary muscles, said bioprosthetic valve comprising:

at least one piece of biocompatible material comprising an unstented a bi-leaflet conduit having dimensions that correspond to the dimensions of the native leaflets of the native mitral valve, said conduit having a proximal end and a distal end, said proximal end and said distal end being spaced apart by a distance corresponding to the dimensions of the native mitral valve leaflets, said proximal end of said conduit defining a first annulus;

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;

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 and which does not include bioprosthetic chordae tendineae, said second annulus configured to be sutured to the ring formed by the free edges of the anterior and posterior leaflets at the distal end of the native mitral valve that remain intact following resection of the native mitral valve so that the native chordae tendineae, 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, whereby the entire circumference of said second annulus formed at said distal end by said first and second leaflets is spaced from the papillary muscles; and

wherein said ring is formed from at least one piece of said bi-leaflet conduit that has been folded over itself and sutured at the proximal end of said conduit.

2. A method for replacing a native mitral valve with a stentless bioprosthetic valve, the native mitral valve having anterior and posterior leaflets that extend from a valve annulus at a proximal end to free edges at a distal end, 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 native anterior and posterior leaflets of the native mitral valve with a circumferential resection at the proximal end of the native leaflets that releases the proximal end of the native leaflets from the valve annulus and another circumferential resection of the distal end of the native leaflets that leaves the free edges of the native anterior and posterior leaflets intact along with the native chordae tendineae, which are attached to the papillary muscles, so that the native chordae tendineae 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.

3. The method of claim 2 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.

4. The method of claim 3 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.

5. The method of claim 3 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.