Total mitral heterologous bioprosthesis to be used in mitral or tricuspid heart replacement

• US 6,074,417 A
• Filed: 02/06/1998
• Issued: 06/13/2000
• Est. Priority Date: 11/16/1992
• Status: Expired due to Term

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Peredo, Mario Osvaldo Vrandecic
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US09/019,748
• Time in Patent Office: 858 Days
• Field of Search: 623/2, 623/900
• 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

Abstract

The present invention relates to a heterologous total stentless mitral valve prosthesis for the use in mitral and tricuspid position which provides for better hemodynamic performance. This mitral valve prosthesis addresses the specific needs of flow and contractility, thereby prolonging durability. The heterologous total stentless mitral heart valve prosthesis of this present invention comprises one sewing ring, leaflets, and subvalvular apparatus having new chordal insertions which are fixed to or in between two heterologous pericardial patches. This heart valve prosthesis is obtained from heterologous mammals, such as swine, ovine, bovine, and moreover, the pericardial patches used may also be of synthetic material. The heart valve prosthesis presents specific design benefits from its anatomical and functional characteristics permitting chordal insertion to the papillary muscles and attachment of its sewing rim to the mitral annulus of the recipient, thereby providing for better hemodynamic performance and avoiding disfunction and dilatation of the left ventricle.

Claims

1. A heterologous total stentless mitral valve prosthesis obtained from a mammal with a size, anatomy and function similar to a human'"'"'s, suitable for mitral and tricuspid valve replacement in a patient, the heterologous total stentless mitral valve prosthesis comprising:

a heart valve having an annulus, leaflets attached to said annulus and chordae extending from said leaflets, the annulus corresponding to the annulus of the valve obtained from said mammal and having a heterologous mitral sewing rim to be secured to the natural valve annulus of the patient; and

a collar secured to said heterologous mitral sewing rim, such that said sewing rim is enveloped, to strengthen said mitral sewing rim.

2. The heterologous total stentless mitral valve prosthesis of claim 1 wherein said collar entirely envelopes said mitral sewing rim.

3. The heterologous total stentless mitral valve prosthesis of claim 1 wherein said collar comprises heterologous pericardial tissue.

4. A heterologous total stentless mitral valve prosthesis according to claim 1, wherein markings are placed on said collar at left and right trigone areas to determine a correct size of the valve.

5. A heterologous total stentless mitral valve prosthesis according to claim 1, wherein a mark is placed at the center of a weak posterior portion of said mitral sewing rim on said collar to provide a reference so that stress may be evenly distributed over said weak posterior portion during attachment of the mitral valve to the patient.

6. A heterologous total stentless mitral valve prosthesis according to claim 1, wherein said pericardial tissue is approximately 1 cm in width and has a length equal to a predetermined circumference of said mitral sewing rim, such that when it is secured to said mitral sewing rim approximately 50 mm of said collar are present on either side of said mitral sewing rim.

7. A heterologous total stentless mitral valve prosthesis according to claim 1, further comprising vertical stripes extending from said collar.

8. A heterologous total stentless mitral valve prosthesis according to claim 1, wherein said collar comprises heterologous pericardial tissue, said heterologous pericardial tissue including naturally secured vertical strips extending from said collar, and wherein said vertical strips have suitable size and placement for attachment to said patient'"'"'s papillary muscle.

9. A method of selecting a heterologous total stentless mitral valve prosthesis of correct size for mitral or tricuspid valve replacement in humans, said heterologous mitral valve comprising a sewing rim to be secured to the natural valve annulus of the patient, the method comprising the steps of:

securing a collar to said sewing rim of said heterologous mitral valve to envelope said sewing rim;

placing markings on said collar at left and right trigone areas to determine correct size of the valve; and

matching the intertrigonal area of the mitral annulus of the patient with a spacing between said markings to select a valve of correct size.

10. The method of claim 9 wherein said collar entirely envelopes said sewing rim.

11. The method of claim 9 wherein said collar comprises heterologous pericardial tissue.

12. The method of claim 9, further comprising the step of:

making a mark at the center of a weak posterior portion of said mitral sewing rim on said collar to provide a reference, so that stress may be evenly distributed over said weak portion during attachment of the mitral valve prosthesis to the patient.