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

• US 5,733,331 A
• Filed: 06/07/1995
• Issued: 03/31/1998
• Est. Priority Date: 07/28/1992
• Status: Expired due to Term

• Current Assignee: Newcor Industrial SA
• Original Assignee: Newcor Industrial SA
• Inventors: Peredo, Mario Osvaldo Vrandecic
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/472,956
• Time in Patent Office: 1,028 Days
• Field of Search: 623/2, 623/900, 623/901
• US Class Current: 623/2.13
• 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 2/2415 Manufacturing methods
• 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: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: Y10S 623/90 Stent for heart valve

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 size, anatomy and function similar to a human'"'"'s, which is to be secured to the mitral annulus and the papillary muscle of the patient for mitral and tricuspid valve replacement, the heterologous total stentless mitral valve prosthesis, which is of an anatomic and functionally specific design that permits anchoring of the mitral valve prosthesis to both the papillary muscles and to a mitral rim of the patient, comprising:

a heterologous mitral sewing rim to be secured to the mitral annulus of the patient;

heterologous mitral leaflets extending from said heterologous mitral sewing rim;

a heterologous subvalvular apparatus comprising chordal attachments with each chordal attachment being of a predetermined spatial geometry and being naturally secured between said mitral leaflets and heterologous portions of papillary muscle of the mammal;

at least two patches to which said heterologous portions of papillary muscle securing said chordal attachments can be sutured; and

wherein said at least two patches can be sutured to the papillary muscle of the patient to thereby satisfy the spatial geometry of each point of insertion of the chordal attachments to each papillary muscle of the patient to preserve the original natural angulation of the chordal origin and thereby avoid directly suturing each chordal attachment to the papillary muscle of the patient.

2. The heart valve prosthesis of claim 1, wherein said mammals are selected from the group consisting of swine, ovine and bovine.

3. The heart valve prosthesis of claim 1, wherein each said chordal attachment is secured to one of said patches by sutures selected from the group consisting of mono- and polyfilament sutures.

4. The heart valve prosthesis of claim 1, wherein the chordal attachments are affixed to patches made of synthetic materials.

5. The heart valve prosthesis of claim 1, wherein said patches comprise heterologous pericardial tissue.

6. The heart valve prosthesis of claim 1, wherein said heterologous portions of papillary muscle are secured to said patches by sutures selected from the group consisting of mono- and polyfilament sutures.

7. The heart valve prosthesis of claim 1, wherein each said chordal attachment is fixed on said pericardial patches by sutures selected from the group consisting of mono- and polyfilament sutures.

8. The heart valve prosthesis of claim 1, wherein each said chordal attachment is fixed between said pericardial patches by sutures selected from the group consisting of mono- and polyfilament sutures.

9. A heterologous total stentless mitral valve prosthesis according to claim 1, wherein:

a first patch of said heterologous pericardial tissue is secured to the underside of said heterologous portions of papillary muscle so as to retain the spatial geometry of said chordal attachments; and

a second patch of said heterologous pericardial tissue having slots is secured to the upper side of said portions of papillary muscle such that the slots fit around said chordal attachments and the spatial geometry of said chordal attachments is retained.

10. A heterologous total stentless mitral valve prosthesis according to claim 9, where said first patch is larger than said portion of papillary muscle so that a free edge is formed after said first patch is secured to said portion of papillary muscle.

11. A heterologous total stentless mitral valve prosthesis according to claim 1, wherein pledgetted sutures are used to secure said patches of pericardial tissue to the papillary muscle of the patient.

12. A heterologous total stentless mitral valve prosthesis according to claim 11, wherein said pledgetted sutures are attached to an anterior and posterior origin of said papillary muscle of the patient and the anterior sutures are connected to a posterior portion of said patch of pericardial tissue and the posterior sutures are connected to an anterior portion of said patch of pericardial tissue.

13. A heterologous total stentless mitral valve prosthesis according to claim 12 wherein at least three pledgetted sutures are attached to said anterior and said posterior origin of the papillary muscle of the patient, respectively.

14. A heterologous total stentless mitral valve prosthesis according to claim 1, further comprising:

a heterologous pericardial collar to be secured to the mitral annulus of the patient, wherein said pericardial collar includes naturally secured vertical strips extending from said pericardial collar to said patches of pericardial tissue and

wherein said vertical strips are secured to said patches of pericardial tissue to maintain the spatial geometry of said chordal attachments and to relieve stress on said chordal attachments.