Heart valve

• US 5,554,184 A
• Filed: 07/27/1994
• Issued: 09/10/1996
• Est. Priority Date: 07/27/1994
• Status: Expired due to Fees

• Current Assignee: Venkat R. Machiraju
• Original Assignee: Venkat R. Machiraju
• Inventors: Machiraju, Venkat R.
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US08/281,305
• Time in Patent Office: 776 Days
• Field of Search: 606/167, 623/2, 623/11, 623/900, 623/901
• US Class Current: 606/167
• 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: Y10S 623/901 Method of manufacturing prosthetic device
• CPC Class Codes: Y10S 623/91 Heart

Abstract

A heart valve, and a technique for effecting valve replacement or repair, which partially or completely replaces the mitral (or tricuspid) valve with an autologous graft from the pericardium, fascia lata or even the dura mater, or a bovine or porcine pericardial or other synthetic sheet material equivalent thereof, preferably in a configuration which substantially restores the original anatomy of the heart including chordae tendineae attached to adjacent papillary muscles of the heart. Most preferably, a section of the patient'"'"'s pericardium is cut to a shape including two leaflets, with each leaflet having a trabeculated tier of chordae tendineae terminating in a spear-shaped tab. The two leaflets are cut out as a single unit, and the two far ends are sutured together to yield a bileaflet valve having appended chordae and tabs.

Claims

1. A method for repairing a human heart valve, comprising the steps of cutting a single sheet of a natural or artificial sheet material into the shape of an excised human heart valve including at least one trabeculated tier of chordae tendineae, said tier terminating in a papillary muscle graft tab, and surgically implanting the cut sheet material into the heart of a patient in whom heart valve repair is indicated.

2. The method according to claim 1 wherein said step of cutting a natural or artificial sheet material is conducted with a cutting tool having blades configured in the shape of an excised human heart valve.

3. The method according to claim 1 wherein said step of cutting a natural or artificial sheet material is conducted with a cutting tool having blades configured in the shape of an excised human mitral valve.

4. The method according to claim 3 wherein said sheet material is selected from the group consisting of autologous pericardium, autologous fascia lata, autologous dura mater, bovine pericardium, porcine pericardium and biocompatible polymer.

5. The method according to claim 4 wherein said sheet material is autologous pericardium.

6. The method according to claim 3 wherein said shape of an excised human mitral valve further comprises an anterior leaflet connected to a posterior leaflet, a plurality of papillary muscle graft tabs and a plurality of chordae tendineae connecting said leaflets to said papillary muscle graft tabs.

7. The method according to claim 3 wherein said shape of an excised human mitral valve includes about 20 chordae tendineae.

8. A cutting tool for preparing a human heart valve graft, comprising a backing and at least one blade configured in the shape of an excised human heart valve including at least one trabeculated tier of chordae tendineae, wherein said chordae tendineae have papillary muscle graft tabs appended thereto.

9. A cutting tool according to claim 8 wherein said at least one blade is disposable, said backing is autoclavable, and said tool is adapted for inclusion in a mechanical cutting system.

10. A cutting tool for preparing a human heart valve graft, comprising a substrate bearing cutouts defining the shape of an excised human mitral valve including chordae tendineae.

11. A method for repairing a human mitral valve, comprising the steps of:

excising at least a portion of the pericardium, in a single piece, of a patient in whom mitral valve repair is indicated;

cutting said pericardium into the shape of a human mitral valve including at least one trabeculated tier of chordae tendineae terminating in a papillary muscle graft tab;

curing the pericardium thus cut in a crosslinking solution, followed by rinsing; and

surgically implanting the cut and cured pericardium in the heart of a patient in whom mitral valve replacement is indicated.

12. The method according to claim 11 wherein said step of cutting said pericardium is conducted with a cutting tool having blades configured in the shape of an excised human mitral valve including chordae tendineae.

13. The method according to claim 11 wherein said shape of an excised human mitral valve including chordae tendineae further comprises an anterior leaflet connected to a posterior leaflet, a plurality of papillary muscle graft tabs and a plurality of chordae tendineae connecting said leaflets to said papillary muscle graft tabs.

14. The method according to claim 13 wherein said shape of an excised human mitral valve further includes about 20 chordae tendineae.

15. The method according to claim 14 wherein said chordae tendineae are trabeculated.

16. The method according to claim 14 wherein said crosslinking solution is aqueous glutaraldehyde.