Atrio-ventricular valvular device

• US 6,358,277 B1
• Filed: 06/21/2000
• Issued: 03/19/2002
• Est. Priority Date: 06/21/2000
• Status: Expired due to Fees

• Current Assignee: The International Heart Institute of Montana Foundation
• Original Assignee: The International Heart Institute of Montana Foundation
• Inventors: Duran, Carlos M. G.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/598,630
• Time in Patent Office: 636 Days
• Field of Search: 623/2.12, 623/2.13, 623/2.36, 623/23.72, 623/2.16
• 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 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

An anatomically designed atrioventricular valve is made of biologically compatible synthetic membrane or biological membrane of autologous, homologous or heterologous origin. A single piece of the selected membrane material is trimmed so as to form two unequal sheaths similar to the normal anterior and posterior mammalian mitral valve leaflets with a wide upper base to be sutured to the host'"'"'s mitral annulus. These two leaflets are prolonged and tapered into two thin bands to be connected to the papillary muscles serving as replacements for the natural marginal chordae tendinae of the normal mitral valve. The two lateral sides of the membrane are joined to form a truncated cone with a wider upper circular base and a narrow extremity formed by the thin chordal bands. A set of sutures are placed between selected points at the base of the cone and the two thin prolongations serving as replacements for the strut or stay basal chords of the natural mitral valve. Thus, the mitral valve prosthesis is anatomical because it is stentless, bicuspid and supported by marginal and basal chordae. Obturators and sizers in the configuration of rods of varying diameter, to measure the host'"'"'s valve annulus diameter and select the appropriate size of the prosthesis are used during implantation of the prosthesis. A rod shaped holder maintains the prosthesis during implantation, and a curved bodied measuring instrument is used to determine the precise location where the chordae tendinae of the prosthesis are to be sutured to the papillary muscles of a recipient mammal.

Claims

1. A stentless heart valve prosthesis to be used for the replacement of a diseased atrioventricular valve in the heart of a recipient mammal, comprising:

a single unitary body of biologically acceptable non-absorbable flexible membrane configured substantially in the shape of an anatomically correct mitral valve, the membrane forming a hollow inverted truncated cone having a substantially circular base forming an annulus at its first end, said base forming annulus corresponding to the mitral annulus of the heart of the recipient and configured and adapted for suturing into the mitral annulus of the heart of the recipient, the membrane further forming an anterior and posterior leaflet configured substantially in the form of the anterior and posterior leaflets of the natural mitral valve of the heart of the recipient, and the membrane still further forming two narrow extensions at its second end opposite to the annulus where the inverted cone is narrower than at its first end, the extensions substantially configured as anatomically correct cords and adapted to be sutured to the papillary muscle of the heart of the recipient, and

two lines of biologically acceptable non-absorbable material, the lines configured and positioned as substantially anatomically correct strut cords of the natural mitral valve, each of said lines being affixed at one end substantially to the base of the truncated cone and at a second end substantially to the extremity of one of the extensions, respectively, whereby after implantation into the heart of the recipient the anterior and posterior leaflets of the prosthesis collapse during systole and form a plurality of scallops in substantial simulation of a natural mitral valve.

2. A heart valve prosthesis in accordance with claim 1 wherein each line configured as a strut cord is shorter than the total distance between the base of the prosthesis and the extremity of the respective extension.

3. A heart valve prosthesis in accordance with claim 1 wherein the membrane forming the truncated cone includes one suture along its length in the axial direction, the suture joining together the anterior and posterior leaflets.

4. A heart valve prosthesis in accordance with claim 3 wherein the membrane consists essentially of biocompatible synthetic material.

5. A heart valve prosthesis in accordance with claim 3 wherein the membrane consists essentially of biocompatible biological material.

6. A heart valve prosthesis in accordance with claim 5 wherein the biological material of the membrane is of autologous, homologous or heterologous origin.

7. A heart valve prosthesis in accordance with claim 1 wherein the membrane forming the truncated cone includes one suture along its length in the axial direction, the suture joining together two substantial halves of the posterior leaflet.

8. A heart valve prosthesis in accordance with claim 7 wherein the membrane consists essentially of biocompatible synthetic material.

9. A heart valve prosthesis in accordance with claim 7 wherein the membrane consists essentially of biocompatible biological material.

10. A heart valve prosthesis in accordance with claim 9 wherein the biological material of the membrane is of autologous, homologous or heterologous origin.

11. A heart valve prosthesis in accordance with claim 1 wherein a biologically acceptable reinforcing member is attached to the extremity of each one of the extensions whereby sutures attaching the extensions to the papillary muscle of the heart of the recipient have a reinforced base.

12. A stentless heart valve prosthesis to be used for the replacement of a diseased atrioventricular valve in the heart of a recipient mammal, comprising:

a single unitary body of biologically acceptable non-absorbable flexible membrane configured substantially in the shape of an anatomically correct mitral valve, the membrane forming a hollow inverted truncated cone having a substantially circular base forming an annulus at its first end, said base forming annulus corresponding to the mitral annulus of the heart of the recipient and configured and adapted for suturing into the mitral annulus of the heart of the recipient, the membrane further forming an anterior and posterior leaflet configured substantially in the form of the anterior and posterior leaflets of the natural mitral valve of the heart of the recipient, and the membrane still further forming two narrow extensions at its second end opposite to the annulus where the inverted cone is narrower than at its first end, the extensions substantially configured as anatomically correct cords and adapted to be sutured to the papillary muscle of the heart of the recipient, and

two lines of biologically acceptable non-absorbable material, the lines configured and positioned as substantially anatomically correct strut cords of the natural mitral valve, each of said lines being affixed at one end substantially to the base of the truncated cone and at a second end substantially to the extremity of one of the extensions, respectively, and each line being shorter than the total distance between the base of the prosthesis and the extremity of the respective extension whereby after implantation into the heart of the recipient the anterior and posterior leaflets of the prosthesis collapse during systole and form a plurality of scallops in substantial simulation of a natural mitral valve.

13. A heart valve prosthesis in accordance with claim 12 wherein the membrane forming the truncated cone includes one suture along its length in the axial direction, the suture joining together the anterior and posterior leaflets.

14. A heart valve prosthesis in accordance with claim 13 wherein the membrane consists essentially of biocompatible biological material of autologous, homologous or heterologous origin.

15. A heart valve prosthesis in accordance with claim 14 wherein a biologically acceptable reinforcing member is attached to the extremity of each one of the extensions whereby sutures attaching the extensions to the papillary muscle of the heart of the recipient have a reinforced base.

16. A heart valve prosthesis in accordance with claim 12 wherein the membrane forming the truncated cone includes one suture along its length in the axial direction, the suture joining together two substantial halves of the posterior leaflet.

17. A heart valve prosthesis in accordance with claim 16 wherein the membrane consists essentially of biocompatible biological material of autologous, homologous or heterologous origin.

18. A heart valve prosthesis in accordance with claim 17 wherein the extremity of each of the extensions comprises a double layer of biological membrane whereby sutures attaching the extensions to the papillary muscle of the heart of the recipient have a reinforced base.