Trileaflet heart valve

• US 6,059,826 A
• Filed: 04/22/1998
• Issued: 05/09/2000
• Est. Priority Date: 05/13/1997
• Status: Expired due to Term

• Current Assignee: Valve Special Purpose Co. LLC (Cryolife Incorporated)
• Original Assignee: On-X Life Technologies, Inc. (Cryolife Incorporated)
• Inventors: Stupka, Jonathan C., More, Robert B., Bokros, Jack C.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US09/064,614
• Time in Patent Office: 748 Days
• Field of Search: 673/2, 673/900
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03

Abstract

A trileaflet heart valve includes a generally annular valve body having an interior wall of nominally circular cross-section into which three wedge-shaped projections radially extend to provide three pairs of flanking flat surfaces between which three leaflets are pivotally supported. The valve body has an outwardly flaring upstream entrance end that, together with the configuration of the leaflets, assures streamlined flow and low transvalvular pressure drop. Wing sections extend laterally in both directions at angles between about 30° and 50° from flat central sections of the leaflets to create V-shaped cross-section leaflet bodies having short flat edge sections along the lateral edges of both wing sections that create a wide open central flow passageway. The three leaflets assume an orientation parallel or nearly parallel to the central axis in full open position. Leaflet movement from open to closed position is partially defined by upstream retainers aligned with the flat central sections of each leaflet and by surfaces formed in or on the side walls of the projections along which the leaflets slide. Radially interior edges of the leaflets are tapered to effectively eliminate cavitation.

Claims

1. A multiple leaflet mechanical prosthetic heart valve which comprises:

a tubular valve body having an interior wall surface of generally circular cross-section which defines a central passageway for blood flow therethrough with a central longitudinal axis extending therethrough in an upstream-downstream direction,

at least three relatively rigid leaflets mounted within said valve body on pivot means so as to alternately pivot between an open position to permit blood flow downstream through said valve body and a closed position to prevent blood flow upstream therethrough,

each of said leaflets having a pair of converging edges that meet at an inner tip which lies generally adjacent said central axis in the closed position, each said edge lying in juxtaposition with the facing edge of an adjacent said leaflet in the closed position, and a major arcuate edge which lies in juxtaposition with said generally circular cross-section interior wall of said valve body in the closed position, and

said converging edges of each said leaflet being shaped so that the radially outer regions of each converging edge interengage with the corresponding portion of said adjacent leaflet, while at least about the radially inner one-half of said converging edge is spaced from the corresponding region of said adjacent leaflet, said inner tips of said multiple leaflets being spaced from and out of contact with one another in the closed position.

2. The prosthetic valve according to claim 1 wherein said converging edges each have a straight radially outer region and a straight radially inner region, which regions are not colinear but are aligned at an obtuse angle to each other greater than about 170°

.

3. The prosthetic valve according to claim 2 wherein each said radially outer edge region has a surface which is substantially rectilinear, being composed of lines which are substantially parallel to said valve body central axis in the closed position.

4. The prosthetic valve according to claim 3 wherein both said radially outer and radially inner edge surface regions are flat.

5. The prosthetic valve according to claim 4 wherein said planes of said radially outer and inner edge surface regions are aligned at a dihedral angle of between about 172°

and about 179°

.

6. The prosthetic valve according to claim 4 wherein there are only three leaflets and wherein said two radially outer regions of each said leaflet lie in planes which are aligned at an angle of about 120°

to each other.

7. The prosthetic valve according to claim 6 wherein said two radially inner edge surface regions of the converging edges of each leaflet lie in planes which form a dihedral angle of between about 121°

and about 125°

.

8. The prosthetic valve according to claim 2 wherein each said radially outer region constitutes at least about one-third of the total length of said converging edge.

9. The prosthetic valve according to claim 2 wherein each said radially outer region constitutes about one-half of the total length of said converging edge.

10. The prosthetic valve according to claim 2 wherein each said radially outer region constitutes about one-third of the total length of said converging edge.

11. The prosthetic valve according to claim 1 wherein said inner tip of each of said leaflets is spaced between about 0.001 inch and about 0.003 inch from said inner tip of any other of said leaflets in the closed position.

12. The prosthetic valve according to claim 1 wherein said relatively rigid leaflets are formed of pyrolytic carbon and have rectilinear outflow surfaces, and in the closed position said rectilinear surfaces are oriented at an angle of about 30°

or less to a plane perpendicular to the central axis of said central passageway of said tubular valve body.

13. The prosthetic valve according to claim 1 wherein there are only three of said leaflets.

14. The prosthetic valve according to claim 13 wherein said valve body has a generally circular cylindrical interior surface which is interrupted by three equally spaced-apart projections, which projections extend radially inward into said central passageway and contain means interengaging with said three leaflets to establish the pivoting movement thereof.

15. A trileaflet prosthetic heart valve which comprises:

a tubular valve body having an interior wall surface of generally circular cross-section which defines a central passageway for blood flow therethrough with a central longitudinal axis extending therethrough in an upstream-downstream direction,

said valve body having a generally circular cylindrical interior surface which is interrupted by three equally spaced-apart projections, which projections extend radially inward into said central passageway,

three leaflets mounted within said valve body and interengaging with pivot means formed on said projections so as to alternately open to permit blood flow downstream through said valve body and close to prevent blood flow upstream therethrough,

each of said leaflets having a pair of converging edges that meet at an inner tip which lies generally adjacent said central axis in the closed position, each said edge lying in juxtaposition with the facing edge of an adjacent said leaflet in the closed position, and a major arcuate edge which lies in juxtaposition with said generally circular cross-section interior wall of said valve body in the closed position, and

said converging edges of each said leaflet being shaped so that the radially outer regions of each converging edge interengage with the corresponding portion of said adjacent leaflet, while at least about the radially inner one-half of said converging edge is spaced from the corresponding region of said adjacent leaflet, said inner tips of said multiple leaflets being spaced between about 0.001 inch and about 0.005 inch from said inner tip of other of said leaflets in the closed position.

16. The prosthetic valve according to claim 15 wherein said converging edges each have a straight radially outer region and a straight radially inner region, which regions are not colinear but are aligned at an obtuse angle to each other greater than about 170°

.