Bi-leaflet prosthetic heart valve

• US 5,607,469 A
• Filed: 10/26/1994
• Issued: 03/04/1997
• Est. Priority Date: 10/28/1993
• Status: Expired due to Fees

• Current Assignee: Inocor GmbH
• Original Assignee: Inocor GmbH
• Inventors: Frey, Rainer H.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/329,165
• Time in Patent Office: 860 Days
• Field of Search: 623/2, 623/900, 137/518, 137/527, 137/499, 137/512.1, 137/527.8
• US Class Current: 623/2.21
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: Y10T 137/7839 Dividing and recombining in a single flow path
• CPC Class Codes: Y10T 137/7903 Weight biased

Abstract

A bi-leaflet prosthetic heart valve including a substantially circular valve ring having an inner circumference defining a flow channel for blood flow. An axle secured to the valve ring. The axle is parallel to but not co-linear with a diameter of the valve ring. Two substantially half-moon shaped leaflets are hingedly connected to the axle and pivot independently of each other. The leaflets have different cross-sectional areas. The leaflets move between the closed position wherein the leaflets are both substantially in a plane of the valve ring and substantially include a flow of blood through the flow channel and an open position wherein each of the leaflets are pivoted about the axle with respect to the closed position, thereby permitting blood to flow through the flow channel.

Claims

1. A bi-leaflet prosthetic heart valve, comprising:

a substantially circular valve ring having an inner circumference defining a flow channel for blood flow;

an axle secured to said valve ring, said axle being parallel to but not co-linear with a diameter of said valve ring;

two substantially half-moon shaped leaflets hingedly connected to said axle and pivoting independently of each other, said leaflets having different cross-sectional areas, said leaflets moving between a closed position wherein the leaflets both are substantially in a plane of said valve ring and substantially occlude a flow of blood through said flow channel, and an open position wherein each of said leaflets are pivoted about said axle with respect to said closed position thereby permitting blood to flow through said flow channel.

2. A bi-leaflet prosthetic heart valve according to claim 1, wherein said axle is located a distance from a diameter of said valve ring that is about 4 to about 22 percent of a length of said diameter.

3. A bi-leaflet prosthetic heart valve according to claim 1, wherein in said closed position one of said leaflets having a larger cross-sectional area occludes from about 55 to about 80 percent of a cross-sectional area of said flow channel and a smaller one of said leaflets occludes from about 20 to about 45 percent of said cross-sectional area of said flow channel.

4. A bi-leaflet prosthetic heart valve according to claim 1, wherein in said closed position one of said leaflets having a larger cross-sectional area occludes from about 60 to about 68 percent of a cross-sectional area of said flow channel and a smaller one of said leaflets occludes from about 32 to about 40 percent of said cross-sectional area of said flow channel.

5. A bi-leaflet prosthetic heart valve according to claim 1, wherein said flow channel includes a larger dorsal section and a smaller ventral section, wherein said valve is adapted for use as an aortal prosthesis, wherein one of said leaflets having a larger cross-sectional area comprises a dorsal section of said valve and one of said leaflets having a smaller cross-sectional area comprises a ventral section of said valve.

6. A bi-leaflet prosthetic heart valve according to claim 1, wherein said flow channel includes a larger dorsal section and a smaller ventral section, wherein said valve is adapted for use as a mitral prosthesis, wherein one of said leaflets having a larger cross-sectional area comprises a dorsal section of said valve and one of said leaflets having a smaller cross-sectional area comprises a ventral section of said valve.

7. A bi-leaflet prosthetic heart valve according to claim 1, wherein said axle includes two end portions and said valve ring includes two shaft bearings for receiving said end portions.

8. A bi-leaflet prosthetic heart valve according to claim 7, wherein said shaft bearings each comprise a recess formed in said valve ring.

9. A bi-leaflet prosthetic heart valve according to claim 8, wherein said recesses forming said shaft bearings each extend along an inner surface of said valve ring from an upstream side to a downstream side.

10. A bi-leaflet prosthetic heart valve according to claim 1, wherein each of said leaflets includes a curved edge section and a substantially straight section in the vicinity of said axle, each of said leaflets includes at least one integrally formed sleeve portion adjacent said straight portion, said sleeve portion including a bore, said axle extending through said bores of each of said leaflets.

11. A bi-leaflet prosthetic heart valve according to claim 10, wherein said axle includes an outside diameter only slightly smaller than an inside diameter of each of said bores thereby forming a narrow gap, said gap being sufficiently large to permit said leaflets to pivot about said axle, and said gap being sufficiently small to hinder an entrance of blood into said gap.

12. A bi-leaflet prosthetic heart valve according to claim 1, wherein;

each of said leaflets includes a curved edge section having an apex;

each of said leaflets also includes a substantially straight section in the vicinity of said axle;

each of said leaflets includes at least one integrally formed curved sleeve portion adjacent said straight portion, said sleeve portion including a bore, said axle extending through said bores of each of said leaflets; and

at least one surface of each of said leaflets has a convex configuration extending from said apex to said straight section, said continuously curving into a curvature of said sleeve portion.

13. A bi-leaflet prosthetic heart valve according to claim 1, wherein each of said leaflets includes a curved edge section having an apex, and an aperture angle is defined by two lines passing through a longitudinal central axis of said axle and said apexes of said leaflets.

14. A bi-leaflet prosthetic heart valve according to claim 13, wherein said aperture angle is between about 10°

and about 40°

when said leaflets are in said open position.

15. A bi-leaflet prosthetic heart valve according to claim 13, wherein said aperture angle is between about 12°

and about 18°

when said leaflets are in said open position.

16. A bi-leaflet prosthetic heart valve according to claim 1, further comprising:

first stop means projecting toward a center of said valve ring and preventing said leaflets from pivoting beyond a maximum open position; and

second stop means projecting toward a center of said valve ring and preventing said leaflets from pivoting beyond a maximum closed position.

17. A bi-leaflet prosthetic heart valve according to claim 16, wherein said first stop means includes projecting step portions projecting toward said center of said valve ring and extending along an inner circumference of said valve ring on opposite sides of a location where said axle is secured to said valve ring in a direction substantially parallel to said valve ring.

18. A bi-leaflet prosthetic heart valve according to claim 17, wherein said step portions each have a length of from about 3 mm to about 6 mm.

19. A bi-leaflet prosthetic heart valve according to claim 16, wherein said second stop means comprises pins, projecting toward a center of said valve ring.

20. A bi-leaflet prosthetic heart valve according to claim 1, wherein at least one of said valve ring and said leaflets includes a multi-layered structure including an exterior layer including a pyrolytic carbon, at least one intermediate layer including a titanium carbide, and a core including metallic titanium.

21. A bi-leaflet prosthetic heart valve according to claim 1, wherein said leaflets are adapted to be moved between said closed position and said open position by blood flow within a heart that said bi-leaflet prosthetic heart valve is implanted into.

22. The bi-leaflet prosthetic heart valve according to claim 1, wherein the axle comprises two end portions wherein each end portion being retained in a shaft bearing formed like a recess in the valve ring;

wherein each shaft bearing comprises the form of a longitudinal recess extending from the left side below the valve ring plane to the right side above the valve ring plane.

23. The bi-leaflet prosthetic heart valve according to claim 22, wherein the valve ring comprises an inner circumference;

and

said inner circumference comprises at least in the area of the two shaft bearings a configuration or contour which widens in the direction of the blood flow.

24. The bi-leaflet prosthetic heart valve according to claim 22, wherein the valve ring comprises a greater height and/or a larger wide in the area of the shaft bearings than in the other sections of the valve ring.

25. The bi-leaflet prosthetic heart valve according to claim 1, wherein the axle comprises a two-part structure consisting of two axle portions;

wherein each axle portion comprises at one end a thickened head portion retained within a shaft bearing; and

comprises at the other end an opposite end portion, wherein one opposite end portion being formed like a socket, and the other opposite end portion being formed like a pin, enabled to be inserted in said socket.

26. The hi-leaflet prosthetic heart valve according to claim 1, wherein the valve ring comprises at least one section of the greater height;

and

said section being arranged adjacent to the leaflet of smaller area.