Heart valves having edge-guided occluders

• US 4,373,216 A
• Filed: 09/15/1981
• Issued: 02/15/1983
• Est. Priority Date: 10/27/1980
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Hemex, Inc. (Aethlon Medical, Inc.)
• Inventors: Klawitter, Jerome J.
• Primary Examiner(s): FRINKS, RONALD
• Application Number:
  US06/302,693
• Time in Patent Office: 518 Days
• Field of Search: 3/1.5, 137/512.1, 137/527, 137/527.8
• US Class Current: 623/2.22
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: F16K 15/035 with a plurality of valve members
• CPC Class Codes: F16K 15/036 Dual valve members with hinges crossing the flow line substantially diametrical
• CPC Class Codes: Y10T 137/7839 Dividing and recombining in a single flow path
• CPC Class Codes: Y10T 137/7898 Pivoted valves
• CPC Class Codes: Y10T 137/7903 Weight biased

Abstract

Heart valves having valve members which are guided between their open and closed positions by projections extending inward from the annular body and interengaging with complementary notches in the peripheries of the occluders. Protuberances associated with the projections cooperate to define the pivotal axes, serve as open and closed position stops, and retain the valve members within the valve body.

Claims

1. A heart valve prosthesis for allowing blood flow therethrough in a specific direction including

a generally annular valve body having an interior surface defining a central passageway for blood flow therethrough,

occluder means for blocking the flow of blood through said passageway, said occluder means having an upstream face and a downstream face,

notches extending through said occluder means between said upstream face and said downstream face and being formed in opposite locations in the periphery of said occluder means,

complementary projections which are elongated generally in a direction between upstream and downstream and of a length substantially greater than the thickness of said occluder means at said notch, which extend generally radially inward from said interior surface into said passageway and which are proportioned to interfit within said notches, said projections being exposed to free flow of blood and having opposite elongated surfaces that are alternately mechanically contacted by edges of said notches during alternate opening and closing movement, the shape of said projections being such to guide said occluder means along a path during shifting between open and closed positions that creates both pivotal and translational movement,

first means in said annular valve body for engaging said upstream face of said occluder means and providing a stop in the closed position, and

second means in said annular valve body for engaging said downstream face of said occluder means and providing a stop in the open position.

2. A heart valve in accordance with claim 1 wherein said projections extend from substantially flat surfaces formed at diametrically opposite locations in the interior surface of said valve body, and said notches are located in straight segments of said periphery of said occluder means.

3. A heart valve in accordance with claim 1 wherein said projections have end sections which substantially fit said notches when said occluder means is stopped in said closed position and said projections decrease in transverse dimension in the direction which said notches travel as said occluder means shifts to said open position to assure washing by the flowing bloodstream of the surfaces defining said notches.

4. A heart valve in accordance with claim 1 wherein said valve body has a substantially uniform height.

5. A heart valve in accordance with claim 1 wherein said valve body has a pair of opposed upstanding standards into which portions of said projections extend.

6. A heart valve in accordance with claim 5 wherein said standards extend from said valve body in the upstream direction.

7. A heart valve in accordance with claim 5 wherein said standards extend from said valve body in the downstream direction.

8. A heart valve in accordance with claim 1 wherein said occluder means has a convex-concave configuration with said upstream face being convex.

9. A heart valve in accordance with claim 1 wherein said occluder means has a concave-convex configuration with said upstream face being concave.

10. A heart valve according to claim 1 having occluder means in the general shape of a sector of a hollow sphere.

11. A heart valve in accordance with claim 1 wherein said upstream face and said downstream face are flat.

12. A heart valve according to claim 1 wherein said occluder means comprises a pair of leaflets each having a curved major edge, a minor edge which lies closely adjacent the minor edge of the other of said leaflets in said closed position and a pair of said notches formed in opposed locations in its periphery.

13. A heart valve according to claim 12 wherein said first means stops said leaflets in said closed position with said major edges lying in planes which meet the centerline of said valve body at angles of between about 65°

and about 90°

.

14. A heart valve according to claim 12 wherein said heart valve body has a pair of protuberances at diametrically opposite locations to contact said leaflets at about the midpoints of said major edges in said closed position.

15. A heart valve in accordance with claim 12 wherein each of said leaflets is generally a section of a tube of curved cross section, each of said leaflets having a generally straight centerline with said notches formed on opposite sides of said centerline.

16. A heart valve in accordance with claim 15 wherein said first means stops said leaflets in said closed position with said centerlines of said leaflets meeting the centerline of said valve body at angles of between about 65°

and about 90°

.

17. A heart valve in accordance with claim 1 wherein said occluder means comprises a unitary occluder.

18. A heart valve in accordance with claim 17 wherein said occluder means has a peripheral edge and said first means stops said occluder in said closed position with said peripheral edge in a plane which meets the centerline of said valve body at an angle of between about 65°

and about 90°

.

19. A heart valve in accordance with claim 1 wherein said second means stops said occluder means in said open position with said upstream face abutting said first means.

20. A heart valve phosthesis for allowing blood flow therethrough in a specific direction including

a generally annular valve body having an interior surface defining a central passageway for blood flow therethrough,

a single occluder having a downstream face and an upstream face,

a pair of notches formed in opposite locations in the periphery of said occluder and extending through said occluder between said upstream face and said downstream face,

a pair of complementary projections which are generally elongated in a direction between upstream and downstream and of a length substantially greater than the thickness of said occluder at said notch, which extend from said interior surface into said passageway and which are proportioned to interfit within said notches for guiding said occluder in pivoting action between open and closed positions, the shape of said projections being such to guide said occluder along a curved path during shifting between said open and closed positions that creates both pivotal and translational movement, the dimension of said notches being such that said occluder is unrestrained from escaping past either end of said elongated projections,

first protruding bump means formed in said annular valve body for engaging said upstream face of said occluder and providing a stop in the closed position, and

second protruding bump means in said annular valve body for engaging said downstream face of said occluder and providing a stop in the open position, said first and second bump means cooperating with said elongated projections to prevent the escape of the occluder therefrom.

21. A heart valve in accordance with claim 20 wherein said occluder is generally a section of a tube of curved cross section, said occluder having a generally straight centerline with said notches formed on opposite sides of said centerline.

22. A heart valve according to claim 21 wherein said occluder is generally a section of a tube in the shape of a hollow right elliptical cylinder with its downstream face being concave, the length of the major elliptical axis being between about 120 and about 200 percent of the diameter of said passageway and the length of the minor elliptical axis being between about 50 and about 170 percent of the length of the diameter of said passageway.

23. A heart valve in accordance to claim 22 wherein the depth of said concave face is between about 15 and about 30 percent of the diameter of said passageway.

24. A heart valve in accordance with claim 20 wherein said occluder is dome-shaped with its downstream face being concave.

25. A heart valve in accordance with claim 24 wherein the height of said dome, from its base to the apex of said concave face, is between about 15 and about 30 percent of the diameter of said passageway.