Heart valve prosthesis having a pivot design for improving flow characteristics

• US 6,206,918 B1
• Filed: 05/12/1999
• Issued: 03/27/2001
• Est. Priority Date: 05/12/1999
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sulzer Carbomedics Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Gourley, Monti R., Campbell, Louis A.
• Primary Examiner(s): MILANO, MICHAEL J
• Application Number:
  US09/310,801
• Time in Patent Office: 685 Days
• Field of Search: 623/2.28, 623/2.29, 623/2.3, 623/2.31, 623/2.32
• US Class Current: 623/2.32
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03

Abstract

A heart valve prosthesis having improved flow characteristics. A heart valve prosthesis includes a valve body and a pair of leaflet occluders. The valve body includes an interior surface that defines a central passage for blood flow. The pair of leaflet occluders are pivotably mounted in the passage via ears or tabs that are received in recesses formed in the interior surface that defines the central passage. The recesses are formed with sloped sidewalls to improve the blood flow therethrough. The recesses are also formed such that the leaflet occluder ears act against at least two surfaces that limit the motion of the leaflet occluder to provide a more stable movement that is less damaging to blood cells.

Claims

1. A heart valve prosthesis, comprising:

a valve body having an interior surface that defines a central passage for blood flow therethrough; and

a pair of leaflet occluders proportioned to be pivotably mounted within the central passage, each leaflet occluder including a pair of mounting ears;

wherein the valve body includes a plurality of recesses for receiving the pairs of mounting ears, each recess being bounded by a base surface and a sidewall, the sidewall defining a narrowed throat region, an upstream expanded region on one side of the throat region and a downstream expanded region on a generally opposite side of the throat region, the sidewall sloping outwardly from the base surface to form an oblique angle with a central axis along the entire length of the sidewall.

2. The heart valve as recited in claim 1, wherein the oblique angle remains constant along the entire length of the sidewall.

3. The heart valve as recited in claim 1, wherein the oblique angle is in the range from approximately one (1) degree to approximately forty five (45) degrees.

4. The heart valve as recited in claim 1, wherein the oblique angle is in the range from approximately ten (10) degrees to approximately thirty five (35) degrees.

5. The heart valve as recited in claim 1, wherein the oblique angle is in the range from approximately twenty five (25) degrees to approximately thirty five (35) degrees.

6. The heart valve as recited in claim 1, wherein the sidewall includes a plurality of stop regions disposed such that each mounting ear contacts at least two cooperating stop regions at an extreme of its pivotable motion.

7. The heart valve as recited in claim 6, wherein each stop region of the plurality of stop regions is disposed at a predetermined distance from a center of the throat region.

8. A heart valve prosthesis, comprising:

a valve body having an interior surface that defines a central passage for conducting blood flow; and

at least one leaflet occluder pivotably mounted to the valve body by a pair of pivots, the interior surface including at least one pair of recesses to receive the pair of pivots, each recess being bounded by a continuously obliquely sloped sidewall extending between the interior surface and a recess base, each recess further including a narrowed throat region disposed such that the continuously obliquely sloped sidewall forms at least one pivot stop on each opposing side of the narrowed throat region to facilitate limiting the pivotal motion of the at least one leaflet occluder.

9. The heart valve prosthesis as recited in claim 8, wherein the at least one leaflet occluder comprises a pair of leaflet occluders.

10. The heart valve prosthesis as recited in claim 8, wherein the at least one pair of recesses includes four recesses.

11. The heart valve prosthesis as recited in claim 10, wherein each pivot of the pair of pivots comprises a generally flat ear.

12. The heart valve prosthesis as recited in claim 8, wherein the continuously obliquely sloped sidewall slopes outwardly from the recess base to form an oblique angle with an axis disposed generally normal to the interior surface, the angle being at least ten (10) degrees.

13. The heart valve prosthesis as recited in claim 12, wherein the oblique angle is in the range from approximately ten (10) degrees to approximately forty five (45) degrees.

14. The heart valve prosthesis as recited in claim 12, wherein the oblique angle is in the range from approximately twenty five (25) degrees to approximately thirty five (35) degrees.

15. A method for facilitating blood flow through a prosthetic heart valve that includes a valve body having an interior surface defining a central passage through which blood flows and a leaflet occluder pivotably mounted in the central passage by a pair of pivot ears, comprising:

creating a first recess and a second recess in the interior surface on generally opposite sides of the central passage to receive a pair of pivot ears of an individual leaflet occluder;

forming each of the first recess and the second recess with a pair of expanded regions separated by a narrower throat region;

defining the first recess by a first sidewall and the second recess by a second sidewall; and

orienting the first and the second sidewalls continously at an oblique angle selected to prevent formation of surfaces generally perpendicular to the interior surface.

16. The method as recited in claim 15, further comprising forming a third recess and a fourth recess to receive an additional pair of pivot ears of a second leaflet occluder.

17. The method as recited in claim 15, further comprising limiting the motion of the individual leaflet occluder by forming stop surfaces along the first sidewall in each expanded region of the first recess;

and orienting the stop surfaces to interfere with a pivot ear of each pair of pivot ears.

18. The method as recited in claim 17, further comprising limiting the motion of the individual leaflet occluder by forming stop surfaces along the second sidewall in each expanded region of the second recess;

and orienting the stop surfaces to interfere with a pivot ear of each pair of pivot ears.

19. The method as recited in claim 17, wherein orienting includes selecting oblique an angle in the range from approximately one (1) degree to approximately forty five (45) degrees as measured between an axis generally normal to the interior surface and the first sidewall or the second sidewall.

20. The method as recited in claim 17, wherein orienting includes selecting an oblique angle in the range from approximately twenty five (25) degrees to approximately thirty five (35) degrees as measured between an axis generally normal to the interior surface and the first sidewall or the second sidewall.

21. The method as recited in claim 15, further comprising placing a first fillet between the first sidewall and a first base surface of the first recess to improve fluid washing characteristics;

and placing a second fillet between the second sidewall and a second base surface of the second recess to improve fluid washing characteristics.