Mechanical prosthetic heart valve

• US 10,182,907 B2
• Filed: 04/30/2008
• Issued: 01/22/2019
• Est. Priority Date: 05/02/2007
• Status: Active Grant

• Current Assignee: Novostia SA
• Original Assignee: Novostia SA
• Inventors: Lapeyre, Didier
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US12/598,516
• Publication Number:
  US 20100131056A1
• Time in Patent Office: 3,919 Days
• Field of Search: 623 223- 227, 623 212, 623 214, 623 126, 623 21, 623 22
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03

Abstract

A mechanical prosthetic heart valve, includes an annular support on which at least two movable flaps and several articular extensions are arranged in an articulated manner. Each flap includes a central part framed by two lateral wings that each cooperate with an articular extension by way of an end portion that has an articulation facet. The two articulation facets of each flap together make up a surface area of less than 5% of the total outer surface area of the flap.

Claims

1. A mechanical prosthetic heart valve, comprising:

an annular support having an internal peripheral surface delimiting an interior that is centered on a longitudinal axis; and

at least two mobile flaps articulated to the internal peripheral surface of the support so that each of the flaps is able to rotate about a flap rotation axis perpendicular to the longitudinal axis from an open position of the valve, in which the flaps in the open position delimit between them a main orifice centered on the longitudinal axis and through which blood flows axially, to a closed position of the valve, in which the flaps in the closed position prevent the blood from flowing back through the main orifice,

the annular support having a downstream edge on a downstream side of an anterograde flow, and a plurality of articular extensions formed by respective portions of the downstream edge that each protrude axially in the downstream direction from respective opposing concave portions of the downstream edge, each articular extension having two opposite-facing sides running along the longitudinal axis in the downstream direction and terminating at an apex,

said two opposite-facing sides comprising curved-portions of the downstream edge that curve along opposite-facing concave paths, said apex formed by a length of the downstream edge connecting the two sides, and the respective curved portions of the two sides each comprise at least a point for which a correspondent tangent line is substantially parallel to the longitudinal axis, a quantity of said plurality of articular extensions corresponding to a quantity of flaps,

said articular extensions accommodating articulation areas with which the flaps cooperate to pass from the open position to the closed position and vice-versa,

each of the flaps having a central part symmetrically bracketed by two lateral wings that are inclined relative to said central part,

said central part having an exterior-facing surface,

the central part of each flap also having an interior surface facing toward the main orifice,

said two lateral wings respectively cooperating, to allow rotation of the flap, with internal surfaces of two articular extensions via a terminal portion of each lateral wing, each terminal portion having an exterior surface portion that defines an articulation facet that, when the flap is open, comes to bear against a corresponding articular extension facet formed by a portion of the internal surface of a corresponding articular extension, an area of the two articulation facets of each flap that contacts a corresponding articular extension facet together adding up to an area less than 5% of a total exterior area of the flap.

2. The valve according to claim 1, wherein each lateral wing of each of the flaps is connected to the central part of the flap by a junction area, an exterior surface of each junction area being convex and having a conical shape, an apex of said conical shape being located at an upstream side of the anterograde flow.

3. The valve according to claim 1, wherein each lateral wing of each of the flaps is joined to the central part of the flap by a junction area, an exterior surface of said junction area being convex and having a semi-cylindrical shape.

4. The valve according to claim 1, wherein the rotation axis of each flap is a virtual axis situated externally of the flap, between the flap and the annular support, and extends in a direction from the one lateral wing of the flap to the opposite lateral wing.

5. The valve according to claim 4, wherein the annular support has a given radius, and in that, in a plane perpendicular to the longitudinal axis of the valve, the flap rotation axis being at a distance from the longitudinal axis that is greater than 75% of the radius of the annular support.

6. The valve according to claim 1, wherein each of the articulation facets of a flap and the corresponding extension facet of the articular extension concerned define between them, when the flap is in the closed position, a flap pivoting space that disappears when the articulation facet of the flap comes, in the open position, to bear against the corresponding extension facet.

7. The valve according to claim 6, wherein the volume of the flap pivoting space is less than 2/100^th of the volume displaced by the flap when the flap moves from the closed position to the open position.

8. The valve according to claim 1, wherein the exterior surface of the central part of the flap has a convex shape in a direction from the one lateral wing to the opposite lateral wing.

9. The valve according to claim 1, wherein, when the valve is in the open position, a main orifice is delimited by the interior surfaces of the flaps and an internal area delimited in the same plane by the annular support, the main orifice having, projected in a plane perpendicular to the longitudinal axis of the annular support, a flow section offered to the flow that is equal at least to 75% of the internal area.

10. The valve according to claim 1, wherein, when the valve is in the open position, each flap defines a secondary orifice between an exterior surface thereof and an internal peripheral surface portion of the annular support that separates the two articular extensions with which the flap cooperates.

11. The valve according to claim 10, wherein each secondary orifice has a crescent moon shape.

12. The valve according to claim 10, wherein a dimension of the secondary orifice in a radial direction projected in a plane perpendicular to the longitudinal axis of the annular support is less than 20% of an inside radius of the annular support.

13. The valve according to claim 10, wherein each secondary orifice has in a plane perpendicular to the longitudinal axis of the annular support a flow section offered to the flow that is less than 7% of the internal area delimited in the same plane by the annular support.

14. The valve according to claim 1, wherein each of the articular extensions is free of any opening through a thickness thereof.

15. The valve according to claim 1, wherein the annular support has for each flap on an internal peripheral surface thereof, in a vicinity of the downstream edge, two stops that cause the flap to pivot into the open position when a pressure of the flow of blood is exerted on an internal face of the flap.

16. The valve according to claim 15, wherein for each flap, the annular support has on the internal peripheral surface thereof two supporting means for supporting the flap in the closed position, said supporting means for each flap being between the two articular extensions with which the respective lateral wings of the flap cooperate.

17. The valve according to claim 16, wherein, projected in a plane perpendicular to the longitudinal axis of the annular support, each stop is spaced angularly from a nearest supporting means by a distance corresponding to at least half a width of said supporting means, the width being measured in the plane concerned in a tangential direction relative to the annular support.

18. The valve according to claim 17, wherein the stops for each flap are between the supporting means of the flap.

19. The valve according to claim 16, wherein each flap has, at a periphery thereof, a leading edge that is on an upstream side of the anterograde flow of blood and cooperates with the internal surface of the annular support in the closed position of the flap and a trailing edge on the downstream side of the anterograde flow.

20. The valve according to claim 19, wherein each of the flap supporting means cooperates with a contact area of the leading edge of the flap through surface contact on closure of said valve.

21. The valve according to claim 20, wherein each flap supporting means has an upper end forming a head having a convex profile, a portion of a surface of the head on a side opposite the nearest articular extension being sloped and having a curvature that cooperates, with surface contact, with a transverse rectilinear contact area of the leading edge of the flap.

22. The valve according to claim 19, wherein the trailing edge of each flap has a triangular shape, and in the closed position of the valve, the trailing edges of the three flaps cooperate with each other to form a trihedron the apex of which is directed downstream.

23. The valve according to claim 1, wherein each flap in the closed position forms, with a plane perpendicular to the longitudinal axis of the annular support, a closure angle between 30°

and 50°

inclusive, and

wherein each flap, in an open position, is parallel to the direction of the flow.

24. The valve according to claim 1,

wherein the valve comprises three of the mobile flaps, and each of the flaps has, in the central part of the flap, at a trailing edge of the flap, an end area aligned with an axis of symmetry of the flap that is ski-tip shaped forming a tip that diverges from the extension of the interior surface of said flap, and

wherein, in a fully closed position of the valve in which the lateral wings of the flaps are contacting each other, said ski-tip shaped end areas of the flaps remain at a distance from each other forming therebetween a central interstice having a star shape.

25. The valve according to claim 24, wherein the ski-tip shaped end area diverges from the extension of the interior surface of the flap at an angle between 2°

to 4°

inclusive.

26. The valve according to claim 24, wherein, in the fully closed position of the valve, the three ski-tip shaped end areas remain at a distance from each other of at least 50 microns.

27. The valve according to claim 24, wherein each one of the respective ski-tip shaped end areas forms a tip that diverges from the extension of the interior surface of the flap, each of said tips extending over a distance corresponding at least to one-third of a total length of the trailing edge of the flap.

28. The valve according to claim 1,

wherein the valve comprises three of the mobile flaps, and each of the flaps has, in the central part of the flap, at a trailing edge of the flap, an end area aligned with an axis of symmetry of the flap that is ski-tip shaped forming a tip that diverges from the extension of the interior surface of said flap, and

wherein the ski-tip shaped end area of each one of the flaps forms a tip that diverges from the extension of the interior surface of the flap so that, in a fully closed position of the valve in which the lateral wings of the flaps are contacting each other, said ski-tip shaped end areas of the flaps remain at a distance from each other forming therebetween a central interstice having a star shape.

29. The valve according to claim 1,

wherein for each flap, the annular support has on the internal peripheral surface thereof two supporting means that support the flap in the closed position, said supporting means for each flap being located between the two articular extensions with which the respective lateral wings of the flap cooperate,

wherein each supporting means has an upper end forming a head having a convex profile, a portion of a surface of the head on a side opposite the nearest articular extension being sloped and having a curvature that cooperates, with surface contact, with a transverse rectilinear contact area of the leading edge of the flap.

30. The valve according to claim 29,

wherein the annular support has for each flap on an internal peripheral surface thereof, two upper bearing stops that cause the flap to pivot into the open position when a pressure of the flow of blood is exerted on an internal face of the flap, the upper bearing stops being offset radially with respect to a circumference of the annular support relative to the lower bearing means and offset axially with respect to the annular support along the longitudinal axis relative to the lower bearing means.

31. The valve according to claim 30,

wherein each upper bearing stop is offset radially with respect to a circumference of the annular support from its nearest lower bearing means by a distance of at least one times a radial width of the nearest lower bearing means.

32. The valve according to claim 1,

wherein a base of each articular extension from which said articular extension protrudes in the downstream direction has a width that is substantially same as a width at the apex.

33. The valve according to claim 1, wherein the area of the two articulation facets of each flap that contacts the corresponding articular extension facet together adds up to an area of 1.4% of the total exterior area of the flap.

34. A mechanical prosthetic heart valve, comprising:

an annular support having an internal peripheral surface delimiting an interior that is centered on a longitudinal axis; and

at least two mobile flaps articulated to the internal peripheral surface of the support so that each of the flaps is able to rotate about a flap rotation axis perpendicular to the longitudinal axis from an open position of the valve, in which the flaps in the open position delimit between them a main orifice centered on the longitudinal axis and through which blood flows axially, to a closed position of the valve, in which the flaps in the closed position prevent the blood from flowing back through the main orifice,

the annular support having a downstream edge on a downstream side of an anterograde flow, and a plurality of articular extensions formed by respective portions of the downstream edge that each protrude axially in the downstream direction from respective opposing concave portions of the downstream edge, each articular extension having two opposite-facing sides running along the longitudinal axis in the downstream direction and terminating at an apex,

said two opposite-facing sides comprising curved-portions of the downstream edge that curve along opposite-facing concave paths, said apex formed by a length of the downstream edge connecting the two sides, and a base of each articular extension having a width that is equal to a width at the apex, a quantity of said plurality of articular extensions corresponding to a quantity of flaps,

said articular extensions accommodating articulation areas with which the flaps cooperate to pass from the open position to the closed position and vice-versa,

each of the flaps having a central part symmetrically bracketed by two lateral wings that are inclined relative to said central part,

said central part having an exterior-facing surface,

the central part of each flap also having an interior surface facing toward the main orifice,

said two lateral wings respectively cooperating, to allow rotation of the flap, with internal surfaces of two articular extensions via a terminal portion of each lateral wing, each terminal portion having an exterior surface portion that defines an articulation facet that, when the flap is open, comes to bear against a corresponding articular extension facet formed by a portion of the internal surface of a corresponding articular extension, an area of the two articulation facets of each flap that contacts a corresponding articular extension facet together adding up to an area less than 5% of a total exterior area of the flap.