Mechanical heart valve prosthesis

• US 6,645,244 B2
• Filed: 12/14/2000
• Issued: 11/11/2003
• Est. Priority Date: 07/22/1997
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Shu, Mark C., Gross, Jeffrey M., Shim, Hong S.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): MATTHEWS, WILLIAM H
• Application Number:
  US09/737,112
• Publication Number:
  US 20010025197A1
• Time in Patent Office: 1,062 Days
• Field of Search: 623/2.31, 623/2.33, 623/2.1, 623/2.17, 623/2.18, 623/2.2, 623/2.22, 623/2.28, 623/2.38
• US Class Current: 623/2.31
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03

Abstract

An improved artificial mechanical heart valve prosthesis having an improved leaflet hinge mechanism which improves washing of the hinge recess, reduces leaflet closing impact force and decreases noise and wear. A generally annular valve body having an annular interior surface extending between an inflow rim and an outflow rim thereof defines an annular orifice therethrough. A pair of leaflets are supported on said annular valve body for alternately blocking blood flow in an inflow direction when seated against the annular interior side wall in a closed position and then allowing the flow of blood through said annular orifice in a predetermined blood outflow direction when rotated into an open position.

Claims

1. A mechanical heart valve prosthesis comprising:

an annular valve body having an interior side wall;

at least one valve leaflet within the annular valve body; and

a plurality of hinges, each hinge comprising;

a hinge recess in the annular valve body interior side wall having a hinge recess bearing surface, the binge recess bearing surface including an inflow portion having an inflow recess bearing surface, and an outflow portion having an outflow recess bearing surface; and

a leaflet ear having a leaflet ear bearing surface projecting from an edge of the at least one valve leaflet, the leaflet ear and hinge recess bearing surface being sized and shaped to flush blood from the hinge recess when the at least one valve leaflet moves;

and wherein;

an entrance ramp is defined in the inflow recess bearing surface to direct laminar blood flow into the hinge recess and over the inflow recess bearing surface as the leaflet ear bearing surface sweeps over the hinge recess bearing surface during movement of the valve leaflet between open and closed positions.

2. The heart valve prosthesis of claim 1, wherein the annular valve body comprises a pair of parallel, inwardly facing, opposed planar surfaces each bounded by planar surface edges, and wherein:

the planar surfaces each have at least one hinge recess extending concavely outwardly from its planar surface into the annular valve body to a maximum depth and shaped to form the hinge recess bearing surface, each hinge recess having side edges shaped to define valve leaflet open and closed positions and each hinge recess having inflow and outflow hinge recess end edges extending between opposed ends of the hinge recess side edges and defining hinge recess boundaries; and

the planar surfaces each have an outflow flat recessed therein that extends from each outflow hinge recess end edge in the outflow direction;

whereby leaflet ears projecting into said hinge recesses allow said at least one valve leaflet to pivot between said open and closed positions and sweep the edges of said leaflet ears over said inflow and outflow hinge recess bearing surfaces and flush blood components from said hinge recesses into said outflow flats.

3. The heart valve prosthesis of claim 2, wherein the outflow flats are recessed into said planar surface to a flat recess depth less than the maximum depth of the hinge recess.

4. The heart prosthesis of claim 3, wherein an outflow transition surface is formed adjacent to said outflow hinge recess end edge to provide an exit ramp to facilitate blood flow from the outflow hinge recess end edge.

5. The heart valve prosthesis of claim 1 wherein said annular valve body is formed with an annular interior surface extending between an inflow rim and an outflow rim and a pair of parallel, inwardly facing, opposed planar surfaces formed along the annular interior surface of said annular valve body and each bounded by planar surface side edges and planar surface inflow and outflow edges;

and further comprising;

a planar inflow chamfer extending from said inflow rim to said planar surface inflow edge for deflecting any blood components susceptible of damage by operation of said hinges away from said hinges and centrally through said prosthesis during blood flow therethrough.

6. The heart valve prosthesis of claim 1, wherein;

said annular valve body is formed with an annular interior surface and a pair of parallel, inwardly facing, opposed planar surfaces formed along the annular interior surface of said annular valve body and each bounded by planar surface edges, and

the planar surfaces each having at least one said hinge recess forming at least one hinge recess pair with a first hinge recess on one planar surface and a second binge recess on a second, opposed planar surface, the first hinge recess of the hinge recess pair extending concavely outwardly from the one planar surface and into said annular valve body to a maximum depth and shaped to compliment and to form a first recess bearing surface for receiving a first one of said leaflet ear of the at least one valve leaflet and the second binge recess of the hinge recess pair extending concavely outwardly from the second planar surface and into said annular valve body to a maximum depth and shaped to compliment and to form a second recess bearing surface for receiving a second one of said leaflet ear of the at least one valve leaflet, each of the first and second hinge recesses of the hinge recess pair having side edges shaped to define leaflet open and closed positions and having inflow and outflow hinge recess end edges extending between opposed ends of the hinge recess side edges and defining hinge recess boundaries, whereby the first and second leaflet ears of the at least one valve leaflet projecting into said first and second hinge recesses, respectively, allow said leaflet to pivot between said open and closed positions and sweep the leaflet ear bearing surfaces over said inflow and outflow recess bearing surfaces and flush blood components from said hinge recesses into outflow flats recessed in the planar surfaces.

7. The heart valve prosthesis of claim 6, wherein the entrance ramp extends along the inflow hinge recess end edge as a convexly curved inflow transition surface merging into a concavely curved inflow recess bearing surface to the recess maximum depth.

8. The heart valve prosthesis of claim 7, wherein the outflow portion comprises a ramped recess bearing surface increasing in depth from the outflow flat and extending along the outflow binge recess end edge through a convexly curved outflow transition surface and a concavely curved outflow recess bearing surface to the recess maximum depth.

9. The heart valve prosthesis of claim 8, wherein the convexly curved inflow transition surface has an inflow radius of curvature and the convexly curved outflow transition surface is curved at an outflow radius of curvature that is less than the inflow radius of curvature.

10. The heart valve prosthesis of any one of the preceding claims 2, 3, 4, 5, 6, 7, 8 further comprising:

a pair of generally convex outflow transition surfaces between an outflow rim and said annular interior side wall, and having a first radius of curvature; and

a pair of generally convex inflow transition surfaces formed each extending in a band between an inflow rim and said annular interior side wall and between said opposed planar surfaces, each convex inflow transition surface having a second radius of curvature greater than said first radius of curvature.

19. The heart valve prosthesis of any one of the preceding claims 2-16, wherein each of said leaflet ears has a leaflet ear inflow side and a leaflet ear outflow side, and further comprising:

a closed stop associated with each of said binge recesses for defining a closed leaflet position, said closed stop comprising an inflow closed recess side wall and an outflow closed recess side wall in each hinge recess, said inflow and outflow closed recess side walls positioned for engaging against said leaflet ear inflow and outflow sides, wherein said inflow and outflow closed recess side walls are shaped with a convex stop edge at a junction of each of said inflow and outflow closed recess side walls with the planar on the annular valve body to provide a contact band portion for each of the inflow and outflow closed recess side walls, the contact band portions

projecting into said hinge recesses to minimize the contact area between the contact band portions and said leaflet ear inflow and outflow sides when the leaflet is in the closed leaflet position; and

an open stop associated with each of said hinge recesses for defining an open leaflet position, said open stop comprising an inflow open recess side wall and an outflow open recess side wall in each hinge recess, said inflow and outflow open recess side walls positioned for engaging against said leaflet ear inflow and outflow sides, wherein said inflow and outflow open recess side walls are shaped with the convex stop edge at a junction of each inflow and outflow open recess side wall with the planar surface of the annular valve body to provide the contact band portion for each inflow and outflow open recess side walls, the contact band portions projecting into said hinge recesses to minimize the contact area between the contact band portions and said leaflet ear inflow and outflow sides when the leaflet is in the open leaflet position.

11. A mechanical heart valve prosthesis comprising:

an annular valve body having an interior side wall;

at least one valve leaflet within the annular valve body; and

a plurality of hinges, each hinge comprising;

a hinge recess in the valve body interior side wall having a hinge recess bearing surface, the hinge recess bearing surface including an inflow portion having an inflow recess bearing surface, and an outflow portion having an outflow recess bearing surface; and

a leaflet ear having a leaflet ear bearing edge projecting from an edge of the leaflet, the leaflet ear bearing edge and hinge recess bearing surface being sized and shaped to flush blood from the recess when the leaflet moves;

and wherein an outflow flat extends from each outflow recess bearing surface in the outflow direction,

whereby the leaflet ear bearing edge sweeps over said recess bearing surface and flushes flood components from said outflow hinge recess into said outflow flat as the leaflet moves between a closed and an open position.

12. The heart valve prosthesis of claim 11, wherein each of said valve recesses is further characterized by an inflow portion defining a ramped recess bearing surface increasing in depth from a planar surface and extending along the inflow hinge recess end edge through a convexly curved inflow transition surface into a concavely curved inflow recess bearing surface to the recess maximum depth whereby blood flowing in the inflow direction is swept in a laminar flow over the inflow hinge recess end edge and through the inflow portion.

13. The heart valve prosthesis of claim 12, wherein each of said hinge recesses is further characterized by the outflow portion defining a further ramped recess bearing surface increasing in depth from said outflow flat and extending along an outflow hinge recess end edge through a convexly curved outflow transition surface and whereby blood flowing in the outflow direction is swept over the outflow hinge recess end edge.

14. The heart valve prosthesis of claim 13, wherein said convexly curved inflow transition surface is curved at an inflow radius of curvature and said convexly curved outflow transition surface is curved at an outflow radius of curvature that is less than said inflow radius of curvature.

15. The heart valve prosthesis of claim 14, wherein said outflow flat is recessed to a flat recess depth that is less than the recessed maximum depth of the hinge recess into said planar surface, whereby the valve leaflet ear is retained in the hinge recess, and the decreased height of the outflow hinge recess end edge and said convexly curved outflow transition surface allows blood funneled into the inflow portion in the inflow direction to more readily flow out of the outflow portion into the outflow flat in the outflow direction.

16. The heart valve prosthesis of claim 13, wherein said inflow portion has an inflow recess bearing surface area and said outflow portion has an outflow recess bearing surface area less than said inflow recess bearing surface area.

17. The heart valve prosthesis of any one of the preceding claims 11-16, wherein;

said leaflet comprises first and second leaflet ears each having an arcuate peripheral leaflet ear bearing edge extending convexly outward and dimensioned to fit within respective first and second hinge recesses forming an opposed pair of hinge recesses so that the arcuate peripheral leaflet ear bearing edge contacts the inflow recess bearing surface and the outflow recess bearing surface of the opposed pair of hinge recesses while allowing lateral and pivotal translation therein; and

said leaflet comprises;

first and second relatively straight outflow shoulders extending between opposite ends of a major arcuate peripheral edge of the leaflet and the arcuate peripheral leaflet ear bearing edge of the first and second leaflet ears, respectively, whereby the first and second outflow shoulders are separated apart by a first distance sufficient to locate said first and second shoulders between a pair of opposed outflow flats; and

first and second relatively straight inflow shoulders extending between opposite ends of a straight peripheral edge of the leaflet and the ear bearing edge of the first and second leaflet ears, respectively,

whereby the first and second inflow shoulders are separated apart by a second distance less than said first distance sufficient to locate said first and second shoulders between a pair of opposed planar surfaces on the annular valve body.

18. The heart valve prosthesis of any one of the preceding claims 12-16, wherein each of said leaflet ears has a leaflet ear inflow side and a leaflet ear outflow side, and further comprising:

a closed stop associated with each of said hinge recesses for defining a closed leaflet position, said closed stop comprising an inflow closed recess side wall and an outflow closed recess side wall in each hinge recess, said inflow and outflow closed recess side walls positioned for engaging against said leaflet ear inflow and outflow sides, wherein said inflow and outflow closed recess side walls are shaped with a convex stop edge at a junction of each of said inflow and outflow closed recess side walls with the planar surface on the annular valve body to provide a contact band portion for each of the inflow and outflow closed recess side walls, the contact band portions projecting into said hinge recesses to minimize the contact area between the contact band portions and said leaflet ear inflow and outflow sides when the leaflet is in the closed leaflet position.