Bileaflet heart valve having dynamic pivot mechanism

• US 5,824,062 A
• Filed: 03/29/1996
• Issued: 10/20/1998
• Est. Priority Date: 03/29/1995
• Status: Expired due to Fees

• Current Assignee: CV Dynamics Incorporated
• Original Assignee: CV Dynamics Incorporated
• Inventors: Patke, Nandkishor G., Mikhail, Adel A., Stobbs, Gene E., Johnson, Shelley N.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US08/626,170
• Time in Patent Office: 935 Days
• Field of Search: 623/2
• US Class Current: 623/2.26
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03

Abstract

A bileaflet heart valve comprising an annular base and pivoting leaflets. Each leaflet if "free-floating" within recesses without fixed rotational axis, to increase translational movement and redistribute stresses. Each recess fluidly communicates with a groove extending at least partially around the inner surface of the annular base and flow is directed through the recesses at different angles during antegrade circulation, retrograde circulation, and valve closure. A recess entrance angle to each of the recesses preferably being less than about 35° and the pivoting mechanism within the recess including first and second fulcrum edges of each leaflet shiftably engaged with side surfaces of the respective recess. The leaflets have a beveled bottom surface having two separate planar surfaces which lie at an angle to one another. In preferred embodiments, a central region of each leaflet is spaced apart from the annular base when the leaflet is in a fully closed position to minimize cavitation.

Claims

1. A bileaflet heart valve prosthesis for controlling a circulation of a fluid within a heart of a patient, said bileaflet heart valve prosthesis having:

an annular base and first and second leaflets, the first and second leaflets each being separately mounted within the annular base for pivotal movement between a closed position and an open position, the annular base defining a bore extending through the base, the annular base having a first lateral side having a first lateral surface, a second lateral side having a second lateral surface, and a pair of transverse sides having respective transverse surfaces individually disposed between the first and second lateral surfaces, the annular base defining a first recess extending radially outward into the annular base from and communicating with the bore, and a second recess extending radially outward into the annular base from and communicating with the bore, the first recess being disposed within the first lateral side, the second recess being disposed within the second lateral side, wherein at least a portion of the first leaflet is received within the first recess and at least a portion of the first leaflet is received within said second recess to retain the first leaflet within the annular base, wherein the annular base further defines third and fourth recesses extending radially outward into the annular base from and communicating with the bore, the third recess being disposed within the first lateral side and the fourth recess being disposed within the second lateral side, wherein at least a portion of the second leaflet is received within the third recess and at least a portion of the second leaflet is received with the fourth recess to retain the second leaflet within the annular base;

wherein each leaflet has an upper surface and a curved peripheral edge and each recess has a bottom surface and an upper side and a lower side, the upper side and the lower side respectively defining upper and lower edges of the bottom surface, the upper side extending from the respective recess proximate the respective lateral side to a location on an adjacent transverse side, the upper edge of each recess forming a seat against which an area on the upper surface, proximate the curved peripheral edge of a leaflet engaged within the respective recess, can abut when the leaflet is in the closed position, the improvement characterized in that each of the respective upper edges forms a seat which extends from one recess generally toward another and diminishes to become a smooth surface which is flush with the respective transverse surface.

2. The bileaflet heart valve prosthesis of claim 1, wherein each upper side has an end point where the seat diminishes into the respective transverse surface and no longer provides a seat against which the upper surface proximate the peripheral edge can abut, wherein the annular base has an inner surface which includes each of the lateral surfaces and the transverse surfaces, the annular base having a radial distance which extends 360°

around the inner surface, wherein the upper side extending from the first recess is the first upper side and the upper side extending from the second recess is the second upper side and the radial distance between the respective end points of the first and second upper sides is from about 5°

to about 55°

.

3. A bileaflet heart valve prosthesis for controlling a circulation of a fluid within a heart of a patient, said bileaflet heart valve prosthesis comprising

an annular base and first and second leaflets, the first leaflet and the second leaflet being mounted within the annular base for pivotal movement between a fully closed position and a fully open position, the annular base defining a bore extending through the base, the annular base having a first lateral side having a first lateral surface, a second lateral side having a second lateral surface, and a pair of transverse sides individually disposed between the first and second lateral sides, wherein each of the respective leaflets have first and second sides, the first side being a top side and the second side being a bottom side, the bottom sides of the respective leaflets generally facing one another when the respective leaflets are in the fully open position;

and wherein each bottom side is substantially defined by an upper surface lying generally in a first plane and a lower surface lying generally in a second plane, the first plane lying at an angle to the second plane; and

the top sides of the respective leaflets having a top surface lying generally in a third plane, the third plane lying at an angle to each of the first and second planes.

4. The bileaflet heart valve prosthesis of claim 3, wherein the first and second planes lie at first and second angles respectively to a horizontal plane passing through a cross-section of the annular base when the respective leaflets are in the fully open position, the first angle being from about 84°

to about 88° and

the second angle being from about 68°

to about 84°

.

5. The bileaflet heart valve prosthesis of claim 3, wherein the angle between the first plane and the second plane is from about 164°

to about 175°

.

6. The bileaflet heart valve prosthesis of claim 3, wherein each of the top planes changes position from a first position to a second position when the respective leaflet changes position from the fully open position to the fully closed position, wherein a travel angle is an angle between the respective top plane when the leaflet is in the first position and the respective top plane when the leaflet is in the second position, and wherein the travel angle for each of the first and second leaflets is from about 35°

to about 49°

.

7. The bileaflet heart valve prosthesis of claim 6, wherein a horizontal plane, which is perpendicular to the lateral sides of the annular base, passes through a horizontal cross-section of the base, and each of the respective top planes lie at a greater angle to the horizontal plane than the second plane on the respective lower surface.

8. The bileaflet heart valve prosthesis of claim 3, wherein a horizontal plane, which is perpendicular to the lateral sides of the annular base, passes through a horizontal cross-section of the base, and the second plane lies at an angle to the horizontal plane when the respective leaflet is in the fully open position, the angle ranging from about 68°

to about 84°

.

9. A bileaflet heart valve prosthesis for controlling a circulation of a fluid within a heart of a patient, said bileaflet heart valve prosthesis having:

an annular base and first and second leaflets, the first leaflet and the second leaflet being mounted within the annular base for pivotal movement between a fully closed position and a fully open position, the annular base defining a bore extending through the base, the annular base having a first lateral side having a first lateral surface, a second lateral side having a second lateral surface, and a pair of transverse sides individually disposed between the first and second lateral sides, the annular base defining a first recess extending radially outward into the annular base from and communicating with the bore, and a second recess extending radially outward into the annular base from and communicating with the bore, the first recess being disposed within the first lateral side, the second recess being disposed within the second lateral side, wherein at least a first side portion of the first leaflet is received within the first recess and at least a second side portion of the first leaflet is received within said second recess to retain the first leaflet within the annular base, wherein the annular base further defines third and fourth recesses extending radially outward into the annular base from and communicating with the bore, the third recess being disposed within the first lateral side and the fourth recess being disposed within the second lateral side, wherein at least a third side portion of the second leaflet is received within the third recess and at least a fourth side portion of the second leaflet is received within the fourth recess to retain the second leaflet within the annular base;

the improvement characterized in that the first, second, third and fourth side portions of the respective leaflets each have a plurality of recess engagement surfaces, two of the plurality of recess engagement surfaces meeting to form a first fulcrum edge and two of the plurality of recess engagement surfaces meeting to form a second fulcrum edge removed from the first fulcrum edge, each of the recesses having an upper and lower recess side surface, wherein each of the respective first and second fulcrum edges engage an upper or lower recess side surface of the recess in which the respective side portion is engaged when the respective leaflet pivots either from the fully open position to the fully closed position or from the fully closed position to the fully open position such that engagement between one of the respective fulcrum edges and the respective side surface of each of the respective recesses is changeable from engagement with a side surface by the first fulcrum edge to engagement with a side surface by the second fulcrum edge as the respective leaflet pivots from one position to the other;

each recess having a recess bottom surface, wherein at least a portion of each recess bottom surface is a cylindrical surface;

the first leaflet having a peripheral edge, wherein the respective side portions of the first leaflet, which are received within the first and second recesses, each have a cylindrical surface along the peripheral edge proximate the respective side portions received within the respective recesses;

the first leaflet having a complementary pair of notches in the peripheral edge proximate each of the respective side portions of the first leaflet which are received within the respective first and second recesses, wherein the complementary pair of notches cooperate to permit the leaflet to pivot within the respective recess and the cylindrical surfaces of the respective peripheral edges mate with the cylindrical bottom surfaces of the respective recesses in which the respective side portions are received when the first leaflet is in the closed position.

10. The bileaflet heart valve prosthesis of claim 9, each of the respective leaflets having first and second sides, the first side being a top side and the second side being a bottom side, the bottom sides of the respective leaflets generally facing one another when the respective leaflets are in an open position;

each bottom side having an upper surface lying generally in a first plane and a lower surface lying generally in a second plane, the first plane lying at an angle to the second plane.

11. The bileaflet heart valve prosthesis of claim 9, each of the respective side portions of the respective leaflets having a cylindrical side surface along a peripheral edge of the leaflet proximate the respective side portion which is received within the respective recess, wherein the respective cylindrical side surfaces mate with the respective cylindrical bottom surfaces of the respective recesses in which the respective side portions are received when the respective leaflets are in the closed position.

12. A bileaflet heart valve prosthesis for controlling a circulation of a fluid within a heart of a patient, said bileaflet heart valve prosthesis having:

an annular base and first and second leaflets, the first leaflet and the second leaflet being separately mounted within the annular base for pivotal movement between a closed position and an open position, the annular base defining a bore extending through the base, the base having a longitudinal axis oriented generally in parallel with the bore, the annular base having a first lateral side having a first lateral surface, a second lateral side having a second lateral surface, and a pair of transverse sides individually disposed between the first and second lateral sides, the annular base defining a first recess extending radially outward into the annular base from and communicating with the bore, and a second recess extending radially outward into the annular base from and communicating with the bore, the first recess being disposed within the first lateral side, the second recess being disposed within the second lateral side, the first recess having a first recess surface, the first recess surface intersecting the first lateral surface of the base such that the first recess surface and the first lateral surface form a first junction, a first recess entrance angle being the largest of a plurality of angles between a first line tangential with the first lateral surface proximate the first junction and any of an infinite number of second lines lying in a first plane with and intersecting the first line, and being generally tangential with any portion of the first recess surface proximate the first junction, the first plane being perpendicular to the first lateral surface, the second recess having a second recess surface intersecting the second lateral surface such that the second recess surface and the second lateral surface form a second junction, a second recess entrance angle being the largest of a plurality of angles between a third line tangential with the second lateral surface proximate the second junction and any of an infinite number of fourth lines lying in a second plane with and intersecting the third line, and being generally and tangential with any portion of the second recess surface proximate the second junction, the second plane being perpendicular to the second lateral surface;

wherein at least a first side portion of the first leaflet is received within the first recess and at least a second side portion of the first leaflet is received within the second recess to retain the first leaflet within the annular base;

the improvement characterized in that each of the first and second recess entrance angles are less than about 35°

;

wherein at least a portion of each of the first and second recess surfaces is a cylindrical surface;

the first leaflet having a peripheral edge, wherein the respective side portions of the first leaflet, which are received within the first and second recesses, each have a cylindrical surface along the peripheral edge proximate the respective side portions received within the respective recesses;

the first leaflet having a complementary pair of notches in the peripheral edge proximate each of the respective side portions of the first leaflet which are received within the respective first and second recesses, wherein the complementary pair of notches cooperate to permit the leaflet to pivot within the respective recess and the cylindrical surfaces of the respective peripheral edges mate with the cylindrical surfaces of the respective recesses in which the respective side portions are received when the first leaflet is in the closed position.

13. The bileaflet heart valve prosthesis of claim 12 wherein the first and second recess entrance angles range from about 20°

and about 34°

.

14. The bileaflet heart valve prosthesis of claim 12, wherein the annular base further defines third and fourth recesses extending radially outward into the annular base from and communicating with the bore, the third recess being disposed within the first lateral side and the fourth recess being disposed within the second lateral side, the third recess having a third recess surface intersecting the first lateral surface such that the third recess surface and the first lateral surface form a third junction, a third recess entrance angle being the largest of a plurality of angles between a fifth line generally tangential with the first lateral surface proximate the third junction and any of an infinite number of sixth lines lying in a third plane with and intersecting the fifth line, and being generally tangential with any portion of said third recess surface proximate the third junction, the third plane being perpendicular to the first lateral surface, the fourth recess having a fourth recess surface intersecting the second lateral surface, the fourth recess surface and the second lateral surface intersecting to form a fourth junction, a fourth recess entrance angle being the largest of a plurality of angles between a seventh line tangential with the second lateral surface proximate the fourth junction and any of an infinite number of eighth lines lying in a fourth plane with and intersecting the seventh line, and being generally tangential with any portion of the fourth recess surface proximate the fourth junction, the fourth plane being perpendicular to the second lateral surface;

each of the third and fourth recess entrance angles being less than about 35°

, wherein at least a third side portion of the second leaflet is received within the third recess and at least a fourth side portion of the second leaflet is received with the fourth recess to retain the second leaflet within the annular base.

15. The bileaflet heart valve prosthesis of claim 12, wherein the first leaflet has first and second sides, the first side being the top side and the second side being the bottom side, the bottom side having an upper surface lying generally in a first plane and a lower surface lying generally in a second plane, the first plane lying at an angle to the second plane.