Abstract: A heart valve holder-inserter (21, 121) is designed to facilitate easy implantation of a mechanical heart valve prosthesis (23, 123). This holder-inserter, at its distal end, incorporates a pair of diametrically opposed guide members (47, 49, 81, 147, 149) which extend well beyond the leading edge of the prosthesis and which have exterior surfaces (53, 83, 153) of substantial dimension that are smoothly curved and proportioned so as to slowly spread the tissue annulus in order to facilitate easy entrance thereinto of the leading edge portion of the mechanical valve body.

Abstract: A prosthetic venous valve having a two-piece housing which includes upstream and downstream sections. The upstream section contains a circular seat against which an occluder comes in sealing contact when the valve is in its closed position. The downstream housing section is shaped so as to prevent escape of the occluder downstream and to halt the reciprocating motion of the occluder in the open position where there is an open pathway past the occluder. A plurality of fins on the interior of the downstream housing section or on the surface of the occluder assure there is a blood flow path downstream past the occluder in the open position. The two-piece construction allows the housing sections to be axially spaced apart so that blood comes in contact with the interior surface of the patient's vein immediately downstream of the upstream section of the housing.

Abstract: A prosthetic heart valve comprising a tubular valve body and a pair of leaflets which pivot, or translate and pivot, between open and closed positions. The valve body is of circular interior cross-section except for a pair of diametrically opposed flat wall sections which contain recesses within which the pivot axes of the leaflets are located. Arcuate edges of the leaflets are irregularly shaped so that a pair of protrusions extend radially outward from an otherwise generally semicircular periphery. The protrusions are strategically located so as to contact the interior surface of the valve body in the closed position at arcuately spaced apart locations which flank the centerline of the leaflet. As a result, contact in the closed position occurs at two spaced apart locations rather than at a single location, and at least a minimum gap is established at the central tip of the leaflet which counteracts potential cavitation, noise and hemolysis.

Abstract: A trileaflet heart valve includes a generally annular valve body having an interior wall of nominally circular cross-section into which three wedge-shaped projections radially extend to provide three pairs of flanking flat surfaces between which three leaflets are pivotally supported. The valve body has an outwardly flaring upstream entrance end that, together with the configuration of the leaflets, assures streamlined flow and low transvalvular pressure drop. Wing sections extend laterally in both directions at angles between about 30.degree. and 50.degree. from flat central sections of the leaflets to create V-shaped cross-section leaflet bodies having short flat edge sections along the lateral edges of both wing sections that create a wide open central flow passageway. The three leaflets assume an orientation parallel or nearly parallel to the central axis in full open position.

Abstract: A prosthetic heart valve is shown which incorporates a valve body design and leaflet pivot arrangements that minimize turbulence and shear stresses having a tendency to generate thrombosis. A valve body having an axially curved entrance that is smoothly joined to a generally cylindrical body of extended axial length provides excellent fluid flow characteristics when combined with leaflets that can assume orientations perfectly aligned with the downstream flow of blood. By constructing such a pyrocarbon valve body which receives a metal ring at an appropriate location, suture rings that permit the tissue annulus to directly contact the exterior surface of the cylindrical valve body are accommodated.

Abstract: A trileaflet heart valve includes a generally annular valve body having an interior wall of nominally circular cross-section into which three wedge-shaped projections radially extend to provide three pairs of flanking flat surfaces between which three leaflets are pivotally supported. The valve body has an outwardly flaring upstream entrance end that, together with the configuration of the leaflets, assures streamlined flow and low transvalvular pressure drop. Wing sections extend laterally in both directions at angles between about 30.degree. and 50.degree. from flat central sections of the leaflets to create V-shaped cross-section leaflet bodies having short flat edge sections along the lateral edges of both wing sections that create a wide open central flow passageway. The three leaflets assume an orientation parallel or nearly parallel to the central axis in full open position.

Abstract: A prosthetic heart valve is shown which incorporates a valve body design and leaflet pivot arrangements that minimize turbulence and shear stresses having a tendency to generate thrombosis. A valve body having an axially curved entrance that is smoothly joined to a generally cylindrical body of extended axial length provides excellent fluid flow characteristics when combined with leaflets that can assume orientations perfectly aligned with the downstream flow of blood. By constructing such a pyrocarbon valve body which receives a metal ring at an appropriate location, suture rings that permit the tissue annulus to directly contact the exterior surface of the cylindrical valve body are accommodated.

Abstract: A bileaflet heart valve incorporates a pivot arrangement that minimizes resistance to downstream blood flow in the open position yet has prompt response and therefore minimal regurgitation upon flow reversal. A valve body having an axially curved entrance that smoothly joins a generally cylindrical body of extended axial length provides excellent fluid flow characteristics when combined with leaflets that can assume orientations perfectly aligned with the downstream flow of blood. Identical flat leaflets can assume a parallel orientation in the fully open position during downstream blood flow or can assume other low energy positions. Flat ears, which extend laterally from opposite surfaces of the leaflets, interengage with cavities of unique design having upstream and downstream lobes separated by an intermediate throat portion defined by inward and outward fulcrums.

Abstract: A trileaflet heart valve includes a generally annular valve body having an interior wall of nominally circular cross-section into which 3 wedge-shaped projections radially extend to provide 3 pairs of flanking flat surfaces between which leaflets are pivotally supported and which includes an outwardly flaring upstream entrance end that, together with an elongated axial length, assures streamlined flow and a low transvalvular pressure drop. The leaflets assume an orientation substantially parallel to the central axis in the open position with their swinging movement in the direction of closing being guided by pairs of arcuate ridges and posts which protrude from the flanking flat walls of the projections and which guide the leaflets in a pivoting and translating swinging movement. The downstream ends of the curved ridges are enlarged in cross-section, compared to the upstream ends, and in combination with the posts create stops which determine the desired open position orientation of the three leaflets.

Abstract: A bileaflet heart valve is shown which incorporates a pivot arrangement that minimizes resistance to downstream blood flow in the open position yet has prompt response and therefore minimal regurgitation upon flow reversal. The valve employs a pair of identical flat leaflets that can assume a precisely parallel orientation in the fully open position at or near peak downstream blood flow or can alternatively assume other low energy positions. As the downstream flow of blood slows near the end of a pumping stroke, downstream displacement of the leaflets results in their prerotation toward the closed position orientation, all being controlled by the interengagement of flat ears, which extend laterally from opposite surfaces of the leaflets, and receiving cavities of unique design. The cavities include upstream and downstream lobes separated by an intermediate throat portion defined by inward and outward fulcrums.

Abstract: Mechanical heart valve prostheses having either a single occluder or a pair of occluders are designed to permit such occluders to assume an open position parallel to the longitudinal axis of the valve passageway. The pivot arrangements are such that an occluder pivots about a constant center or pivot axis substantially offset from the locations where engagement occurs between the occluder and the valve body, whereby prompt smooth pivoting movement toward the closed position is initiated from an open position parallel to the valve centerline. For example, elongated arcuate shoes protruding from lateral edges of the occluders follow arcuate paths of matching complementary curvature defined by grooves in diametrically opposed flat sidewall sections of the valve body.

Abstract: Heart valves are shown which utilize pivot arrangements that create prompt response to flow reversal and minimize resistance to blood flow in the open position. Illustrated are valves having a pair of identical leaflets that can assume an orientation in the fully open position near maximum blood flow rate that is precisely parallel to the centerline of the passageway. The ability of the leaflets to assume a precisely parallel or low energy position in the bloodstream reduces pressure drop across the valve and results in improved flow characteristics. A camming action adjacent the upstream edges of the leaflets in combination with interengagement at downstream locations on the valve body, spaced from the locations where the camming action with said upstream edges occurs, positively guide the leaflets to assure effective closing movement regardless of momentary deviations in the dynamics of the reverse flow of blood through the valve.

Abstract: Bi-leaflet heart valves have valve body contours and pivot arrangements that create quick valve response to flow reversal. Valve members or leaflets, which can have flat or curved inflow and outflow surfaces, are slidably and pivotally mounted in a heart valve body of contoured profile so they can be aligned precisely parallel to blood flow in the open position. The leaflets engage either projections extending radially inward from flat wall sections in the valve body sidewall or grooves in these flat wall sections. The shape and relationship of these interengaging surfaces, together with a centrally directed surge of backflowing blood which results from the strategic location of a pair of downstream recesses in the annular valve body, cooperate to provide prompt closing rotation of the leaflets from a parallel open orientation.

Abstract: Bi-leaflet and single occluder heart valves have improved pivot arrangements that create quick valve response to flow reversal and minimize impact. Valve members or occluders, which have curved inflow and outflow surfaces, are slidably and pivotally mounted in a heart valve body and can be aligned precisely parallel to blood flow in the open position. Lugs on the valve members engage surfaces on projections extending radially inward from flat wall sections in the valve body sidewall, and the shape and relationship of these interengaging surfaces provide prompt initial rotation, low wear and reduced impact upon closing. Laterally directed ears engage the valve body arcuate sidewall and assist in defining the path of closing movement.

Abstract: Prosthetic heart valves having a single occluder, or a pair of identical mating occluders, guided in their movement from the open to the closed position by pairs of elongated slots in diametrically opposed flat sidewall sections of the valve body. Each occluder is formed with two ears that protrude from opposite flat side surfaces along the lateral edges thereof. The ears may be frustoconical or hemispherical or the like and are slidingly received in elongated slots which can be straight or arcuate. The main body portions of the occluders have rectilinear surfaces that are aligned parallel to the centerline through the valve in the open position, so as to give low resistance to blood flow. However, when the backflow of blood displaces the occluders upstream, the slot arrangements are such that even though the occluder bodies are parallel, pivoting towards the closed position orientation begins essentially immediately, and the closing movement is of short duration so as to minimize regurgitation.

Abstract: Bi-leaflet heart valves have improved flow characteristics in their open position as a result of employing valve bodies of elongated axial dimension. By elongating the axial dimension of valve bodies which have straight, smooth interior wall surfaces oriented parallel to the centerline through the valve and to the flow path of blood, and by employing a pair of occluders which have major surfaces that are rectilinear and can assume an orientation that is substantially parallel to the centerline in the open position, a streamlining of blood flow occurs. The pivot arrangements avoid the use of acute angular surface orientations and cause the occluders, although aligned substantially parallel to blood flow in the open position, to promptly pivot toward the closed position upon reversal of blood flow. This streamlining substantially reduces turbulence and results in low head loss, both significant advantages in bi-leaflet heart valve performance.

Abstract: Heart valves, particularly those having two identical leaflets, are shown which utilize improved pivot arrangements that create prompt response to flow reversal and minimize impact at the instant of closing. Illustrated are valves having pairs of leaflets that can assume an orientation in the fully open position that is precisely parallel to the centerline of the passageway, yet which will promptly respond upon blood flow reversal and quickly close to prevent substantial regurgitation. The ability of the leaflets to assume a precisely parallel or low energy position in the bloodstream reduces pressure drop across the valve and results in improved flow characteristics. Prompt closing movement pivoting from a parallel position is effected by creating a camming action adjacent the upstream edges of the leaflets while positively guiding the overall path of leaflet translation and rotation by interengagement at other locations spaced from the upstream edges.

Abstract: Bi-leaflet and single occluder heart valves have improved pivot arrangements that create quick valve response to flow reversal and minimize impact. Valve members or occluders, which are slidably and pivotally mounted in a heart valve body, can be aligned precisely parallel to blood flow in the open position. Lugs on the valve members engage surfaces on projections extending radially inward from flat wall sections in the valve body sidewall, and the shape and relationship of these interengaging surfaces provide prompt initial rotation, low wear and reduced impact upon closing. Laterally directed ears engage the valve body arcuate sidewall and assist in defining the path of closing movement.

Abstract: Bi-leaflet heart valves have improved flow characteristics in their open position as a result of employing valve bodies of elongated axial dimension. By elongating the axial dimension of valve bodies which have straight, smooth interior wall surfaces oriented parallel to the centerline through the valve and to the flow path of blood, and by employing a pair of occluders which have major surfaces that are rectilinear and can assume an orientation that is substantially parallel to the centerline in the open position, a streamlining of blood flow occurs. The pivot arrangements avoid the use of acute angular surface orientations and cause the occluders, although aligned substantially parallel to blood flow in the open position, to promptly pivot toward the closed position upon reversal of blood flow. This streamlining substantially reduces turbulence and results in low head loss, both significant advantages in bi-leaflet heart valve performance.

Abstract: A bi-leaflet heart valve having an improved hinge arrangement that allows the valve to respond quickly to flow reversals and minimizes fluttering of the leaflets in the open position. A pair of leaflets are slidably and pivotally mounted in a heart valve body for movement between closed and open positions. Notches in the leaflets matingly engage complementary surfaces on pivot projections extending inward from the valve body sidewall. Downstream stops interengage with complementary surfaces on the leaflets to cushion the final opening movement and reduce wear in critical locations to improve operating characteristics.