Carbomedics Inc.

Onx, Inc.

General Atomic Company

Medical Carbon Research Institute, LLC

On-x Life Technologies, Inc.

Other

Carbon Implants, Inc.

Carbo Mediec Inc.

Valve Special Purpose Co., LLC

Jack C Bokros

Jonathan C Stupka

Axel D Haubold

Michael R Emken

T Scott Peters

C Thomas Waits

John L Ely

Robert B More

Fletcher Derek Southard

Victor Slivenko

Jeffery Poehlmann

Josep Gatell Ferre

Elva Correa

Francisco Javier Ruyra-Baliarda

Willard H Ellis

Hong S Shim

Michael Jarcho

Ned H Hwang

Jere B Horsley, Jr

Manuel Tascon

Robert J Akins, Sr

Josep Gatell Feere

Jeffrey Poehlmann

An embodiment of the invention includes a sewing cuff for aortic heart valves that better approximates native anatomy by better mating with the crown-like anatomical annulus. Limiting distortion of the crown-like annulus provides better blood flow and overall valve function and provides a physician greater ease of implantation since native anatomy is not flattened. Thus, the surgeon may attach sutures to the fibrous tissue of the crown-like anatomical annulus without distorting the shape of the native anatomy. An embodiment includes a scalloped sewing cuff assembly (with semilunar arches) that tracks the crown-like annulus. Another embodiment provides a sewing cuff positioned over the majority of the valve's length, thus allowing the surgeon greater flexibility as to where he or she can attach sutures to the surgical annulus. Conventional valves, which are primarily 'low-profile' devices, do not offer such ability. Other embodiments are described herein.

Heart valve sewing cuff

A heart valve holder-inserter () is designed to facilitate easy implantation of a mechanical heart valve prosthesis (). This holder-inserter, at its distal end, incorporates a pair of diametrically opposed guide members () which extend well beyond the leading edge of the prosthesis and which have exterior surfaces () 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.

Heart valve inserter

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. Such arrangement is biologically advantageous and permits momentary deflections of either of the housing sections from its normal coaxial orientation without harm to the valve or disruption of its functioning.

Prosthetic venous valves

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.

Prosthetic heart valve

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. Leaflet movement from open to closed position is partially defined by upstream retainers aligned with the flat central sections of each leaflet and by surfaces formed in or on the side walls of the projections along which the leaflets slide. Radially interior edges of the leaflets are tapered to effectively eliminate cavitation.

Trileaflet heart valve

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.

Prosthetic heart valve with improved blood flow

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. Leaflet movement from open to closed position is partially defined by upstream retainers aligned with the flat central sections of each leaflet and by surfaces formed in or on the side walls of the projections along which the leaflets slide.

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. The downstream lobes may be designed to facilitate movement to the parallel orientation or to cause the leaflets to optionally prerotate toward the closed position. As soon as reverse flow begins, upstream displacement of the leaflets causes the ears to contact straight camming surfaces located upstream of the outward fulcrums which, in combination with the fulcrums and a downwardly directed, concave surface at the upstream end of the upstream lobe, positively guide each leaflet through efficient closing which ends in substantially rotational movement. A pyrocarbon valve body receives suture rings that permit the tissue annulus to directly contact an exterior surface region of the valve body.

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.

Prosthetic trileaflet heart valve

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. As soon as reverse flow begins, upstream displacement of the leaflets causes the ears to contact straight camming surfaces located upstream of the outward fulcrums which, in combination with the fulcrums and a downwardly directed, concave surface at the upstream end of the upstream lobe, positively guide each leaflet through efficient closing which ends in substantially rotational movement.

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.

Heart valve prostheses

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. More particularly, slight closing movement pivoting, following assumption of such a parallel orientation, is effected by designing the interengagement so that the leaflets shift slightly downstream from the precisely parallel orientation when the blood flow slows prior to reversing and simultaneously rotate slightly toward their closed position orientation.

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Austin, TX, United States of America

Jack C Bokros