Abstract: A prosthetic heart valve rotator with an eccentric socket attached to a bendable shaft. The heart valve is manipulated by a rotator head which is attached to the socket in any of a plurality of selectable angular positions. The rotator head is held in the socket by a spring which circumscribes the socket, thereby reducing stress in the spring.

Abstract: A prosthetic mechanical heart valve with a suture ring and stiffening ring combination which minimizes the radial thickness of the sewing ring. The valve comprises an annular stiffening ring captured between .upper and lower rings which are sewed into a knit fabric tube. The entire assembly of sewing ring and stiffening ring is then assembled as a unit onto the mechanical heart valve.

Abstract: A prosthetic mechanical heart valve with an annular valve body and with a suture ring and stiffening ring combination wherein the stiffening ring is compressible before contacting a wall of the valve body. The inside diameter of the stiffening ring is consistently greater than the outside diameter of the annular valve body, forming a gap. This inhibits compressive forces from being transmitted to the annular valve body. The heart valve also has beveled stops or recesses for controlling the opening angle of leaflets mounted in the valve body. Because of the gap between the valve body and the stiffening ring, the body can deform in a spring-like manner, providing a spring-closing action.

Abstract: A sizing apparatus for a supra-annular heart valve comprising a sizing probe mounted on a bendable shaft. The sizing probe comprises a cylindrical body with a proximal surrounding lip, the body and lip having a combined height equivalent to a similar height of the supra-annular heart valve. The body has an outside diameter which corresponds to that of the body of the supra-annular heart valve, and the lip has an outside diameter which corresponds to that of the sewing ring brim. Proximal from the lip is an annulus sizer having a shape corresponding to the interior opening or orifice of the selected heart valve. In use, the annulus sizer is placed in the aorta to pass through the annulus in the heart at the site of the excised natural valve, so that the attending physician will be able to recognize the largest permissible size for the supra-annular heart valve. A set of sizers is supplied corresponding to the different sizes of available heart valves.

Abstract: A tri-leaflet heart valve wherein the leaflets have supporting ears adapted to slide in curved tracks provided in an annular body. The leaflets ears are further supported and guided by conical-segment surfaces adjacent the curved grooves. A common stop between two grooves for adjacent leaflets limits the motion of the leaflets as the valve closes. Posts between opposed grooves for each leaflet arrest the motion of a leaflet if the leaflets are closing simultaneously closed position. Each leaflet comprises a substantially planar surface with a central vertex where all three leaflets meet in closed position. Edges of the leaflets adjacent the curved grooves are canted up-stream and are scalloped to form ears which slide in the curved grooves.

Abstract: A bi-leaflet heart valve having an annular body and a pair of leaflets. The leaflets pivot around improved ears, whose motion is constrained by generally triangular recesses. The triangular recesses have a pivotal vertex in proximity to a centerline of the annular base and on the upstream side of the heart valve. Opposite the pivotal vertex is a slightly concave base. An upstream wall of the recess is convex.

Abstract: A bi-leaflet heart valve having pivot ears comprising frusto-conical segments, located substantially at a diametral edge of leaflet occluders of the valve. Pivots on adjacent edges of both occluders share a common recess in an annular body of the valve.

Abstract: A bioprosthetic heart valve comprising leaflets with free edges which do not impinge on adjacent leaflets when the leaflets are closed before being implanted and subject to body fluids and cardiac pressure cycles. Commissures supporting the leaflets have semi-permeable membranes which reduce the pressure load on the leaflets during implantation. In response to immersion in body fluids, the membranes become substantially impermeable. The leaflets can stretch in response to loads and hydration, so that the free edges mate shortly after implantation. First and second mechanisms for supporting leaflets to provide multiple effective spring constants. An inner frame supporting commissures of the valve is elastic, permitting the commissures to bend in toward the center of the prosthetic heart valve at very low loads. A relatively rigid annular support ring supports the elastic frame and provides the second spring constant mechanism.

Abstract: A bi-leaflet heart valve having an annular body and a pair of leaflets. The leaflets pivot around improved ears, whose motion is constrained by generally triangular recesses. The triangular recesses have a pivotal vertex in proximity to a centerline of the annular base and on the upstream side of the heart valve. Opposite the pivotal vertex is a slightly convex base. The opening angle of the leaflets can be adjusted by varying the inclination of a wall of the triangular recess adjacent the center line. The opening angle should be adjusted, according to the teachings of the present invention, to minimize energy loss for a particular inside diameter of the heart valve. The optimum opening angle can be determined by in vitro testing using an adjustable valve and a pulse duplicator.

Abstract: A combined mechanical heart valve and vascular graft having a shortened transition area between the valve and the graft. The mechanical valve comprises a rigid circular annulus supporting internal leaflets. A stiffening ring surrounds the annulus and provides support for a sewing ring to attach the valve to the heart. The stiffening ring also captures a proximal end of the vascular graft between the stiffening ring and the annulus.

Abstract: A suture ring for a mechanical heart valve comprised of essentially three parts: a stiffening ring which fits over an outer surface of the heart valve; a knit fabric sewing cuff attached to the stiffening ring, and a locking ring for securing the stiffening ring to the heart valve. The preferred embodiment comprises a locking ring which is generally crescent-shaped in cross-section and has a split ring configuration. Radial expansion or contraction is a first mode of deformation for the locking ring. The stiffening ring and the valve body can be locked together because the locking ring is capable of deforming in a second mode with respect to thickness of the ring. In the case of the preferred embodiment, the locking ring deforms by a slight flattening of the cresent cross-section of the ring.

Abstract: A bioprosthetic heart valve comprising first and second mechanisms for supporting leaflets to provide multiple effective spring constants. An inner frame supporting commissures of the valve is elastic, permitting the commissures to bend in toward the center of the prosthetic heart valve at very low loads. A relatively rigid annular support ring supports the elastic frame and provides the second spring constant mechanism. An attachment system for sewing bioprosthetic leaflets to the frame and clamping the leaflets between the frame and the annular ring minimizes stress risers in the leaflets. The leaflets have an uncoupled mating edge where the leaflets meet in the center of the valve. The uncoupled portions of the leaflets permit the leaflets to roll by each other.

Abstract: A heart valve prosthesis having an annular valve body, a pair of leaflet occluders mounted therein for pivoting and translational movement between closed and open positions. The leaflet occluders have mating diametrical edges and arcuate edges which engage the valve body when the leaflets are closed. Generally part conical mounting ears extend outwardly from the leaflet edge, adjacent the diametrical edge thereof. The ears are received in crescent-shaped recesses formed in the annular body. The recesses have opposed upstream and downstream surfaces for guiding the mounting ears during opening and closing of the leaflet.

Abstract: A heart valve prosthesis having an annular valve body, a pair of leaflet occluders mounted therein for pivoting and translational movement between closed and open positions. The leaflet occluders have mating diametrical edges and arcuate edges which engage the valve body when the leaflets are closed. Generally part spherical mounting ears extend outwardly from the leaflet edge, adjacent the diametrical edge thereof. The ears are received in crescent-shaped recesses formed in the annular body. The recesses have opposed upstream and downstream surfaces for guiding the mounting ears during opening and closing of the leaflet.

Abstract: A heart valve prosthesis having an annular valve body, a pair of leaflet occluders mounted therein for pivoting and translational movement between closed and open positions. Leaflet occluders have mating diametrical edges and arcuate edges which engage the valve body when the leaflets are closed. Generally frustoconical mounting ears extend outwardly from the leaflet edge, adjacent the diametrical edge thereof. The ears are received in recesses formed in the annular body. The recesses have an upper section extending in the direction of blood flow and a downstream section inclined thereto in a direction extending outwardly. The leaflets each have a flat upstream surface and a generally cylindrical downstream surface.

Abstract: Improved versions of heart valve prostheses include the usual generally annular body having an interior surface defining a blood flow passageway and having one or two occluders supported thereon for alternately blocking and then allowing the flow of blood in a predetermined direction. Notches are formed at opposite locations in the periphery of an occluder, and each is disposed about a pivot post that projects radially inward from the interior surface of the annular body. A pair of stops flank each pivot post, having curved surfaces at locations adjacent to the pivot posts but radially inward from the ends thereof that function as oppositely disposed fulcrums and cooperate with the pivot posts in defining the opening and closing movement of each occluder. Preferably, the pivot posts and the stop means are formed as an integral structure. Self-centering seats can be used to provide a better seal in the closed position.

Abstract: Improved versions of heart valve prostheses include the usual generally annular body having an interior surface defining a blood flow passageway and having one or two occluders supported thereon for alternately blocking and then allowing the flow of blood in a predetermined direction. Notches are formed at opposite locations in the periphery of an occluder, and each is disposed about a pivot post that projects radially inward from the interior surface of the annular body. A pair of stops flank each pivot post, having curved surfaces at locations adjacent to the pivot posts but radially inward from the ends thereof that function as oppositely disposed fulcrums and cooperate with the pivot posts in defining the opening and closing movement of each occluder. Preferably, the pivot posts and the stop means are formed as an integral structure. Self-centering seats can be used to provide a better seal in the closed position.

Abstract: A heart valve prosthesis with an annular body portion and at least one valve leaflet moveable between open, closed, and intermediate positions. The body includes leaflet ear support formations, each with a contoured recess having spaced apart, tapered arcuate guide wall surfaces and spaced apart convex ear support surfaces. Each valve leaflet includes mounting ears with upper and lower support surfaces of generally trapezoidal outline, a generally flat end face portion, and two spaced apart guide surface portions tapered so as to lie in closely spaced apart relation to the tapered guide walls in the recess.

Abstract: A protective stabilizer cap for use with a percutaneous device. The cap includes an annulate band carrying an ahesive for cutaneous contact in juxtaposition with the percutaneous device so that relative motion is between the percutaneous device and the skin is restricted.

Abstract: A percutaneous access device having at least one substantially rectilinear passageway that extends between the internal region of a living body and the region exterior of the body when the device is anchored therein. A second passageway intersects with the first so as to provide communication between the internal region and the exterior region through the lower portion of the first rectilinear passageway and the second passageway. Disposed within the rectilinear passageway is a plunger having a sealing tip on the distal end thereof and access to the internal region of the body is achieved by withdrawing the sealing tip of the plunger past the point where the second passageway intersects the rectilinear passageway. The plunger shaft has a non-uniform cross section along its length and the exterior opening of the rectilinear passageway is in the form of a keyway so that the plunger is movable within the rectilinear passageway only upon selective rotation of the plunger.