Abstract: Mechanical heart valve prostheses are disclosed that inherently reduce the probability of thrombus formation by minimizing blood flow disturbance, high shear stress, and stagnation. The pivot configuration includes a recess, preferably in the housing, that has a profile which promotes smooth blood flow.

Abstract: A heart valve prosthesis having a valve housing providing a lumen therethrough. The valve housing has a first annulus on one end and a second annulus on the other end spaced apart from the first annulus. A suture cuff is used for attaching the valve housing to heart tissue of a patient. The cuff is attached between the first annulus and the second annulus. The cuff is positioned such that prosthesis is attached in a supra-annular position relative to a tissue annulus of the heart. The design allows for an increased valve lumen.

Abstract: A prosthesis is formed from a substrate with an associated attraction compound. The attraction compound binds viable precursor cells to the substrate. Thus, the substrate forms a synthetic tissue supporting viable cells once the substrate is contacted with a solution containing viable precursor cells. Preferred precursor cells differentiate into fibroblasts or into endothelial cells.

Abstract: A prosthetic heart valve includes an orifice ring adapted to carry blood therethrough. An annular recess is formed in an outer surface of the orifice ring and has first and second axially spaced walls. A sewing cuff is adapted to be coupled to a native tissue annulus of a heart and includes an inner annular cuff portion adapted to conform to the first and second recess walls in the orifice ring. A cuff retaining ring extends around the inner annular fabric portion such that the inner annular cuff portion is positioned between the cuff retaining ring and the annular recess.

Abstract: A holder is provided for carrying a prosthetic ring which allows for manipulation and handling of the ring during implantation in a heart. The holder includes a holder body configured to fit the ring. A boss extends around the holder body. A backing lip extends from a proximal end of the boss and has a diameter that is greater than a diameter of the boss. A shoulder tab extends only partially around the distal end of the boss and extends beyond a diameter of the boss. The prosthetic ring mates with the boss and the backing lip to thereby hold the prosthetic ring.

Abstract: The invention involves a bioprosthetic article including a biocompatible material having at least one bound exogenous storage structure, the storage structures having collectively greater than about 0.5 mg metal cations per gram of biocompatible material. The calcification inhibitors preferably decrease calcium deposition by greater than 95% relative to untreated tissue. The calcification inhibitors are bonded to the bioprosthetic material preferably at a pH between about 6.0 and 8.5.

Abstract: A variety of new ways can be used for associating antimicrobial elemental metal with a medical article. The associated antimicrobial metal reduces the risk of infection associated with the medical use of the medical article. New medical articles are produced by some of these new approaches. Some of the methods involve ways of adjusting the dissociation rate of associated elemental metal such that desired degrees of antimicrobial activity can be achieved over selected periods of time.

Abstract: This invention relates to heart valve annuloplasty prostheses that are fashioned of bioresorbable materials. The prostheses are eventually resorbed by the patient, during which time regenerated tissue replaces the prosthesis. This leaves the patient with a biological and functional annular structure, resulting in improved heart valve function.

Abstract: A semilunar stentless valve is constructed entirely of biocompatible material, and has a plurality of leaflets that are joined to form an annulus and coapt to form a one-way valve. The leaflets open fully to minimize obstruction. A narrow rim strip overlies commissures where the leaflets join and around a base of the valve. The valve is of a conical design, flexible, easy to fit and preserves the integrity of the coronary sinuses. The valves can be implanted with a single suture row, reducing implant time significantly.

Abstract: A device for engaging a heart valve prosthesis during implantation includes a hanger and a holder. The holder includes a distal engaging surface adapted for engaging the heart valve prosthesis. The hanger is used to suspend the prosthesis in packaging and may be used to manipulate the prosthesis during implantation.

Abstract: An apparatus is disclosed for differentially treating a medical device. One portion of the device is treated with a first fluid and a separate portion is treated with a second fluid. The second fluid generally is substantially different from the first fluid. The first fluid can be contacted with an flow region of the medical device. The apparatus can include a conduit system, where fluid flowing through the conduit system flows through the flow region. Sheet material can be treated differentially on the opposite surfaces of the sheet. The medical device can include vascular tissue.

Abstract: A variety of new ways can be used for associating antimicrobial elemental metal with a medical article. The associated antimicrobial metal reduces the risk of infection associated with the medical use of the medical article. New medical articles are produced by some of these new approaches. Some of the methods involve ways of adjusting the dissociation rate of associated elemental metal such that desired degrees of antimicrobial activity can be achieved over selected periods of time.

Abstract: A prosthetic heart valve for implantation in a heart includes an outer orifice ring for coupling to a tissue annulus of a heart. An inner orifice ring includes at least one leaflet occluder carried in a lumen of the inner orifice ring which is movable between an open position, which allows blood flow through the lumen, and a closed position which blocks blood flow through the lumen. The inner orifice ring is adapted to be coupled to the outer orifice ring after the outer orifice ring has been attached to the tissue annulus.

Abstract: A bi-leaflet prosthetic heart valve, comprising an annular body having an upstream edge, a downstream edge and a passageway therebetween includes first and second leaflets pivotally mounted in the annular body. Each leaflet has an upstream edge, a downstream edge and a leaflet length therebetween. First and second pivot axes associated respectively with the first and second leaflets are provided and each leaflet rotates about its respective pivot axes between an open position allowing blood flow through the passageway of the annular body and a closed position blocking blood flow. The valve is configured such that the leaflets have an angle in the naturally open position of more than about 85°.

Abstract: An annuloplasty ring includes an elongated main body having a generally partial shape extending between first and second ends. An elongated secondary body also includes first and second ends which couple to, respectively, the first and second ends of the main body. A first cut zone couples the first end of the main body to the first end of the secondary body. A second cut zone couples the second end of the main body to the second end of the secondary body. The annuloplasty ring may be selectively formed generally into a partial annuloplasty ring shape by severing the first and second cut zones and removing the secondary body.

Abstract: The invention relates to a holder/rotator device which may be used to hold and then rotate a heart valve prosthesis during implantation of the heart valve prosthesis. The device comprises holder/rotator which includes a post and a rotator head, and a handle. The rotator head comprises a gripping surface of a material which engages and grips the surface of the heart valve prosthesis and facilitates the smooth rotation of the valve.

Abstract: A mechanical heart valve for implantation in a heart of a patient includes an orifice body having an outer circumference and defining a lumen for blood flow therethrough. At least one leaflet carried in the lumen of the orifice body is movable between an open position, allowing flow through the lumen, and a closed position blocking flow through the lumen. A flange ring around the outer circumference of the orifice body includes a plurality of suture holes defined therein. The suture holes are adapted for receiving a suture and thereby attaching the heart valve to tissue of the heart.

Abstract: A manipulable low profile heart valve holder that can be pivotally attached to a handle that permits the heart valve holder and a retained heart valve prosthesis to be manipulated remotely during implantation. The heart valve holder is pivotable from a position wherein the plane of the orifice of a retained heart valve is parallel to the axis of the handle, to a second position wherein the plane of the retained heart valve is substantially 90.degree. to the axis of the handle. This pivoting arrangement particularly aids in manipulation of the heart valve prosthesis during implantation using trocars for access to the body cavity. Manipulation is accomplished by having controllable elements on the handle and retained on the exterior of the patient. Manipulation of the heart valve holder also may be done through separate instruments operating through separate trocars.

Abstract: Packaging and a holder is provided for a heart valve prosthesis. The holder is adapted to grasp the heart valve prosthesis and includes a post. The packaging includes a collar for holding the post of the holder. An inner tray of the packaging receives the collar such that the prosthesis is suspended within the inner tray. An outer tray receives the inner tray. An inner tray lid seals the inner tray and an outer tray lid seals the outer tray.

Abstract: A holder for engaging a heart valve prosthesis during implantation includes a mechanism for attaching the holder to the heart valve prosthesis. The heart valve prosthesis includes a circular valve body having an annulus with a substantially annular aperture therein. At least one movable occluder is carried in the aperture and is movable between an open position and a closed position. The attachment mechanism attaches to the occluder thereby securing the holder to the heart valve prosthesis.