Abstract: A stented valve including a stent structure including a generally tubular body portion having a first end, a second end, an interior area, a longitudinal axis, and a plurality of vertical wires extending generally parallel to the longitudinal axis around a periphery of the body portion, wherein the plurality of vertical wires includes multiple commissure wires and at least one structural wire positioned between adjacent commissure wires, and a plurality of V-shaped wire structures having a first end, a second end, and a peak between the first and second ends, wherein a first end of each V-shaped structure extends from a first vertical wire and a second end of each V-shaped structure extends from a second vertical wire that is adjacent to the first vertical wire, wherein each V-shaped structure is oriented so that its peak is facing in the same direction relative to the first and second ends of the body portion, and a valve structure including a plurality of leaflets attached to the stent structure within the

Abstract: A stented valve including a stent structure including a generally tubular body portion that has a first end and a second end, wherein an area adjacent the first end has a first stiffness, an area adjacent the second end has a second stiffness, and a central region between the areas at the first and second ends has a third stiffness that is less than the stiffness adjacent the first and second ends, wherein the stent structure can be reconfigured in its central area to match a curved patient anatomical region. The stented valve further includes a valve structure attached within the generally tubular portion.

Abstract: A replacement heart valve and fixture assembly for limiting longitudinal stretch during fixation of a harvested aortic root including valve leaflets. The assembly includes an inflow plug inserted into the inflow section of the aortic root and having an apertured tube or cannula extending through the valve leaflets to an outflow plug inserted into the outflow section of the aortic root. Apertures in the tube are located on either side of the valve leaflets and the tube is coupled to a fluid inlet, preferably located on the outflow plug. The outflow plug is slidable relative to the tube and is provided with an engagement mechanism such as a setscrew for fixing the location of the outflow plug relative to the tube and the inflow plug.

Abstract: A method and apparatus for limiting longitudinal stretch during fixation of a harvested aortic root including valve leaflets and the product produced. The apparatus includes an inflow plug inserted into the inflow section of the aortic root and having an apertured tube or cannula extending through the valve leaflets to an outflow plug inserted into the outflow section of the aortic root. Apertures in the tube are located on either side of the valve leaflets and the tube is coupled to a fluid inlet, preferably located on the outflow plug. The outflow plug is slidable relative to the tube and is provided with an engagement mechanism such as a setscrew for fixing the location of the outflow plug relative to the tube and the inflow plug. After assembly of the aortic root to the apparatus, the fluid inlet is coupled to a source of defined pressure and the root is inflated.

Abstract: A method an apparatus for limiting longitudinal stretch during fixation of a harvested aortic root including valve leaflets and the product produced. The apparatus includes an inflow plug inserted into the inflow section of the aortic root and having an apertured tube or cannula extending through the valve leaflets to an outflow plug inserted into the outflow section of the aortic root. Apertures in the tube are located on either side of the valve leaflets and the tube is coupled to a fluid inlet, preferably located on the outflow plug. The outflow plug is slidable relative to the tube and is provided with an engagement mechanism such as a setscrew for fixing the location of the outflow plug relative to the tube and the inflow plug. After assembly of the aortic root to the apparatus, the fluid inlet is coupled to a source of defined pressure and the root is inflated.

Abstract: A supported bioprosthetic heart valve is provided. The valve includes a stent and a bilogical valve member. The stent has an annular frame defined by a support rail. The support rail is formed to define a triad of axially-projecting circumferentially-spaced commissure posts, each post having an inverted U-shaped configuration and a pair of legs. Each of the pair of legs has an upper end and a lower end. The lower end of each leg merges smoothly with the lower end of a leg of an adjacent commissure post. A sleeve having an inflow end and an outflow end is fitted around the annular frame. The biological valve member is defined by a tubular wall and three leaflets, the three leaflets being attached to the tubular wall and axially converging along three commissures. The biological valve member has a shape which fits the contour of the support rail and is disposed under the support rail. The biological valve member is sutured to the support rail and the outflow end of the sleeve.

Abstract: A method of creating a simulated aorta patterned from a natural aorta and having a preselected amount of compliance is disclosed. The dimensions of a simulated aortic root patterned according to the dimensions of a natural aorta are first selected and a mold provided. The amount of circumferential compliance desired in the simulated aorta is then selected, based on natural circumferential compliancies. A material such as silicone rubber formed of an elastomer and a filler is used to form the aorta, the durometer of the material being varied by varying the relative amount of the components, to provide the selected amount of circumferential compliance in a simulated aorta having the selected dimensions. The aorta is then formed curing the material in the mold for about 24 hours. Groups of simulated aortas so produced, sometimes having different sizes and/or compliancies are also disclosed. A method of testing non-stented valves using the aortas is included.

Abstract: A natural tissue heart valve includes a tubular wall having an outflow section and valve leaflets which allow flow into the outflow section. A heart valve of this type is subjected to a fixative fluid to provide a first differential fluid pressure across the tubular wall of the outflow section and a second differential fluid pressure across the valve leaflets. The first differential fluid pressure acts outwardly on the tubular wall, and the differential pressures are unequal.

Abstract: A holder for a prosthetic heart valve is disclosed. The holder, comprising a holder assembly disposed at the distal end of an elongate handle, includes a plurality of distally-projecting fingers adapted to engage the commissure posts of a stented prosthetic valve. The commissure-engaging fingers are movable in a radially-inward direction toward the longitudinal axis of the holder. A mechanism is provided for retaining the fingers in an inwardly-moved position. When the commissure posts of the valve are coupled to the fingers, inward movement of the fingers causes the commissure posts to be deflected inward with respect to the valve, improving the implanting surgeon's access to the valve's suture ring and surrounding tissue.

Abstract: A fixture for testing a circumferentially compliant bioprosthetic valve. The fixture comprises a silicone rubber simulated aorta which approximates the geometry of a healthy human aorta and a cradle for the aorta. The compliance characteristics of the aorta can be selected by varying the proportions of ingredients in the silicone rubber, so that simulated aortas of different compliance but identical geometries can be provided. The compliant valve is disposed inside the aorta and held in place by suturing or the like. In one embodiment, the aorta and valve are supported by means of a cylindrical cradle, with the inflow and outflow ends of the aorta being folded over cylindrical rims on the respective inflow and outflow ends of the cradle. End caps are then fitted in place over the folded-over ends of the aorta, the end caps having holes therein to allow flow through the aorta and valve.

Abstract: A holder for a prosthetic heart valve is disclosed. The holder, comprising a holder assembly disposed at the distal end of an elongate handle, includes a plurality of distally-projecting fingers adapted to engage the commissure posts of a stented prosthetic valve. The commissure-engaging fingers are movable in a radially-inward direction toward the longitudinal axis of the holder. A mechanism is provided for retaining the fingers in an inwardly-moved position. When the commissure posts of the valve are coupled to the fingers, inward movement of the fingers causes the commissure posts to be deflected inward with respect to the valve, improving the implanting surgeon's access to the valve's suture ring and surrounding tissue.

Abstract: A fixture for testing a circumferentially compliant bioprosthetic valve. The fixture comprises a silicone rubber simulated aorta which approximates the geometry of a healthy human aorta and a cradle for the aorta. The compliance characteristics of the aorta can be selected by varying the proportions of ingredients in the silicone rubber, so that simulated aortas of different compliance but identical geometries can be provided. The compliant valve is disposed inside the aorta and held in place by suturing or the like. In one embodiment, the aorta and valve are supported by means of a cylindrical cradle, with the inflow and outflow ends of the aorta being folded over cylindrical rims on the respective inflow and outflow ends of the cradle. End caps are then fitted in place over the folded-over ends of the aorta, the end caps having holes therein to allow flow through the aorta and valve.

Abstract: A method of preserving porcine heart valves so that they may be incorporated into prosthetic heart valves for human implant. During fixation, the leaflets of the valves are repeatedly flexed throughout their full range of motion. Flexing of the leaflets continues throughout fixation, and is accomplished by providing for alternating fluid flow through the valve from the inflow and outflow sides sufficient to cause the leaflets to fully open and close.