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 method of assembling a prosthetic valve using sheets of material, such as pericardium material, polymer or bioengineered film, or other material. The method provides an accurate and repeatable system of making pericardial valves in which sheets or pieces of material are held securely in place relative to each other throughout the steps of assembling the valve. In addition, methods of the present invention include maintaining consistent alignment of the fixtures and pericardium material throughout the valve assembly process and utilize features that make the tooling components easy to assemble and handle. Certain aspects of the invention can be used to help establish a repeatable sewing and cutting technique for creating a pattern shape for valve leaflets, establishing stitch lengths, and determining the exact placement of stitches.

Abstract: The invention relates to a system for testing heart valve leaflets. The system includes a leaflet support assembly with a support post for receiving and supporting a leaflet to be tested, the post being disposed in a target region of the support assembly. The system also has a transmitter assembly that includes a light source and is configured and arranged to direct light from the light source onto the target region. The system further includes a receiver assembly that has an image sensor configured and arranged to sense an image of the target region and generate image information indicative of the sensed image, such as leaflet droop.

Abstract: A method of assembling a prosthetic valve using sheets of material, such as pericardium material, polymer or bioengineered film, or other material. The method provides an accurate and repeatable system of making pericardial valves in which sheets or pieces of material are held securely in place relative to each other throughout the steps of assembling the valve. In addition, methods of the present invention include maintaining consistent alignment of the fixtures and pericardium material throughout the valve assembly process and utilize features that make the tooling components easy to assemble and handle. Certain aspects of the invention can be used to help establish a repeatable sewing and cutting technique for creating a pattern shape for valve leaflets, establishing stitch lengths, and determining the exact placement of stitches.

Abstract: A method of forming a leaflet of a prosthetic valve includes placing a first piece of material on a working surface. A leaflet mold is placed on the first piece of material, and provides a outer peripheral shape comprising a curved portion. A second piece of material is placed over the first piece and the leaflet mold. The first and second pieces of material are stitched to one another along at least a portion of the curved portion of the leaflet mold. The leaflet mold is removed from first and second pieces of material.

Abstract: A mold assembly for forming a prosthetic valve having at least one leaflet, which includes a first plate having a first side from which at least one leaflet mold extends and a planar portion adjacent the at least one leaflet mold, wherein the planar portion has multiple access holes through its thickness, and a second plate having at least one mold opening and a planar portion adjacent the at least one mold opening, wherein each mold opening is sized and shaped to correspond with one of the leaflet molds of the first plate, and wherein the planar portion has multiple access holes through its thickness. The second plate is positionable relative to the first plate so that each of the leaflet molds of the first plate extend at least partially through one of the mold openings of the second plate.

Abstract: A multi-leaflet valve, which includes at least two leaflets, an outer tube, and a seam protector for each seam. Each seam protector is positioned to be in contact with a portion of the outer tube, with tube portions and leaflet ends being positioned between adjacent seam protection pieces. The seam protectors provide a lower stress surface about which the leaflets can bend or flex during their opening and closing. The seam protectors may include an enlarged end portion with an extending straight surface, an inverted U-shaped structure, or a sinusoidal-shaped structure, for example. The valve can further be provided with a seam cover or protector that is stitched onto the seam allowance of the layers of one or more of the seams. The seams can be provided with one or more inserts to fill spaces between adjacent tissue layers and create tension in certain material sheets.

Abstract: A method of assembling a prosthetic valve using sheets of material, such as pericardium material, polymer or bioengineered film, or other material. The method provides an accurate and repeatable system of making pericardial valves in which sheets or pieces of material are held securely in place relative to each other throughout the steps of assembling the valve. In addition, methods of the present invention include maintaining consistent alignment of the fixtures and pericardium material throughout the valve assembly process and utilize features that make the tooling components easy to assemble and handle. Certain aspects of the invention can be used to help establish a repeatable sewing and cutting technique for creating a pattern shape for valve leaflets, establishing stitch lengths, and determining the exact placement of stitches.

Abstract: A mold assembly for forming a prosthetic valve having at least one leaflet, which includes a first plate having a first side from which at least one leaflet mold extends and a planar portion adjacent the at least one leaflet mold, wherein the planar portion has multiple access holes through its thickness, and a second plate having at least one mold opening and a planar portion adjacent the at least one mold opening, wherein each mold opening is sized and shaped to correspond with one of the leaflet molds of the first plate, and wherein the planar portion has multiple access holes through its thickness. The second plate is positionable relative to the first plate so that each of the leaflet molds of the first plate extend at least partially through one of the mold openings of the second plate.

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