Abstract: A prosthetic heart or venous valve, the valve including a central tissue structure with multiple tissue lobes extending from a common central area, wherein each of the lobes includes a longitudinal slot. The valve further includes a plurality of leaflets, each extending from the central tissue structure and positioned between two adjacent lobes, wherein each of the leaflets has a free end spaced from the central tissue structure, and also has a compressible and expandable stent frame with a plurality of extending arms, wherein each of the extending arms of the stent frame is positioned at least partially within one of the longitudinal slots of the central tissue structure.

Abstract: A valve holder for a prosthetic valve having a stent comprising a stent base and multiple commissure posts projecting from the stent base, the valve holder including a connector hub, a plurality of legs connected to the connector hub, each leg having an elongate portion and a commissure post engaging plate, a sliding member slideably connected to each leg of the plurality of legs and positioned between the connector hub and the commissure post engaging plates of the plurality of legs and slideably positionable at a first position relative to the connector hub with the commissure post engaging plates in an uncompressed configuration and a second position relative to the connector hub with the commissure post engaging plates in a compressed configuration, and a handle extending from the connector hub.

Abstract: A device and method for valve replacement or valve repair is disclosed comprising the steps of acquiring an anatomical image of a patient, correlating the image to the patient, guiding a valve replacement delivery member or a valve repair delivery member within the patient while tracking the position of the delivery member in the patient, positioning the valve replacement member or valve repair member in a desired position to replace a valve or repair valve and removing the delivery member from the patient.

Abstract: A method of delivering a replacement prosthetic valve to a previously implanted prosthetic valve including the steps of compressing a replacement prosthetic valve having an expandable stent within a sheath of a delivery system, wherein the delivery system comprises a proximal end, a distal end, and a centering structure positioned between the proximal and distal ends, advancing the delivery system and compressed replacement prosthetic valve into a vessel of a patient until the distal end of the delivery system is positioned adjacent to a second side of a previously implanted prosthetic valve, deploying the centering structure to radially reposition the distal end of the delivery system, further advancing the delivery system toward the previously implanted prosthetic valve, and deploying the replacement prosthetic valve

Abstract: A method of delivering a replacement prosthetic valve to a previously implanted prosthetic valve including the steps of compressing a replacement prosthetic valve having an expandable stent within a sheath of a delivery system, wherein the delivery system comprises a proximal end, a distal end, and a centering structure positioned between the proximal and distal ends, advancing the delivery system and compressed replacement prosthetic valve into a vessel of a patient until the distal end of the delivery system is positioned adjacent to a second side of a previously implanted prosthetic valve, deploying the centering structure to radially reposition the distal end of the delivery system, further advancing the delivery system toward the previously implanted prosthetic valve, and deploying the replacement prosthetic valve.

Abstract: A device and method for valve replacement or valve repair is disclosed comprising the steps of acquiring an anatomical image of a patient, correlating the image to the patient, guiding a valve replacement delivery member or a valve repair delivery member within the patient while tracking the position of the delivery member in the patient, positioning the valve replacement member or valve repair member in a desired position to place a valve or repair valve and removing the delivery member from the patient. In one aspect of the invention, a delivery system is provided for percutaneous delivery of a heart valve to a predetermined position in the heart of a patient, where the delivery system itself includes features that allow it to be accurately positioned in the heart. In another aspect of the invention, a delivery system is provided for percutaneous repair of a heart valve in the heart of a patient, where the repair system itself includes features that allow it to be accurately positioned in the heart.

Abstract: A delivery system with sequential release mechanism and method of delivering and deploying an implantable stented device into a body lumen including a tabular body, a plurality of activation members extending from the distal end of the tubular body, and a plurality of disks. Each disk includes a proximal and distal surface, at least one stent engagement element attached to the distal surface of the disk and at least one aperture. At least one activation member attaches to the proximal surface of a first disk and at least one activation member passes through an aperture of the first disk and attaches to the proximal surface of a second disk. At least one stent engagement element attached to the distal surface of the first disk passes through an aperture of the second disk. Axially movement of the activation members causes sequential release of the stent engagement elements from a stented device.

Abstract: An annuloplasty prosthesis including a sheath, an arcuate stiffening element, and an imaging element. The arcuate stiffening element is disposed within the sheath and defines discrete, first and second ends separated by a lateral spacing. The imaging element is disposed within the sheath along the lateral spacing. With this configuration, following implant to the valve annulus, the imaging element provides a mechanism for non-invasively evaluating a shape of the valve annulus, for example, via radiographic, echogenic and/or other image enhancing visualization techniques. In some embodiments, the annuloplasty prosthesis provides a radiographic, echogenic and/or other image enhanced image of a near entirety of the valve annulus.

Abstract: A method of deploying an implantable stented device in an anatomical location of a patient, including the steps of providing a delivery system with first and second stent engagement structures at its distal end, attaching a first structural element of the stented device to the first stent engagement structure and attaching a second structural element of the stented device to the second stent engagement structure, advancing the stented device to an implantation site, and sequentially disengaging the first structural element of the stented device from the first stent engagement structure of the delivery system and then disengaging the second structural element of the stented device from the second stent engagement structure.

Abstract: A delivery system for delivering a stented prosthetic heart valve to a lumen of a patient, the delivery system including a tubular body having a proximal end and a distal end, and a plurality of wires extending from the distal end of the tubular body, wherein each of the wires has a distal end that is coiled for engagement with a stent of a stented prosthetic heart valve.

Abstract: An annuloplasty band comprising a sheath, and a generally arcuate stiffening element disposed within the sheath. The stiffening element extends from a first end to a second end, and preferably includes eyelets at its first and second ends adapted to receive sutures to secure the annuloplasty band to a valve annulus. The annuloplasty band preferably has a low profile (e.g., a thickness less than 3 mm). In embodiments intended for mitral valve repair, the eyelets are particularly adapted to receive sutures to secure the annuloplasty band to the antero-lateral trigone and postero-medial trigone. A holder and sizer device useful with the annuloplasty band are also provided.

Abstract: Described is a set of at least two annuloplasty devices having a particular size that corresponds to an inter-trigonal or inter-commissural distance of a heart valve annulus, wherein the at least two annuloplasty devices have different anterior-posterior ratios. Also, described is a kit for annuloplasty repair of a heart valve annulus including a plurality of annuloplasty devices each comprising one of a plurality of different sizes, wherein the different sizes each correspond to a different inter-trigonal or inter-commissural distance of a heart valve annulus, and for each of the plurality of different sizes there are at least two devices each having the same size but having different anterior-posterior ratios. Additionally, a method of choosing an annuloplasty device for implantation in a valve annulus is described.

Abstract: Methods and apparatus for holding and maneuvering a valve during preparation and attachment to patient, providing increased visibility of the prosthetic valve and the sewing ring to prevent suture entanglement. A handle attachment is spaced from the valve for improved visibility of the sewing ring and the outlet end of the valve during attachment. Commissure posts are bent inward at the tips while preventing crashing of the commissure posts into each other causing damage. A release force needed to remove the holder and unthread the holder sutures is reduced. The holder and related methods can provide a kink free holder suture path to reduce suture entanglement and prevent damage to the implanted valve during holder removal by reducing the release force needed to remove the holder sutures by up to 30%.

Abstract: The present invention is an improved apparatus for holding and maneuvering a valve during preparation and attachment to patient. The present invention is particularly useful for increased visibility of the prosthetic valve and the sewing ring to prevent suture entanglement. The present invention is used most effectively with mitral valves having commissure posts on the outflow side of the valve structure but may be used with other valve configurations. The present invention spaces the handle attachment from the valve for improved visibility of the sewing ring and the outlet end of the valve during attachment. The present invention is adapted to safely bend the commissure posts inward at the tips while preventing crashing the commissure posts into each other causing damage.

Abstract: A simplified and more easily employed tool for holding an implantable annuloplasty prosthesis during passage of sutures through the prosthesis and for conveniently and efficiently releasing the prosthesis from the tool. Separation of the implantable prosthesis and the tool may be conveniently accomplished without requiring the use of a sharp instrument. Attachment between the prosthesis and its surgical carrying tool can be accomplished in a suture-less fashion. The tool includes a suture management device in some embodiments for selectively receiving and maintaining sutures otherwise securing the prosthesis to tissue.

Abstract: A heart valve that can be expanded following its implantation in a patient, such as to accommodate the growth of a patient and the corresponding growth of the area where the valve is implanted, and to minimize paravalvular leakage. In one aspect, the invention may maximize the orifice size of the surgical valve. The invention includes expandable implantable conduits and expandable bioprosthetic stented valves. In one aspect of the invention, the valve may be adapted to accommodate growth of a patient to address limitation on bioprosthetic valve lifespans.

Abstract: A prosthetic heart valve system including a prosthetic heart valve and a deflection device. The deflection device includes a line and a connector assembly including a tensioning component. The line interconnects and passes through free ends of stent posts associated with the heart valve, and is further connected to the tensioning component. The tensioning component is transitionable to a tensioning state in which the line is tensioned to inwardly deflect the stent posts. In this regard, the tensioning component is self-locking relative to the line in the tensioning state, and an entirety of the line extending distal the tensioning device does not extend beyond a stent portion of the heart valve opposite the stent posts. In a preferred embodiment, a holder body is further included, coupled to the heart valve apart from the deflection device.

Abstract: A stented valve including a generally tubular stent structure that has a longitudinal axis, first and second opposite ends, a plurality of commissure support structures spaced from the first and second ends and extending generally parallel to the longitudinal axis, at least one structural wire positioned between each two adjacent commissure support structures, and at least one wing portion extending from two adjacent commissure support structures and toward one of the first and second ends of the stent structure. The stented valve further includes a valve structure attached within the generally tubular stent structure to the commissure support structures.

Abstract: A simplified and more easily employed tool for holding an implantable annuloplasty prosthesis during passage of sutures through the prosthesis and for conveniently and efficiently releasing the prosthesis from the tool. Separation of the implantable prosthesis and the tool may be conveniently accomplished without requiring the use of a sharp instrument. Attachment between the prosthesis and its surgical carrying tool can be accomplished in a suture-less fashion. The tool includes a suture management device in some embodiments for selectively receiving and maintaining sutures otherwise securing the prosthesis to tissue.

Abstract: Described is a set of at least two annuloplasty devices having a particular size that corresponds to an inter-trigonal or inter-commissural distance of a heart valve annulus, wherein the at least two annuloplasty devices have different anterior-posterior ratios. Also, described is a kit for annuloplasty repair of a heart valve annulus including a plurality of annuloplasty devices each comprising one of a plurality of different sizes, wherein the different sizes each correspond to a different inter-trigonal or inter-commissural distance of a heart valve annulus, and for each of the plurality of different sizes there are at least two devices each having the same size but having different anterior-posterior ratios. Additionally, a method of choosing an annuloplasty device for implantation in a valve annulus is described.