Abstract: A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

Abstract: This material comprises an annuloplasty member (12) able to be introduced using a catheter (2) through minimally invasive vascular access, then to be delivered by said catheter and fixed to the valve annulus (104).

Abstract: A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. If desired, one or more anchor may be used. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned. The anchor engages the lumen wall when expanded and prevents substantial migration of the valve assembly when positioned in place. The prosthetic valve assembly is compressible about a catheter, and restrained from expanding by an outer sheath. The catheter may be inserted inside a lumen within the body, such as the femoral artery, and delivered to a desired location, such as the heart.

Abstract: A prosthetic heart valve comprises a biological tissue valve and a collapsible and expandable support frame having a longitudinal axis. The frame comprises an outflow circumferential structure defining an outflow end of the frame and consisting essentially of a single row of diamond-shaded expandable cells. The frame also comprises three V-shaped structures spaced apart from the outflow circumferential structure and three struts longitudinally aligned with the longitudinal axis of the frame. The three struts are configured to facilitate mounting the biological tissue valve to the frame and interconnect the outflow circumferential structure to the three V-shaped structures. The frame also includes three undulating structures, each of the three undulating structures interconnecting respective adjacent V-shaped structures of the three V-shaped structures.

Abstract: A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

Abstract: A prosthetic heart valve comprises a biological tissue valve and a collapsible and expandable support frame comprising a longitudinal axis. The frame comprises an outflow circumferential structure defining an outflow end of the frame and defining a similar row of expandable cells, and a circumferential undulating strut structure spaced apart from the outflow circumferential structure. The frame also comprises three struts longitudinally aligned with the longitudinal axis, configured to facilitate mounting the biological tissue valve to the frame, and interconnecting the outflow circumferential structure to the circumferential undulating structure. Each strut comprises a first end terminating at a respective junction between two adjacent expandable cells of the outflow circumferential structure, and a second end terminating at the circumferential undulating strut structure.

Abstract: A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable contact the anatomical annulus of the native valve when the assembly is properly positioned. Portions of the valve support may expand to a preset diameter to maintain coaptivity of the replacement valve and to prevent occlusion of the coronary ostia.

Abstract: A prosthetic valve comprises a valve assembly having a base, a plurality of leaflets, and commissures. The valve also comprises a support stent having a plurality of expandable cells and a plurality of longitudinal struts. The support stent is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the prosthetic valve is positioned in situ. The support stent supports the base. The commissures of the valve assembly are secured at the longitudinal struts and adjacent one or more of the expandable cells. The longitudinal struts of the support stent further comprise a plurality of holes, and the plurality of leaflets are secured to the longitudinal struts via threads passing through the plurality of holes.

Abstract: A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. If desired, one or more anchor may be used. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned. The anchor engages the lumen wall when expanded and prevents substantial migration of the valve assembly when positioned in place. The prosthetic valve assembly is compressible about a catheter, and restrained from expanding by an outer sheath. The catheter may be inserted inside a lumen within the body, such as the femoral artery, and delivered to a desired location, such as the heart.

Abstract: Methods for delivering a prosthetic heart valve include advancing a delivery catheter containing the prosthetic heart valve to a deployment location at a native heart valve, advancing an inner core movably coupled to a restraining sheath of the delivery catheter to expose a first end of the prosthetic heart valve, and advancing the inner core and the restraining sheath to expose a second end of the prosthetic heart valve. The delivery catheter can include a distal flange located at a distal end of an outer core of the catheter body, configured to restrict distal longitudinal displacement of the prosthetic heart valve, and a retaining structure located proximally from the distal flange along the outer core of the catheter body, configured to restrict proximal longitudinal displacement of the prosthetic heart valve.

Abstract: Methods for delivering a medical device loaded onto a catheter include positioning a first tube relative to a second concentric tube such that sheathing material having a first end affixed to the first tube and a second end affixed to the second tube forms an inner layer and an outer layer having at least one inversion point, such that no portion of the first tube is between any portion of the inner and outer layers of the sheathing material. Upon positioning the catheter at a desired target site, the first tube can be moved relative to the second tube so that the inversion point moves to expose the medical device, thereby permitting expansion of the medical device at the target site.

Abstract: A prosthetic heart valve comprises a biological tissue valve and a collapsible and expandable support frame comprising longitudinal axis. The frame comprises an outflow circumferential structure defining an outflow end of the frame and defining a single row of expandable cells, and a circumferential undulating strut structure spaced apart from the outflow circumferential structure. The frame also comprises three struts longitudinally aligned with the longitudinal axis, configured to facilitate mounting the biological tissue valve to the frame, and interconnecting the outflow circumferential structure to the circumferential undulating structure. Each strut comprises a first end terminating at a respective junction between two adjacent expandable cells of the outflow circumferential structure, and a second end terminating at the circumferential undulating strut structure.

Abstract: A prosthetic heart valve comprises a collapsible and expandable support frame comprising a longitudinal axis. The frame comprises a first circumferential undulating structure defining an outflow end of the frame, and a second circumferential undulating structure spaced apart from the first circumferential undulating structure. The frame also comprises a plurality of struts longitudinally aligned with the longitudinal axis of the frame, and connecting: the first circumferential undulating structure to the second circumferential undulating structure. Each strut of the plurality of struts comprises a first end terminating at a trough of the first circumferential undulating structure, and a second end terminating at a peak of the second circumferential undulating structure. The prosthetic heat valve also comprises a biological tissue valve coupled to the frame.

Abstract: An implantable prosthetic valve assembly includes a radially expandable frame including an inflow portion and a second portion. The inflow portion is configured, in an expanded state, to bear against a native cardiac annulus in a manner so as to resist migration. The second portion extends from the inflow zone in an outflow direction, and is configured, in an expanded state, not to bear against the native cardiac annulus and an ascending aorta. The valve assembly also includes a prosthetic valve coupled to the frame substantially within the second portion.

Abstract: A prosthetic heart valve comprises a biological tissue valve and a collapsible and expandable support frame having a longitudinal axis. The frame comprises an outflow circumferential structure defining an outflow end of the frame and consisting essentially row of diamond-shaded expandable cells. The frame also comprises three V-shaped structures spaced apart from the outflow circumferential structure and three struts longitudinally aligned with the longitudinal axis of the frame. The three struts are configured to facilitate mounting the biological tissue valve to the frame and interconnect the outflow circumferential structure to the three V-shaped structures. The frame also includes three undulating structures, each of the three undulating structures interconnecting respective adjacent V-shaped structures of the three V-shaped structures. The prosthetic heart valve is configured to be collapsed for introduction into a patient using; a catheter and to be expanded for deployment at an implantation site.

Abstract: A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable prosthesis frame. The valve may be delivered transluminally or transmyocardially using a thorascopic or other limited access approach using a delivery catheter. Preferably, the initial partial expansion of the valve is performed against the native valve annulus to provide adequate anchoring and positioning of the valve as the remaining portions of the valve expand. The valve may be delivered using a retrograde or antegrade approach. When delivered using a retrograde approach, a delivery catheter with a pull-back sheath may be used, while antegrade delivery is preferably performed with a delivery catheter with a push-forward sheath that releases the proximal end of the valve first.

Abstract: A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. If desired, one or more anchors may be used. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned. Portions of the valve support may expand to a preset diameter to maintain coaptivity of the replacement valve and to prevent occlusion of the coronary ostia. A radial restraint, comprising a wire, thread or cuff, may be used to ensure expansion does not exceed the preset diameter.

Abstract: A catheter that comprises a sheath that is connected at opposing ends to concentric tubes that move relative to each other in a manner that alternatively covers and exposes a medical device loaded onto the catheter. A portion of the sheath is arranged so as to invert upon itself so that axial movement of one tube relative to the other simultaneously moves the inversion point over or away from the device, alternatively covering or exposing the device.

Abstract: A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. If desired, one or more anchor may be used. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned. The anchor engages the lumen wall when expanded and prevents substantial migration of the valve assembly when positioned in place. The prosthetic valve assembly is compressible about a catheter, and restrained from expanding by an outer sheath. The catheter may be inserted inside a lumen within the body, such as the femoral artery, and delivered to a desired location, such as the heart.