Abstract: A collapsible prosthetic heart valve includes a stent and a valve assembly. The stent includes an annulus section and at least one foldable section. The stent is movable between an unfolded condition in which the foldable section is longitudinally spaced from the annulus section, and a folded condition in which the foldable section is at least partially positioned radially adjacent the annulus section. The valve assembly is positioned within the annulus section of the stent in the folded condition of the stent.

Abstract: A stent for use in a prosthetic heart valve has a plurality of expandable and collapsible closed cells, a portion of which form an annulus section adapted for placement within the annulus of the native heart valve. Anchor features of the stent residing within at least some closed cells are adapted to engage tissue of the heart, including native valve leaflets, the sinotubular junction, or another implanted device when the prosthetic valve is implanted in the heart. The anchor features may help to retain the prosthetic valve in position, without interfering with the opening and closing of the valve leaflets. Furthermore, the anchor features may be configured to allow the stent to be resheathed into a delivery device after the portion of the stent with the anchor feature has expanded out of the delivery device.

Abstract: A prosthetic heart valve includes a stent having a collapsed condition and an expanded condition, the stent having a proximal end, a distal end and a plurality of commissure features. The heart valve further includes a valve assembly secured to the stent, the valve assembly including a cuff and a plurality of leaflets, each of the leaflets having a free edge having a first end and a second end, and a second edge secured to the cuff, the second edge having a first end, a second end, a first folded portion adjacent the first end, a second folded portion adjacent the second end, and an unfolded portion between the first and second folded portions. The first and second folded portions couple the leaflet to ones of the commissure features.

Abstract: A method of making a prosthetic heart valve may include providing an annular stent having a plurality of annularly spaced commissure portions having tips, covering each of the tips with a first fabric cover, covering the first fabric covers and the remainder of the stent with a second fabric cover, covering the second fabric cover with a first tissue membrane, and covering the outside of the first tissue membrane with a second tissue membrane, the second tissue membrane forming leaflet portions that extend inwardly between the commissure portions.

Abstract: A prosthetic heart valve (10) (e.g., a prosthetic aortic valve) is designed to be somewhat circumferentially collapsible and then re-expandable. The collapsed condition may be used for less invasive delivery of the valve into a patient. When the valve reaches the implant site in the patient, it re-expands to normal operating size, and also to engage surrounding tissue of the patient. The valve includes a stent portion (200) and a ring portion (100) that is substantially concentric with the stent portion but downstream from the stent portion in the direction of blood flow through the implanted valve. When the valve is implanted, the stent portion engages the patient's tissue at or near the native valve annulus, while the ring portion engages tissue downstream from the native valve site (e.g., the aorta).

Abstract: A cardiovascular valve assembly is disclosed including a housing assembly comprising a first portion and a second portion removably attached to the first portion. A valve may be positioned within the housing assembly. The valve, which may be a mechanical valve, a biological tissue valve, or a polymeric valve, may be structured to allow fluid to flow through the housing assembly in a single direction. In certain embodiments, the valve assembly may further include at least one coupling structure provided on the second portion and at least one aperture defined in the first portion, with the aperture structured to receive the coupling structure to couple the first portion to the second portion. Corresponding systems incorporating cardiovascular valve assemblies are also disclosed.

Abstract: A prosthetic heart valve includes a balloon-expandable stent including a plurality of struts and a plurality of commissure posts, each commissure post containing an elongated slot. A plurality of leaflets is made from pericardial tissue and includes flaps. An intermediate polymer sheet is disposed between the stent and the plurality of leaflets. At least one reinforcing polymer core is attached to at least one leaflet and the intermediate polymer sheet using stitches that loop around an end of the at least one leaflet. A plurality of patches covers the elongated slots of the commissure posts, the flaps of the leaflets being attached to the patches. A cuff contacts an exterior of the stent, the cuff and the intermediate polymer sheet sutured to one another so as to cover an axial end of the stent.

Abstract: A prosthetic heart valve includes an annularly collapsible and re-expandable supporting structure extending between an inflow end and an outflow end and including a plurality of struts, the inflow end having an inflow edge, a plurality of leaflets disposed inside the supporting structure and operative to allow flow in an antegrade direction from the inflow end to the outflow end but to substantially block flow in a retrograde direction from the outflow end to the inflow end, a first material disposed on a luminal surface of the supporting structure adjacent the inflow end, and a second material disposed on an abluminal surface of the supporting structure adjacent the inflow end, the first material and the second material being secured to selected struts of the supporting structure, and separately secured to each other adjacent the inflow edge.

Abstract: A collapsible prosthetic heart valve includes a stent and a valve assembly. The stent has an annulus section with a relatively small cross-section, and an aortic section with a relatively large cross-section. The valve assembly, including a cuff and a plurality of leaflets, is secured to the stent in the annulus section such that the valve assembly can be entirely deployed in the native valve annulus and function as intended while at least a portion of the aortic section is held by the delivery device in a manner that allows for resheathing. The configuration of the prosthetic valve is such that the valve leaflets can fully coapt and the valve can function properly even when the stent and/or valve assembly become distorted upon deployment or use.

Abstract: A prosthetic heart valve for replacing a native valve includes a stent extending between a proximal end and a distal end and including a plurality of struts forming cells, the stent having a collapsed condition and an expanded condition. At least one runner is coupled a cell, the at least one runner being configured to transition from a first configuration to a second configuration when the stent moves from the collapsed condition to the expanded condition, the at least one runner projecting radially outwardly from the cell in the second configuration. A valve assembly is disposed within the stent, the valve assembly including a plurality of leaflets, a cuff at least partially disposed on a luminal surface of the stent, and a covering material disposed on an abluminal surface of the stent and covering the at least one runner in the second configuration.

Abstract: A prosthetic heart valve having an inflow end and an outflow end includes a collapsible and expandable stent having a plurality of commissure features, a plurality of first struts and a plurality of second struts. The plurality of first struts define a substantially cylindrical portion and the plurality of second struts have first ends attached to the cylindrical portion and free ends projecting radially outward from the cylindrical portion and configured to couple to adjacent heart tissue to anchor the stent. A collapsible and expandable valve assembly disposed within the stent has a plurality of leaflets coupled to the commissure features.

Abstract: A prosthetic heart valve includes a stent having an expanded condition and a collapsed condition. The stent includes a plurality of distal cells, a plurality of proximal cells, a plurality of support struts coupling the proximal cells to the distal cells, and at least one support post connected to a plurality of proximal cells. The proximal cells are longitudinally spaced apart from the distal cells. Various strut configurations and connections of the struts to the proximal cells and of the proximal cells to the support post improve stent flexibility and reduce stress in the valve leaflets.

Abstract: A method of making a prosthetic heart valve may include providing an annular stent having a plurality of annularly spaced commissure portions having tips, covering each of the tips with a first fabric cover, covering the first fabric covers and the remainder of the stent with a second fabric cover, covering the second fabric cover with a first tissue membrane, and covering the outside of the first tissue membrane with a second tissue membrane, the second tissue membrane forming leaflet portions that extend inwardly between the commissure portions.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent and a plurality of commissure features disposed on the stent. A collapsible and expandable valve assembly includes a plurality of leaflets connected to the plurality of commissure features, each commissure feature including a body having a proximal end and a distal end. A plurality of eyelets is arranged in rows and columns on the body for distributing load from the plurality of leaflets.

Abstract: A prosthetic heart valve having an inflow end and an outflow end includes a stent having a collapsed condition, an expanded condition, and a plurality of cells arranged in circumferential rows. The stent may include one or more securement features. One securement feature may be an anchor arm having a body portion and a free end extending from the body portion, the body portion being coupled to a perimeter of one of the plurality of cells, with the free end extending toward the inflow end in an expanded condition of the anchor arm. Another securement feature may include a flange formed of a braided mesh and having a body portion coupled to the stent and a flared portion adjacent the inflow end of the prosthetic heart valve. A valve assembly is disposed within the stent and has a plurality of leaflets.

Abstract: A prosthetic heart valve having an inflow end and an outflow end includes a collapsible and expandable stent including a plurality of cells arranged in rows extending around a circumference of the stent, at least one of the rows forming a flared portion having a diameter that is larger than diameters of others of the rows. The stent further includes engaging arms disposed adjacent the outflow end and extending toward the inflow end, the engaging arms being configured to couple to heart tissue to anchor the stent. A collapsible and expandable valve assembly has a plurality of leaflets disposed within the stent.

Abstract: A device for repairing a native heart valve includes a reinforcing structure configured to couple to a portion of the native heart valve to remodel a geometry of the native heart valve, and at least one supporting member connected to the reinforcing structure.

Abstract: A loading tool for loading a collapsible prosthetic heart valve into a delivery device may include a body extending in a longitudinal direction between a proximal end and a distal end, an extension on the distal end of the body, and a slot extending through the extension from a free end of the extension toward the distal end of the body. The body may include a lumen extending between the proximal end and the distal end, the body lumen having a first diameter. The extension may have a lumen coaxial with the body lumen, the extension lumen having a second diameter less than the first diameter so as to define a shelf surface between the proximal end of the body and the free end of the extension.

Abstract: A collapsible and expandable stent body includes a generally tubular annulus section, one or more prosthetic valve elements mounted to the stent body, and a cuff attached to the stent body. The prosthetic valve is operative to allow flow in an antegrade direction but to substantially block flow in a retrograde direction. The prosthetic heart valve may include paravalvular leak mitigation features in the form of first and second sealing members. The sealing members are attached to the cuff and extend circumferentially around an abluminal surface of the stent body. The sealing members each have an open side facing in a first axial direction and a closed side facing in an opposite second axial direction. Flow of blood in the second axial direction will tend to force blood into the sealing members and cause the sealing members to billow outwardly relative to the stent body, helping to mitigate paravalvular leak.

Abstract: A prosthetic heart valve is provided with a cuff having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion adapted to bear on the LVOT when the valve is implanted in a native aortic valve. The valve may include elements for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part of the cuff may be movable relative to the stent during implantation.