Abstract: A prosthetic heart valve may include an expandable stent having a plurality of struts forming cells connected to one another in a plurality of annular rows around the stent, a cuff attached to an annulus section of the stent by cuff sutures that have a plurality of stitches extending through material of the cuff and looping around the struts, and a plurality of leaflets each having a belly attached to the cuff within an interior region of the stent. The leaflets may together have a coapted position occluding the interior region of the stent and an open position in which the interior region is not occluded. The belly of each leaflet may be attached to the cuff by leaflet sutures extending in a path that crosses some of the struts in overlap zones. Those struts may be devoid of the stitches within the overlap zones.

Abstract: A delivery device for a collapsible prosthetic heart valve includes an inner shaft, an outer shaft, and a distal sheath. The distal sheath may be disposed distal to the outer shaft and about a portion of the inner shaft to form a compartment with the inner shaft. The compartment may be sized to receive the prosthetic heart valve. The inner shaft and the distal sheath may be movable relative to one another. A spine may extend along the outer shaft, the spine biasing the outer shaft so that the outer shaft tends to bend in a pre-determined direction.

Abstract: In some examples, a method of manufacturing a prosthetic heart valve includes providing a stent and a valve assembly, the valve assembly including at least one of an inner cuff and an outer cuff, and a plurality of leaflets, sputter coating a layer of one or more target materials onto a surface of at least one component selected from the plurality of leaflets, the inner cuff and the outer cuff, and coupling the valve assembly to the stent.

Abstract: A delivery device for a collapsible prosthetic heart valve includes an inner shaft, an outer shaft, and a distal sheath. The distal sheath may be disposed distal to the outer shaft and about a portion of the inner shaft to form a compartment with the inner shaft. The compartment may be sized to receive the prosthetic heart valve. The inner shaft and the distal sheath may be movable relative to one another. A spine may extend along the outer shaft, the spine biasing the outer shaft so that the outer shaft tends to bend in a pre-determined direction.

Abstract: A prosthetic heart valve may include an expandable stent having a plurality of struts forming cells connected to one another in a plurality of annular rows around the stent, a cuff attached to an annulus section of the stent by cuff sutures that have a plurality of stitches extending through material of the cuff and looping around the struts, and a plurality of leaflets each having a belly attached to the cuff within an interior region of the stent. The leaflets may together have a coapted position occluding the interior region of the stent and an open position in which the interior region is not occluded. The belly of each leaflet may be attached to the cuff by leaflet sutures extending in a path that crosses some of the struts in overlap zones. Those struts may be devoid of the stitches within the overlap zones.

Abstract: A method of implanting a prosthetic heart valve may include crimping the valve onto a delivery device from a larger initial diameter to a smaller crimped diameter. Before crimping, the prosthetic leaflets of the valve may be in an uncompressed condition, and after crimping, the prosthetic leaflets may be in a compressed condition. The prosthetic heart valve may be advanced through a patient's vasculature while crimped and then deployed into a valve annulus of the patient. After crimping the prosthetic heart valve form the initial diameter to the compressed diameter, the prosthetic heart valve may have a crimp magnitude of between 110% and 135%. The crimp magnitude may be calculated as a ratio of (i) a size of the prosthetic leaflets in the uncompressed condition to (ii) a total amount of available size that the prosthetic leaflets can occupy when the prosthetic leaflets are in the compressed condition.

Abstract: In some examples, a method of manufacturing a prosthetic heart valve includes providing a collapsible and expandable stent, providing a valve assembly that includes a plurality of tissue leaflets and a cuff, treating the plurality of tissue leaflets with aldehyde neutralization and glycerol-based drying steps, assembling the valve assembly and the collapsible and expandable stent; and confirming proper treatment of the plurality of tissue leaflets by examining a color value of the plurality of tissue leaflets post-treatment.

Abstract: At least a portion of fabrics for use in medical devices is formed from polymeric materials. The fabrics may be uncoated, partially coated or fully coated with one or more layers of a polymer. The fabrics may be used for the leaflets and/or cuffs of prosthetic heart valves and as a component of other medical devices.

Abstract: A system for delivering a prosthetic heart valve may include, a handle, an outer catheter, an inner catheter, a nose cone coupled to the inner catheter, and an inflatable balloon having a proximal leg coupled to the outer catheter and a distal leg coupled to the nose cone or the inner catheter. A first valve retainer may be coupled to the inner catheter and positioned within the balloon. In an assembled state of the first valve retainer, an inner stop is directly fixed to the inner catheter and an outer stop is positioned around and coupled to the inner stop. The inner stop has a maximum outer diameter that is smaller than a maximum inner diameter of the distal leg. In the assembled condition of the first valve retainer, the outer stop has a maximum outer diameter that is larger than the maximum inner diameter of the distal leg.

Abstract: In some embodiments, a balloon-expandable prosthetic heart valve includes a collapsible and expandable stent comprising a plurality of commissure attachment features, the collapsible and expandable stent having at least one of an inflow flare and an outflow flare, and a valve assembly coupled to the collapsible and expandable stent, the valve assembly comprising a cuff and a plurality of leaflets, the plurality of leaflets defining a noncylindrical profile with a narrowed waist.

Abstract: A prosthetic heart valve includes a support structure and a valve assembly. The valve assembly includes a cuff and a plurality of leaflets, each of the prosthetic leaflets being composed of a synthetic material. The prosthetic leaflets have a closed condition in which the prosthetic leaflets coapt to restrict blood from flowing in a retrograde direction through the support structure and an open condition in which the prosthetic leaflets allow blood to flow in an antegrade direction through the structure. The synthetic material may be heat set to bias the leaflets to the open or closed condition, or to bias one portion of the leaflet to the open condition and another portion of the leaflet to the closed condition.

Abstract: In some examples, a prosthetic heart valve includes a stent having a plurality of commissure attachment features, a cuff coupled to the stent, and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, each of the plurality of leaflets having two leaflet attachment tabs, a free edge and an attached edge opposite the free edge, each of the plurality of leaflets having a first region with a first stress response characteristic and a second region with a second stress response characteristic.

Abstract: In some embodiments, a prosthetic heart valve includes a stent having a plurality of commissure attachment features, each of the plurality of commissure attachment features having an arch shape formed by a single continuous strut, a cuff coupled to the stent, a plurality of swatches, each of the plurality of swatches being coupled to each of the plurality of commissure attachment features, and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, each of the plurality leaflets having two leaflet attachment regions, the leaflet attachment regions being coupled to a respective one of the plurality of swatches.

Abstract: In some embodiments, a balloon-expandable prosthetic heart valve includes a collapsible and expandable stent comprising a plurality of commissure attachment features, and a valve assembly coupled to the collapsible and expandable stent, the valve assembly comprising a plurality of leaflets, and a pleated outer cuff having a plurality of shape-set pleats, the pleated outer cuff being coupled to the collapsible and expandable stent at positions between the plurality of shape-set pleats.

Abstract: A method of implanting a prosthetic aortic may include advancing a delivery device into the patient until a distal end is positioned within or adjacent to a native aortic valve annulus while the prosthetic aortic is collapsed within the delivery device. While the distal end portion of the delivery device is within or adjacent to the native aortic valve annulus, an alignment wire that is operably coupled to the delivery device may be advanced into a coronary artery and/or an aortic head vessel of the patient. The prosthetic aortic valve may be deployed into the native aortic valve annulus of the patient by expanding the prosthetic aortic valve so that prosthetic commissures of the prosthetic aortic valve rotationally align with native commissures of a native aortic valve of the patient.

Abstract: In some embodiments, a prosthetic heart valve includes a collapsible and expandable stent comprising a plurality of commissure attachment features, a valve assembly coupled to the collapsible and expandable stent, the valve assembly comprising a cuff and a plurality of leaflets, and a suture pattern coupling at least one of the plurality of leaflets to at least one of the cuff and the collapsible and expandable stent, the suture pattern comprising a reverse-running stitch having a first leg and a second leg.

Abstract: A prosthetic heart valve may include an expandable stent, a cuff attached to an annulus section of the stent, and a plurality of leaflets disposed within an interior region of the stent and attached to at least one of the cuff or the stent. The stent may have a plurality of cells connected to one another in a plurality of annular rows around the stent. The leaflets together may have a coapted position occluding the interior region of the stent and an open position in which the interior region is not occluded. Each leaflet may include a primary leaflet material, as well as features that reinforce specific regions of the leaflet.

Abstract: In some examples, a prosthetic heart valve includes a collapsible and expandable stent comprising a plurality of commissure attachment features, each of the plurality of commissure attachment features including a generally rectangular body having a top strut, a bottom strut and two sides struts, and defining a central aperture, a valve assembly comprising a cuff and a plurality of leaflets, and a plurality of commissure regions, each of the plurality of commissure regions including a fabric folded over the top strut of one of the plurality of commissure attachment features to form an inner fabric layer and an outer fabric layer, and one or more sutures coupling the inner fabric layer and the outer fabric layer via the central aperture.

Abstract: In some embodiments, a prosthetic heart valve system includes a stent having a plurality of commissure attachment features, a cuff coupled to the stent, and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, each of the plurality leaflets having two leaflet attachment regions, the leaflet attachment regions being folded adjacent the plurality of commissure attachment features.

Abstract: A delivery device for a collapsible prosthetic heart valve includes an inner shaft, an outer shaft, and a distal sheath. The distal sheath may be disposed distal to the outer shaft and about a portion of the inner shaft to form a compartment with the inner shaft, the compartment being sized to receive the prosthetic heart valve in a collapsed condition. The inner shaft and the distal sheath may be movable relative to one another. The delivery device may also include a tube member and an outer sleeve overlying the tube member. The tube member may be configured to rotate or twist upon axial movement of the outer sleeve with respect to the tube member, the rotation or twisting of the tube member configured to rotate the prosthetic heart valve when the prosthetic heart valve is received within the compartment in the collapsed condition.