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 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: A prosthetic mitral valve may include a collapsible stent including a plurality of struts, a plurality of cells arranged in circumferential rows, the circumferential rows including a first row at an outflow end of the stent and a second row at an inflow end of the stent, and a plurality of strut intersections where at least two of the struts connect to one another. A cuff is attached to the stent. A prosthetic valve assembly is adapted to allow blood to flow in only one direction through the valve. The prosthetic valve assembly includes a first prosthetic leaflet having a first end attached directly to a first one of the strut intersections, and a second prosthetic leaflet having a first end attached directly to the first strut intersection. The first strut intersection is partially formed of one of the struts of one of the cells in the first row.

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 prosthetic heart valve includes a non-collapsible annular frame extending in a longitudinal direction between an inflow edge and an outflow edge, and a valve assembly connected to the frame. The frame includes a plurality of annularly spaced commissure posts adjacent the outflow edge, each of the commissure posts including a tip and a post slot spaced apart from the tip. The prosthetic heart valve further includes a radiopaque element including an elongated main body having a first end and a second end. The radiopaque element may extend around the tip and through the post slot of at least one of the commissure posts so that a portion of the main body extends between the slot and the tip. Alternatively or additionally, a radiopaque element may be positioned adjacent a base of the frame.

Abstract: A prosthetic heart valve includes a support structure and a valve assembly disposed within the support structure, the valve assembly including a plurality of leaflets. Each leaflet includes a sewing edge and a free edge. The leaflet is formed from a sheet of leaflet material which is processed so that the resulting leaflet has a non-uniform thickness. Various methods may be used to form the leaflet with a non-uniform thickness.

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: A prosthetic heart valve includes a support structure and a valve assembly disposed within the support structure, the valve assembly including a plurality of leaflets. Each leaflet is formed from a predetermined leaflet material. Some leaflet materials include a metal body with a plurality of openings. The metal body may be coated with a polymer. Other leaflet materials include natural mammalian tissue subjected to a plastination preservation process.

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

Abstract: A stabilized fabric composed of a mesh or a woven fabric is disclosed as are methods of their manufacture, the manufacture of medical devices made using a stabilized fibers and stabilized medical devices are all disclosed. Fabrics can be stabilized by several techniques including: using mechanical, chemical and/or energetic fasteners at warp and weft intersections in the weave; by using various weaving techniques and fibers. Meshes can be stabilized when properly dimensioned and arranged junctions and struts of the necessary properties are used. All of these stabilized fabrics can be made of synthetic polymer materials such as ultrahigh molecular weight PE or PP and expanded PTFE.

Abstract: A guidewire may be configured for insertion into a heart of a patient during a procedure such as a transcatheter aortic valve replacement procedure. The guidewire may include a proximal end and a distal end portion. The distal end portion may include (i) a leading section, (ii) a loop structure at a terminal distal end of the guidewire, and (iii) a transition section extending between the leading section and the loop structure. In the absence of applied forces, the leading section is not tangential to the loop structure. With such a configuration, the guidewire may avoid contact with the ventricular septum of the heart when the loop structure is seated within the left ventricle, which may mitigate potential interference with conduction pathways in the ventricular septum, which may in turn mitigate the need for a pacemaker.

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: Methods of preparing calcification-resistant bioprosthetic tissue include providing fresh biological tissue, cross-linking the tissue, treating the cross-linked tissue with an alcohol for a time sufficient to allow the alcohol to be diffused into the tissue, and treating the alcohol-treated fixed tissue with a polyol for a time sufficient to allow fluid in the tissue to be replaced by the polyol. The methods may include sterilizing the cross-linked tissue in a solution including propylene oxide or peracetic acid either before or after the alcohol treatment step; or drying the alcohol/polyol-treated, cross-linked tissue, sterilizing the dried tissue by exposure to ethylene oxide or peracetic acid, and storing the sterilized tissue in a dry, ambient environment. The treated tissue may be a tissue component for a bioprosthetic valve, a valve assembly for a bioprosthetic valve or a fully assembled bioprosthetic valve incorporating the tissue.

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 prosthetic heart valve may include a stent, a valve assembly disposed within the stent, a flange, and a plurality of anchor arms coupled to the stent. The stent may have collapsed and expanded conditions and inflow and outflow ends. The flange may include a plurality of braided wires and may be coupled to the stent and may be positioned adjacent the inflow end of the stent in the expanded condition of the stent. Each anchor arm may have a first end coupled to the stent adjacent the outflow end of the stent, a second end coupled to the stent adjacent the outflow end of the stent, and center portions extending from the first and second ends toward the inflow end of the stent. The center portions may be joined together to form a tip pointing toward the inflow end of the stent in the expanded condition of the stent.

Abstract: A method of augmenting the length of a native leaflet to improve leaflet coaptation includes delivering a cutting tool to a surgical site adjacent the native leaflet, cutting a slit through the native leaflet, inserting a collapsible and expandable occlusion device into the slit, expanding the occlusion device, engaging a first surface of the first disk with a first surface of the native leaflet, and engaging a second surface of the second disk with a second surface of the native leaflet opposite the first surface. The occlusion device includes a first disk, a second disk, and an intermediate portion coupling the first disk to the second disk.

Abstract: A prosthetic mitral valve may include a collapsible stent including a plurality of struts, a plurality of cells arranged in circumferential rows, the circumferential rows including a first row at an outflow end of the stent and a second row at an inflow end of the stent, and a plurality of strut intersections where at least two of the struts connect to one another. A cuff is attached to the stent. A prosthetic valve assembly is adapted to allow blood to flow in only one direction through the valve. The prosthetic valve assembly includes a first prosthetic leaflet having a first end attached directly to a first one of the strut intersections, and a second prosthetic leaflet having a first end attached directly to the first strut intersection. The first strut intersection is partially formed of one of the struts of one of the cells in the first row.

Abstract: An apparatus for stabilizing a prosthetic heart valve within an atrioventricular valve includes a collapsible and expandable stent having an inflow end, an outflow end, and struts forming a plurality of cells connected to one another in a plurality of annular rows around the stent. The stent further includes a collapsible and expandable valve assembly secured to the stent. The valve assembly includes a cuff and a plurality of leaflets having an open configuration and a closed configuration. A cord connected to the stent includes an attachment device adapted to couple the stent to heart tissue of a patient. A method of stabilizing a prosthetic heart valve within an atrioventricular valve annulus is also described.

Abstract: An apparatus for augmenting the length of native chordae tendineae to restore physiological leaflet coaptation. The apparatus includes a delivery device having a lumen therein which at least partially houses a prosthetic cord. The prosthetic cord has a first end with a first clasp configured to attach to a native chordae tendineae and a second end with a second clasp configured to attach to the native chordae tendineae. The native chordae tendineae is severed between the first clasp and the second clasp, and the length of the prosthetic cord between the first clasp and the second clasp is adjusted until physiological leaflet coaptation is restored.

Abstract: Methods of preparing calcification-resistant bioprosthetic tissue include providing fresh biological tissue, cross-linking the tissue, treating the cross-linked tissue with an alcohol for a time sufficient to allow the alcohol to be diffused into the tissue, and treating the alcohol-treated fixed tissue with a polyol for a time sufficient to allow fluid in the tissue to be replaced by the polyol. The methods may include sterilizing the cross-linked tissue in a solution including propylene oxide or peracetic acid either before or after the alcohol treatment step; or drying the alcohol/polyol-treated, cross-linked tissue, sterilizing the dried tissue by exposure to ethylene oxide or peracetic acid, and storing the sterilized tissue in a dry, ambient environment. The treated tissue may be a tissue component for a bioprosthetic valve, a valve assembly for a bioprosthetic valve or a fully assembled bioprosthetic valve incorporating the tissue.