An embodiment of the invention includes a sewing cuff for aortic heart valves that better approximates native anatomy by better mating with the crown-like anatomical annulus. Limiting distortion of the crown-like annulus provides better blood flow and overall valve function and provides a physician greater ease of implantation since native anatomy is not flattened. Thus, the surgeon may attach sutures to the fibrous tissue of the crown-like anatomical annulus without distorting the shape of the native anatomy. An embodiment includes a scalloped sewing cuff assembly (with semilunar arches) that tracks the crown-like annulus. Another embodiment provides a sewing cuff positioned over the majority of the valve's length, thus allowing the surgeon greater flexibility as to where he or she can attach sutures to the surgical annulus. Conventional valves, which are primarily “low-profile” devices, do not offer such ability. Other embodiments are described herein.

A prosthetic heart valve may include a collapsible and expandable stent extending in a flow direction between a proximal end and a distal end, a cuff attached to an annulus section of the stent and having an outer surface facing in a radial direction orthogonal to the flow direction, a plurality of prosthetic valve leaflets attached to the cuff, and a sealing structure attached to the annulus section of the stent at an inner edge of the sealing structure. The flow direction may be defined from the proximal end toward the distal end. The sealing structure may have an outer edge remote from the inner edge. The sealing structure may have a collapsed condition with the outer edge disposed adjacent the outer surface of the cuff and an expanded condition with the outer edge spaced apart from the outer surface of the cuff.

Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a prosthetic valve for regulating blood flow direction. In one aspect, the leaflet material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The leaflet material includes a coherent single layer and an elastomer, wherein the elastomer is present in the pores of the porous coherent single layer.

A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart includes a handle portion and an elongated shaft extending from and movable relative to the handle portion. The shaft includes a proximal end portion coupled to the handle portion and a distal end portion configured to mount a prosthetic heart valve in a radially compressed state. The handle portion includes a control member movable longitudinally with respect to the handle portion, the control member engaging a gear assembly operable to convert longitudinal motion of the control member to rotational motion of the gear assembly. The gear assembly engages the elongated shaft such that rotational motion of the gear assembly causes corresponding longitudinal motion of the elongated shaft relative to the handle portion.

A prosthetic heart valve includes a frame, a valve, and an expansion element. The frame is movable between contracted and expanded configurations and includes first struts and second struts non-hingedly coupled together. The second struts are configured to pivot relative to the first struts as the frame moves between the contracted and expanded configurations. The valve is coupled to the frame and includes leaflets. The expansion element extends through a lumen of the first struts. The expansion element is slidable relative to the lumen of the first struts and is configured to move the frame incrementally from the contracted configuration and the expanded configuration and from the expanded configuration to the contracted configuration.

Apparatus is provided, comprising a ring, comprising a plurality of struts arranged in a pattern of alternating peaks and troughs, each strut having a first end-portion and a second end-portion, each peak defined by convergence of adjacent first end-portions disposed at an angle with respect to each other, and each trough defined by convergence of adjacent second end-portions. The apparatus also comprises a plurality of anchors. Each anchor has a longitudinal axis, is configured to be driven along the longitudinal axis into tissue of the heart, and is coupled to the ring at a respective trough in a manner that facilitates (i) movement of the anchor along the longitudinal axis with respect to the trough, and (ii) deflection of the longitudinal axis with respect to the trough.

A modular heart valve prosthesis includes a first heart valve device and a second heart valve device. The first heart valve device includes a first valve support including a first prosthetic valve disposed within the valve support, and an anchoring frame surrounding the first valve support and coupled to the first valve support. The first prosthetic valve includes synthetic fabric leaflets having a first thickness. The second heart valve device includes a second valve support including a second prosthetic valve disposed within the second valve support. The second prosthetic valve includes tissue leaflets having a second thickness, wherein the second thickness is greater than the first thickness. In a first configuration, the second heart valve device is separate from the first heart valve device, and in a second configuration, the second heart valve device is disposed within the first valve support of the first heart valve device.

Embodiments of a leaflet clip device and method of reducing regurgitation through a native heart valve are disclosed. A leaflet clip device can include an elongated clipping member having a first end portion and a second end portion and a tensioning mechanism coupled to the clipping member. The leaflet clip device can further include one or more tensioning members disposed within a lumen of the clipping member, wherein the one or more tensioning members are operatively connected to the tensioning mechanism to transform the clipping member from a delivery configuration to an implantation configuration.

An anchoring device that can be positioned within a native valve, such as the native mitral valve, to secure a replacement prosthetic valve in place. The anchoring device can comprise a docking station formed of a super elastic wire-like member defining a continuous, closed shape. The docking station can have an upper or atrial ring with at least two ring portions or half rings that are spaced apart across gaps. Descending bends from the ends of the two ring portions lead to a pair of anchors. The anchors can include oppositely-directed rounded V-shaped arms that extend generally parallel to the upper ring. When installed by a delivery device, the anchors can be located in the subvalvular space or the region/vicinity of the native leaflets and pinch the leaflets and the annulus against the upper ring which is located on the other side of the annulus.

The expandable sheath and methods of use disclosed herein are used to deliver a prosthetic device through a patient's vasculature. The sheath is constructed to be expandable in the circumferential direction, while maintaining sufficient stiffness in the longitudinal direction to withstand pushing and resist kinking The sheath includes a plurality of curved arms extending outwardly from a longitudinally extending spine. The curved arms move away from the longitudinal axis of the sheath when pushed radially outwardly by a passing prosthetic device, and move back toward the longitudinal axis once the prosthetic device has passed.