Abstract: Prosthetic heart valves are described. Prosthetic heart valves can include radially expandable and compressible inner and outer metal frames. The inner frame can be disposed within a lumen of the outer frame and can be coupled to the outer frame. An outflow end of the inner frame can be coupled to and/or located at an outflow end of the outer frame. An end portion of the inner frame can be spaced radially inwardly from an inner surface of the outer frame, such that a radial gap exists between the inner surface of the outer frame and an outer surface of the inner frame. Prosthetic heart valves can further include a plurality of leaflets disposed within and supported by the inner frame, such as by commissure posts of the inner frame.

Abstract: A prosthetic heart valve for replacing a defective aortic valve includes a self-expandable annular frame made of shape-memory material. A one-way valve structure is disposed within an interior of the frame. The frame includes a plurality of posts projecting axially from an outflow end portion of the frame, wherein each of the posts includes an axial post portion and a terminal post portion. The terminal post portions have greater circumferential dimensions than the axial post portions. The terminal post portions are preferably formed with concave inner surfaces and convex outer surfaces for conforming to the shape of a delivery catheter. Each of the posts is shaped for placement within a corresponding recess along a distal end portion of the delivery catheter for ensuring that the prosthetic heart valve remains coupled to the delivery catheter while the prosthetic heart valve is expanded within the defective aortic valve.

Abstract: A delivery assembly includes a prosthetic device, a catheter shaft, a release wire, a first line, and a second line. The prosthetic device has a first arm and a second arm. The release wire extends through the catheter shaft. The first line includes a first loop. The first line extends from the catheter shaft, through the first arm of the prosthetic device, and to the release wire, where the release wire extends through the first loop. The second line includes a second loop. The second line extends from the catheter shaft, through the second arm of the prosthetic device, and to the release wire, where the release wire extends through the second loop.

Abstract: Apparatus and methods are described for treating a subject with a diseased mitral valve. A docking element (100) is implanted within the subject's left atrium such that no portion of the docking element extends through the subject's mitral valve. The docking becomes anchored to tissue of the left atrium at least partially via ingrowth of the tissue of the left atrium. The docking element (100) includes a ring (102), which is implanted at the subject's mitral valve annulus, and a frame (104), having a height of at least 15 mm, which extends upwardly from the ring. A prosthetic mitral valve apparatus (20) is placed at least partially inside the docking element subsequent to the ingrowth of the tissue of the left atrium having occurred, and becomes anchored to the docking element, at least partially by radially expanding against the ring. Other applications are also described.

Abstract: Apparatus and methods are described for treating a subject with a diseased valve (24), and for use with a delivery device (34). A prosthetic valve apparatus (20) includes a valve support frame (30) and prosthetic valve leaflets (32). Prosthetic valve apparatus (20) is delivered to an aperture (22) through a first leaflet (25) of the diseased valve, while maintained in a generally cylindrical shape inside the delivery device. Subsequent to the delivery device being retracted, the support frame of the prosthetic valve apparatus becomes anchored to the first leaflet of the valve, by end portions (36A, 36V) at each end of the valve support frame at least partially inverting to trap tissue of the first leaflet between the inverted portions, and a central portion (38) of the valve support frame radially expanding. Other applications are also described.

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

Abstract: Embodiments of the present disclosure provide methods of loading a prosthetic heart valve within a delivery apparatus such that it can be used for delivery of the prosthetic heart valve to a native valve site via the human vasculature. The methods can include attaching the prosthetic heart valve to a valve-retaining mechanism at a distal end of the catheter and causing a torque shaft of the delivery apparatus to rotate relative to the catheter, wherein the torque shaft extends within the catheter and is coupled to the valve delivery sheath. Rotation of the torque shaft relative to the catheter can cause relative longitudinal movement between the valve sheath and the prosthetic heart valve such that the prosthetic heart valve is covered by the valve sheath.

Abstract: Embodiments of the present disclosure provide a prosthetic heart valve usable with a heart valve delivery apparatus for delivery of the prosthetic heart valve to a native valve site via the human vasculature. In one embodiment, a self-expanding valve comprises an expandable stent that is shaped to maintain the valve in the aortic annulus against axial without anchors or retaining devices that engage the surrounding tissue. The prosthetic heart valve can have a curved shape that tapers inwardly from the inflow end to a reduced diameter section, increases in diameter from the reduced diameter section to an intermediate section, and then tapers from the intermediate section to the outflow end.

Abstract: An assembly for transvascular replacement of a native aortic heart valve can have a radially collapsible and self-expandable prosthetic heart valve and a delivery apparatus. The valve can have an annular metal frame made of a shape-memory material with a plurality of posts extending from an end portion of the frame. The delivery apparatus can have a shaft comprising a valve connection portion that is releasably coupled to the posts of the valve. The valve connection portion can have a plurality of discrete radially facing recesses that receive the posts. The delivery apparatus can have a delivery sheath that is positioned around the prosthetic heart valve and the valve connection portion of the shaft to maintain the prosthetic heart valve in a radially compressed state and maintain the posts within the recesses. The delivery apparatus can cause relative axial motion between the delivery sheath and the valve.

Abstract: A method of implanting a prosthetic heart valve within a patient can comprise inserting a distal end portion of a delivery apparatus and a prosthetic heart valve into the patient and advancing the prosthetic heart valve to a deployment location within the heart of the patient and inflating one or more of a plurality of differently-sized balloons in a balloon-assembly on the distal end portion of the delivery apparatus. The prosthetic heart valve can be mounted on the balloon assembly in a crimped state and the inflating of the one or more of the plurality of differently-sized balloons can expand the prosthetic heart valve from the crimped state to a radially expanded state having a non-cylindrical shape.

Abstract: A handle assembly for a transvascular prosthetic heart valve delivery apparatus including a handle housing, a main shaft extending distally from the handle housing, the main shaft configured to be coupled to a distal valve sheath that is configured to retain a prosthetic heart valve in a radially compressed state within the valve sheath, a screw shaft, a control knob that is rotatable relative to the handle housing and the screw shaft, a screw engagement latch that is adjustable between an engaged position and a disengaged position. In the engaged position, the latch can couple the control knob to the screw shaft such that rotation of the control knob relative to the handle housing causes the main shaft to move axially relative to the handle housing. In the disengaged position, the latch can decouple the control knob from the screw shaft such that the main shaft can move axially relative to the handle housing without rotation of the control knob.

Abstract: A prosthetic heart valve comprises a radially collapsible and expandable annular frame and a leaflet structure comprising three leaflets. Each leaflet has an upper edge portion, a curved lower edge portion and two side flaps, wherein each side flap is connected to an adjacent side flap of another leaflet to form commissures of the leaflet structure, with each commissure being attached to the frame. An annular inner sleeve comprises three U-shaped portions positioned along the curved lower edge portions of the leaflets. An annular outer sleeve extends around are outer surface of the frame, wherein the outer sleeve is made of pericardium. The frame is made of Nitinol and the prosthetic valve can be radially crimped to a radially collapsed configuration inside a sheath for delivery into a patient's body and self-expand to a radially expanded configuration when released from the sheath inside the patient's body.

Abstract: A method of delivering a prosthetic heart valve to a native aortic heart valve region of a patient can include introducing a prosthetic heart valve on a transvascular delivery apparatus into an artery of the patient, advancing the delivery apparatus through an aorta of the patient to the native aortic heart valve region, and releasing the prosthetic heart valve from the delivery apparatus. The delivery apparatus can have a shaft with a valve connection portion that is releasably coupled to posts of the prosthetic heart valve. The delivery apparatus can have a delivery sheath positioned around the prosthetic heart valve and the valve connection portion. The releasing the prosthetic valve can include moving the delivery sheath proximally relative to the shaft and the prosthetic heart valve such that the delivery sheath uncovers the prosthetic heart valve and the prosthetic heart valve can self-expand.

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

Abstract: An assembly for replacing a native heart valve can have a prosthetic heart valve with an annular metal frame made from shape-memory material and a valve member disposed in an interior of the metal frame. The assembly can have a delivery apparatus with a handle, a shaft with a proximal end portion and a distal end portion. The proximal end portion can be coupled to the handle and the distal end portion can be releasably coupled to the prosthetic heart valve. The delivery apparatus can also have a delivery sheath and a hydraulic power source operatively connected to the delivery sheath. The prosthetic heart valve can be positioned within the delivery sheath in a radially compressed state. The hydraulic power source can be configured to move the delivery sheath longitudinally relative to the valve to allow the valve to self-expand from the radially compressed state to a radially expanded state.

Abstract: An assembly for transvascular replacement of a native aortic heart valve can have a radially collapsible and self-expandable prosthetic heart valve and a delivery apparatus. The valve can have an annular metal frame made of a shape-memory material with a plurality of posts extending from an end portion of the frame. The delivery apparatus can have a shaft comprising a valve connection portion that is releasably coupled to the posts of the valve. The valve connection portion can have a plurality of discrete radially facing recesses that receive the posts. The delivery apparatus can have a delivery sheath that is positioned around the prosthetic heart valve and the valve connection portion of the shaft to maintain the prosthetic heart valve in a radially compressed state and maintain the posts within the recesses. The delivery apparatus can cause relative axial motion between the delivery sheath and the valve.

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

Abstract: Prosthetic heart valves are described. Prosthetic heart valves can include radially expandable and compressible inner and outer metal frames. The inner frame can be disposed within a lumen of the outer frame and can be coupled to the outer frame. An outflow end of the inner frame can be coupled to and/or located at an outflow end of the outer frame. An end portion of the inner frame can be spaced radially inwardly from an inner surface of the outer frame, such that a radial gap exists between the inner surface of the outer frame and an outer surface of the inner frame. Prosthetic heart valves can further include a plurality of leaflets disposed within and supported by the inner frame, such as by commissure posts of the inner frame.