Abstract: A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state.

Abstract: This application relates to methods, systems, and apparatus for replacing native heart valves with prosthetic heart valves and treating valvular insufficiency. In a representative embodiment, a support frame configured to be implanted in a heart valve comprises a main body formed by formed by a plurality of inner members forming an inner clover and a plurality of outer members forming an outer clover. The support frame can include gaps located between inner members of the plurality of inner members and outer members of the plurality of outer members. The inner clover can be radially inside the outer clover, and the outer clover can have larger dimensions than the inner clover. The support frames herein can be radially expandable and collapsible.

Abstract: An implantable prosthetic valve includes a radially collapsible and expandable annular frame having three commissure attachment posts and four rows of circumferential struts. The rows include a first row, a second row downstream of the first row, a third row downstream of the second row, and a fourth row downstream of the third row and defining an outflow end of the frame. Each row of circumferential struts includes angled struts arranged in a zig-zag pattern. A leaflet structure includes three leaflets forming three commissures, each commissure being connected to one of the commissure attachment posts only at locations along the commissure attachment posts between a first plane that is perpendicular to a longitudinal axis of the frame and intersects crowns of the third row of struts and a second plane that is perpendicular to the longitudinal axis and intersects crowns of the fourth row of struts.

Abstract: A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state.

Abstract: Prosthetic heart valves and methods of implantation thereof are disclosed herein. In embodiments, a prosthetic heart valve includes a self-expandable frame configured to support of valve member and comprising a plurality of interconnected strut members forming a mesh structure. An inflow end and outflow end portions of the mesh structure respectively define an inflow terminal end and an outflow terminal end of the frame. A portion of the frame tapers inwardly from the inflow terminal end to form a reduced diameter section. In implementations, the frame increases in diameter from the reduced diameter section to an intermediate section. In implementations, the valve member is secured to the frame at the inflow end portion. In implementations, the frame further comprises a plurality of retaining arms that extend from the outflow terminal end and are configured to engage with a valve retaining mechanism of a delivery apparatus.

Abstract: Apparatus and methods are described for treating a subject with a diseased atrioventricular valve. A docking element is implanted within the subject's atrium such that no portion of the docking element extends through the subject's atrioventricular valve. The docking becomes anchored to tissue of the atrium at least partially via ingrowth of the tissue of the atrium. The docking element includes a ring, which is implanted at the annulus of the atrioventricular valve, and a frame having a height of at least 15 mm, which extends upwardly from the ring. A prosthetic atrioventricular valve apparatus is placed at least partially inside the docking element subsequent to the ingrowth of the tissue of the 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: 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 method of crimping an implantable prosthetic valve can include placing protective material over at least a portion of the implantable prosthetic valve. The protective material can be configured to occupy space between open cells of a frame of the implantable prosthetic valve to prevent damage to a leaflet structure of the implantable prosthetic valve. The method can also include crimping the implantable prosthetic valve with the protective material on the implantable prosthetic valve, and removing the protective material from between the frame and the leaflet structure of the implantable prosthetic 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: 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: An implantable prosthetic valve includes an annular metallic frame and a valve assembly supported within the frame. The annular support frame is constructed with three longitudinal support beams of fixed length and web-like constructions that extend between and connect the support beams. The support beams are spaced apart in a substantially equidistant manner. The web-like constructions allow the annular support frame to be radially collapsible and expandable. Each support beam preferably has a column of pre-formed openings or bores extending along a length of the support beam. The valve assembly includes three valve leaflets, wherein each leaflet has opposing side portions and each side portion is paired with an adjacent side portion of an adjacent leaflet to form a commissure. The three commissures are secured to three respective support beams with stitching that extends through the leaflets and through the pre-formed openings or bores.

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: 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: 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 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 system for replacing a deficient native aortic valve includes an implantable prosthetic valve having a self-expandable frame and a valve assembly formed with three valve leaflets. The self-expandable frame includes three angularly spaced longitudinal bars of fixed length defining respective slots and a plurality of web-like constructions extending between and connected to the longitudinal bars. The valve assembly includes commissures extending outwardly through the slots where they are supported on the outside of the frame. Each leaflet includes an inlet end portion secured to the inside of the frame with stitching extending through the leaflet and around adjacent frame portions. The system also includes a restriction tube adapted for insertion into a patient's body. The prosthetic valve is capable of being crimped for insertion into the restriction tube and capable of self-expansion upon release from the restriction tube for deployment in the deficient native aortic 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: 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 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: 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.