Abstract: A prosthetic heart valve for implantation within a native atrioventricular heart valve. The prosthetic heart valve includes a radially collapsible and radially expandable annular frame having an annular main body and a valve member disposed within the main body. The frame further includes a plurality of serpentine arms that are arranged side-by-side in a circumferential direction around the main body, wherein each serpentine arm has one end connected to an atrial end of the main body and extends away from the main body.

Abstract: Methods and systems for replacing a native heart valve are disclosed. A system comprises a delivery catheter having a deflectable distal tip configured to bend in one or more directions relative to a native annulus of a native heart valve when the distal tip is positioned within an atrium of a heart and a helical anchor configured to be carried within the delivery catheter in a delivery configuration and to be axially movable relative to the deflectable distal tip. The helical anchor has a coiled configuration comprising a plurality of turns after being delivered from the deflectable distal tip into the heart, where the coiled configuration is configured to support a heart valve prosthesis.

Abstract: Methods and systems for implanting a helical anchor are disclosed. A method comprises, proximate a native heart valve, positioning a helical anchor arranged inside a shaft in a delivery configuration and a distal end of the shaft at a first position relative to one another such that the distal end of the shaft has a first radius of curvature, wherein the helical anchor has a coiled configuration comprising a plurality of turns after being delivered at the native heart valve. The method further comprises moving the helical anchor and the distal end of the shaft into a second position relative to one another such that the shaft has a second radius of curvature.

Abstract: An implantable device or implant is configured to be positioned within anatomy such as a native heart valve to repair the valve. The implantable device or implant is configured to be attached to one or more portions of the anatomy or native heart valve, such as one or more portions thereof can be moved closer together. For example, native valve leaflets, chordae tendinea, papillary muscles, a leaflet cleft, etc. can be moved to prevent or inhibit regurgitant flow through the native valve.

Abstract: A system for replacing a native valve of the heart includes a delivery apparatus having a sheath and a prosthetic valve. The prosthetic valve includes a frame having an annular main body, a plurality of ventricular anchors attached to the main body, an atrial anchor attached to an atrial end portion of the main body, and a valve structure disposed within the main body of the frame. The prosthetic valve is disposed within a distal end portion of the sheath in a compressed, delivery state. When the prosthetic valve is deployed from the sheath, the main body of the frame radially expands to a radially expanded state, the ventricular anchors expand to a deployed state alongside the main body of the frame for capturing native leaflets of the native valve, and the atrial anchor expands to a deployed state extending radially outwardly from the main body.

Abstract: A system comprises an anchor, having an anchor head that defines a forward-torque face and a reverse-torque face. A delivery tool comprises a transluminally advanceable driver, comprising a driveshaft, and a distal drive head. The drive head is shaped to engage the anchor head such that while the driveshaft presses the drive head distally into engagement with the anchor head, forward rotation of the drive head screws the anchor into the tissue. Reverse rotation of the drive head hooks the drive head onto the anchor head. While the drive head remains hooked onto the anchor head, reverse rotation of the drive head, and pulling the anchor head by tensioning of the driveshaft, unscrews the anchor from the tissue. Tensioning the driveshaft while the drive head is not hooked onto the anchor head pulls the drive head away from the anchor head. Other embodiments are also disclosed.

Abstract: A prosthetic heart valve includes a multi-part frame having a first annular body and an anchor component that includes a second annular body circumscribing the first annular body. The first annular body includes a plurality of struts arranged in a lattice pattern and defining a lumen. The anchor component further includes one or more ventricular anchors extending from the second annular body toward an inflow end portion of the first annular body. A fabric layer is disposed on an inner surface of the first annular body and sutured to the struts. A valve structure including three leaflets is disposed within the lumen and inlet ends of the leaflets are sutured to the fabric layer. The multi-part frame is radially compressible for delivery within a sheath of a delivery catheter and is self-expandable for deployment within an annulus of a native valve.

Abstract: A method of implanting a prosthetic heart valve assembly includes advancing a delivery catheter through a vein and toward a native heart valve. The prosthetic heart valve assembly is deployed from a lumen of the delivery catheter, allowing the prosthetic heart valve assembly to self-expand from a compressed state to a functional size within an annulus of the native heart valve with a flared upper portion of the stent located in an atrium against a supra-annular surface of the annulus of the native heart valve. An elongate anchoring member is attached to a septum of a ventricle at a location below the annulus. The flared upper portion contacts a supra-annular surface of the native heart valve for preventing downward migration of the prosthetic heart valve assembly toward the ventricle and the elongate anchoring member prevents upward migration of the prosthetic heart valve assembly toward the atrium.

Abstract: A method for heart valve replacement comprises forming an incision in a wall of a ventricle of a heart and inserting a delivery apparatus and a prosthetic heart valve through the incision and into the ventricle of the heart. The prosthetic valve comprises a self-expanding frame having an annular main body and a valve member disposed within the annular main body. The prosthetic valve further comprises an atrial sealing member formed by an annular metal ring and a fabric, wherein only the fabric of the atrial sealing member is connected to the main body for enhancing the flexibility and conformability of the atrial sealing member. The method further comprises deploying the prosthetic valve from the delivery apparatus such that the atrial sealing member extends radially outwardly from the main body within an atrium of the heart and the main body self-expands to a deployed state within a native heart valve.

Abstract: An implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion. The prosthetic device can be movable between multiple configurations. Each anchor is configured to be positioned behind a native valve leaflet of the two native leaflets such that the native leaflet is captured between the anchor and the spacer body.

Abstract: A prosthetic heart valve including a multi-part frame having an annular main body formed from a plurality of struts, an atrial anchor that extends radially outward from an inflow end portion of the main body, one or more ventricular anchors that are configured to be positioned behind a native valve leaflet, and a valve structure disposed in a lumen of the main body. Each of the ventricular anchors includes first and second end portions coupled to the outflow end portion of the main body and an intermediate portion forming a bend that forms a free end portion of the ventricular anchor that extends toward an inflow end portion of the main body. The multi-part frame is radially compressible for delivery within a sheath of a delivery catheter and is self-expandable for deployment within an annulus of a native valve.

Abstract: A prosthetic device includes a main body, a first anchor, and a second anchor. The main body has an atrial end and a ventricular end. The main body tapers from the atrial end to the ventricular end. The first and second anchors are coupled to the main body and are movable toward and away from the main body.

Abstract: A method of implanting a prosthetic heart valve assembly includes advancing a delivery catheter through a vein and toward a native heart valve. The prosthetic heart valve assembly is deployed from a lumen of the delivery catheter, allowing the prosthetic heart valve assembly to self-expand from a compressed state to a functional size within an annulus of the native heart valve with a flared upper portion of the stent located in an atrium against a supra-annular surface of the annulus of the native heart valve. An elongate anchoring member is attached to a septum of a ventricle at a location below the annulus. The flared upper portion contacts a supra-annular surface of the native heart valve for preventing downward migration of the prosthetic heart valve assembly toward the ventricle and the elongate anchoring member prevents upward migration of the prosthetic heart valve assembly toward the atrium.

Abstract: A prosthetic heart valve includes a multi-part frame having a first annular body and an anchor component that includes a second annular body circumscribing the first annular body. The first annular body includes a plurality of struts arranged in a lattice pattern and defining a lumen. The anchor component further includes one or more ventricular anchors extending from the second annular body toward an inflow end portion of the first annular body. A fabric layer is disposed on an inner surface of the first annular body and sutured to the struts. A valve structure including three leaflets is disposed within the lumen and inlet ends of the leaflets are sutured to the fabric layer. The multi-part frame is radially compressible for delivery within a sheath of a delivery catheter and is self-expandable for deployment within an annulus of a native valve.

Abstract: A prosthetic heart valve assembly includes a self-expandable stent having a flared upper portion, a lower portion, and an intermediate portion extending from the upper portion to the lower portion. The stent includes upwardly bent hooks extending from an outer surface of the stent, which are adapted to engage native leaflet tissue. The stent further includes an elongate anchoring member extending from the lower portion of the stent, which is adapted to be secured to a ventricle wall via a prong portion. When deployed within the native heart valve, the flared upper portion contacts a supra-annular surface of the native heart valve for preventing downward migration of the prosthetic heart valve assembly toward the ventricle and the upwardly bent hooks and the elongate anchoring member prevent upward migration of the prosthetic heart valve assembly toward an atrium.

Abstract: A prosthetic heart valve for implantation at a native heart valve includes a multi-part frame. The multi-part frame includes a cylindrical main body and a ventricular anchor component surrounding the main body. The main body includes a plurality of struts arranged in a lattice pattern. The ventricular anchor component is attached to the main body only at an outflow end of the main body and extends toward an inflow end of the main body. The prosthetic valve further includes a valve structure having three leaflets made from pericardium. The multi-part frame is radially compressible for delivery within a sheath of a delivery catheter and is self-expandable for deployment within an annulus of the native valve. The main body and the ventricular anchor component are formed separately and are attached by a locking mechanism for reducing strain between the main body and the ventricular anchor component.

Abstract: Systems and methods are disclosed for use with a valve of a heart. An implant (100) includes a wing (120); a flexible frame (124); and a pair of anchor receivers (150). A pair of shafts (660) are transluminally advanced through a catheter (40), while the shafts are each engaged with a respective anchor receiver (150), to deploy the implant out of the catheter such that the wing extends away from the anchor receivers and over a first leaflet of the valve and toward an opposing leaflet of the valve, with a contact face (122) of the wing facing the first leaflet. A pair of drivers (70) secure the implant using a pair of anchors (30) to anchor each anchor receiver to tissue at respective sites of the heart. Other implementations are also described.

Abstract: A prosthetic heart valve for implantation within a native atrioventricular heart valve. The prosthetic heart valve includes a self-expanding frame having an annular main body and a valve member disposed within the main body. The prosthetic heart valve includes an atrial sealing member formed by a fabric cover and a plurality of arms that are arranged side-by-side in a circumferential direction around the main body. The atrial sealing member extends radially outwardly from the main body and a peripheral portion of the atrial sealing member curves upwardly for conforming to surrounding native anatomy. The prosthetic heart valve further includes one or more ventricular anchors extending from the main body for capturing native leaflet tissue and thereby securing the prosthetic heart valve within the native atrioventricular heart valve.

Abstract: An anchor for a prosthetic heart valve includes a core, a first cover layer, and a second cover layer. The core includes a plurality of helical turns. One or more outflow turns of the plurality of helical turns has a diameter configured to be disposed on an outflow side of a native valve, and one or more inflow turns of the plurality of helical turns has a diameter configured to be disposed on an inflow side of a native valve. The first cover layer is disposed over and contacts the helical core, and the first cover layer includes a first material. The second cover layer is disposed over and contacts the first cover layer, and the second cover layer includes a second material, which is different than the first material.

Abstract: A method of implanting a prosthetic apparatus preferably includes delivering the prosthetic apparatus to a native mitral valve and exposing ventricular anchors and a spacer body of the prosthetic apparatus from a distal end portion of a delivery apparatus. The ventricular anchors are controllably and forcibly expanded outwardly from the spacer body to an expanded configuration. The prosthetic apparatus is positioned relative to the native mitral valve such that native mitral valve leaflets are located between the ventricular anchors and the spacer body. The ventricular anchors are then contracted radially inwardly toward the spacer body to a compressed configuration. In the compressed configuration, the native mitral valve leaflets are secured between the ventricular anchors and the spacer body. After implantation, the spacer body is held between the native mitral valve leaflets, thereby blocking regurgitation and improving the function of the native mitral valve.