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.

Abstract: Systems, and methods for treating valvular regurgitation, prolapse, and other valve problems are described. Some embodiments include occluding and/or obstructing devices that traverse an annulus, some implementations anchor an occluding device via a coil. Some implementations provide systems and methods to bring native leaflets in closer proximity to each other to prevent valvular problems. Some embodiments provide outflow-side solutions that encircle chordae tendineae, while some implementations provide inflow-side solutions via joined tissue anchors that can be cinched together.

Abstract: In one representative embodiment, 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. The spacer body can be configured to extend radially outwardly as the spacer body extends away from the distal end toward the proximal end. A delivery apparatus can have a first shaft and a second shaft, wherein movement of the first shaft relative to the second shaft moves the anchor portion relative to the spacer body.

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 heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve has a base stent that is deployed at a treatment site, and a valve component configured to quickly connect to the base stent. The base stent may take the form of a self- or balloon-expandable stent that expands outward against the native valve with or without leaflet excision. The valve component has a non-expandable prosthetic valve and a self- or balloon-expandable coupling stent for attachment to the base stent, thereby fixing the position of the valve component relative to the base stent. The prosthetic valve may be a commercially available to valve with a sewing ring and the coupling stent attaches to the sewing ring. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment. A catheter-based system and method for deployment is provided.

Abstract: A prosthetic spacer assembly includes a spacer body, a first anchor, and a second anchor. The first anchor and the second anchor each extend from the spacer body. The spacer body is radially compressible and self-expandable. The spacer body is configured for placement between the anterior and posterior native valve leaflets.

Abstract: A system, for use with a leaflet of a valve of a subject's heart, comprises a catheter, a cutting device, a helical needle, and a suture. The catheter is transluminally advanceable toward the heart. The cutting device is advanceable distally out of the catheter, and is adapted to cut through tissue of the leaflet to form cut tissue and cut edges at the cardiac valve. The helical needle defines a helical lumen, the helical needle configured to be advanced distally out of the catheter and to rotationally extend through, and secure together, two tissue segments of the leaflet. The suture extends through the helical lumen of the helical needle. The helical needle and the suture are configured to extend along the two tissue segments of the leaflet to suture the two tissue segments to each other. Other embodiments are also described.

Abstract: An implant includes a frame, and a textile mounted on the frame. The textile includes fibers formed from a mixture of a polymer and an additive molecule. The additive molecule includes a polyurethane backbone and one or more fluorinated end-groups at at least one end of the backbone. Other embodiments are also described.

Abstract: A prosthetic spacer assembly includes a spacer body, a first anchor, and a second anchor. The first anchor and the second anchor are each connected to the spacer body. The first anchor is configured to capture a first native valve leaflet between the first anchor and the spacer body. The second anchor is configured to capture a second native valve leaflet between the second anchor and the spacer body. When inside a delivery sheath, the first anchor and the second anchor can extend distally from the spacer body.

Abstract: In one example, 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. A size of the spacer body is configured to be adjusted after the spacer body is placed between the native valve leaflets and the pair of anchors are placed against the ventricular surfaces of the native heart valve leaflets. A delivery apparatus can have a first shaft and a second shaft, wherein movement of the first shaft relative to the second shaft moves the anchor portion relative to the spacer body.

Abstract: In one representative embodiment, 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. The spacer body can be made from braided, self-expandable metallic thread. A delivery apparatus can have a first shaft and a second shaft, wherein movement of the first shaft relative to the second shaft moves the anchor portion relative to the spacer body.

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.