Abstract: A prosthetic heart valve includes a frame having a plurality of strut members, an inflow end, and an outflow end. The prosthetic heart valve further includes a leaflet structure situated at least partially within the frame, and a covering disposed around the frame. The covering has a first layer and a second layer, wherein the second layer has a plush surface. The first layer is folded over a circumferential edge portion of the second layer to form a protective portion that extends beyond the strut members in a direction along a longitudinal axis of the prosthetic heart valve.

Abstract: A method of treating mitral valve stenosis in a human heart includes advancing a delivery apparatus through a right femoral vein, across a septal wall, and through a calcified mitral valve. A prosthetic heart valve is provided along a distal end portion of the delivery apparatus, wherein the prosthetic heart valve includes a metallic frame having a plurality of tissue-engaging elements positioned along an exterior surface and a leaflet structure for replacing the function of the calcified mitral valve. The prosthetic heart valve is radially expanded within an annulus of the calcified mitral valve such that at least some of the tissue-engaging elements of the prosthetic heart valve embed into the annulus. After radial expansion, the prosthetic heart valve is retained in position within the annulus via the tissue-engaging element and the leaflet structure replaces the function of the native mitral valve.

Abstract: A prosthetic heart valve includes an annular frame including a plurality of strut members that is radially collapsible and expandable. A leaflet structure is situated within the frame, and includes a plurality of leaflets having opposing commissure tab portions on opposite sides of the leaflet. Each commissure tab portion is paired with an adjacent commissure tab portion of an adjacent leaflet to form one or more commissures. A commissure support element is positioned at each of the commissures, and comprise a first member and a second member that are separable from each other and configured to receive leaflets therebetween. The first and second members are detached from the frame and spaced radially inwardly from the frame such that the members contact the leaflets radially inward from the frame and limit movement of the leaflets so that they articulate at a location that is spaced radially inwardly from the frame.

Abstract: In one embodiment, a prosthetic valve can comprise a radially expandable and compressible frame, which can include a plurality of struts which are pivotally joined together without requiring individual rivets. In some embodiments, the struts are interwoven, and can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In another embodiment, the frame comprises a plurality of inner struts and outer struts which are connected by a plurality of chains of interconnected rivets, avoiding the need to provide individual rivets at each junction between struts. In still another embodiment, separate hinges or flanged rivets are provided to interconnect the struts.

Abstract: Exemplary embodiments of devices and method for affecting at least one anatomical tissue can be provided. A configuration can be provided that includes a structure which is expandable (i) having and/or (ii) forming at least one opening or a working space through which the anatomical tissue(s) is placed in the structure. For example, the structure, prior to being expanding, can have at least one partially rigid portion. In addition, or as an alternative, upon a partial or complete expansion thereof, the structure can be controllable to have a plurality of shapes. Further, the structure can be controllable to provide the working space with multiple shapes and/or multiple sizes.

Abstract: Valvular implants and blood vessel closure devices herein are configured to be positioned in the heart and to block regurgitant blood flow from the heart into blood vessels supplying blood to the heart. The valvular implants can have a cover, a membrane, a valve, a resilient frame, and/or other features. Some valvular implants can have anchors to be positioned in the blood vessels, such as in pulmonary veins, and can anchor the implant to the heart wall. Various embodiments of covers and/or membranes act as valves contracting and expanding, to alternately permit and block blood flow. The valvular implants can cover one or more blood vessels, such as one, two, three, or four pulmonary veins, and can also be configured and implanted to block an appendage to the heart, such as the left atrial appendage.

Abstract: A prosthetic heart valve includes a frame having an inflow end and an outflow end, and defining a longitudinal axis. The prosthetic heart valve further includes a leaflet structure situated at least partially within the frame, and a covering disposed around the frame. The covering includes a first woven portion extending circumferentially around the frame and including a plurality of texturized strands or yarns extending along the longitudinal axis of the frame. The covering further includes a second woven portion extending circumferentially around the frame and spaced apart from the first woven portion along the longitudinal axis of the frame. The texturized strands extend along the longitudinal axis of the frame from the first woven portion to the second woven portion and form a floating portion between the first woven portion and the second woven portion.

Abstract: A prosthetic heart valve is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. The heart valve includes an annular inner frame formed with a plurality of angled first strut members, the inner frame being configured to foreshorten from a first length corresponding to the collapsed configuration to a second length corresponding to the expanded configuration. A leaflet structure is situated at least partially within the inner frame. An outer frame is disposed radially outward of the inner frame and coupled to the inner frame. The outer frame is configured to collapse with the inner frame and radially expand with the inner frame, and includes a plurality of second strut members. Portions of the second strut members are configured to bend radially outwardly into a curved shape as the inner frame and the outer frame move from the collapsed configuration to the expanded configuration.

Abstract: Systems and methods usable in delivering a docking device to a native valve of a patient's heart. A distal region of a delivery catheter can be positioned in an atrium of the heart and a distal tip can be positioned at or near a commissure of the native valve. The docking device can be located within the delivery catheter. A pusher, such as a pusher wire or tube, of a pusher tool can be advanced distally through the delivery catheter, wherein the pusher can push the docking device along within the delivery catheter. The docking device can be connected to the pusher tool by a line, such as a suture. A member of the pusher tool can be rotatable to change the amount of the suture extending from the pusher tool.

Abstract: In one embodiment, a prosthetic valve can comprise a radially expandable and compressible frame, which can include a plurality of struts which are pivotally joined together without requiring individual rivets. In some embodiments, the struts are interwoven, and can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In another embodiment, the frame comprises a plurality of inner struts and outer struts which are connected by a plurality of chains of interconnected rivets, avoiding the need to provide individual rivets at each junction between struts. In still another embodiment, separate hinges or flanged rivets are provided to interconnect the struts.

Abstract: A prosthetic heart valve includes a frame having an inflow end and an outflow end, and defining a longitudinal axis. The prosthetic heart valve further includes a leaflet structure situated at least partially within the frame, and a covering disposed around the frame. The covering includes a first woven portion extending circumferentially around the frame and including a plurality of texturized strands or yarns extending along the longitudinal axis of the frame. The covering further includes a second woven portion extending circumferentially around the frame and spaced apart from the first woven portion along the longitudinal axis of the frame. The texturized strands extend along the longitudinal axis of the frame from the first woven portion to the second woven portion and form a floating portion between the first woven portion and the second woven portion.

Abstract: An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient's chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle.

Abstract: A delivery catheter is in various embodiments configured to deliver an anchoring device to a native valve annulus of a patient's heart, where the anchoring device can better secure a prosthesis at the native annulus. The delivery catheter can includes a distal section that includes one or more spines or is laser cut to assume a particular shape for better facilitating delivery of the anchoring device at the implant site and can include a flexible tube, a first pull wire, and a second pull wire. The flexible tube can comprise a bore extending between the first end and the second end sized for passing the anchoring device therethrough. The distal portion can comprise a first flexing section and a second flexing section. Actuation of the first pull wire and the second pull wire can cause the flexible tube to move from a first configuration to a second configuration.

Abstract: Systems and methods usable in delivering a docking device to a native valve of a patient's heart. A distal region of a delivery catheter can be positioned in an atrium of the heart and a distal tip can be positioned at or near a commissure of the native valve. The docking device can be located within the delivery catheter. A pusher, such as a pusher wire or tube, of a pusher tool can be advanced distally through the delivery catheter, wherein the pusher can push the docking device along within the delivery catheter. The docking device can be connected to the pusher tool by a line, such as a suture. A member of the pusher tool can be rotatable to change the amount of the suture extending from the pusher tool.

Abstract: An implantable prosthetic device can include a frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The frame can have a first set of a plurality of struts extending in a first direction, and a second set of a plurality of struts extending in a second direction, and each strut of the first set of struts can be pivotably connected to at least one strut of the second set of struts. Each strut can be curved helically with respect to a first, longitudinal axis of the frame, and each strut can be curved with respect to a second axis that is perpendicular to the first, longitudinal axis of the frame.

Abstract: An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient's chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle.

Abstract: Docking devices for docking a prosthetic valve at a native valve of a heart can include a coiled docking anchor and a retrieval suture. The docking device and retrieval suture can be configured for improved retention and retrieval of the docking device after deployment. The docking devices can have an end portion with a central axis. The retrieval suture can be connected to the end portion such that a line of force applied by applying tension to the retrieval suture is substantially aligned with the central axis.

Abstract: Methods of implanting docking devices for prosthetic valves at a native heart valve include positioning a distal end of a delivery catheter into a first chamber of a heart, advancing a tubular body of a docking device from within the delivery catheter so that the distal end of the tubular body is advanced between native valve leaflets and positioned in a second chamber of the heart. The methods further include inserting a coil into a lumen of the docking device so that the tubular body adopts a configuration, releasing a proximal end of the docking device in the first chamber, inserting a replacement valve in an inner space of the docking device, and radially expanding the replacement valve until there is a retention force between the replacement valve and the docking device to hold the replacement valve in a stable position in the native valve.

Abstract: An assembly can comprise a radially expandable and compressible annular frame, at least one linear actuator assembly coupled to the frame and at least one locking mechanism coupled to the frame. The linear actuator can be configured to apply a distally directed force and/or a proximally directed force to the frame to radially expand or compress the frame. The locking mechanism can comprise a first sleeve member connected to the frame at a first location, a second sleeve member having internal threads and being connected to the frame at a second location, and a first screw configured to engage the internal threads of the second sleeve member to retain the frame in a radially expanded state.

Abstract: Exemplary embodiments of devices and method for affecting at least one anatomical tissue can be provided. A configuration can be provided that includes a structure which is expandable (i) having and/or (ii) forming at least one opening or a working space through which the anatomical tissue(s) is placed in the structure. For example, the structure, prior to being expanding, can have at least one partially rigid portion. In addition, or as an alternative, upon a partial or complete expansion thereof, the structure can be controllable to have a plurality of shapes. Further, the structure can be controllable to provide the working space with multiple shapes and/or multiple sizes.