Abstract: Prosthetic heart valve assemblies and methods, apparatus, and systems used to deliver a prosthetic heart valve assembly. A prosthetic heart valve assembly includes an inner frame, a prosthetic leaflet section disposed within the inner frame extending between in inflow row of cells and an outflow row of cells of the inner frame, and an outer support stent. The inner frame is disposed within the outer support stent, and the outer support stent is coupled and/or fastened to the inner frame. The outer support stent includes a plurality leaflet capturing arms for capturing native leaflets between the leaflet capturing arms and a portion of the prosthetic heart valve assembly when the prosthetic heart valve assembly is implanted in a native valve. For example, the native leaflets can be frictionally secured between the leaflet capturing arms of the support stent and the inner frame.

Abstract: A steerable catheter includes a shaft and a pull wire. The shaft includes a proximal portion and a distal portion. The shaft includes an inner layer that defines an inner lumen of the shaft. The shaft comprises an outer layer that defines an outer diameter of the shaft. The shaft comprises a pull-wire lumen between the inner layer and the outer layer. The pull wire extends through the pull-wire lumen. The pull wire has a proximal end portion and a distal end portion. The distal end portion of the pull wire is fixed to the distal portion of the shaft. The proximal end portion of the pull wire extends radially outward of the outer layer. Increasing tension in the pull wire curves the distal portion of the shaft.

Abstract: This application relates to methods, systems, and apparatus for replacing native heart valves with prosthetic heart valves and treating valvular insufficiency. In some implementations, a heart valve leaflet clipping mechanism includes a delivery apparatus and clipping arms. The clipping arms are coupled to the delivery apparatus. The clipping arms are movable between an open position and a closed position. The two clipping arms are biased to the closed position. The delivery apparatus is configured to hold the clipping arms in the open position. The delivery apparatus is configured to allow the clipping arms to move to the closed position to engage native heart valve leaflet tissue.

Abstract: A delivery apparatus includes a steerable guide sheath. The steerable guide sheath has a steerable portion, a pull ring located in the distal portion, and a pull wire coupled at one end to the pull ring and coupled at the opposite end to a control handle. The pull wire extends longitudinally through a pull-wire conduit. The steerable guide sheath further includes a compression-resistance portion made of metal and located in the distal portion.

Abstract: This application relates to methods, systems, and apparatus for replacing native heart valves with prosthetic heart valves and treating valvular insufficiency. In some implementations, a heart valve leaflet clipping mechanism includes a delivery apparatus and clipping arms. The clipping arms are coupled to the delivery apparatus. The clipping arms are movable between an open position and a closed position. The two clipping arms are biased to the closed position. The delivery apparatus is configured to hold the clipping arms in the open position. The delivery apparatus is configured to allow the clipping arms to move to the closed position to engage native heart valve leaflet tissue.

Abstract: Prosthetic heart valve assemblies and methods, apparatus, and systems used to deliver a prosthetic heart valve assembly. A prosthetic heart valve assembly includes an inner frame, a prosthetic leaflet section disposed within the inner frame extending between in inflow row of cells and an outflow row of cells of the inner frame, and an outer support stent. The inner frame is disposed within the outer support stent, and the outer support stent is coupled and/or fastened to the inner frame. The outer support stent includes a plurality leaflet capturing arms for capturing native leaflets between the leaflet capturing arms and a portion of the prosthetic heart valve assembly when the prosthetic heart valve assembly is implanted in a native valve. For example, the native leaflets can be frictionally secured between the leaflet capturing arms of the support stent and the inner frame.

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: Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support structure and an expandable prosthetic valve are advanced through the aortic arch of a patient using a delivery system. The support structure is delivered to a position on or adjacent to the surface of the outflow side of the aortic valve (the support structure defining a support-structure interior). The expandable prosthetic valve is delivered into the aortic valve and into the support-structure interior. The expandable prosthetic heart valve is expanded while the expandable prosthetic heart valve is in the support-structure interior and while the support structure is at the position on or adjacent to the surface of the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the support structure and the expanded prosthetic heart valve.

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: Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve assembly. In embodiments, a prosthetic heart valve assembly, including a self-expandable support structure and a self-expanding heart valve, are advanced through the aortic arch of a patient using a delivery system. The support structure, which includes a plurality leaflet retaining arms, is at least partially expanded and positioned on or adjacent to the outflow side of the aortic valve. The prosthetic heart valve is positioned in the aortic valve. The prosthetic heart valve is expanded while it is within an interior of the support structure and while the support structure is positioned on or adjacent to the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the arms of the support structure and the expanded prosthetic heart valve.

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: Embodiments of the present disclosure include an implantable assembly for a native heart valve that includes a prosthetic heart valve and a braided support structure. The prosthetic valve includes a frame and prosthetic leaflets. The braided support structure has an inner braided layer and an outer braided layer. The outer braided layer is disposed over the inner braided layer. The outer braided layer is less porous to blood than the inner braided layer. The braided support structure defines a plurality of arms that are angularly spaced around the prosthetic heart valve such that each arm extends radially outwardly from the prosthetic heart valve. Other embodiments are also described.

Abstract: This application relates to methods, systems, and apparatus for replacing native heart valves with prosthetic heart valves and treating valvular insufficiency. In some implementations, a heart valve leaflet clipping mechanism includes a delivery apparatus and clipping arms. The clipping arms are coupled to the delivery apparatus. The clipping arms are movable between an open position and a closed position. The two clipping arms are biased to the closed position. The delivery apparatus is configured to hold the clipping arms in the open position. The delivery apparatus is configured to allow the clipping arms to move to the closed position to engage native heart valve leaflet tissue.

Abstract: In a representative embodiment, a method comprises implanting first and second inflatable bodies within an annulus of a native heart valve by securing the inflatable bodies to tissue of the native heart valve with sutures, and implanting a prosthetic heart valve between the inflatable bodies such that the prosthetic heart valve is retained within the annulus by the inflatable bodies.

Abstract: A delivery apparatus includes a steerable guide sheath. The steerable guide sheath has a steerable portion, a pull ring located in the distal portion, and a pull wire coupled at one end to the pull ring and coupled at the opposite end to a control handle. The pull wire extends longitudinally through a pull-wire conduit. The steerable guide sheath further includes a compression-resistance portion made of metal and located in the distal portion.

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: A delivery apparatus includes a steerable shaft having a pull-wire conduit. A pull wire extends through the pull-wire conduit. The steerable shaft includes one or more layers. A compression-resistance portion is incorporated into at least one of the one or more layers. A cross-section of the compression-resistance portion has an arcuate shape that extends along a portion of a cross-section of the steerable shaft. The compression-resistance portion has a hardness that is greater than a hardness of the one or more layers that the compression-resistance portion is incorporated into.

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: Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve assembly. In embodiments, a prosthetic heart valve assembly, including a self-expandable support structure and a self-expanding heart valve, are advanced through the aortic arch of a patient using a delivery system. The support structure, which includes a plurality leaflet retaining arms, is at least partially expanded and positioned on or adjacent to the outflow side of the aortic valve. The prosthetic heart valve is positioned in the aortic valve. The prosthetic heart valve is expanded while it is within an interior of the support structure and while the support structure is positioned on or adjacent to the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the arms of the support structure and the expanded prosthetic heart valve.