Abstract: Systems and methods are provided for positioning an intravascular device. A sensing device includes a plurality of nodes disposed on a distal portion of the sensing device. The distal portion of the sensing device is inserted into a circumflex artery. A plurality of node locations of the plurality of nodes are determined in a coordinate system when the distal portion of the sensing device is inserted into the circumflex artery. A projected plane of a mitral annulus is determined in the coordinate system based on the plurality of node locations. A projected deployment point for the intravascular device is determined in the coordinate system based on the plurality of node locations.

Abstract: The present disclosure describes devices, systems, and methods for intravascularly delivering an intravascular device to a targeted cardiac valve.

Abstract: A prosthetic heart valve includes an inner frame having a longitudinal axis, a plurality of prosthetic leaflets coupled to the inner frame, the plurality of prosthetic leaflets configured to allow blood to flow through the inner frame in an antegrade direction along the longitudinal axis and to substantially block blood from flowing through the inner frame in a retrograde direction along the longitudinal axis, an outer frame connected to the inner frame, and a sealing feature coupled to the inner frame at a coupling point and extending partially, but not completely, between the coupling point and a point of the outer frame that is radially outward of the coupling point in a direction substantially orthogonal to the longitudinal axis, and wherein in an implanted condition, the sealing feature is positioned such that backpressure from ventricular systole acts on the sealing feature.

Abstract: The present invention comprises a novel and safer mechanism of deployment using a self-positioning, self-centering, and self-anchoring method. To embody the present invention, a disk-based valve apparatus allowing the repositioning and retrieval of the implantable valve while working on a dysfunctional valve structure is disclosed. The disk-based valve apparatus may comprise one or more disks, either proximal or distal, a valve-housing component and a valve component. The one or more disks may be either proximal or distal, may be either connected to each other or disconnected from each other and may either be symmetrical or have different shapes and dimensions. The disk-based valve apparatus may be self anchoring, such as anchored by pressure from the one or more disk, or may be anchored using any anchoring.

Abstract: A system for heart valve repair includes a collapsible and expandable replacement heart valve and a delivery device for implanting the implanting the valve. The delivery device includes a base unit positioned at a proximal end of the delivery device, an outer catheter extending from the base unit, a first inner catheter positioned within the outer catheter, a second inner catheter positioned within the first inner catheter, a mandrel positioned within the second inner catheter, and a nosecone adapted to be couple to the second inner catheter.

Abstract: A prosthetic valve delivery device includes a handle and a delivery catheter. The delivery catheter includes a central elongate member extending from the handle and a proximal sheath configured to slide over and relative to the central elongate member. The proximal sheath is connected to a hollow helical strand, and the hollow helical strand is configured to rotate to retract the proximal sheath and expose at least a portion of the prosthetic valve.

Abstract: A medical device delivery system includes a steering catheter including a first steering ring having a plurality of apertures positioned in the wall of the first steering ring. The plurality of apertures are positioned at spaced distances around a circumference of the first steering ring. A first steering cable passes through a first one of the apertures, and a first return cable passes through a second one of the apertures. A second steering cable passes through a third one of the apertures, and a second return cable passes through a fourth one of the apertures. The first steering cable is positioned about 180 degrees from the second steering cable. A handle is operably coupled to a proximal end of the steering catheter. A first control member controls the first steering and first return cable, and a second control member controls the second steering and second return cable.

Abstract: A steerable catheter has a body with an outer surface and an inner surface defining a central lumen. The outer surface and inner surface define a wall of the body, which has a plurality of steering lumen and control lumen extending longitudinally therethrough. The body includes a body material. The steering lumen and control lumen have a control lumen lining and steering lumen lining, respectively, with a higher durometer than the body material. A steering wire is positioned within the steering lumen and a control wire is positioned within the control lumen.

Abstract: A delivery device includes a central elongate structure including an annular member at the distal end, a sheath, a plurality of tethers extending through the central elongate structure, a handle, and a control on the handle. The handle is connected to the elongate structure, the sheath, and the plurality of tethers. The control is configured to move the sheath proximally and distally over the central elongate structure. The annular member includes a plurality of pockets extending radially therearound. Each tether includes a feature on a distal end thereof configured to fit within a pocket of the plurality of pockets to hold the tethers in place.

Abstract: The present disclosure describes devices, systems, and methods for intravascularly delivering an implantable device to a targeted anatomical site such as the mitral annulus. A delivery system includes a delivery member coupled to a handle assembly and extending distally from the handle assembly. A delivery catheter is concentrically positioned within an outer member and configured to advance the intravascular device relative to the outer member. The delivery catheter includes a distal can structure configured to house at least a portion of the intravascular device in a compressed, pre-deployed position.

Abstract: The present disclosure describes devices, systems, and methods for loading, delivering, positioning, and deploying an artificial heart valve device at the mitral annulus. A delivery system includes a delivery member coupled to a handle assembly and extending distally from the handle assembly. The valve device is attached at the distal end of the delivery member, and is constrained within a valve cover of an outer sheath. A delivery catheter is configured to advance the valve relative to the outer sheath, and a suture catheter includes sutures/tethers which maintain proximal tension on the valve prior to deployment.

Abstract: The present disclosure provides replacement heart valves that include an outer frame, an inner frame, and arms extending therebetween. The outer frame and inner frame may be formed by a plurality of cells, such as diamond shaped cells. The arms may extend from an apex of a diamond shaped cell on the inner frame and be fastened to an apex where adjacent cells of the outer frame adjoin. The arms may include one or more bends. For example, the arms may extend in a first direction for a predefined length, have a bend point, and then extend in a second direction opposite the first. The arms may isolate the inner frame from the outer frame such that forces exerted on the outer frame are absorbed by the arms and do not deform the inner frame.

Abstract: A tubular instrument includes a tubular assembly having first and second handling tubes extending from a proximal operating area to a distal functional area, a radially self-expanding wire structure, and a holding device. The first and second handling tubes are rotatable relative to each other. A control interface is provided at the proximal operating area for the relative rotational motion actuation of the first and second handling tubes. The holding device includes a first connecting unit and a second connecting unit. The first connecting unit includes a first filament connecting unit having a first connecting filament fixed to a first structural connection interface of the wire structure and to a tube connection interface of the first handling tube and extends therebetween with a radial directional component, and which winds onto or unwinds from the first handling tube upon rotation of the first and second handling tubes.

Abstract: A system for heart valve repair includes a packaging assembly for storing the replacement heart valve. The packaging assembly includes a valve support having a base for holding the replacement heart valve, a ring positioned within the valve support and configured to fit around a circumference of the replacement heart valve, and a retention mechanism. The retention mechanism includes a cap and plurality of sutures configured to be attached to the cap and to the replacement heart. The packaging assembly having a locked configuration in which the ring and the valve support are locked together and the sutures tension the replacement heart valve. The packaging assembly is designed to hold and transport a replacement heart valve and fits within a shipment jar.

Abstract: An intravascular device delivery system has an elongated member with a flexible hypotube. The hypotube can be rotationally keyed to a steerable catheter. The flexible hypotube includes one or more cuts to allow bending of the flexible hypotube within a first plane. The steerable catheter is steerable to bend the flexible hypotube within the first plane, and longitudinally movable relative to the flexible hypotube to allow distal movement of the steerable catheter relative to a distal end of the flexible hypotube.

Abstract: Systems and methods for delivery a medical device to a heart valve annulus are disclosed. A method of delivering a medical device to a heart valve annulus includes: (1) aligning a first imaging sensor such that a view of the first imaging sensor is along a primary plane of the heart valve annulus; (2) aligning a second imaging sensor such that a view of the second imaging sensor is along a longitudinal axis of the heart valve annulus; (3) attaching a delivery system holding the medical device to a delivery arm; (4) adjusting the delivery arm to set an angle of the delivery system perpendicular to the primary plane using images from the first imaging sensor; (5) adjusting the delivery arm to center the delivery device in the heart valve annulus using images from the second imaging sensor; and (6) deploying the medical device into the heart valve annulus.

Abstract: A method for sealing and flushing a delivery member includes sealing one or more lumens and flushing air from the one or more lumens. An interventional device delivery system includes a handle assembly and a delivery member. The handle assembly includes a catheter holder with a passageway therethrough. A flush block is associated with the catheter holder and has a flush port and a flush chamber. The delivery member is associated with the handle assembly and includes a plurality of catheters. At least one of the catheters has a proximal end disposed within the passageway in the catheter holder and is in fluid communication with the flush chamber.

Abstract: A prosthetic mitral valve includes an anchor assembly, a strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The ventricular anchor and the atrial anchor are configured to flare radially outwards relative to the central portion. The annular strut frame is disposed radially within the anchor assembly and is attached to the anchor assembly. The central portion is configured to align with a native valve orifice and the ventricular anchor and the atrial anchor are configured to compress native cardiac tissue therebetween.

Abstract: A prosthetic mitral valve includes an anchor assembly, an annular strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The annular strut frame is disposed radially within the anchor assembly. An atrial end of the annular strut frame is attached to the anchor assembly such that a ventricular end of the annular strut frame is spaced away from the anchor assembly.

Abstract: A suture rigging assembly for use with a prosthetic heart valve delivery device includes a coupling ring having a plurality of apertures, and at least one tether coupled to the apertures of the coupling ring and extending distally therefrom. Each tether is formed by two lengths of suture thread, the lengths of suture thread joined together at a position spaced from the coupling ring, and a second joining of the lengths of suture thread forming an attachment loop at the distal end of the tether. The first connection in the tethers collectively define the shortest and longest lengths of each of the tethers, and the attachment loops provide a mechanism to releasably attach the tethers to a prosthetic heart valve. Optionally, knots can be used to join the tethers and one or more tethers may include a radiopaque marker secured thereon between two knots.