Systems, devices and methods related to various heart valve implants and for delivery of those heart valve implants are described. The implants may be used to re-size a native valve annulus or to replace a native heart valve. The implants include a re-sizable frame having angled struts. Anchors secure the implant to tissue and collars are used to decrease the angle between the struts and contract the frame. The implant thus expands from a first size inside of a delivery catheter, to a second and larger deployed size inside the heart to engage and anchor with the tissue, and then to a third and contracted size to re-size the annulus and/or provide a secure fit for a replacement heart valve. Various delivery systems including imaging capabilities for precise delivery, positioning and anchoring of the various implants are further described.

A method of repairing a defective heart valve involves positioning first and second support rings of an annuloplasty device in a first configuration on opposite sides of native heart valve leaflets and activating a contracted state of the annuloplasty device so that a first pitch distance between the first and second support rings in the first configuration is reduced to a second pitch distance that is shorter than the first pitch distance to move the first and second support rings toward each other to pinch the native heart valve leaflets.

A prosthetic heart valve has a plurality of valve leaflets that control directional flow of blood through a heart and a stent structure having a plurality of commissure posts supporting the valve leaflets. The stent structure has a covering over the plurality of commissure posts and has a sewing ring at an inflow end of the stent structure. Each of the plurality of commissure posts has a tip and a suture loop is attached to the covering at a location adjacent to or on the tip of the commissure post. Each suture loop provides a passage for a suture to pass through between the covering and the suture loop.

A side-deliverable prosthetic heart valve includes a valve frame defining an aperture that extends along a central axis and a flow control component mounted within the aperture and configured to permit selective blood flow therethrough. The prosthetic heart valve has a compressed configuration for side-delivery to a heart of a patient via a delivery catheter. The prosthetic heart valve is configured to transition to an expanded configuration when released from the delivery catheter for seating in a native annulus. The valve frame includes distal, proximal, and septal anchoring elements, each of which is insertable through the native annulus prior to seating the prosthetic heart valve therein. The septal anchoring element is configured to extend below the annulus and contact ventricular septal tissue to stabilize the prosthetic heart valve in the annulus when the prosthetic heart valve is seated in the annulus.

Various examples address support structures (e.g., prosthetic valve support structures or frames) that incorporate a frame that, upon transitioning to a deployed configuration, include a proximal section has increased stiffness, or resistance to deformation in a transverse plane to a longitudinal axis of a device, including resistance to a change in shape, size, or both. Such an increase in transverse deformation resistance may be measured as an increase in radial compressive resistance or an increase in flat plate stiffness, for example, or both. Such increases in transverse deformation resistance may be realized through a reduction in length of the increased stiffness region of the support structure, such as through longitudinal compression of the region following an initial radial expansion of the region.

Prosthetic implant systems for diameter adaptation may be provided. The systems may provide for increased flexibility of providing implants having various diameters, and reducing expense associated with keeping a stock of implants at various sizes. Embodiments as disclosed herein may utilize a prosthetic implant having a docking frame that may be configured to expand to a range of working diameters. The docking frame may dock with a valve frame that may be configured to expand to a working diameter that is more closely tailored to the diameter of the implantation site. The valve frame may have a lesser range of expansion of working diameters than the docking frame.

Apparatus and methods are described herein for use in the delivery of a prosthetic mitral valve. In some embodiments, an apparatus includes an epicardial pad configured to engage an outside surface of a heart to secure a prosthetic heart valve in position within the heart. The epicardial pad defines a lumen configured to receive therethrough a tether extending from the prosthetic valve. The epicardial pad is movable between a first configuration in which the epicardial pad has a first outer perimeter and is configured to be disposed within a lumen of a delivery sheath and a second configuration in which the epicardial pad has a second outer perimeter greater than the first outer perimeter. The epicardial pad can be disposed against the outside surface of the heart when in the second configuration to secure the prosthetic valve and tether in a desired position within the heart.

A prosthetic heart valve system includes a collapsible and expandable outer frame extending from an atrial end to a ventricular end, the atrial and ventricular ends coupled by a central portion, the outer frame including a plurality of suture receiving rings formed around a circumference of the ventricular end. The system further includes a collapsible and expandable inner frame positioned radially inward of and coupled to the outer frame. The system further includes a prosthetic valve assembly coupled to, and positioned radially inward of, the inner frame, and a strand extending from a first free end to a second free end. A middle portion of the strand passes through each of the suture receiving rings in a delivery configuration of the prosthetic heart valve system. The first and second free ends are configured to be pulled simultaneously by a user to radially collapse the ventricular end of the outer frame.

A coaxial multilumen annulus plane catheter, including an outer pigtail catheter enclosing one or two additional lumens, each housing either a slidable shaped wire or a second pigtail catheter shaped to fit into a wide range of annulus diameters and/or depths. In embodiments, the device may include a catheter delivery handle with thumb/finger-actuated sliders that extend or retract the shaped wires and are sized to enable side-to-side or radial motion, imparting a torque to the pre-shaped wires which translates the length of the wires to enable individually controlled rotation or sweep of each wire to accommodate different annulus diameters. The delivery handle includes hemostasis controls and flush ports. In other embodiments, a handle is obviated by direct lumen axial and rotational control at a proximal end.

Methods and tools for implanting prosthetic heart valves and modifying leaflets of an existing valvular structure in a subject are disclosed herein. Prior to or during implantation of the prosthetic heart valve within the existing valvular structure, each tool can be provided in the ascending aorta (or equivalent thereof) of a subject and can be used to pierce, lacerate, slice, tear, cut or otherwise modify a leaflet or commissure of the existing valvular structure. The existing valvular structure can be a native aortic valve or other native heart valve, or a previously-implanted prosthetic heart valve. The modification can avoid, or at least reduce the likelihood of, issues that leaflets of the existing valvular structure might otherwise cause once the prosthetic heart valve has been fully installed, for example, obstruction of blood flow to the coronary arteries and/or improper valve mounting due to a non-circular cross-section.