Abstract: Methods and systems for attaching a radiopaque marker to a prosthetic heart valve to indicate a location of a commissure of the prosthetic heart valve are disclosed. As one example, a prosthetic heart valve can include a frame, a plurality of leaflets arranged within the frame, and at least one commissure comprising an attachment member comprising a central portion and a flap extending outward from the central portion, the flap folded over a radially outward facing side of the central portion, and the attachment member arranged across a selected cell of the frame. The commissure further comprises commissure tabs of two adjacent leaflets coupled to a radially inward facing side of the central portion, and a radiopaque marker arranged on the flap of the attachment member, between the flap and the radially outward facing side of the central portion.

Abstract: A method of treating a deficient native mitral valve of a heart of a patient includes advancing a steerable, first catheter through the patient's vasculature, advancing the distal end portion of the first catheter into the heart to position the distal end portion of the first catheter adjacent the native mitral valve, adjusting the curvature of the distal end portion of the first catheter to form a first curve, advancing a distal end portion of a second catheter from a distal end of the first catheter, wherein the distal end portion of the second catheter is pre-shaped to form a second curve when advanced from the first catheter, and deploying a wire from the second catheter such that the wire extends around native leaflets of the native mitral valve.

Abstract: A prosthetic heart valve holder system includes a prosthetic heart valve having a base at an inflow end, a plurality of commissure posts extending from the base toward an outflow end, and valve leaflets secured to the commissure posts to permit flow through the heart valve. A deflector is provided at the outflow end having a central hub and a plurality of arms extending from the central hub secured to and covering the tips of respective commissure posts. A valve support body is secured to the base and a post connects the valve support body to the hub of the deflector.

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: Packaging for prosthetic heart valves including an assembly for stabilizing dry prosthetic tissue implants such as heart valves during storage. The packaging assembly can be used for storing a bioprosthetic heart valve without a liquid preservative solution. The packaging assembly can have a valve holder configured for removably attaching a bioprosthetic heart valve, a storage tray comprising an open end and a cavity, and a retaining member configured for removably attaching the valve holder. The retaining member can be generally planar and have a slot having a closed end and an open outer end. The valve holder can be configured to be retained at the closed end of the slot in the retaining member.

Abstract: A system that can be used for suturing implants includes a first automated fixture that can comprise an articulation arm and a target device holder and a second automated fixture configured to operate as a sewing machine to sew material onto the implant. The second automated fixture uses a curved needle to form a stitch without having to release the needle in the process. The second automated fixture can also include a stitch looper that moves in coordination with the curved needle to perform a single-suture or single-thread stitch.

Abstract: A replacement heart valve has an expandable frame configured to engage a native valve annulus and a valve body mounted to the expandable frame. The valve body can have a plurality of valve leaflets configured to open to allow flow in a first direction and engage one another so as to close and prevent flow in a second direction, the second direction being opposite the first direction.

Abstract: A prosthetic tricuspid remodeling annuloplasty ring having two free ends that are upturned in the inflow direction to help avoid unnecessary leaflet abrasion. The free ends are desirably separated across a gap that is large enough to reduce the risk of passing sutures through the conductive system of the heart, yet not too large that support of the septal leaflet of the tricuspid annulus is degraded. The tricuspid ring may have four sequential segments looking from the inflow side and extending in a clockwise direction from a free end located adjacent the antero septal commissure after implant. The ring may define an inflow bulge in the first segment and/or an inflow bulge in the fourth segment that help the ring conform to the natural bulges created by the adjacent aorta, thereby reducing stress and the potential for ring dehiscence.

Abstract: Various features and associated advantages are described for diametrically adjustable support structures, adjustable valve structures, removable/replaceable valve structures, and associated systems and methods. Although some examples are directed toward prosthetic valve that is a conduit having a valve structure, or a “valved conduit” (e.g., used to replace a pulmonary valve and a portion of the corresponding pulmonary artery or an aortic valve and the aortic root), and other examples are directed toward prosthetic valves implanted native valve orifices (e.g., to replace an aortic or mitral valve), the features and advantages of the structures associated with those examples are interchangeable regardless of a particular application for which the examples are described.

Abstract: Described embodiments are directed toward prosthetic valves having leaflets of a particular shape that improves bending character without requiring a long length valve. In accordance with an embodiment, a prosthetic valve comprises a leaflet frame, a plurality of leaflets that are coupled to the leaflet frame, where each leaflet has a free edge and a base. The base of each leaflet is truncated in which the leaflet in cross section shows a line in an alpha plane onto the leaflet frame.

Abstract: A delivery system and method for delivering a prosthetic heart valve to the aortic valve annulus via a transaortic approach. The system includes a balloon catheter for delivering a balloon-expandable prosthetic heart valve through an introducer from an approach from outside the patient, through a minimally-invasive opening in the chest cavity through an incision in the aorta, and into the aorta and aortic annulus. The balloon catheter includes a flexible, tapered tip just distal of the balloon to facilitate positioning of the prosthetic heart valve in the proper orientation within the aortic annulus. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.

Abstract: A method for use with a heart of a subject includes advancing a tool distally along a flexible elongate contracting member, toward an anchor implanted at the heart. Tension is applied to the contracting member such that the contracting member slides proximally through a fastener disposed at the heart while a stop coupled to the fastener maintains the fastener in an open state. Using the tool, the stop is pulled proximally (i) away from the fastener, such that the fastener responsively clamps to the contracting member, thereby locking the tension in the contracting member, and (ii) against a cutting element of the tool such that the cutting element moves in a manner that severs the contracting member. Other embodiments are also described.

Abstract: Methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve are provided. For example, a support member is positioned to at least partially surround the native leaflets of a valve. A locking member is used to couple both ends of the support member, forming a support band. An expandable prosthetic heart valve is delivered into the native heart valve and expanded while the expandable prosthetic valve is at least partially within the support band, thereby causing one or more of the native leaflets of the native heart valve to be frictionally secured between the support band and the expanded prosthetic heart valve.

Abstract: A catheter system including a wire, a translatable catheter, and first and second tethers is introduced into a body of a subject. The translatable catheter has a curved portion proximate a distal end of the translatable catheter. The first tether is coupled to the wire, and passes proximally through the translatable catheter. The second tether is attached to the curved portion. The catheter system is positioned such that the wire is disposed at a first location in the body. While the wire remains at the first location, the translatable catheter is translated away from the wire by manipulating the first tether and the second tether. Other embodiments are also described.

Abstract: In one embodiment, a delivery apparatus handle, such as for a mechanical heart valve frame can comprise an actuation knob with a toggle mechanism that can toggle the actuation knob from a first state in which the actuation knob is operable to cause the linear or rotational movement of multiple elements or sets of elements, such as tubes that are attached to, e.g., a mechanical heart valve frame to cause expansion or collapsing of the frame, to a second state in which only a single element or set of elements is moved, allowing for additional operations, such as, e.g., locking the frame and/or releasing it from the delivery apparatus.

Abstract: A first anchor is anchored inside a coronary sinus of a heart of a subject. A second anchor can be driven into a tricuspid annulus of the heart. A distal portion of the second anchor can be disposed adjacent and parallel to a center portion of the second anchor. The second anchor can be seated against a surface of the annulus, for example, such that (i) the distal portion is disposed perpendicular to the center portion, (ii) the center portion extends through the annulus, and (iii) a proximal portion of the second anchor is disposed in the atrium. A distance between the first and second anchors can be reduced by applying tension to a tensioning member coupled to the first anchor and the proximal portion of the second anchor. Other embodiments are also described.

Abstract: A catheter, advanced toward an anatomical site, has a proximal end and a steerable distal end. An anchor is advanced through the catheter. An anchor driver drives the anchor out of the catheter's distal end, anchoring the anchor at the site. A first constraining member engages tissue, and inhibits, after the anchor has been driven out of the catheter and before the anchoring, movement of at least the anchor driver's distal end, on a first axis between the anchor driver's distal end and a site at which the first constraining member engages the tissue. A second constraining member inhibits, after the anchor has been driven out of the catheter and before the anchoring, movement of at least the anchor driver's distal end, on a second axis. Other embodiments are also described.

Abstract: An anchoring system and related methods are provided for treatment of dilated hearts and of functional valve regurgitation, the system comprising one or more self-expandable or manually expandable anchors and associated devices for fixating a valve splint within the heart. For example, a spade-shaped assembly may be configured to be deployed in a right ventricle of the heart and to stabilize a puncturing instrument to puncture the septum. Various puncturing instruments may also be part of the anchoring system, including one or more of a flexible needle having a multiplicity of slits disposed along the length of the needle, a trocar catheter with a retractable head, and a catheter needle having a blunt introducer to protect nearby tissue within the heart during advancing a guidewire. A cutter catheter and puncture location catheter may also be part of the system and be used during treatment.

Abstract: The expandable sheath and methods of use disclosed herein are used to deliver a prosthetic device through a patient's vasculature. The sheath is constructed to be expandable in the circumferential direction, while maintaining sufficient stiffness in the longitudinal direction to withstand pushing and resist kinking. The sheath includes a plurality of curved arms extending outwardly from a longitudinally extending spine. The curved arms move away from the longitudinal axis of the sheath when pushed radially outwardly by a passing prosthetic device, and move back toward the longitudinal axis once the prosthetic device has passed.

Abstract: A handle shaft is disposed at a proximal end of a catheter. A wire extends from a distal part of the catheter, proximally through the catheter to the handle shaft. A knob is disposed outside of the handle shaft. A threaded mechanism provides operative coupling between the knob and the handle shaft such that (i) rotation of the knob with respect to the handle shaft alters tension in the wire via the threaded mechanism functioning as a linear actuator; and (ii) non-rotational axial movement of the knob with respect to the handle shaft alters tension in the wire without the threaded mechanism functioning as a linear actuator. Other embodiments are also described.