Abstract: The present invention relates to implantable prosthetic devices, and more particularly, to 3D-shaped skirts having various coatings and/or configurations thereof.

Abstract: In one embodiment, a method of assembling a prosthetic valve can comprise forming a radially expandable and compressible frame by pivotally joining together a plurality of struts without requiring individual rivets. In some embodiments, the frame is formed by interweaving the struts, which 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 other embodiments, separate hinges are provided to interconnect the struts. In still other embodiments, separate flanged rivets are provided to connect the struts.

Abstract: A delivery apparatus for an expandable prosthetic heart valve includes a handle, and a shaft having a proximal end portion coupled to the handle and a distal end portion including a delivery capsule. The delivery capsule having an inner surface, an outer surface, and a plurality of elongate and axially extending inner and outer guide rails, the inner guide rails being spaced apart circumferentially around and extending radially inwardly from the inner surface and the outer guide rails being spaced apart circumferentially around and extending radially outwardly from the outer surface. The inner guide rails are configured to engage the prosthetic heart valve in a radially-compressed configuration and the outer guide rails are configured to contact an inner surface of an outer shaft.

Abstract: A method for improving leaflet prolapse and/or valve regurgitation associated with a heart valve involves delivering a spacer device into a ventricle of a heart using a delivery system comprising a catheter, fixing the spacer device to a wall of the ventricle, expanding the spacer device to reposition a papillary muscle disposed in the ventricle away from the wall, the papillary muscle being connected to a leaflet of an atrioventricular heart valve via chordae tendineae, and releasing the spacer device from the catheter.

Abstract: In one embodiment, a method of assembling a prosthetic valve can comprise forming a radially expandable and compressible frame by pivotally joining together a plurality of struts without requiring individual rivets. In some embodiments, the frame is formed by interweaving the struts, which 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 other embodiments, separate hinges are provided to interconnect the struts. In still other embodiments, separate flanged rivets are provided to connect the struts.

Abstract: Disclosed herein is a storage container for an expandable prosthetic heart valve that crimps the valve upon opening the container and removal of the valve from the container. The container includes a housing sized to receive the heart valve in its expanded configuration and a crimping mechanism. The crimping mechanism is incorporated into the container and engages the heart valve so as to operably convert the heart valve from its expanded configuration to its smaller crimped configuration upon opening the container and removing the valve.

Abstract: Disclosed herein is a method of crimping a prosthetic heart valve using a compact crimping mechanism. The crimping mechanism includes a plurality of jaws configured for coordinated inward movement toward a crimping axis to reduce the size of a crimping iris around a stented valve. A rotating cam wheel acts on the jaws and displaces them inward. An actuation mechanism includes a lead screw, carriage assembly and a linkage to rotate the cam wheel with significant torque.

Abstract: A transcatheter delivery system including an expandable transition element is disclosed. As one example, an assembly may comprise a prosthetic valve and a delivery device. The delivery device may comprise an outer shaft with a distal end portion forming a sheath adapted to enclose the prosthetic valve therein in a radially compressed configuration; an inner shaft arranged within the outer shaft and including a nosecone arranged at a distal end of the inner shaft, the nosecone arranged outside of the outer shaft, at the distal end portion of the outer shaft; and an expandable transition element adapted to expand from a non-expanded state within the outer shaft to an expanded state outside the outer shaft, wherein, in the expanded state, the transition element forms a continuous transition from the nosecone to the prosthetic valve when the sheath is moved away from the nosecone to uncover the prosthetic valve.

Abstract: Disclosed herein is a storage container for an expandable prosthetic heart valve that crimps the valve upon opening the container and removal of the valve from the container. The container includes a housing sized to receive the heart valve in its expanded configuration and a crimping mechanism. The crimping mechanism is incorporated into the container and engages the heart valve so as to operably convert the heart valve from its expanded configuration to its smaller crimped configuration upon opening the container and removing the valve.

Abstract: Disclosed herein is a method of crimping a prosthetic heart valve using a compact crimping mechanism. The crimping mechanism includes a plurality of jaws configured for coordinated inward movement toward a crimping axis to reduce the size of a crimping iris around a stented valve. A rotating cam wheel acts on the jaws and displaces them inward. An actuation mechanism includes a lead screw, carriage assembly and a linkage to rotate the cam wheel with significant torque.

Abstract: Disclosed herein is a method of crimping a prosthetic heart valve using a compact crimping mechanism. The crimping mechanism includes a plurality of jaws configured for coordinated inward movement toward a crimping axis to reduce the size of a crimping iris around a stented valve. A rotating cam wheel acts on the jaws and displaces them inward. A number of Cartesian guide elements cooperate with the jaws to distribute forces within the crimping mechanism. The guide elements are located between the crimping jaws and an outer housing and are constrained by the outer housing for movement along lines that are tangential to a circle centered on the crimping axis. The guide elements engage at least some of the crimping jaws while the rest are in meshing engagement so as to move in synch. An actuation mechanism includes a lead screw, carriage assembly and a linkage to rotate the cam wheel with significant torque.

Abstract: The present invention relates to devices, assemblies and methods for monitoring radial expansion of a prosthetic valve during prosthetic valve implantation procedures.

Abstract: A delivery apparatus for implanting a prosthetic valve includes a handle, a first shaft, a plurality of actuation shafts, and a control mechanism. The first shaft has one or more lumens extending from the first end portion to the second end portion. The actuation shafts each have a proximal end portion and a distal end portion, and the actuation shafts extend through the one or more lumens of the first shaft. The control mechanism is coupled to the actuation shafts and to the handle. The control mechanism is configured such that the actuation shafts can move axially relative to each other in a first operational mode and such that the actuation shafts can be moved axially simultaneously in a second operational mode. Additionally or alternatively, the first shaft can include a plurality of helical lumens configured for receiving the actuation shafts.

Abstract: An assembly can comprise a prosthetic valve comprising a radially expandable and compressible frame and a rotatable screw connected to the frame, where the screw comprises a screw head having an annular bore with internal threads, and where the screw is rotatable to radially expand the frame. The assembly further comprises a delivery apparatus releasably coupled to the screw, the delivery apparatus comprising a first shaft and a first head disposed at an end of the first shaft, the first head comprising external threads configured to engage with the internal threads of the screw head, and a second shaft that is coaxial with and surrounds the first shaft, the second shaft comprising a second head disposed at an end of the second shaft. The second head is configured to releasably engage with an exterior surface of the screw head and rotate the screw.

Abstract: The present invention relates to devices and methods for measuring physiological parameters, such as flow, pressure, temperature, electric conductivity and/or visual indication of thrombus formation or deposits accumulations, prior to, during and/or after prosthetic heart valve implantation procedures.

Abstract: A prosthetic valve having a frame, a leaflet structure having leaflets forming a primary valve mounted inside the frame, and at least one secondary valve is disclosed. The secondary valve can have a valve element with stationary portion and a detached portion, and at least one aperture in at least one leaflet. The secondary valve can be formed by a portion of at least one leaflet.

Abstract: An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration includes an annular frame including a plurality of angled strut members, a plurality of leaflets disposed within the frame and secured to the frame, and a skirt member secured to the frame. The skirt member is disposed about an edge portion of a leaflet of the plurality of leaflets, and the skirt member includes a plurality of extension portions wrapped around at least one strut member. A cord member is threaded through at least a portion of the plurality of extension portions in a direction along an axis of the at least one strut member to secure the skirt member to the at least one strut member.

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: A medical assembly can include a radially expandable prosthetic heart valve and a delivery apparatus. The delivery apparatus can include a handle, an actuation member, and a force limiting mechanism within the handle including a pivot arm coupled to a base portion. The actuation member can apply a proximally directed force to the prosthetic valve to cause the valve to expand. The actuation member can be coupled to the pivot arm such that a force applied to the actuation member causes the pivot arm to pivot. The force limiting mechanism can pinch the actuation member between the pivot arm and the base portion when the force applied to the actuation member exceeds a predetermined force to prevent proximal movement of the actuation member and can allow proximal movement of the actuation member to produce radial expansion of the prosthetic valve when the force applied is less than the predetermined force.

Abstract: Docking stations for transcatheter valves are described. The docking stations can include an expandable frame, at least one sealing portion, and a valve seat. The expandable frame can be configured to conform to an interior shape of a portion of the circulatory system when expanded inside the circulatory system. The sealing portion can be configured to contact an interior surface of the circulatory system to create a seal. The valve seat can be connected to the expandable frame and can be configured to support an expandable transcatheter valve. The docking stations are adaptable to different anatomies/locations to allow implantation of a transcatheter valve in a variety of anatomies/locations.